montelukast 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
leukotriene receptor antagonists 1836 158966-92-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • montelukast
  • montelukast sodium
  • singulair
Montelukast is an orally active compound that binds with high affinity and selectivity to the CysLT1 receptor (in preference to other pharmacologically important airway receptors, such as the prostanoid, cholinergic, or beta-adrenergic receptor). Montelukast inhibits physiologic actions of cysteinyl leukotriene LTD4 at the CysLT1 receptor without any agonist activity.
  • Molecular weight: 586.19
  • Formula: C35H36ClNO3S
  • CLOGP: 8.33
  • LIPINSKI: 2
  • HAC: 4
  • HDO: 2
  • TPSA: 70.42
  • ALOGS: -7.85
  • ROTB: 12
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.20 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.28 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 62 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.15 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.68 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.00 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Feb. 20, 1998 FDA MERCK

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 5205.44 10.20 3913 208958 123648 63152503
Wheezing 2171.69 10.20 2098 210773 93497 63182654
Eosinophilic granulomatosis with polyangiitis 1307.18 10.20 425 212446 1767 63274384
Obstructive airways disorder 988.16 10.20 700 212171 19999 63256152
Cough 935.30 10.20 2615 210256 290128 62986023
Dyspnoea 926.28 10.20 4516 208355 656797 62619354
Sleep disorder due to a general medical condition 726.60 10.20 473 212398 11715 63264436
Sputum discoloured 703.05 10.20 519 212352 15828 63260323
Full blood count abnormal 664.77 10.20 667 212204 31050 63245101
Productive cough 618.93 10.20 903 211968 62305 63213846
Pemphigus 587.82 10.20 5 212866 183721 63092430
Chest discomfort 586.41 10.20 1200 211671 108769 63167382
Forced expiratory volume decreased 541.13 10.20 285 212586 4683 63271468
Synovitis 500.35 10.20 32 212839 186886 63089265
Hand deformity 497.95 10.20 7 212864 159450 63116701
Systemic lupus erythematosus 447.80 10.20 80 212791 208838 63067313
Glossodynia 441.53 10.20 44 212827 178832 63097319
Rhinitis allergic 432.99 10.20 340 212531 11387 63264764
Urticaria 415.93 10.20 1362 211509 164440 63111711
Arthropathy 384.55 10.20 153 212718 234639 63041512
Toxicity to various agents 378.16 10.20 178 212693 247072 63029079
Bronchitis 363.74 10.20 1081 211790 123854 63152297
Nasal congestion 362.24 10.20 727 212144 64933 63211218
Pericarditis 353.62 10.20 22 212849 131557 63144594
Contraindicated product administered 352.86 10.20 144 212727 217504 63058647
Nasal polyps 351.69 10.20 231 212640 5808 63270343
Sinusitis 340.94 10.20 1584 211287 225069 63051082
Impaired quality of life 339.82 10.20 317 212554 13466 63262685
Upper respiratory tract infection 336.19 10.20 806 212065 81241 63194910
Drug intolerance 314.25 10.20 343 212528 308318 62967833
Chronic obstructive pulmonary disease 310.48 10.20 664 212207 62022 63214129
Treatment failure 303.18 10.20 144 212727 198899 63077252
Joint swelling 297.67 10.20 398 212473 327268 62948883
Food allergy 294.22 10.20 269 212602 11132 63265019
Wound 286.51 10.20 95 212776 163168 63112983
Alopecia 280.98 10.20 436 212435 337100 62939051
Gastrooesophageal reflux disease 279.68 10.20 829 212042 94810 63181341
Blood immunoglobulin E increased 270.98 10.20 166 212705 3683 63272468
Rheumatoid factor positive 262.15 10.20 4 212867 84402 63191749
Therapeutic product effect decreased 257.64 10.20 165 212706 193022 63083129
Helicobacter infection 257.03 10.20 13 212858 92772 63183379
Off label use 254.63 10.20 1281 211590 673181 62602970
Sleep apnoea syndrome 253.38 10.20 394 212477 28739 63247412
Pneumonia 251.96 10.20 2486 210385 454281 62821870
Middle insomnia 248.65 10.20 257 212614 12386 63263765
Asthmatic crisis 244.03 10.20 120 212751 1693 63274458
Seasonal allergy 240.19 10.20 323 212548 20627 63255524
Maternal exposure during pregnancy 230.01 10.20 239 212632 219823 63056328
Breath sounds abnormal 228.43 10.20 230 212641 10743 63265408
Polycystic ovaries 226.80 10.20 157 212714 4314 63271837
Upper-airway cough syndrome 218.98 10.20 229 212642 11189 63264962
Nightmare 218.64 10.20 295 212576 18899 63257252
Dermatitis atopic 217.58 10.20 212 212659 9512 63266639
Temperature regulation disorder 216.10 10.20 173 212698 5959 63270192
Therapeutic product effect incomplete 214.21 10.20 909 211962 124147 63152004
Respiratory tract infection 214.16 10.20 447 212424 41036 63235115
Infusion related reaction 214.02 10.20 307 212564 245214 63030937
Eosinophil count increased 212.86 10.20 221 212650 10707 63265444
Anaphylactic reaction 211.60 10.20 592 212279 65508 63210643
Dyspnoea exertional 210.95 10.20 558 212313 59744 63216407
Abdominal discomfort 205.29 10.20 485 212386 320400 62955751
Muscle injury 203.33 10.20 3 212868 65342 63210809
Neutropenia 201.66 10.20 174 212697 174831 63101320
Folliculitis 200.82 10.20 8 212863 70309 63205842
Influenza 193.78 10.20 800 212071 107922 63168229
Product dose omission issue 189.59 10.20 1390 211481 232923 63043228
Acute kidney injury 186.72 10.20 376 212495 263039 63013112
Sensitisation 186.24 10.20 125 212746 3261 63272890
Completed suicide 177.56 10.20 137 212734 145536 63130615
Impaired healing 175.79 10.20 62 212809 102480 63173671
Rhinorrhoea 173.49 10.20 549 212322 65028 63211123
Loss of personal independence in daily activities 171.10 10.20 713 212158 96577 63179574
Stomatitis 170.95 10.20 129 212742 138596 63137555
Secretion discharge 169.19 10.20 207 212664 12024 63264127
Blood test abnormal 168.63 10.20 234 212637 15395 63260756
General physical health deterioration 162.79 10.20 265 212606 201137 63075014
Malignant neoplasm progression 154.50 10.20 42 212829 82079 63194072
Coeliac disease 150.82 10.20 200 212671 12597 63263554
Pancytopenia 149.23 10.20 69 212802 96864 63179287
Product quality issue 147.52 10.20 353 212518 35512 63240639
Infective pulmonary exacerbation of cystic fibrosis 146.60 10.20 164 212707 8653 63267498
Eczema 145.05 10.20 329 212542 31962 63244189
Anaemia 144.61 10.20 502 212369 292928 62983223
Ejection fraction 142.45 10.20 93 212778 2313 63273838
Eosinophilia 140.08 10.20 264 212607 22492 63253659
Blister 135.52 10.20 141 212730 129673 63146478
Suicidal ideation 133.76 10.20 487 212384 61934 63214217
Swelling 133.74 10.20 474 212397 274904 63001247
Bronchospasm 132.87 10.20 221 212650 17059 63259092
Drug interaction 131.25 10.20 366 212505 228765 63047386
Vital capacity decreased 130.60 10.20 78 212793 1650 63274501
Death 130.21 10.20 730 212141 373651 62902500
Rheumatic fever 129.97 10.20 3 212868 43108 63233043
Pulmonary function test abnormal 129.02 10.20 79 212792 1751 63274400
Reversible airways obstruction 128.54 10.20 79 212792 1763 63274388
Drug abuse 125.74 10.20 43 212828 72475 63203676
Rhinitis 125.36 10.20 172 212699 11194 63264957
Intentional product use issue 124.62 10.20 147 212724 127745 63148406
Illness 123.65 10.20 404 212467 48655 63227496
Musculoskeletal stiffness 123.62 10.20 272 212599 184346 63091805
Disease progression 122.97 10.20 138 212733 122620 63153531
Total lung capacity increased 121.62 10.20 83 212788 2227 63273924
Febrile neutropenia 121.02 10.20 131 212740 118318 63157833
Sneezing 120.50 10.20 218 212653 18000 63258151
C-reactive protein abnormal 120.01 10.20 9 212862 46087 63230064
Liver injury 119.53 10.20 28 212843 60492 63215659
Rheumatoid arthritis 118.54 10.20 444 212427 253375 63022776
Oropharyngeal pain 117.38 10.20 626 212245 93861 63182290
Discomfort 116.72 10.20 241 212630 167133 63109018
Headache 114.68 10.20 2854 210017 630387 62645764
Dysphonia 113.68 10.20 385 212486 47229 63228922
Aggression 112.95 10.20 246 212625 23252 63252899
Thrombocytopenia 112.00 10.20 210 212661 150947 63125204
Throat clearing 111.23 10.20 80 212791 2339 63273812
C-reactive protein increased 110.46 10.20 93 212778 94614 63181537
Respiratory tract congestion 109.91 10.20 207 212664 17625 63258526
Neuropsychiatric symptoms 109.55 10.20 53 212818 720 63275431
Drug ineffective 109.08 10.20 2672 210199 1042093 62234058
Nasal oedema 108.06 10.20 66 212805 1456 63274695
Bronchial secretion retention 108.01 10.20 83 212788 2690 63273461
Sputum increased 107.79 10.20 79 212792 2380 63273771
Anxiety 107.56 10.20 1159 211712 216382 63059769
Pruritus 107.43 10.20 1755 211116 359698 62916453
Sinus disorder 105.68 10.20 246 212625 24307 63251844
Confusional state 105.54 10.20 421 212450 235959 63040192
Eye pruritus 104.41 10.20 208 212663 18463 63257688
Hyponatraemia 103.36 10.20 134 212737 111766 63164385
Multiple allergies 102.76 10.20 174 212697 13628 63262523
Perfume sensitivity 101.59 10.20 51 212820 754 63275397
Peak expiratory flow rate decreased 101.00 10.20 47 212824 582 63275569
Rales 99.79 10.20 164 212707 12533 63263618
Lung hyperinflation 99.29 10.20 59 212812 1236 63274915
Immunodeficiency 98.44 10.20 213 212658 20041 63256110
Sleep disorder due to general medical condition, insomnia type 97.66 10.20 27 212844 52190 63223961
Irritable bowel syndrome 97.25 10.20 80 212791 82332 63193819
Gastrointestinal disorder 95.75 10.20 184 212687 131055 63145096
Hepatic enzyme increased 94.38 10.20 354 212517 201974 63074177
Heart rate increased 93.34 10.20 588 212283 93650 63182501
Angioedema 92.63 10.20 362 212509 47603 63228548
Status asthmaticus 90.40 10.20 49 212822 855 63275296
Sensitivity to weather change 89.77 10.20 116 212755 7121 63269030
Hypotension 89.10 10.20 542 212329 272062 63004089
Multiple organ dysfunction syndrome 87.95 10.20 40 212831 56712 63219439
Asthma-chronic obstructive pulmonary disease overlap syndrome 87.61 10.20 65 212806 1996 63274155
Forced vital capacity decreased 87.57 10.20 51 212820 1028 63275123
Dust allergy 87.08 10.20 44 212827 660 63275491
Mucosal inflammation 86.40 10.20 25 212846 46903 63229248
Ear pruritus 86.01 10.20 85 212786 3880 63272271
Sleep terror 84.76 10.20 71 212800 2609 63273542
Diarrhoea 82.37 10.20 1801 211070 713565 62562586
Leukopenia 81.72 10.20 83 212788 77207 63198944
Intentional overdose 81.44 10.20 77 212794 74075 63202076
Rash erythematous 81.41 10.20 320 212551 42190 63233961
Chronic spontaneous urticaria 79.16 10.20 49 212822 1108 63275043
Abnormal behaviour 78.72 10.20 202 212669 21224 63254927
Respiratory rate increased 78.67 10.20 154 212717 13494 63262657
Respiration abnormal 78.26 10.20 102 212769 6315 63269836
Pulmonary mass 76.86 10.20 207 212664 22389 63253762
Rhonchi 76.86 10.20 66 212805 2510 63273641
Renal impairment 76.36 10.20 111 212760 88244 63187907
Carpal tunnel syndrome 75.18 10.20 195 212676 20622 63255529
Emphysema 75.04 10.20 133 212738 10805 63265346
Allergy to animal 73.37 10.20 48 212823 1198 63274953
Respiratory symptom 73.06 10.20 72 212799 3275 63272876
Sinus congestion 73.04 10.20 177 212694 17946 63258205
Toxic epidermal necrolysis 71.93 10.20 3 212868 25331 63250820
Sputum culture positive 71.84 10.20 59 212812 2108 63274043
COVID-19 71.72 10.20 635 212236 112468 63163683
Red blood cell sedimentation rate increased 71.34 10.20 29 212842 43953 63232198
Mobility decreased 71.20 10.20 191 212680 120968 63155183
Septic shock 71.07 10.20 71 212800 66558 63209593
Restrictive pulmonary disease 70.51 10.20 54 212817 1741 63274410
Throat tightness 69.16 10.20 212 212659 24675 63251476
Bronchiectasis 68.67 10.20 161 212710 15981 63260170
Pulmonary function test decreased 68.35 10.20 75 212796 3872 63272279
Bradycardia 68.32 10.20 87 212784 73140 63203011
Nasal obstruction 67.83 10.20 52 212819 1679 63274472
Sinusitis fungal 67.39 10.20 53 212818 1778 63274373
Hypokalaemia 66.14 10.20 157 212714 103647 63172504
Chronic sinusitis 65.80 10.20 138 212733 12705 63263446
Hip arthroplasty 65.79 10.20 39 212832 47607 63228544
Poor quality device used 65.77 10.20 55 212816 2016 63274135
Bronchial obstruction 65.12 10.20 48 212823 1459 63274692
Bronchial disorder 64.73 10.20 45 212826 1245 63274906
Nasal discharge discolouration 63.36 10.20 56 212815 2215 63273936
Depressed level of consciousness 63.00 10.20 69 212802 62009 63214142
Crying 62.23 10.20 196 212675 23147 63253004
Coma 61.59 10.20 75 212796 64289 63211862
Asthma exercise induced 61.32 10.20 27 212844 291 63275860
Haemoglobin decreased 61.22 10.20 265 212606 145220 63130931
Bone marrow failure 61.00 10.20 12 212859 29278 63246873
Vocal cord dysfunction 60.79 10.20 32 212839 525 63275626
Throat irritation 59.30 10.20 267 212604 37380 63238771
Factor V Leiden mutation 59.18 10.20 24 212847 207 63275944
Live birth 58.96 10.20 8 212863 25622 63250529
Blood pressure systolic increased 58.81 10.20 314 212557 47083 63229068
Insomnia 58.65 10.20 1031 211840 214221 63061930
Abnormal dreams 58.61 10.20 117 212754 10399 63265752
Bronchial neoplasm 58.21 10.20 30 212841 470 63275681
Urticaria chronic 58.16 10.20 33 212838 632 63275519
Ejection fraction abnormal 57.92 10.20 48 212823 1737 63274414
Cystic fibrosis 57.72 10.20 63 212808 3233 63272918
Hyper IgE syndrome 57.65 10.20 30 212841 480 63275671
Therapy non-responder 57.48 10.20 104 212767 75797 63200354
Infusion site erythema 56.96 10.20 123 212748 11556 63264595
Inflammation 56.86 10.20 119 212752 82154 63193997
Blood pressure increased 56.52 10.20 809 212062 161253 63114898
Nasal turbinate hypertrophy 56.52 10.20 34 212837 729 63275422
Infusion site swelling 54.81 10.20 109 212762 9661 63266490
Burning sensation 54.80 10.20 341 212530 54066 63222085
Salpingo-oophorectomy unilateral 54.48 10.20 35 212836 846 63275305
Product use issue 54.36 10.20 475 212396 220045 63056106
Liver disorder 54.12 10.20 60 212811 53627 63222524
Nephrectomy 54.11 10.20 43 212828 1465 63274686
Haemoptysis 54.00 10.20 215 212656 28511 63247640
Arthralgia 53.76 10.20 1477 211394 568233 62707918
Bronchial haemorrhage 53.46 10.20 30 212841 562 63275589
Alanine aminotransferase increased 53.43 10.20 174 212697 103596 63172555
Blood cholesterol increased 53.18 10.20 151 212720 93881 63182270
Mood altered 53.13 10.20 138 212733 14605 63261546
Viral infection 52.53 10.20 248 212623 35415 63240736
Malaise 52.26 10.20 1792 211079 414162 62861989
Decreased appetite 52.09 10.20 564 212307 250488 63025663
Bronchopulmonary aspergillosis allergic 51.96 10.20 50 212821 2208 63273943
Poor quality sleep 51.87 10.20 166 212705 19769 63256382
Humidity intolerance 51.84 10.20 25 212846 337 63275814
Metabolic acidosis 51.63 10.20 45 212826 45024 63231127
Infusion site pruritus 51.60 10.20 81 212790 5954 63270197
Ascites 51.26 10.20 37 212834 40691 63235460
Hyperkalaemia 50.97 10.20 64 212807 54139 63222012
Depression 50.64 10.20 933 211938 195559 63080592
Frustration tolerance decreased 50.57 10.20 87 212784 6901 63269250
Migraine 50.25 10.20 549 212322 102797 63173354
Platelet count decreased 49.77 10.20 210 212661 115912 63160239
Sepsis 49.68 10.20 305 212566 152818 63123333
Body tinea 49.66 10.20 45 212826 1840 63274311
Total lung capacity decreased 49.60 10.20 48 212823 2135 63274016
Anger 49.49 10.20 121 212750 12335 63263816
Sarcoidosis 49.37 10.20 87 212784 7035 63269116
Aspirin-exacerbated respiratory disease 49.12 10.20 33 212838 862 63275289
Lacrimation increased 48.51 10.20 166 212705 20465 63255686
Hereditary angioedema 48.12 10.20 89 212782 7473 63268678
Respiratory disorder 47.86 10.20 258 212613 38824 63237327
Idiopathic intracranial hypertension 47.84 10.20 54 212817 2877 63273274
Prolonged expiration 47.56 10.20 35 212836 1061 63275090
Nasopharyngitis 47.26 10.20 1151 211720 253106 63023045
Knee arthroplasty 46.93 10.20 68 212803 54138 63222013
Aphonia 46.83 10.20 104 212767 9959 63266192
Psoriatic arthropathy 46.74 10.20 154 212717 91366 63184785
Drug tolerance decreased 46.68 10.20 3 212868 17470 63258681
Ear infection 46.62 10.20 252 212619 37961 63238190
Scratch 46.55 10.20 81 212790 6484 63269667
Inappropriate schedule of product administration 46.35 10.20 543 212328 103422 63172729
Sopor 46.32 10.20 9 212862 22155 63253996
Infusion site pain 46.22 10.20 143 212728 16726 63259425
Neoplasm progression 45.97 10.20 33 212838 36395 63239756
Smoke sensitivity 45.88 10.20 25 212846 441 63275710
Cardio-respiratory arrest 45.53 10.20 82 212789 59877 63216274
Feeling abnormal 45.24 10.20 724 212147 147668 63128483
Metastases to bone 45.08 10.20 8 212863 21011 63255140
Bone erosion 44.62 10.20 4 212867 17713 63258438
Mast cell activation syndrome 44.28 10.20 30 212841 795 63275356
Fluid retention 44.16 10.20 347 212524 59339 63216812
Cardiac failure 44.16 10.20 152 212719 88990 63187161
Inhibitory drug interaction 43.98 10.20 51 212820 2798 63273353
Hypoventilation 43.72 10.20 66 212805 4688 63271463
FEV1/FVC ratio decreased 42.82 10.20 16 212855 108 63276043
Metastases to liver 42.77 10.20 13 212858 23626 63252525
Cardiac disorder 42.44 10.20 304 212567 50512 63225639
Skin plaque 42.16 10.20 89 212782 8231 63267920
White blood cell count decreased 41.59 10.20 284 212587 138820 63137331
Glucose tolerance impaired 41.34 10.20 77 212794 6500 63269651
Bursitis 41.03 10.20 238 212633 36803 63239348
Palmar-plantar erythrodysaesthesia syndrome 41.02 10.20 13 212858 23002 63253149
Aspartate aminotransferase increased 40.73 10.20 160 212711 90117 63186034
Increased bronchial secretion 40.44 10.20 39 212832 1727 63274424
Oral allergy syndrome 40.37 10.20 13 212858 52 63276099
Creatinine renal clearance decreased 40.22 10.20 4 212867 16304 63259847
Agranulocytosis 40.07 10.20 17 212854 25117 63251034
Neurotoxicity 39.81 10.20 5 212866 16985 63259166
Lung opacity 39.64 10.20 51 212820 3117 63273034
Atopy 39.54 10.20 19 212852 254 63275897
Tic 39.48 10.20 36 212835 1484 63274667
Lactic acidosis 39.46 10.20 42 212829 38245 63237906
Delirium 39.39 10.20 68 212803 50473 63225678
Cytomegalovirus infection 38.86 10.20 11 212860 20941 63255210
Cardiac murmur 38.61 10.20 122 212749 14430 63261721
Erythema 38.05 10.20 813 212058 174938 63101213
Mastocytosis 38.03 10.20 24 212847 562 63275589
Bronchial wall thickening 37.95 10.20 35 212836 1464 63274687
Endometrial ablation 37.86 10.20 29 212842 935 63275216
Mite allergy 37.83 10.20 25 212846 635 63275516
Product use in unapproved indication 37.68 10.20 825 212046 178255 63097896
Respiratory tract inflammation 37.36 10.20 24 212847 580 63275571
Cholecystitis chronic 37.35 10.20 97 212774 10264 63265887
Mood swings 37.09 10.20 140 212731 18108 63258043
Swelling face 36.98 10.20 350 212521 63125 63213026
Hepatocellular injury 36.98 10.20 23 212848 27358 63248793
Infusion site extravasation 36.96 10.20 97 212774 10329 63265822
Infection susceptibility increased 36.91 10.20 52 212819 3469 63272682
Cholestasis 36.71 10.20 27 212844 29407 63246744
Eosinophilic pneumonia 36.54 10.20 41 212830 2170 63273981
Gastrointestinal haemorrhage 36.54 10.20 144 212727 81032 63195119
Joint range of motion decreased 36.39 10.20 33 212838 32395 63243756
Cardiac arrest 36.27 10.20 173 212698 92372 63183779
Prescribed underdose 36.04 10.20 28 212843 29661 63246490
Encephalopathy 35.90 10.20 46 212825 38574 63237577
Lipohypertrophy 35.26 10.20 24 212847 641 63275510
Pain 35.24 10.20 2079 210792 738549 62537602
Embolism venous 35.19 10.20 48 212823 3106 63273045
Infusion site haemorrhage 35.09 10.20 62 212809 5024 63271127
Heart sounds 34.88 10.20 28 212843 968 63275183
Peripheral swelling 34.76 10.20 655 212216 265287 63010864
Neutrophil count decreased 34.59 10.20 87 212784 56319 63219832
Dehydration 34.13 10.20 394 212477 172960 63103191
Bronchitis chronic 33.90 10.20 56 212815 4297 63271854
Hypomagnesaemia 33.76 10.20 28 212843 28709 63247442
Sleep disorder 33.72 10.20 420 212451 81146 63195005
Acute myeloid leukaemia 33.72 10.20 8 212863 17139 63259012
Eosinophil count abnormal 33.04 10.20 22 212849 566 63275585
Pulmonary pain 32.88 10.20 49 212822 3441 63272710
Affective disorder 32.61 10.20 67 212804 6079 63270072
Spirometry abnormal 32.58 10.20 16 212855 225 63275926
Skin ulcer 32.57 10.20 59 212812 42986 63233165
Hypocalcaemia 32.45 10.20 35 212836 31678 63244473
Infection 32.29 10.20 557 212314 228616 63047535
Stress 32.27 10.20 356 212515 66811 63209340
Occupational asthma 32.20 10.20 14 212857 146 63276005
Chest X-ray abnormal 32.09 10.20 56 212815 4493 63271658
Colitis 32.03 10.20 72 212799 48456 63227695
Neutropenic sepsis 31.68 10.20 8 212863 16430 63259721
Biliary dyskinesia 31.16 10.20 42 212829 2687 63273464
Interstitial lung disease 31.04 10.20 105 212766 61803 63214348
Condition aggravated 30.94 10.20 1071 211800 401146 62875005
Rhabdomyolysis 30.84 10.20 63 212808 43888 63232263
Drug level increased 30.84 10.20 19 212852 22717 63253434
Orthostatic hypotension 30.67 10.20 46 212825 36114 63240037
Pneumothorax spontaneous 30.39 10.20 24 212847 810 63275341
Irritability 30.27 10.20 196 212675 31498 63244653
Psoriasis 30.25 10.20 434 212437 86523 63189628
Circulatory collapse 30.23 10.20 18 212853 21920 63254231
Respiratory gas exchange disorder 30.17 10.20 18 212853 380 63275771
Blood creatinine increased 30.05 10.20 172 212699 87672 63188479
Oxygen saturation decreased 29.98 10.20 440 212431 88145 63188006
Renal disorder 29.73 10.20 201 212670 32773 63243378
Rash 29.64 10.20 1558 211313 559313 62716838
Renal failure 29.59 10.20 252 212619 117400 63158751
Blood creatine phosphokinase increased 29.59 10.20 35 212836 30395 63245756
Osteonecrosis of jaw 29.49 10.20 45 212826 35078 63241073
Premature delivery 29.26 10.20 35 212836 30246 63245905
Lymphocyte count decreased 29.21 10.20 35 212836 30222 63245929
Dysphemia 28.78 10.20 40 212831 2635 63273516
Anuria 28.67 10.20 4 212867 12547 63263604
Disseminated intravascular coagulation 28.63 10.20 14 212857 19037 63257114
Rash maculo-papular 28.61 10.20 39 212832 31857 63244294
Pharyngeal oedema 28.49 10.20 106 212765 13615 63262536
Blood lactic acid increased 28.33 10.20 69 212802 7017 63269134
Gamma-glutamyltransferase increased 28.19 10.20 44 212827 33987 63242164
Infusion site bruising 28.12 10.20 48 212823 3784 63272367
Hypothyroidism 27.85 10.20 241 212630 42391 63233760
Lip swelling 27.79 10.20 189 212682 30874 63245277
Ankle fracture 27.64 10.20 126 212745 17729 63258422
Facet joint syndrome 27.42 10.20 4 212867 12134 63264017
Hysterectomy 27.40 10.20 82 212789 9417 63266734
Neurosensory hypoacusis 27.36 10.20 14 212857 216 63275935
Quality of life decreased 27.32 10.20 78 212793 8725 63267426
Increased viscosity of bronchial secretion 27.28 10.20 16 212855 327 63275824
Vomiting 27.25 10.20 1567 211304 558050 62718101
Product dose omission in error 27.17 10.20 71 212800 7541 63268610
Laryngeal stenosis 26.96 10.20 25 212846 1053 63275098
Mononeuropathy multiplex 26.92 10.20 15 212856 277 63275874
Hepatic failure 26.86 10.20 49 212822 35607 63240544
Pharyngeal swelling 26.29 10.20 63 212808 6341 63269810
Hypercapnia 26.26 10.20 57 212814 5374 63270777
Pharyngitis streptococcal 26.09 10.20 87 212784 10585 63265566
Progressive multifocal leukoencephalopathy 25.61 10.20 6 212865 12965 63263186
Ear discomfort 25.46 10.20 71 212800 7835 63268316
Injection site pain 25.42 10.20 592 212279 129208 63146943
Joint stiffness 25.35 10.20 65 212806 41804 63234347
Lung diffusion test decreased 25.25 10.20 20 212851 678 63275473
Acute respiratory distress syndrome 25.18 10.20 25 212846 23509 63252642
Upper airway obstruction 25.12 10.20 20 212851 683 63275468
Night sweats 25.01 10.20 82 212789 48732 63227419
Ill-defined disorder 24.88 10.20 166 212705 81589 63194562
Hepatic function abnormal 24.60 10.20 55 212816 37087 63239064
Bronchospasm paradoxical 24.48 10.20 10 212861 88 63276063
Swollen tongue 24.47 10.20 200 212671 34600 63241551
Mycotic allergy 24.45 10.20 23 212848 987 63275164
Spinal operation 24.43 10.20 72 212799 8199 63267952
Blood pressure fluctuation 24.29 10.20 77 212794 46240 63229911
Influenza like illness 24.24 10.20 336 212535 66488 63209663
Hiatus hernia 24.07 10.20 139 212732 21455 63254696
Nocturnal fear 24.07 10.20 6 212865 6 63276145
Oropharyngeal discomfort 24.07 10.20 54 212817 5206 63270945
Frequent bowel movements 24.01 10.20 25 212846 22997 63253154
Cognitive disorder 23.87 10.20 101 212770 55714 63220437
Conjunctivitis allergic 23.86 10.20 22 212849 920 63275231
Lung disorder 23.79 10.20 316 212555 61945 63214206
Incorrect dose administered 23.60 10.20 306 212565 59662 63216489
Chest pain 23.30 10.20 915 211956 215044 63061107
Increased upper airway secretion 23.09 10.20 43 212828 3629 63272522
Foot deformity 23.08 10.20 36 212835 27817 63248334
Neuroleptic malignant syndrome 22.98 10.20 6 212865 12050 63264101
Appetite disorder 22.85 10.20 65 212806 7256 63268895
Thinking abnormal 22.75 10.20 83 212788 10560 63265591
Drug resistance 22.71 10.20 26 212845 22907 63253244
Airway remodelling 22.57 10.20 9 212862 74 63276077
Tenosynovitis 22.52 10.20 9 212862 13786 63262365
Anosmia 22.48 10.20 62 212809 6798 63269353
Pregnancy 22.44 10.20 57 212814 36779 63239372
Overweight 22.44 10.20 43 212828 3708 63272443
Muscle spasticity 22.36 10.20 24 212847 21770 63254381
Separation anxiety disorder 22.35 10.20 7 212864 25 63276126
Metastases to central nervous system 22.32 10.20 8 212863 13097 63263054
Inappropriate antidiuretic hormone secretion 22.29 10.20 12 212859 15450 63260701
Ligament pain 22.26 10.20 12 212859 207 63275944
Sedation 22.17 10.20 62 212809 38747 63237404
Blood alkaline phosphatase increased 22.14 10.20 72 212799 42895 63233256
CFTR gene mutation 22.07 10.20 10 212861 116 63276035
Infusion site urticaria 22.05 10.20 27 212844 1569 63274582
Drug eruption 22 10.20 39 212832 28655 63247496
Myalgia 21.92 10.20 645 212226 145884 63130267
Cerebral infarction 21.65 10.20 29 212842 23864 63252287
Nasal inflammation 21.54 10.20 16 212855 492 63275659
Bacteraemia 21.52 10.20 16 212855 17332 63258819
Skin necrosis 21.35 10.20 10 212861 13940 63262211
Torsade de pointes 21.33 10.20 9 212862 13342 63262809
Hypercalcaemia 21.26 10.20 39 212832 28283 63247868
Depressed mood 21.16 10.20 217 212654 39974 63236177
Somnambulism 21.13 10.20 53 212818 5490 63270661
Panniculitis 21.07 10.20 6 212865 11379 63264772
Lower respiratory tract congestion 20.98 10.20 36 212835 2850 63273301
Drug reaction with eosinophilia and systemic symptoms 20.89 10.20 52 212819 33784 63242367
Pre-existing condition improved 20.86 10.20 68 212803 8176 63267975
Skin lesion 20.77 10.20 175 212696 30546 63245605
Anaphylactic shock 20.67 10.20 143 212728 23490 63252661
Expiratory reserve volume decreased 20.65 10.20 7 212864 34 63276117
Foetal exposure during pregnancy 20.62 10.20 48 212823 31914 63244237
Hepatotoxicity 20.55 10.20 60 212811 36981 63239170
Colitis ulcerative 20.42 10.20 35 212836 26056 63250095
Choking sensation 20.36 10.20 40 212831 3514 63272637
Rhinitis perennial 20.32 10.20 7 212864 36 63276115
Serotonin syndrome 20.22 10.20 41 212830 28641 63247510
Major depression 20.17 10.20 66 212805 7952 63268199
Acute hepatic failure 20.15 10.20 19 212852 18308 63257843
Oesophageal dilatation 20.15 10.20 14 212857 387 63275764
Obstruction 20.14 10.20 37 212834 3090 63273061
Exposure to allergen 20.14 10.20 13 212858 317 63275834
Paranasal sinus discomfort 20.11 10.20 45 212826 4331 63271820
Musculoskeletal pain 20.04 10.20 205 212666 92072 63184079
Educational problem 19.99 10.20 14 212857 392 63275759
Hyperhidrosis 19.94 10.20 488 212383 107348 63168803
Dyspnoea at rest 19.94 10.20 43 212828 4036 63272115
Pneumonia aspiration 19.86 10.20 55 212816 34485 63241666
Hospitalisation 19.84 10.20 398 212473 84683 63191468
Muscle tension dysphonia 19.75 10.20 11 212860 203 63275948
Epilepsy 19.67 10.20 38 212833 27027 63249124
Atrial fibrillation 19.62 10.20 274 212597 116362 63159789
Ligament sprain 19.57 10.20 90 212781 12710 63263441
Product container issue 19.57 10.20 27 212844 1766 63274385
Ulcer 19.55 10.20 36 212835 26071 63250080
Nephropathy toxic 19.49 10.20 4 212867 9475 63266676
Pleural effusion 19.46 10.20 209 212662 93001 63183150
Exposure during pregnancy 19.42 10.20 386 212485 155161 63120990
Eosinophilic oesophagitis 19.40 10.20 13 212858 338 63275813
Eosinophilic pneumonia acute 19.38 10.20 14 212857 412 63275739
Cytokine release syndrome 19.36 10.20 12 212859 14302 63261849
Ischaemic stroke 19.30 10.20 19 212852 17938 63258213
Injection site movement impairment 19.25 10.20 6 212865 21 63276130
Product substitution issue 19.18 10.20 105 212766 15891 63260260
Self-injurious ideation 19.11 10.20 33 212838 2626 63273525
Electrocardiogram QT prolonged 19.07 10.20 119 212752 59411 63216740
Body temperature decreased 19.00 10.20 125 212746 20194 63255957
Blood immunoglobulin E decreased 18.96 10.20 8 212863 77 63276074
Airway peak pressure increased 18.94 10.20 12 212859 283 63275868
Liver function test abnormal 18.91 10.20 90 212781 48091 63228060
Candida infection 18.90 10.20 161 212710 28190 63247961
Tuberculosis 18.83 10.20 7 212864 11204 63264947
Allergy test positive 18.73 10.20 16 212855 604 63275547
Adrenal suppression 18.56 10.20 19 212852 905 63275246
Upper limb fracture 18.54 10.20 118 212753 18850 63257301
Ear swelling 18.52 10.20 24 212847 1477 63274674
Sinus polyp degeneration 18.52 10.20 7 212864 49 63276102
Accidental overdose 18.49 10.20 31 212840 23278 63252873
Sinus operation 18.46 10.20 32 212839 2554 63273597
Cold urticaria 18.30 10.20 9 212862 127 63276024
Cytopenia 18.25 10.20 8 212863 11593 63264558
Eye swelling 18.21 10.20 140 212731 23778 63252373
Fungal infection 17.96 10.20 196 212675 36678 63239473
Functional residual capacity increased 17.95 10.20 8 212863 89 63276062
Hypoglycaemia 17.76 10.20 123 212748 59942 63216209
Emotional distress 17.74 10.20 177 212694 32372 63243779
Lactose intolerance 17.65 10.20 34 212837 2944 63273207
Vasculitis 17.63 10.20 113 212758 18096 63258055
Speech disorder 17.56 10.20 211 212660 40418 63235733
Bronchial hyperreactivity 17.49 10.20 25 212846 1690 63274461
Peritonitis 17.47 10.20 19 212852 17135 63259016
Weight decreased 17.39 10.20 1113 211758 275685 63000466
Diverticulum 17.37 10.20 83 212788 11908 63264243
Hypoalbuminaemia 17.25 10.20 9 212862 11796 63264355
Sputum culture 17.23 10.20 11 212860 263 63275888
Paranoia 17.04 10.20 81 212790 11598 63264553
Altered state of consciousness 17.00 10.20 37 212834 25193 63250958
Premature baby 16.99 10.20 27 212844 20708 63255443
Injection site scab 16.92 10.20 13 212858 421 63275730
Eye paraesthesia 16.92 10.20 9 212862 151 63276000
Insurance issue 16.87 10.20 52 212819 6069 63270082
Lymphopenia 16.86 10.20 22 212849 18305 63257846
Blood calcium decreased 16.84 10.20 40 212831 26411 63249740
Metastases to lung 16.82 10.20 11 212860 12739 63263412
Acute sinusitis 16.78 10.20 39 212832 3848 63272303
Vocal cord disorder 16.77 10.20 22 212849 1371 63274780
Gluten sensitivity 16.72 10.20 15 212856 605 63275546
Subarachnoid haemorrhage 16.67 10.20 14 212857 14269 63261882
Haematochezia 16.65 10.20 108 212763 53436 63222715
Blood parathyroid hormone decreased 16.63 10.20 6 212865 9785 63266366
Forced expiratory volume 16.63 10.20 5 212866 15 63276136
Diabetic ketoacidosis 16.52 10.20 27 212844 20478 63255673
Immunisation reaction 16.52 10.20 15 212856 615 63275536
Respiratory tract irritation 16.48 10.20 13 212858 438 63275713
Stevens-Johnson syndrome 16.48 10.20 37 212834 24913 63251238
Grip strength decreased 16.46 10.20 31 212840 22256 63253895
Pneumococcal infection 16.38 10.20 13 212858 442 63275709
Breast cancer metastatic 16.36 10.20 10 212861 12008 63264143
Onychophagia 16.36 10.20 7 212864 70 63276081
Melaena 16.26 10.20 50 212821 30315 63245836
Pulmonary thrombosis 16.25 10.20 65 212806 8637 63267514
Bronchial irritation 16.16 10.20 5 212866 17 63276134
Palpitations 15.95 10.20 493 212378 112277 63163874
Nodular vasculitis 15.94 10.20 5 212866 18 63276133
Oxygen consumption decreased 15.93 10.20 10 212861 232 63275919
Snoring 15.83 10.20 40 212831 4162 63271989
Posterior reversible encephalopathy syndrome 15.77 10.20 21 212850 17324 63258827
Sinus headache 15.75 10.20 48 212823 5568 63270583
Pulmonary toxicity 15.72 10.20 6 212865 9449 63266702
Attention deficit hyperactivity disorder 15.70 10.20 33 212838 3043 63273108
Mouth swelling 15.69 10.20 43 212828 4697 63271454
Haemophagocytic lymphohistiocytosis 15.68 10.20 8 212863 10619 63265532
Forced expiratory volume abnormal 15.62 10.20 7 212864 79 63276072
Allergic sinusitis 15.53 10.20 19 212852 1103 63275048
Cortisol decreased 15.52 10.20 20 212851 1224 63274927
Sinus polyp 15.51 10.20 12 212859 393 63275758
Acute generalised exanthematous pustulosis 15.44 10.20 9 212862 11090 63265061
Depressive symptom 15.40 10.20 39 212832 4063 63272088
Product availability issue 15.29 10.20 39 212832 4082 63272069
Drug-induced liver injury 15.28 10.20 76 212795 40146 63236005
Neurogenic shock 15.25 10.20 11 212860 323 63275828
Nervousness 15.24 10.20 165 212706 30814 63245337
Unresponsive to stimuli 15.20 10.20 60 212811 33756 63242395
Diastolic dysfunction 15.15 10.20 52 212819 6419 63269732
Acute myocardial infarction 15.09 10.20 56 212815 32068 63244083
Device expulsion 15.05 10.20 63 212808 34859 63241292
Hypothermia 15.03 10.20 14 212857 13567 63262584
SARS-CoV-2 test positive 14.90 10.20 60 212811 7996 63268155
Forced expiratory flow decreased 14.88 10.20 7 212864 89 63276062
Miller Fisher syndrome 14.88 10.20 7 212864 89 63276062
Intentional dose omission 14.82 10.20 60 212811 8015 63268136
Lip dry 14.82 10.20 18 212853 15452 63260699
Coagulopathy 14.80 10.20 29 212842 20515 63255636
Laryngitis fungal 14.79 10.20 8 212863 139 63276012
Otorrhoea 14.71 10.20 21 212850 1418 63274733
Proteinuria 14.70 10.20 26 212845 19119 63257032
Blood lactate dehydrogenase increased 14.69 10.20 35 212836 23081 63253070
Low birth weight baby 14.68 10.20 3 212868 7126 63269025
Oral pruritus 14.62 10.20 27 212844 2264 63273887
Osteomyelitis 14.54 10.20 42 212829 25978 63250173
Hepatic encephalopathy 14.53 10.20 10 212861 11272 63264879
Medication error 14.52 10.20 109 212762 52175 63223976
Nausea 14.44 10.20 2584 210287 851887 62424264
Temperature intolerance 14.43 10.20 64 212807 8900 63267251
Sedation complication 14.43 10.20 15 212856 13807 63262344
Jaundice 14.40 10.20 50 212821 29201 63246950
Basal cell carcinoma 14.35 10.20 47 212824 27944 63248207
Hallucination 14.34 10.20 261 212610 54556 63221595
Body temperature abnormal 14.23 10.20 25 212846 2016 63274135
Pulmonary function challenge test abnormal 14.10 10.20 3 212868 0 63276151
Glomus tumour 14.10 10.20 3 212868 0 63276151
Sleep study abnormal 14.10 10.20 3 212868 0 63276151
Cardiogenic shock 14.09 10.20 24 212847 17908 63258243
Administration site erythema 14.06 10.20 15 212856 750 63275401
PCO2 increased 14.04 10.20 19 212852 1220 63274931
Product taste abnormal 14.01 10.20 25 212846 2042 63274109
Clostridium difficile colitis 14.00 10.20 30 212841 20539 63255612
Infusion site mass 14.00 10.20 25 212846 2043 63274108
Product contamination physical 13.91 10.20 7 212864 104 63276047
Pneumocystis jirovecii pneumonia 13.88 10.20 22 212849 16892 63259259
Macular degeneration 13.88 10.20 39 212832 24337 63251814
Sinus bradycardia 13.87 10.20 17 212854 14534 63261617
Respiratory tract infection viral 13.82 10.20 26 212845 2211 63273940
Uveitis 13.82 10.20 13 212858 12540 63263611
International normalised ratio increased 13.76 10.20 95 212776 46330 63229821
Blood calcium increased 13.75 10.20 65 212806 9285 63266866
Alice in wonderland syndrome 13.74 10.20 5 212866 31 63276120
Bipolar disorder 13.71 10.20 58 212813 7902 63268249
Left ventricular dysfunction 13.69 10.20 12 212859 11976 63264175
Squamous cell carcinoma of the oral cavity 13.62 10.20 10 212861 302 63275849
Myelodysplastic syndrome 13.55 10.20 22 212849 16732 63259419
Sciatica 13.54 10.20 64 212807 34260 63241891
Lip discolouration 13.42 10.20 13 212858 579 63275572
Product packaging confusion 13.40 10.20 8 212863 169 63275982
Respiratory arrest 13.39 10.20 60 212811 32585 63243566
Miosis 13.38 10.20 4 212867 7349 63268802
Infusion site rash 13.36 10.20 24 212847 1970 63274181
Injection site hypoaesthesia 13.36 10.20 12 212859 485 63275666
Pneumonia respiratory syncytial viral 13.29 10.20 17 212854 1033 63275118
Lung diffusion disorder 13.29 10.20 6 212865 69 63276082
Vaccination complication 13.26 10.20 18 212853 1159 63274992
Upper gastrointestinal haemorrhage 13.25 10.20 27 212844 18825 63257326
Sputum retention 13.23 10.20 13 212858 589 63275562
Mandibular mass 13.20 10.20 8 212863 174 63275977
Atrioventricular block first degree 13.16 10.20 4 212867 7269 63268882
Mucosal discolouration 13.13 10.20 12 212859 496 63275655
Distal intestinal obstruction syndrome 13.07 10.20 11 212860 407 63275744
Hepatic cirrhosis 13.05 10.20 41 212830 24693 63251458
Blood urea increased 13.04 10.20 45 212826 26334 63249817
Female sterilisation 13.00 10.20 13 212858 602 63275549
Aplastic anaemia 12.97 10.20 8 212863 9561 63266590
Stress urinary incontinence 12.88 10.20 26 212845 2329 63273822
Female reproductive neoplasm 12.88 10.20 5 212866 38 63276113
Cold agglutinins positive 12.88 10.20 5 212866 38 63276113
Weight increased 12.82 10.20 1028 211843 259764 63016387
Injection site urticaria 12.81 10.20 86 212785 13987 63262164
Incorrect route of product administration 12.80 10.20 48 212823 27404 63248747
Neoplasm malignant 12.79 10.20 54 212817 29807 63246344
Body mass index increased 12.76 10.20 18 212853 1202 63274949
Therapeutic response unexpected 12.75 10.20 107 212764 18652 63257499
Disease recurrence 12.75 10.20 147 212724 27883 63248268
Nocturnal dyspnoea 12.72 10.20 18 212853 1206 63274945
Decubitus ulcer 12.67 10.20 10 212861 10510 63265641
Vaccination site swelling 12.65 10.20 5 212866 40 63276111
Product appearance confusion 12.65 10.20 5 212866 40 63276111
Eczema impetiginous 12.62 10.20 4 212867 15 63276136
Functional residual capacity decreased 12.57 10.20 6 212865 79 63276072
Neuropsychiatric syndrome 12.55 10.20 5 212866 41 63276110
Cholelithiasis 12.51 10.20 212 212659 43713 63232438
Hyperventilation 12.49 10.20 47 212824 6069 63270082
Back pain 12.47 10.20 1038 211833 263107 63013044
Malnutrition 12.46 10.20 20 212851 15278 63260873
Hyperlipidaemia 12.45 10.20 110 212761 19461 63256690
Inhalation therapy 12.44 10.20 5 212866 42 63276109
Hypertensive crisis 12.43 10.20 20 212851 15266 63260885
Pulmonary eosinophilia 12.43 10.20 10 212861 347 63275804
Rectal haemorrhage 12.33 10.20 105 212766 48925 63227226
Glossitis 12.31 10.20 30 212841 3052 63273099
Nasal septum deviation 12.29 10.20 20 212851 1516 63274635
Renal tubular necrosis 12.27 10.20 13 212858 11865 63264286
Device delivery system issue 12.27 10.20 14 212857 755 63275396
Abnormal weight gain 12.23 10.20 22 212849 1808 63274343
Injection site pruritus 12.22 10.20 216 212655 44900 63231251
Skin sensitisation 12.22 10.20 15 212856 874 63275277
Neuropathy peripheral 12.18 10.20 289 212582 113378 63162773
Painful respiration 12.16 10.20 28 212843 2746 63273405
Femur fracture 12.10 10.20 86 212785 41670 63234481
Breast cancer stage I 12.09 10.20 4 212867 6885 63269266
Dyslipidaemia 12.07 10.20 53 212818 7340 63268811
Oropharyngitis fungal 12.05 10.20 5 212866 46 63276105
Muscular weakness 12.05 10.20 315 212556 122038 63154113
Platelet adhesiveness decreased 12.04 10.20 3 212868 3 63276148
Defiant behaviour 12.04 10.20 3 212868 3 63276148
Accident 12.03 10.20 46 212825 5986 63270165
Asthenia 12.00 10.20 1115 211756 382489 62893662
Tubulointerstitial nephritis 11.97 10.20 31 212840 19872 63256279
Cephalo-pelvic disproportion 11.94 10.20 8 212863 208 63275943
Poisoning deliberate 11.91 10.20 12 212859 11206 63264945
Flushing 11.91 10.20 333 212538 74754 63201397
Diverticulum oesophageal 11.89 10.20 7 212864 144 63276007
Sensation of foreign body 11.88 10.20 39 212832 4706 63271445
Middle ear effusion 11.88 10.20 26 212845 2465 63273686
Quarantine 11.86 10.20 5 212866 48 63276103
Klebsiella infection 11.84 10.20 7 212864 8559 63267592
Hypereosinophilic syndrome 11.84 10.20 9 212862 287 63275864
Mechanical urticaria 11.83 10.20 11 212860 465 63275686
Pulmonary embolism 11.78 10.20 491 212380 116193 63159958
Proctalgia 11.72 10.20 3 212868 6107 63270044
Dermatitis bullous 11.69 10.20 7 212864 8501 63267650
Obsessive-compulsive disorder 11.67 10.20 35 212836 4025 63272126
Vasomotor rhinitis 11.64 10.20 7 212864 150 63276001
Prothrombin time prolonged 11.63 10.20 9 212862 9555 63266596
Drug level decreased 11.63 10.20 6 212865 7913 63268238
Obsessive thoughts 11.59 10.20 12 212859 579 63275572
Injection site erythema 11.59 10.20 363 212508 82811 63193340
School refusal 11.58 10.20 3 212868 4 63276147
Gastroenteritis viral 11.55 10.20 126 212745 23574 63252577
Gallbladder disorder 11.53 10.20 105 212766 18737 63257414
Agoraphobia 11.52 10.20 10 212861 386 63275765
Status epilepticus 11.41 10.20 21 212850 15212 63260939
Exposure to fungus 11.40 10.20 7 212864 156 63275995
Infusion site nodule 11.36 10.20 19 212852 1473 63274678
Gait inability 11.35 10.20 118 212753 52841 63223310
Phlebectomy 11.35 10.20 5 212866 54 63276097
Hypertransaminasaemia 11.31 10.20 4 212867 6605 63269546
Abdominal pain lower 11.27 10.20 46 212825 25632 63250519
Angiodysplasia 11.24 10.20 10 212861 399 63275752
PO2 decreased 11.23 10.20 19 212852 1487 63274664
Mycobacterium avium complex infection 11.22 10.20 29 212842 3059 63273092
Screaming 11.21 10.20 30 212841 3232 63272919
Enterobiasis 11.19 10.20 5 212866 56 63276095
Finger deformity 11.18 10.20 6 212865 7739 63268412
Cerebral haemorrhage 11.14 10.20 59 212812 30670 63245481
Oesophagogastroduodenoscopy 11.09 10.20 7 212864 164 63275987
Skin swelling 11.08 10.20 31 212840 3428 63272723
Poisoning 11.07 10.20 18 212853 13682 63262469
Infusion site warmth 11.07 10.20 21 212850 1797 63274354
Vaccination site pain 11.01 10.20 7 212864 166 63275985
Hyperbilirubinaemia 11.01 10.20 13 212858 11301 63264850
Administration site pruritus 11.00 10.20 9 212862 320 63275831
Blood immunoglobulin G decreased 10.99 10.20 25 212846 2433 63273718
Mental disorder 10.94 10.20 134 212737 25785 63250366
Myoclonus 10.92 10.20 23 212848 15845 63260306
Laryngeal oedema 10.91 10.20 43 212828 5675 63270476
Hearing aid user 10.88 10.20 5 212866 60 63276091
Pulmonary arterial hypertension 10.84 10.20 39 212832 22538 63253613
Peak expiratory flow rate increased 10.83 10.20 3 212868 6 63276145
Deformity 10.77 10.20 14 212857 11670 63264481
Fear 10.76 10.20 90 212781 15676 63260475
Endocarditis 10.70 10.20 3 212868 5747 63270404
Hypovolaemia 10.68 10.20 12 212859 10661 63265490
Lupus-like syndrome 10.67 10.20 22 212849 15273 63260878
Therapy partial responder 10.64 10.20 12 212859 10646 63265505
Intentional product misuse 10.64 10.20 142 212729 60775 63215376
Chronic kidney disease 10.63 10.20 99 212772 45299 63230852
Paraesthesia oral 10.63 10.20 105 212766 19151 63257000
Anaphylactoid reaction 10.61 10.20 32 212839 3691 63272460
Breast neoplasm 10.59 10.20 18 212853 1414 63274737
Alcohol intolerance 10.57 10.20 6 212865 115 63276036
Gastroenteritis eosinophilic 10.57 10.20 6 212865 115 63276036
Glomerular filtration rate decreased 10.55 10.20 18 212853 13423 63262728
Serum sickness 10.54 10.20 27 212844 2833 63273318
Urinary retention 10.54 10.20 59 212812 30242 63245909
Mouth ulceration 10.53 10.20 66 212805 32918 63243233
Oliguria 10.53 10.20 9 212862 9092 63267059
Postpartum anxiety 10.52 10.20 3 212868 7 63276144
Haemorrhage intracranial 10.50 10.20 18 212853 13401 63262750
Congenital naevus 10.48 10.20 7 212864 181 63275970
Granulocytopenia 10.48 10.20 3 212868 5669 63270482
Surgery 10.48 10.20 174 212697 35738 63240413
Eyelid infection 10.46 10.20 9 212862 343 63275808
Administration site swelling 10.43 10.20 17 212854 1290 63274861
Anticholinergic syndrome 10.39 10.20 24 212847 2358 63273793
Femoral neck fracture 10.39 10.20 8 212863 8515 63267636
Microscopic polyangiitis 10.38 10.20 7 212864 184 63275967
Muscle rigidity 10.38 10.20 14 212857 11486 63264665
Intestinal perforation 10.36 10.20 15 212856 11948 63264203
Pulmonary renal syndrome 10.35 10.20 10 212861 444 63275707
Breast conserving surgery 10.27 10.20 15 212856 1034 63275117
Restless legs syndrome 10.21 10.20 101 212770 18430 63257721

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 3319.83 11.09 1743 81984 40913 34832291
Wheezing 1452.29 11.09 1016 82711 40386 34832818
Eosinophilic granulomatosis with polyangiitis 898.87 11.09 288 83439 1699 34871505
Obstructive airways disorder 825.74 11.09 495 83232 14999 34858205
Cough 556.12 11.09 1155 82572 148985 34724219
Full blood count abnormal 530.75 11.09 404 83323 18264 34854940
Forced expiratory volume decreased 450.28 11.09 197 83530 3006 34870198
Productive cough 416.99 11.09 483 83244 37330 34835874
Dyspnoea 399.09 11.09 1868 81859 374914 34498290
Abnormal behaviour 355.58 11.09 365 83362 24604 34848600
Suicidal ideation 346.99 11.09 455 83272 39933 34833271
Sleep disorder due to a general medical condition 334.23 11.09 188 83539 5033 34868171
Therapeutic product effect incomplete 322.60 11.09 494 83233 50047 34823157
Toxicity to various agents 309.02 11.09 54 83673 200308 34672896
Chest discomfort 290.59 11.09 491 83236 54039 34819165
Aggression 289.27 11.09 409 83318 38555 34834649
Nightmare 288.07 11.09 254 83473 14137 34859067
Sleep terror 282.43 11.09 129 83598 2189 34871015
Nasal congestion 271.81 11.09 305 83422 22752 34850452
Sinusitis 260.38 11.09 402 83325 41000 34832204
Blood immunoglobulin E increased 258.73 11.09 125 83602 2421 34870783
Sputum discoloured 253.18 11.09 183 83544 7629 34865575
Middle insomnia 249.81 11.09 172 83555 6630 34866574
Anger 234.35 11.09 208 83519 11676 34861528
Nasal polyps 213.20 11.09 109 83618 2394 34870810
Acute kidney injury 212.74 11.09 251 83476 304737 34568467
Loss of personal independence in daily activities 211.17 11.09 324 83403 32855 34840349
Anaemia 194.74 11.09 164 83563 233171 34640033
Impaired quality of life 183.32 11.09 134 83593 5684 34867520
Anxiety 178.72 11.09 584 83143 98844 34774360
Depression 157.45 11.09 551 83176 96547 34776657
Bronchial wall thickening 150.69 11.09 71 83656 1297 34871907
Pulmonary function test abnormal 143.13 11.09 85 83642 2525 34870679
Asthma-chronic obstructive pulmonary disease overlap syndrome 142.40 11.09 67 83660 1220 34871984
Mood altered 140.47 11.09 138 83589 8814 34864390
Pulmonary function test decreased 139.83 11.09 107 83620 4868 34868336
Bronchiectasis 135.35 11.09 141 83586 9660 34863544
Gastrooesophageal reflux disease 134.24 11.09 287 83440 37637 34835567
Drug interaction 133.04 11.09 210 83517 225736 34647468
Dermatitis atopic 133.01 11.09 107 83620 5240 34867964
Death 132.57 11.09 499 83228 397550 34475654
Sleep disorder 127.70 11.09 253 83474 31435 34841769
Thrombocytopenia 127.53 11.09 112 83615 156135 34717069
Bronchial secretion retention 125.37 11.09 65 83662 1471 34871733
Urticaria 124.46 11.09 380 83347 61997 34811207
Chronic obstructive pulmonary disease 124.00 11.09 325 83402 48593 34824611
Febrile neutropenia 121.79 11.09 90 83637 136759 34736445
Rhinorrhoea 120.84 11.09 219 83508 25449 34847755
Crying 120.35 11.09 105 83622 5757 34867447
Eosinophilia 120 11.09 221 83506 26001 34847203
Off label use 118.62 11.09 560 83167 418964 34454240
Infective pulmonary exacerbation of cystic fibrosis 118.35 11.09 111 83616 6690 34866514
Seasonal allergy 116.27 11.09 109 83618 6566 34866638
Bronchial hyperreactivity 116.09 11.09 64 83663 1645 34871559
Nasopharyngitis 112.43 11.09 396 83331 69572 34803632
Neuropsychiatric symptoms 109.26 11.09 50 83677 852 34872352
Right atrial hypertrophy 108.25 11.09 48 83679 757 34872447
Eosinophil count increased 105.46 11.09 116 83611 8456 34864748
Bronchitis 103.50 11.09 276 83451 41687 34831517
Hypotension 100.06 11.09 241 83486 221408 34651796
Tic 99.93 11.09 62 83665 1996 34871208
Obstruction 98.05 11.09 68 83659 2651 34870553
Rhinitis 96.28 11.09 96 83631 6242 34866962
Pancytopenia 93.49 11.09 56 83671 95101 34778103
Bronchospasm 92.21 11.09 121 83606 10610 34862594
Irritability 92.17 11.09 191 83536 24499 34848705
Asthmatic crisis 90.85 11.09 37 83690 467 34872737
Upper-airway cough syndrome 90.20 11.09 72 83655 3486 34869718
Influenza 89.35 11.09 292 83435 49374 34823830
Multiple organ dysfunction syndrome 88.91 11.09 36 83691 76530 34796674
Malignant neoplasm progression 87.64 11.09 51 83676 87995 34785209
Dyspnoea exertional 85.68 11.09 263 83464 43016 34830188
Bronchial obstruction 84.38 11.09 51 83676 1565 34871639
Drug abuse 83.28 11.09 69 83658 99027 34774177
Neutropenia 81.88 11.09 157 83570 156621 34716583
Sneezing 80.73 11.09 80 83647 5162 34868042
Hypersensitivity 79.44 11.09 323 83404 60712 34812492
Right ventricular hypertrophy 79.04 11.09 48 83679 1486 34871718
Sensitivity to weather change 78.99 11.09 49 83678 1577 34871627
Blood creatinine increased 78.74 11.09 67 83660 94909 34778295
Hyponatraemia 77.99 11.09 51 83676 82640 34790564
Sepsis 76.77 11.09 179 83548 166382 34706822
Lower respiratory tract infection 74.90 11.09 205 83522 31432 34841772
Vital capacity decreased 74.87 11.09 30 83697 362 34872842
Upper respiratory tract infection 73.14 11.09 209 83518 32850 34840354
Mood swings 72.44 11.09 92 83635 7809 34865395
Ear infection 72.33 11.09 105 83622 10126 34863078
Eosinophilic pneumonia chronic 72.08 11.09 27 83700 268 34872936
Dysplastic naevus 71.31 11.09 31 83696 465 34872739
Photodermatosis 70.69 11.09 32 83695 531 34872673
Allergy to animal 70.23 11.09 29 83698 380 34872824
Diarrhoea 69.56 11.09 599 83128 389313 34483891
Breath sounds abnormal 69.31 11.09 84 83643 6797 34866407
Bronchopulmonary aspergillosis allergic 69.24 11.09 37 83690 892 34872312
Leukopenia 69.08 11.09 32 83695 62824 34810380
Solar lentigo 68.29 11.09 31 83696 518 34872686
Illness 68.25 11.09 119 83608 13410 34859794
Screaming 67.76 11.09 43 83684 1441 34871763
Sleep apnoea syndrome 67.56 11.09 150 83577 20171 34853033
Confusional state 67.16 11.09 154 83573 144006 34729198
Haemoglobin decreased 66.54 11.09 117 83610 120655 34752549
Multiple allergies 66.14 11.09 56 83671 2947 34870257
Osteoporosis 65.96 11.09 113 83614 12555 34860649
Disease progression 64.86 11.09 99 83628 107978 34765226
Completed suicide 64.80 11.09 84 83643 98084 34775120
Vocal cord dysfunction 64.71 11.09 22 83705 160 34873044
Blood cholesterol 63.88 11.09 23 83704 202 34873002
Depressed mood 63.56 11.09 142 83585 19175 34854029
Discomfort 63.20 11.09 140 83587 18798 34854406
Renal failure 62.83 11.09 137 83590 130420 34742784
Psychomotor hyperactivity 62.63 11.09 95 83632 9527 34863677
Respiratory tract congestion 61.93 11.09 75 83652 6064 34867140
Product dose omission issue 61.72 11.09 494 83233 119217 34753987
Rhinitis allergic 61.34 11.09 54 83673 2996 34870208
Social avoidant behaviour 60.37 11.09 54 83673 3060 34870144
Sputum increased 60.16 11.09 48 83679 2322 34870882
Insomnia 59.82 11.09 440 83287 103467 34769737
Headache 59.56 11.09 738 82989 199897 34673307
Dehydration 58.01 11.09 142 83585 129827 34743377
Rhabdomyolysis 57.82 11.09 47 83680 68116 34805088
Obesity 56.97 11.09 107 83620 12771 34860433
Septic shock 56.73 11.09 53 83674 71781 34801423
Aortic valve stenosis 56.66 11.09 49 83678 2654 34870550
Victim of child abuse 55.61 11.09 32 83695 895 34872309
Rhinitis perennial 55.52 11.09 23 83704 304 34872900
Nasal disorder 55.35 11.09 42 83685 1886 34871318
Eye disorder 54.97 11.09 89 83638 9439 34863765
Renal impairment 54.40 11.09 89 83638 94424 34778780
Chronic sinusitis 53.30 11.09 44 83683 2235 34870969
Panic attack 52.92 11.09 87 83640 9345 34863859
Platelet count decreased 52.48 11.09 132 83595 119585 34753619
Eye pruritus 51.69 11.09 76 83651 7413 34865791
Chest X-ray abnormal 51.49 11.09 58 83669 4340 34868864
Suffocation feeling 50.89 11.09 26 83701 570 34872634
Pruritus 49.55 11.09 539 83188 141442 34731762
Educational problem 49.39 11.09 25 83702 537 34872667
Ascites 49.20 11.09 25 83702 46546 34826658
Dyspnoea at rest 49.17 11.09 53 83674 3775 34869429
Eosinophil count 48.28 11.09 17 83710 139 34873065
Eczema 48.23 11.09 124 83603 18312 34854892
Anaphylactic reaction 47.74 11.09 178 83549 32123 34841081
Oropharyngeal pain 46.31 11.09 188 83539 35297 34837907
Gastrointestinal haemorrhage 45.79 11.09 89 83638 88388 34784816
General physical health deterioration 45.64 11.09 156 83571 128113 34745091
Aspirin-exacerbated respiratory disease 45.46 11.09 21 83706 366 34872838
Product quality issue 45.00 11.09 115 83612 16920 34856284
Respiratory disorder 44.76 11.09 124 83603 19140 34854064
Throat clearing 44.39 11.09 20 83707 328 34872876
Heart rate increased 44.35 11.09 224 83503 46119 34827085
Hyperkalaemia 44.12 11.09 61 83666 69328 34803876
Food allergy 44.02 11.09 33 83694 1455 34871749
Reversible airways obstruction 43.70 11.09 22 83705 467 34872737
Sputum purulent 43.40 11.09 22 83705 474 34872730
Cardiac arrest 42.93 11.09 105 83622 96054 34777150
Personality change 42.69 11.09 57 83670 5082 34868122
Blood pressure increased 42.38 11.09 358 83369 87744 34785460
Epidural lipomatosis 41.90 11.09 28 83699 1026 34872178
Forced vital capacity decreased 41.84 11.09 25 83702 751 34872453
Product use in unapproved indication 41.41 11.09 447 83280 117052 34756152
Perfume sensitivity 41.40 11.09 14 83713 100 34873104
Dust allergy 40.74 11.09 26 83701 880 34872324
Coma 40.63 11.09 30 83697 45648 34827556
Bone marrow failure 40.62 11.09 10 83717 29243 34843961
Myocardial infarction 40.58 11.09 151 83576 120934 34752270
Negative thoughts 40.46 11.09 23 83704 628 34872576
Foetal exposure during pregnancy 39.44 11.09 21 83706 38080 34835124
Nasal inflammation 38.92 11.09 17 83710 258 34872946
Sinus congestion 38.86 11.09 57 83670 5548 34867656
Peak expiratory flow rate decreased 38.68 11.09 14 83713 125 34873079
Hypoventilation 38.23 11.09 44 83683 3370 34869834
Smoke sensitivity 38.10 11.09 14 83713 131 34873073
Eye swelling 38.09 11.09 78 83649 9917 34863287
Cardio-respiratory arrest 37.81 11.09 46 83681 55227 34817977
Drug resistance 37.72 11.09 8 83719 25919 34847285
Attention deficit hyperactivity disorder 37.47 11.09 38 83689 2521 34870683
Intentional overdose 37.17 11.09 30 83697 43644 34829560
Blood pressure systolic increased 36.90 11.09 130 83597 22822 34850382
Serotonin syndrome 36.45 11.09 3 83724 19930 34853274
Respiratory tract infection 36.42 11.09 117 83610 19595 34853609
Restrictive pulmonary disease 36.28 11.09 27 83700 1177 34872027
Pleural effusion 35.65 11.09 90 83637 81456 34791748
Ocular discomfort 35.54 11.09 34 83693 2100 34871104
Hypokalaemia 35.21 11.09 53 83674 58161 34815043
Emotional disorder 35.19 11.09 55 83672 5661 34867543
Nausea 35.11 11.09 588 83139 339320 34533884
Body temperature decreased 34.44 11.09 88 83639 12946 34860258
Intervertebral disc degeneration 34.41 11.09 58 83669 6359 34866845
Diastolic dysfunction 34.35 11.09 57 83670 6170 34867034
Nasal oedema 34.11 11.09 17 83710 353 34872851
Anosmia 33.99 11.09 45 83682 3979 34869225
C-reactive protein increased 33.95 11.09 48 83679 54050 34819154
Cardiac failure 33.80 11.09 109 83618 91139 34782065
Lung hyperinflation 33.61 11.09 23 83704 877 34872327
Agranulocytosis 33.35 11.09 8 83719 23813 34849391
Suicidal behaviour 33.14 11.09 28 83699 1469 34871735
Respiratory rate increased 32.84 11.09 73 83654 9821 34863383
Status asthmaticus 32.69 11.09 16 83711 319 34872885
Acute myocardial infarction 31.44 11.09 50 83677 53669 34819535
Morbid thoughts 31.39 11.09 14 83713 224 34872980
Oesophageal polyp 31.34 11.09 10 83717 58 34873146
Nasal discharge discolouration 31.06 11.09 15 83712 290 34872914
Blood test abnormal 30.93 11.09 58 83669 6913 34866291
Neoplasm progression 30.40 11.09 9 83718 23291 34849913
Sinus polyp 30.39 11.09 13 83714 187 34873017
Self-injurious ideation 30.29 11.09 28 83699 1656 34871548
Metabolic acidosis 30.24 11.09 36 83691 43644 34829560
Bradycardia 30.13 11.09 87 83640 75331 34797873
Adjustment disorder 29.79 11.09 24 83703 1177 34872027
Total lung capacity abnormal 29.79 11.09 12 83715 147 34873057
International normalised ratio increased 29.69 11.09 42 83685 47285 34825919
Delirium 29.67 11.09 37 83690 43954 34829250
Throat irritation 29.57 11.09 73 83654 10512 34862692
Cytomegalovirus infection 29.18 11.09 13 83714 26122 34847082
Electrocardiogram QT prolonged 29.16 11.09 33 83694 40919 34832285
Homicidal ideation 29.08 11.09 34 83693 2648 34870556
Pneumonia 28.98 11.09 1101 82626 361526 34511678
Eosinophilic bronchitis 28.98 11.09 13 83714 211 34872993
Respiratory symptom 28.74 11.09 28 83699 1769 34871435
Cystic fibrosis 28.73 11.09 27 83700 1631 34871573
Cardiogenic shock 28.55 11.09 14 83713 26604 34846600
Cerebral haemorrhage 28.50 11.09 25 83702 34912 34838292
Prolonged expiration 28.33 11.09 13 83714 223 34872981
Sinus disorder 27.84 11.09 56 83671 7029 34866175
Pleural thickening 27.76 11.09 15 83712 370 34872834
Constipation 27.73 11.09 203 83524 136779 34736425
Asthenia 27.71 11.09 417 83310 244834 34628370
Polyp 27.59 11.09 40 83687 3852 34869352
Syncope 27.49 11.09 119 83608 91332 34781872
Juvenile idiopathic arthritis 27.46 11.09 28 83699 1869 34871335
Panic reaction 27.46 11.09 25 83702 1450 34871754
Forced expiratory volume abnormal 27.30 11.09 8 83719 33 34873171
Neuroleptic malignant syndrome 27.21 11.09 5 83722 17929 34855275
Blebitis 27.17 11.09 6 83721 4 34873200
Eosinophilic oesophagitis 27.07 11.09 14 83713 315 34872889
Rheumatoid arthritis 27.03 11.09 31 83696 38207 34834997
Melaena 26.88 11.09 27 83700 35353 34837851
Encephalopathy 26.78 11.09 27 83700 35292 34837912
Contraindicated product administered 26.77 11.09 9 83718 21472 34851732
Endocarditis fibroplastica 26.60 11.09 6 83721 5 34873199
Mucosal inflammation 26.56 11.09 32 83695 38590 34834614
Hypoglycaemia 26.53 11.09 57 83670 54583 34818621
Attention-seeking behaviour 26.22 11.09 8 83719 39 34873165
Snoring 26.10 11.09 36 83691 3310 34869894
Decreased appetite 25.92 11.09 264 83463 166128 34707076
Lactic acidosis 25.89 11.09 27 83700 34745 34838459
Hepatic failure 25.50 11.09 27 83700 34504 34838700
Product substitution issue 25.48 11.09 67 83660 10028 34863176
Nasal discomfort 25.35 11.09 25 83702 1603 34871601
Excessive eye blinking 25.03 11.09 16 83711 543 34872661
Blood bilirubin increased 25.01 11.09 33 83694 38263 34834941
Hypereosinophilic syndrome 24.99 11.09 12 83715 229 34872975
Throat tightness 24.80 11.09 59 83668 8299 34864905
Pigment dispersion syndrome 24.74 11.09 6 83721 9 34873195
Intentional product use issue 24.63 11.09 68 83659 59748 34813456
Tubulointerstitial nephritis 24.20 11.09 10 83717 21014 34852190
White blood cell count decreased 24.17 11.09 132 83595 95313 34777891
Malaise 23.83 11.09 598 83129 185227 34687977
Alanine aminotransferase increased 23.78 11.09 106 83621 80709 34792495
Stiff person syndrome 23.70 11.09 9 83718 93 34873111
Blood lactic acid 23.62 11.09 13 83714 333 34872871
Stomatitis 23.55 11.09 41 83686 42473 34830731
Hyperkaliuria 23.53 11.09 9 83718 95 34873109
Rhonchi 23.42 11.09 26 83701 1914 34871290
Vomiting 23.39 11.09 435 83292 247186 34626018
Benign prostatic hyperplasia 23.21 11.09 82 83645 14413 34858791
Asthma exercise induced 23.20 11.09 9 83718 99 34873105
Abnormal dreams 23.03 11.09 54 83673 7524 34865680
Sleep talking 23.01 11.09 15 83712 527 34872677
Palmar-plantar erythrodysaesthesia syndrome 22.82 11.09 6 83721 16789 34856415
Respiratory tract irritation 22.67 11.09 11 83716 215 34872989
Diaphragmatic disorder 22.55 11.09 21 83706 1254 34871950
Enuresis 22.53 11.09 28 83699 2325 34870879
Depressed level of consciousness 22.23 11.09 43 83684 42798 34830406
Meningitis eosinophilic 22.20 11.09 6 83721 17 34873187
Haematuria 22.07 11.09 55 83672 50011 34823193
Fear 21.97 11.09 65 83662 10411 34862793
Behaviour disorder 21.97 11.09 41 83686 4869 34868335
Gastroenteritis viral 21.91 11.09 51 83676 7073 34866131
Allergic respiratory disease 21.88 11.09 7 83720 41 34873163
NPM1 gene mutation 21.86 11.09 9 83718 117 34873087
Blood immunoglobulin G decreased 21.80 11.09 22 83705 1451 34871753
Sputum abnormal 21.67 11.09 14 83713 484 34872720
Haematochezia 21.40 11.09 50 83677 46484 34826720
Secretion discharge 21.23 11.09 45 83682 5860 34867344
Haematemesis 21.22 11.09 21 83706 27690 34845514
Temperature intolerance 21.16 11.09 33 83694 3389 34869815
Sedation 21.12 11.09 12 83715 20994 34852210
Child abuse 21.08 11.09 13 83714 414 34872790
Dysphonia 20.96 11.09 111 83616 23272 34849932
Obsessive-compulsive disorder 20.70 11.09 43 83684 5521 34867683
Nasal turbinate abnormality 20.62 11.09 6 83721 24 34873180
Bronchiolitis obliterans syndrome 20.58 11.09 10 83717 196 34873008
Fall 20.54 11.09 352 83375 202533 34670671
Cerebrovascular accident 20.54 11.09 119 83608 84692 34788512
Acute myeloid leukaemia 20.53 11.09 9 83718 18261 34854943
Physical assault 20.52 11.09 19 83708 1126 34872078
Urinary tract infection 20.35 11.09 118 83609 83963 34789241
Status epilepticus 20.29 11.09 3 83724 12611 34860593
Injection site pain 20.08 11.09 161 83566 38844 34834360
Injection site swelling 20.02 11.09 67 83660 11460 34861744
Blood urea increased 20.00 11.09 26 83701 30338 34842866
Hypohidrosis 19.96 11.09 10 83717 210 34872994
Eye irritation 19.92 11.09 51 83676 7510 34865694
Pyrexia 19.64 11.09 628 83099 332385 34540819
Pulmonary oedema 19.59 11.09 54 83673 47475 34825729
Somnambulism 19.52 11.09 30 83697 3042 34870162
Acute respiratory distress syndrome 19.52 11.09 20 83707 25949 34847255
Mite allergy 19.51 11.09 15 83712 687 34872517
Angina pectoris 19.50 11.09 28 83699 31335 34841869
Lower respiratory tract congestion 19.40 11.09 19 83708 1208 34871996
Hyperglycaemia 19.32 11.09 41 83686 39439 34833765
Sopor 19.26 11.09 3 83724 12133 34861071
Steroid diabetes 19.24 11.09 25 83702 2170 34871034
Nasal septum deviation 19.24 11.09 18 83709 1081 34872123
Airway remodelling 19.18 11.09 10 83717 229 34872975
Cytokine release syndrome 19.11 11.09 16 83711 22861 34850343
Upper respiratory tract congestion 19.11 11.09 16 83711 829 34872375
Lung hernia 19.10 11.09 7 83720 65 34873139
Gout 19.07 11.09 94 83633 19159 34854045
Hostility 19.06 11.09 16 83711 832 34872372
Stress 18.87 11.09 131 83596 30216 34842988
Scleroderma 18.86 11.09 21 83706 1551 34871653
Forced expiratory flow decreased 18.83 11.09 9 83718 170 34873034
Unresponsive to stimuli 18.79 11.09 23 83704 27546 34845658
Pneumocystis jirovecii pneumonia 18.78 11.09 12 83715 19698 34853506
Hypomagnesaemia 18.60 11.09 15 83712 21836 34851368
Prostatomegaly 18.40 11.09 40 83687 5301 34867903
Hypercalcaemia 18.39 11.09 7 83720 15461 34857743
Self esteem decreased 18.32 11.09 13 83714 526 34872678
Lung disorder 18.29 11.09 144 83583 34552 34838652
Oedema peripheral 18.27 11.09 191 83536 119621 34753583
Bronchitis viral 18.17 11.09 10 83717 256 34872948
Nasal mucosal disorder 18.16 11.09 8 83719 124 34873080
Hospitalisation 17.99 11.09 212 83515 56690 34816514
Altered state of consciousness 17.93 11.09 17 83710 22876 34850328
Hyperbilirubinaemia 17.85 11.09 9 83718 16834 34856370
Mental disorder 17.83 11.09 78 83649 15131 34858073
Drug level increased 17.79 11.09 16 83711 22080 34851124
Neuritis 17.72 11.09 16 83711 918 34872286
Nocturnal dyspnoea 17.68 11.09 13 83714 556 34872648
Ocular hyperaemia 17.66 11.09 64 83663 11388 34861816
Aspartate aminotransferase increased 17.56 11.09 93 83634 67690 34805514
Subdural haematoma 17.41 11.09 14 83713 20407 34852797
Mononeuropathy multiplex 17.34 11.09 9 83718 204 34873000
Clostridium difficile colitis 17.28 11.09 8 83719 15722 34857482
Bronchial disorder 17.28 11.09 19 83708 1384 34871820
Circulatory collapse 17.22 11.09 15 83712 21023 34852181
COVID-19 17.16 11.09 271 83456 77279 34795925
Weight increased 16.92 11.09 315 83412 92718 34780486
Tearfulness 16.89 11.09 26 83701 2641 34870563
Hepatic encephalopathy 16.88 11.09 7 83720 14678 34858526
Bronchopulmonary aspergillosis 16.83 11.09 7 83720 14652 34858552
Extrapyramidal disorder 16.76 11.09 5 83722 12875 34860329
Interstitial lung disease 16.68 11.09 90 83637 65192 34808012
Conjunctivitis 16.49 11.09 56 83671 9649 34863555
Hypoacusis 16.44 11.09 80 83647 16221 34856983
Alopecia areata 16.40 11.09 9 83718 229 34872975
Neutrophil count decreased 16.28 11.09 65 83662 51039 34822165
Subarachnoid haemorrhage 16.26 11.09 5 83722 12630 34860574
Chimerism 16.23 11.09 9 83718 234 34872970
Bronchiolitis 16.10 11.09 28 83699 3148 34870056
Mast cell activation syndrome 15.99 11.09 9 83718 241 34872963
Hemiparesis 15.88 11.09 9 83718 15769 34857435
Diabetic ketoacidosis 15.83 11.09 12 83715 18020 34855184
Ventricular fibrillation 15.80 11.09 19 83708 22935 34850269
Renal tubular necrosis 15.70 11.09 9 83718 15671 34857533
Hepatotoxicity 15.64 11.09 17 83710 21468 34851736
Generalised anxiety disorder 15.58 11.09 14 83713 798 34872406
Glaucoma 15.57 11.09 44 83683 6868 34866336
Poor quality device used 15.57 11.09 15 83712 935 34872269
Peritonitis 15.54 11.09 10 83717 16355 34856849
Lymphopenia 15.49 11.09 10 83717 16325 34856879
Bone density decreased 15.42 11.09 21 83706 1908 34871296
Affective disorder 15.42 11.09 33 83694 4327 34868877
Small airways disease 15.39 11.09 5 83722 31 34873173
Eosinophilic pneumonia 15.37 11.09 29 83698 3472 34869732
Sputum retention 15.37 11.09 11 83716 451 34872753
Agitation 15.22 11.09 207 83520 57192 34816012
Cortisol decreased 15.17 11.09 16 83711 1111 34872093
Cephalo-pelvic disproportion 15.11 11.09 3 83724 0 34873204
Exophthalmos congenital 15.11 11.09 3 83724 0 34873204
Autophobia 15.11 11.09 3 83724 0 34873204
Pigmentary glaucoma 15.11 11.09 3 83724 0 34873204
Seizure anoxic 15.11 11.09 3 83724 0 34873204
ACTH stimulation test abnormal 15.11 11.09 3 83724 0 34873204
Disseminated intravascular coagulation 15.08 11.09 18 83709 21798 34851406
Ischaemic stroke 14.95 11.09 13 83714 18237 34854967
Metastases to liver 14.93 11.09 7 83720 13656 34859548
Chronic spontaneous urticaria 14.90 11.09 7 83720 127 34873077
Mycobacterial infection 14.83 11.09 23 83704 2351 34870853
Electrolyte imbalance 14.83 11.09 8 83719 14404 34858800
Injection site bruising 14.73 11.09 50 83677 8613 34864591
Dysarthria 14.72 11.09 39 83688 34743 34838461
Chronic kidney disease 14.71 11.09 50 83677 41160 34832044
Oropharyngeal discomfort 14.69 11.09 27 83700 3169 34870035
Central obesity 14.65 11.09 12 83715 603 34872601
Frustration tolerance decreased 14.64 11.09 24 83703 2572 34870632
Allergy to plants 14.63 11.09 4 83723 12 34873192
Deep vein thrombosis 14.52 11.09 94 83633 65154 34808050
Treatment failure 14.50 11.09 60 83667 46637 34826567
Proteinuria 14.42 11.09 14 83713 18628 34854576
Feeling abnormal 14.37 11.09 222 83505 63013 34810191
Injection site pruritus 14.33 11.09 43 83684 6940 34866264
Tachycardia 14.23 11.09 132 83595 84640 34788564
Haemophilus infection 14.12 11.09 16 83711 1205 34871999
Eosinophil count abnormal 14.09 11.09 9 83718 305 34872899
Facial discomfort 14.08 11.09 5 83722 42 34873162
Liver disorder 13.96 11.09 37 83690 32960 34840244
Magnetic resonance imaging heart 13.95 11.09 4 83723 15 34873189
Coronary artery disease 13.82 11.09 64 83663 48241 34824963
Premature baby 13.78 11.09 16 83711 19617 34853587
Abdominal pain 13.74 11.09 293 83434 163325 34709879
Haemodynamic instability 13.73 11.09 3 83724 9520 34863684
Haematocrit decreased 13.73 11.09 36 83691 32180 34841024
Stridor 13.71 11.09 23 83704 2511 34870693
Shock 13.68 11.09 23 83704 24156 34849048
Total lung capacity decreased 13.68 11.09 14 83713 939 34872265
Sinus bradycardia 13.62 11.09 7 83720 12956 34860248
Dacryostenosis congenital 13.59 11.09 5 83722 47 34873157
Anuria 13.57 11.09 4 83723 10381 34862823
Duodenal ulcer 13.46 11.09 4 83723 10328 34862876
Choking 13.39 11.09 34 83693 4981 34868223
Sinus operation 13.34 11.09 12 83715 685 34872519
Metastases to lung 13.30 11.09 3 83724 9317 34863887
Atrioventricular block complete 13.30 11.09 3 83724 9316 34863888
Vasculitis 13.29 11.09 58 83669 11238 34861966
Idiopathic intracranial hypertension 13.28 11.09 12 83715 689 34872515
Atopy 13.28 11.09 8 83719 244 34872960
Device related infection 13.27 11.09 13 83714 17224 34855980
Drug reaction with eosinophilia and systemic symptoms 13.24 11.09 38 83689 32974 34840230
Growth retardation 13.11 11.09 19 83708 1829 34871375
Disturbance in social behaviour 13.09 11.09 19 83708 1832 34871372
Migraine 13.04 11.09 79 83648 17399 34855805
Labelled drug-drug interaction medication error 13.04 11.09 10 83717 14929 34858275
Cronobacter infection 13.03 11.09 4 83723 20 34873184
Ear discomfort 13.01 11.09 23 83704 2619 34870585
Spirometry abnormal 12.95 11.09 12 83715 712 34872492
Tachypnoea 12.83 11.09 15 83712 18337 34854867
Synovitis 12.81 11.09 9 83718 14057 34859147
Intentional self-injury 12.77 11.09 66 83661 13705 34859499
Overdose 12.74 11.09 148 83579 90911 34782293
Posterior reversible encephalopathy syndrome 12.70 11.09 4 83723 9950 34863254
Quality of life decreased 12.70 11.09 29 83698 3972 34869232
Scratch 12.60 11.09 26 83701 3322 34869882
Separation anxiety disorder 12.58 11.09 3 83724 4 34873200
Infusion site swelling 12.47 11.09 22 83705 2502 34870702
Respiration abnormal 12.35 11.09 25 83702 3151 34870053
Haemorrhage intracranial 12.30 11.09 12 83715 15934 34857270
Disease prodromal stage 12.28 11.09 4 83723 25 34873179
Sudden death 12.25 11.09 11 83716 15190 34858014
Actinic keratosis 12.23 11.09 31 83696 4536 34868668
Social problem 12.23 11.09 13 83714 911 34872293
Onychophagia 12.21 11.09 5 83722 64 34873140
Fight in school 12.18 11.09 3 83724 5 34873199
Viral myelitis 12.14 11.09 5 83722 65 34873139
Lacrimation increased 11.91 11.09 46 83681 8436 34864768
Kidney infection 11.82 11.09 34 83693 5360 34867844
Hepatocellular injury 11.78 11.09 22 83705 22189 34851015
Acne 11.66 11.09 55 83672 11011 34862193
Prostate cancer 11.66 11.09 52 83675 39597 34833607
Acute hepatic failure 11.56 11.09 10 83717 14064 34859140
Dizziness exertional 11.55 11.09 7 83720 216 34872988
Accidental overdose 11.54 11.09 19 83708 20121 34853083
Occupational exposure to dust 11.52 11.09 3 83724 7 34873197
Lymphocyte count decreased 11.48 11.09 23 83704 22599 34850605
Product dose omission in error 11.46 11.09 20 83707 2254 34870950
Myoclonus 11.46 11.09 11 83716 14714 34858490
Hyposmia 11.43 11.09 7 83720 220 34872984
Oesophagitis 11.42 11.09 9 83718 13252 34859952
Hyperaesthesia teeth 11.40 11.09 10 83717 552 34872652
Lymphoma 11.40 11.09 8 83719 12499 34860705
Pulmonary embolism 11.38 11.09 149 83578 89597 34783607
Acidosis 11.37 11.09 6 83721 10939 34862265
Product taste abnormal 11.29 11.09 14 83713 1160 34872044
Emphysema 11.28 11.09 49 83678 9476 34863728
Upper gastrointestinal haemorrhage 11.27 11.09 28 83699 25490 34847714
Dermatitis allergic 11.25 11.09 39 83688 6791 34866413
Pulmonary artery dilatation 11.21 11.09 7 83720 228 34872976
Swelling face 11.15 11.09 94 83633 23011 34850193
Pneumonia aspiration 11.13 11.09 57 83670 41846 34831358
Myelodysplastic syndrome 11.12 11.09 18 83709 19190 34854014

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 6745.55 9.88 4482 233825 130613 79375468
Wheezing 3027.84 9.88 2622 235685 114042 79392039
Eosinophilic granulomatosis with polyangiitis 1830.55 9.88 604 237703 3056 79503025
Obstructive airways disorder 1586.97 9.88 1053 237254 30406 79475675
Cough 1287.74 9.88 3157 235150 363632 79142449
Dyspnoea 1067.30 9.88 5212 233095 851813 78654268
Full blood count abnormal 1064.89 9.88 918 237389 39556 79466525
Productive cough 955.18 9.88 1247 237060 87084 79418997
Forced expiratory volume decreased 908.06 9.88 451 237856 7363 79498718
Sputum discoloured 894.22 9.88 642 237665 21101 79484980
Sleep disorder due to a general medical condition 751.63 9.88 491 237816 13786 79492295
Chest discomfort 725.27 9.88 1400 236907 136644 79369437
Toxicity to various agents 686.68 9.88 204 238103 421336 79084745
Nasal congestion 569.31 9.88 905 237402 75647 79430434
Urticaria 510.43 9.88 1459 236848 183742 79322339
Nightmare 485.26 9.88 486 237821 25375 79480706
Nasal polyps 481.29 9.88 290 238017 7037 79499044
Middle insomnia 468.85 9.88 387 237920 15682 79490399
Rhinitis allergic 463.02 9.88 344 237963 11925 79494156
Blood immunoglobulin E increased 434.06 9.88 251 238056 5631 79500450
Gastrooesophageal reflux disease 420.49 9.88 949 237358 103297 79402784
Acute kidney injury 412.20 9.88 571 237736 518833 78987248
Sinusitis 389.15 9.88 1377 236930 194124 79311957
Bronchitis 379.14 9.88 1049 237258 129595 79376486
Off label use 365.34 9.88 1437 236870 905778 78600303
Impaired quality of life 363.49 9.88 319 237988 14067 79492014
Therapeutic product effect incomplete 363.33 9.88 1088 237219 140557 79365524
Chronic obstructive pulmonary disease 359.49 9.88 791 237516 84628 79421453
Synovitis 336.86 9.88 31 238276 150703 79355378
Food allergy 326.92 9.88 266 238041 10558 79495523
Seasonal allergy 316.42 9.88 313 237994 16093 79489988
Abnormal behaviour 312.12 9.88 460 237847 35961 79470120
Suicidal ideation 311.16 9.88 698 237609 75642 79430439
Upper respiratory tract infection 302.96 9.88 770 237537 90398 79415683
Anaemia 292.02 9.88 554 237753 444461 79061620
Sleep terror 291.64 9.88 176 238131 4282 79501799
Aggression 289.83 9.88 535 237772 50423 79455658
Drug interaction 287.46 9.88 500 237807 414683 79091398
Upper-airway cough syndrome 282.90 9.88 253 238054 11440 79494641
Loss of personal independence in daily activities 279.27 9.88 805 237502 101775 79404306
Neutropenia 276.63 9.88 271 238036 287439 79218642
Breath sounds abnormal 275.52 9.88 287 238020 15697 79490384
Dyspnoea exertional 275.49 9.88 722 237585 86351 79419730
Hand deformity 273.47 9.88 8 238299 103911 79402170
Influenza 272.57 9.88 930 237377 128676 79377405
Asthmatic crisis 269.85 9.88 128 238179 1878 79504203
Completed suicide 269.72 9.88 204 238103 245563 79260518
Pemphigus 268.34 9.88 6 238301 99576 79406505
Sleep apnoea syndrome 265.22 9.88 427 237880 36051 79470030
Rhinorrhoea 255.32 9.88 645 237662 75429 79430652
Pulmonary function test abnormal 254.18 9.88 157 238150 3987 79502094
Dermatitis atopic 248.09 9.88 220 238087 9836 79496245
Eosinophil count increased 242.33 9.88 277 238030 16828 79489253
Eosinophilia 240.39 9.88 462 237845 44883 79461198
Pancytopenia 238.86 9.88 98 238209 165647 79340434
Febrile neutropenia 236.91 9.88 205 238102 230794 79275287
Temperature regulation disorder 236.42 9.88 171 238136 5682 79500399
Polycystic ovaries 233.90 9.88 144 238163 3635 79502446
Drug abuse 233.15 9.88 97 238210 162594 79343487
Blood test abnormal 219.75 9.88 268 238039 17442 79488639
Anger 218.31 9.88 263 238044 16899 79489182
Pericarditis 216.21 9.88 28 238279 104208 79401873
Thrombocytopenia 215.67 9.88 286 238021 264973 79241108
Hypotension 213.35 9.88 643 237664 439674 79066407
Respiratory tract infection 211.74 9.88 457 237850 48232 79457849
Malignant neoplasm progression 206.58 9.88 74 238233 135916 79370165
Bronchial secretion retention 205.92 9.88 137 238170 3967 79502114
Asthma-chronic obstructive pulmonary disease overlap syndrome 205.14 9.88 125 238182 3096 79502985
Anxiety 205.06 9.88 1358 236949 247154 79258927
Infective pulmonary exacerbation of cystic fibrosis 200.73 9.88 219 238088 12632 79493449
Death 199.34 9.88 943 237364 565571 78940510
Arthropathy 189.19 9.88 151 238156 176960 79329121
Headache 184.98 9.88 2859 235448 650913 78855168
Sensitisation 184.41 9.88 118 238189 3193 79502888
Treatment failure 181.29 9.88 146 238161 170340 79335741
Product dose omission issue 180.80 9.88 1313 236994 246224 79259857
Sneezing 179.40 9.88 256 238051 19427 79486654
Glossodynia 179.22 9.88 44 238263 103293 79402788
Systemic lupus erythematosus 177.19 9.88 70 238237 121079 79385002
Bronchospasm 175.27 9.88 287 238020 24572 79481509
Anaphylactic reaction 175.18 9.88 600 237707 83143 79422938
Multiple organ dysfunction syndrome 175.01 9.88 70 238237 120176 79385905
Joint swelling 174.87 9.88 376 237931 288270 79217811
Hyponatraemia 173.76 9.88 165 238142 177683 79328398
Bronchiectasis 173.70 9.88 270 238037 22116 79483965
Pneumonia 172.73 9.88 2850 235457 657396 78848685
Secretion discharge 168.30 9.88 216 238091 14806 79491275
Coeliac disease 166.19 9.88 187 238120 11164 79494917
Respiratory tract congestion 165.17 9.88 248 238059 19706 79486375
Rhinitis 164.46 9.88 212 238095 14595 79491486
Pulmonary function test decreased 162.88 9.88 154 238153 7483 79498598
Disease progression 161.09 9.88 188 238119 184174 79321907
Eczema 160.46 9.88 368 237939 40450 79465631
Rheumatoid factor positive 159.69 9.88 4 238303 59835 79446246
Helicobacter infection 159.32 9.88 13 238294 69691 79436390
Contraindicated product administered 158.81 9.88 142 238165 157396 79348685
General physical health deterioration 158.17 9.88 369 237938 274869 79231212
Confusional state 157.78 9.88 459 237848 317538 79188543
Multiple allergies 157.74 9.88 175 238132 10285 79495796
Oropharyngeal pain 157.28 9.88 696 237611 108657 79397424
Mood altered 156.63 9.88 228 238079 17619 79488462
Illness 152.53 9.88 391 237916 46120 79459961
Sensitivity to weather change 152.35 9.88 152 238155 7895 79498186
Nasopharyngitis 151.36 9.88 1285 237022 252596 79253485
Pruritus 151.17 9.88 1823 236484 392825 79113256
Drug intolerance 150.24 9.88 356 237951 263763 79242318
Stomatitis 149.48 9.88 131 238176 146626 79359455
Vital capacity decreased 148.82 9.88 83 238224 1733 79504348
Crying 145.16 9.88 253 238054 22790 79483291
Therapeutic product effect decreased 144.33 9.88 166 238141 163697 79342384
Product quality issue 143.49 9.88 315 237992 33625 79472456
Sputum increased 140.64 9.88 114 238193 4499 79501582
Bronchial wall thickening 139.40 9.88 91 238216 2550 79503531
Intentional product use issue 138.46 9.88 150 238157 151962 79354119
Eye pruritus 137.67 9.88 232 238075 20338 79485743
Reversible airways obstruction 137.44 9.88 84 238223 2092 79503989
Ejection fraction 136.72 9.88 85 238222 2184 79503897
Renal impairment 136.64 9.88 162 238145 157621 79348460
Throat clearing 136.56 9.88 90 238217 2564 79503517
Depression 135.98 9.88 1110 237197 215680 79290401
Diarrhoea 133.70 9.88 1842 236465 878647 78627434
C-reactive protein increased 130.40 9.88 116 238191 128911 79377170
Heart rate increased 130.36 9.88 708 237599 120016 79386065
Total lung capacity increased 128.24 9.88 82 238225 2216 79503865
Bronchial obstruction 126 9.88 87 238220 2681 79503400
Nasal oedema 125.69 9.88 73 238234 1651 79504430
Septic shock 123.38 9.88 111 238196 122690 79383391
Sepsis 122.89 9.88 404 237903 269024 79237057
Perfume sensitivity 121.04 9.88 57 238250 822 79505259
Intentional overdose 119.98 9.88 85 238222 105875 79400206
Forced vital capacity decreased 119.69 9.88 71 238236 1672 79504409
Haemoglobin decreased 119.55 9.88 308 237999 221811 79284270
Allergy to animal 118.55 9.88 66 238241 1373 79504708
Folliculitis 116.97 9.88 14 238293 55366 79450715
Muscle injury 116.94 9.88 7 238300 48554 79457527
Peak expiratory flow rate decreased 115.18 9.88 51 238256 632 79505449
Rhabdomyolysis 115.11 9.88 84 238223 103047 79403034
Impaired healing 115.09 9.88 59 238248 87596 79418485
Platelet count decreased 112.56 9.88 260 238047 194404 79311677
Wound 112.03 9.88 109 238198 116070 79390011
Irritability 112.01 9.88 323 237984 40821 79465260
Leukopenia 111.56 9.88 110 238197 116403 79389678
Vocal cord dysfunction 110.45 9.88 48 238259 567 79505514
Dust allergy 109.24 9.88 64 238243 1472 79504609
Dysphonia 108.19 9.88 395 237912 56477 79449604
C-reactive protein abnormal 107.87 9.88 10 238297 48357 79457724
Infusion related reaction 107.22 9.88 342 237965 229895 79276186
Insomnia 106.06 9.88 1160 237147 244010 79262071
Sleep disorder 106.03 9.88 522 237785 85155 79420926
Lung hyperinflation 105.39 9.88 67 238240 1792 79504289
Bronchopulmonary aspergillosis allergic 104.82 9.88 81 238226 2980 79503101
Respiratory rate increased 103.51 9.88 211 238096 21389 79484692
Sinus congestion 103.33 9.88 201 238106 19695 79486386
Bronchial hyperreactivity 103.13 9.88 80 238227 2960 79503121
Mucosal inflammation 102.05 9.88 49 238258 75531 79430550
Coma 101.08 9.88 91 238216 100558 79405523
Restrictive pulmonary disease 100.69 9.88 74 238233 2521 79503560
Blood pressure systolic increased 100.59 9.88 432 237875 66554 79439527
Sinus disorder 98.96 9.88 212 238095 22252 79483829
Bone marrow failure 98.44 9.88 17 238290 51090 79454991
Hyperkalaemia 97.39 9.88 119 238188 114279 79391802
Rales 96.58 9.88 196 238111 19805 79486276
Ascites 96.05 9.88 53 238254 75509 79430572
Blood creatinine increased 95.47 9.88 200 238107 154857 79351224
Respiratory symptom 95.35 9.88 93 238214 4698 79501383
Status asthmaticus 95.08 9.88 51 238256 983 79505098
Right atrial hypertrophy 94.03 9.88 46 238261 725 79505356
Ear pruritus 93.58 9.88 86 238221 4029 79502052
Bradycardia 92.92 9.88 164 238143 135393 79370688
Cardiac arrest 92.30 9.88 239 238068 171857 79334224
Hypokalaemia 91.91 9.88 182 238125 143858 79362223
Renal failure 91.84 9.88 301 238006 200667 79305414
Alopecia 91.54 9.88 368 237939 230987 79275094
Chronic sinusitis 91.30 9.88 150 238157 12876 79493205
Rhonchi 91.10 9.88 84 238223 3952 79502129
Cardio-respiratory arrest 90.15 9.88 115 238192 108395 79397686
Immunodeficiency 89.72 9.88 200 238107 21568 79484513
Aspirin-exacerbated respiratory disease 87.71 9.88 51 238256 1156 79504925
Depressed level of consciousness 84.98 9.88 98 238209 96554 79409527
Respiratory disorder 84.85 9.88 311 237996 44545 79461536
Hypoventilation 84.28 9.88 106 238201 7118 79498963
Cystic fibrosis 84.20 9.88 79 238228 3801 79502280
Metabolic acidosis 83.61 9.88 74 238233 82455 79423626
Obstruction 83.46 9.88 85 238222 4525 79501556
Mood swings 83.45 9.88 184 238123 19696 79486385
Nasal discharge discolouration 82.62 9.88 65 238242 2456 79503625
Blood pressure increased 82.35 9.88 980 237327 210380 79295701
Poor quality device used 81.61 9.88 62 238245 2223 79503858
Chest X-ray abnormal 81.55 9.88 109 238198 7774 79498307
Dehydration 81.36 9.88 423 237884 247764 79258317
Rash erythematous 80.25 9.88 364 237943 57405 79448676
Respiration abnormal 79.52 9.88 107 238200 7681 79498400
Gastrointestinal haemorrhage 79.32 9.88 205 238102 147514 79358567
Decreased appetite 78.15 9.88 651 237656 341767 79164314
Malaise 77.90 9.88 1965 236342 487904 79018177
Cardiac failure 77.80 9.88 222 238085 154620 79351461
Lower respiratory tract infection 77.40 9.88 655 237652 128565 79377516
Neurotoxicity 77.36 9.88 5 238302 32513 79473568
Tic 77.00 9.88 67 238240 2919 79503162
Chronic spontaneous urticaria 76.67 9.88 47 238260 1177 79504904
Hypersensitivity 76.56 9.88 1154 237153 261085 79244996
Liver injury 75.98 9.88 37 238270 56577 79449504
Smoke sensitivity 75.87 9.88 37 238270 579 79505502
Abnormal dreams 75.42 9.88 128 238179 11284 79494797
Depressed mood 75.37 9.88 316 237991 48164 79457917
Throat tightness 74.91 9.88 218 238089 27689 79478392
Bronchial disorder 74.80 9.88 61 238246 2428 79503653
Maternal exposure during pregnancy 74.45 9.88 188 238119 136350 79369731
Throat irritation 74.20 9.88 280 238027 40666 79465415
Alanine aminotransferase increased 73.91 9.88 244 238063 162326 79343755
Nasal turbinate hypertrophy 73.52 9.88 38 238269 677 79505404
Educational problem 73.33 9.88 32 238275 382 79505699
White blood cell count decreased 72.89 9.88 302 238005 187986 79318095
Rheumatic fever 72.22 9.88 3 238304 28522 79477559
Musculoskeletal stiffness 72.00 9.88 274 238033 174734 79331347
Nasal obstruction 71.36 9.88 56 238251 2108 79503973
Lacrimation increased 70.64 9.88 186 238121 22291 79483790
Lactic acidosis 69.00 9.88 65 238242 70294 79435787
Blister 68.69 9.88 160 238147 119316 79386765
Emphysema 68.57 9.88 151 238156 16149 79489932
Ear infection 67.90 9.88 242 238065 34190 79471891
Prolonged expiration 67.59 9.88 44 238263 1227 79504854
Neoplasm progression 67.52 9.88 35 238272 51647 79454434
Agranulocytosis 67.51 9.88 25 238282 45005 79461076
Frustration tolerance decreased 66.06 9.88 96 238211 7406 79498675
Delirium 65.92 9.88 94 238213 84533 79421548
Carpal tunnel syndrome 65.92 9.88 166 238141 19362 79486719
Encephalopathy 65.23 9.88 63 238244 67334 79438747
Cytomegalovirus infection 65.08 9.88 23 238284 42621 79463460
Migraine 64.85 9.88 466 237841 87027 79419054
Therapy non-responder 64.77 9.88 110 238197 92195 79413886
Total lung capacity decreased 64.68 9.88 60 238247 2845 79503236
Sopor 63.53 9.88 11 238296 32999 79473082
Eosinophilic pneumonia chronic 63.46 9.88 31 238276 487 79505594
Sinusitis fungal 62.70 9.88 54 238253 2320 79503761
Right ventricular hypertrophy 61.98 9.88 46 238261 1591 79504490
Liver disorder 61.98 9.88 75 238232 72342 79433739
Rhinitis perennial 61.53 9.88 27 238280 327 79505754
Poor quality sleep 61.47 9.88 178 238129 22544 79483537
Dyspnoea at rest 60.78 9.88 91 238216 7211 79498870
Dysplastic naevus 59.39 9.88 31 238276 564 79505517
Sleep disorder due to general medical condition, insomnia type 59.16 9.88 28 238279 43528 79462553
Feeling abnormal 58.87 9.88 731 237576 158468 79347613
Hepatic failure 58.34 9.88 58 238249 61154 79444927
Bronchial neoplasm 58.07 9.88 29 238278 479 79505602
Humidity intolerance 57.92 9.88 27 238280 380 79505701
Hyper IgE syndrome 57.71 9.88 30 238277 541 79505540
Acute myocardial infarction 57.63 9.88 88 238219 76948 79429133
Idiopathic intracranial hypertension 57.59 9.88 59 238248 3163 79502918
Red blood cell sedimentation rate increased 57.27 9.88 33 238274 45909 79460172
Pulmonary mass 57.20 9.88 204 238103 28830 79477251
Angioedema 55.79 9.88 404 237903 75631 79430450
Scratch 55.53 9.88 94 238213 8269 79497812
Aspartate aminotransferase increased 55.13 9.88 220 238087 138421 79367660
Burning sensation 54.82 9.88 331 237976 58301 79447780
Salpingo-oophorectomy unilateral 54.74 9.88 33 238274 801 79505280
Palmar-plantar erythrodysaesthesia syndrome 53.87 9.88 16 238291 33118 79472963
Abdominal discomfort 53.47 9.88 485 237822 250242 79255839
Drug resistance 53.08 9.88 30 238277 42183 79463898
Neutropenic sepsis 52.13 9.88 9 238298 27055 79479026
Acute myeloid leukaemia 51.91 9.88 14 238293 30871 79475210
Hypoglycaemia 51.50 9.88 145 238162 101449 79404632
Hypomagnesaemia 51.31 9.88 39 238268 46872 79459209
Neuroleptic malignant syndrome 51.28 9.88 10 238297 27549 79478532
Screaming 51.21 9.88 61 238246 3872 79502209
Viral infection 51.02 9.88 259 238048 42757 79463324
Nasal inflammation 50.93 9.88 30 238277 697 79505384
International normalised ratio increased 50.70 9.88 111 238196 84610 79421471
Body tinea 50.66 9.88 43 238264 1811 79504270
Psychomotor hyperactivity 50.50 9.88 137 238170 16712 79489369
Rheumatoid arthritis 50.43 9.88 390 237917 208080 79298001
Acute respiratory distress syndrome 50.33 9.88 35 238272 44032 79462049
Melaena 50.08 9.88 65 238242 60825 79445256
Blood creatine phosphokinase increased 49.91 9.88 75 238232 66015 79440066
Cardiac murmur 49.78 9.88 131 238176 15693 79490388
Ejection fraction abnormal 49.75 9.88 48 238259 2392 79503689
Serotonin syndrome 48.53 9.88 38 238269 44989 79461092
Victim of child abuse 48.26 9.88 32 238275 921 79505160
Sputum culture positive 48.18 9.88 58 238249 3723 79502358
Swelling face 48.07 9.88 371 237936 70841 79435240
Photodermatosis 47.93 9.88 32 238275 932 79505149
Hepatocellular injury 47.81 9.88 43 238264 47550 79458531
Mastocytosis 47.79 9.88 26 238281 516 79505565
Urticaria chronic 47.77 9.88 27 238280 579 79505502
Irritable bowel syndrome 47.62 9.88 70 238237 62171 79443910
Sedation 47.39 9.88 51 238256 51844 79454237
Aphonia 47.37 9.88 99 238208 10213 79495868
Body temperature decreased 47.24 9.88 206 238101 31939 79474142
Cardiogenic shock 46.94 9.88 34 238273 41880 79464201
Skin plaque 46.86 9.88 101 238206 10644 79495437
Mononeuropathy multiplex 46.51 9.88 24 238283 426 79505655
Toxic epidermal necrolysis 46.33 9.88 39 238268 44542 79461539
Neutrophil count decreased 46.24 9.88 136 238171 93823 79412258
Mast cell activation syndrome 46 9.88 28 238279 692 79505389
Drug level increased 45.94 9.88 31 238276 39620 79466461
Nephrectomy 45.77 9.88 43 238264 2072 79504009
Myocardial infarction 45.70 9.88 342 237965 183787 79322294
Solar lentigo 45.53 9.88 33 238274 1100 79504981
Eye swelling 45.50 9.88 178 238129 26290 79479791
Bursitis 45.48 9.88 220 238087 35624 79470457
Metastases to liver 45.44 9.88 14 238293 28300 79477781
Disseminated intravascular coagulation 44.31 9.88 26 238281 35816 79470265
Interstitial lung disease 43.31 9.88 181 238126 112419 79393662
Cytokine release syndrome 43.27 9.88 27 238280 35971 79470110
Anosmia 43.09 9.88 87 238220 8757 79497324
Diastolic dysfunction 43.06 9.88 98 238209 10713 79495368
Sarcoidosis 43.03 9.88 84 238223 8251 79497830
Rash maculo-papular 42.97 9.88 63 238244 56015 79450066
Social avoidant behaviour 42.97 9.88 62 238245 4752 79501329
Circulatory collapse 42.91 9.88 30 238277 37638 79468443
Endometrial ablation 42.86 9.88 29 238278 864 79505217
Stress 42.72 9.88 394 237913 79218 79426863
Eosinophil count 42.50 9.88 16 238291 126 79505955
Haematochezia 42.31 9.88 128 238179 87517 79418564
Pleural effusion 41.92 9.88 258 238049 145004 79361077
Inflammation 41.04 9.88 143 238164 93610 79412471
Electrocardiogram QT prolonged 40.83 9.88 136 238171 90250 79415831
Colitis 40.68 9.88 100 238207 73207 79432874
Rheumatoid nodule 40.55 9.88 3 238304 17435 79488646
Haemophagocytic lymphohistiocytosis 40.47 9.88 8 238299 21829 79484252
Nasal disorder 40.35 9.88 53 238254 3716 79502365
Anuria 40.31 9.88 7 238300 20956 79485125
Ear discomfort 40.13 9.88 83 238224 8500 79497581
COVID-19 39.63 9.88 677 237630 156997 79349084
Erythema 39.41 9.88 909 237398 222381 79283700
Negative thoughts 39.36 9.88 33 238274 1366 79504715
Metastases to bone 39.34 9.88 12 238295 24415 79481666
Product use in unapproved indication 39.31 9.88 1003 237304 249356 79256725
Cerebral haemorrhage 39.30 9.88 70 238237 57603 79448478
Suffocation feeling 39.22 9.88 36 238271 1684 79504397
Personality change 39.20 9.88 91 238216 10079 79496002
Hepatic enzyme increased 39.01 9.88 353 237954 182257 79323824
Bone erosion 38.98 9.88 4 238303 17843 79488238
Hepatic function abnormal 38.81 9.88 102 238205 73005 79433076
Blood urea increased 38.18 9.88 54 238253 48736 79457345
FEV1/FVC ratio decreased 38.09 9.88 17 238290 215 79505866
Haemoptysis 37.93 9.88 292 238015 55707 79450374
Product substitution issue 37.93 9.88 140 238167 20116 79485965
Infection susceptibility increased 37.80 9.88 51 238256 3670 79502411
Eosinophilic oesophagitis 37.69 9.88 23 238284 571 79505510
Injection site pain 37.69 9.88 571 237736 129267 79376814
Haemodynamic instability 37.69 9.88 4 238303 17378 79488703
Pneumonia aspiration 37.43 9.88 91 238216 66876 79439205
Cardiac disorder 37.10 9.88 329 237978 65428 79440653
Eosinophilic pneumonia 37.01 9.88 61 238246 5249 79500832
Drug reaction with eosinophilia and systemic symptoms 36.95 9.88 86 238221 64158 79441923
Blood pressure fluctuation 36.94 9.88 92 238215 67053 79439028
Nausea 36.72 9.88 2417 235890 954779 78551302
Mite allergy 36.66 9.88 30 238277 1200 79504881
Skin ulcer 36.65 9.88 66 238241 54084 79451997
Osteoporosis 36.56 9.88 282 238025 53830 79452251
Respiratory tract inflammation 36.52 9.88 26 238281 842 79505239
Lower respiratory tract congestion 36.44 9.88 52 238255 3945 79502136
Eosinophilic bronchitis 36.31 9.88 21 238286 471 79505610
Poisoning 36.28 9.88 15 238292 25257 79480824
Transplant rejection 36.28 9.88 7 238300 19430 79486651
Heart sounds 36.25 9.88 27 238280 939 79505142
Nervousness 36.05 9.88 196 238111 33219 79472862
Atopy 35.76 9.88 20 238287 420 79505661
Cholestasis 35.73 9.88 63 238244 52046 79454035
Separation anxiety disorder 35.43 9.88 10 238297 26 79506055
Gastrointestinal disorder 35.29 9.88 217 238090 121988 79384093
Neuropsychiatric symptoms 34.99 9.88 31 238276 1384 79504697
Accidental overdose 34.93 9.88 40 238267 39541 79466540
Bronchial haemorrhage 34.81 9.88 30 238277 1290 79504791
Blood cholesterol 34.69 9.88 23 238284 662 79505419
Epidural lipomatosis 34.62 9.88 29 238278 1199 79504882
Live birth 34.46 9.88 7 238300 18737 79487344
Tubulointerstitial nephritis 34.44 9.88 38 238269 38197 79467884
Neuropathy peripheral 34.32 9.88 264 238043 141041 79365040
Hypereosinophilic syndrome 34.22 9.88 21 238286 527 79505554
Pharyngeal swelling 34.17 9.88 73 238234 7646 79498435
Respiratory tract irritation 34.13 9.88 22 238285 603 79505478
Lipohypertrophy 33.83 9.88 25 238282 859 79505222
Affective disorder 33.79 9.88 76 238231 8243 79497838
Somnambulism 33.69 9.88 61 238246 5660 79500421
Joint range of motion decreased 33.51 9.88 30 238277 33252 79472829
Infusion site swelling 33.49 9.88 73 238234 7753 79498328
Ischaemic stroke 33.20 9.88 30 238277 33101 79472980
Cognitive disorder 33.12 9.88 103 238204 69823 79436258
Creatinine renal clearance decreased 33.11 9.88 8 238299 18994 79487087
Hyperbilirubinaemia 32.93 9.88 16 238291 24502 79481579
Altered state of consciousness 32.83 9.88 50 238257 43772 79462309
Asthenia 32.67 9.88 1225 237082 510464 78995617
Hypercalcaemia 32.67 9.88 40 238267 38390 79467691
Unresponsive to stimuli 32.63 9.88 74 238233 55714 79450367
Clostridium difficile colitis 32.63 9.88 29 238278 32254 79473827
Lymphocyte count decreased 32.58 9.88 57 238250 47232 79458849
Bacteraemia 32.56 9.88 30 238277 32794 79473287
Gamma-glutamyltransferase increased 32.41 9.88 72 238235 54608 79451473
Biliary dyskinesia 32.36 9.88 39 238268 2506 79503575
Hysterectomy 32.12 9.88 63 238244 6209 79499872
Hepatic encephalopathy 32.11 9.88 16 238291 24150 79481931
Sinus polyp 32.03 9.88 20 238287 518 79505563
Pneumocystis jirovecii pneumonia 31.91 9.88 30 238277 32478 79473603
Fluid retention 31.85 9.88 334 237973 69475 79436606
Hip arthroplasty 31.70 9.88 36 238271 35720 79470361
Prescribed underdose 31.69 9.88 25 238282 29489 79476592
Forced expiratory flow decreased 31.57 9.88 16 238291 273 79505808
Subarachnoid haemorrhage 31.32 9.88 17 238290 24448 79481633
Airway remodelling 31.31 9.88 16 238291 278 79505803
Temperature intolerance 31.20 9.88 81 238226 9624 79496457
Nephropathy toxic 31.18 9.88 11 238296 20408 79485673
Lung diffusion test decreased 31.00 9.88 28 238279 1282 79504799
Orthostatic hypotension 30.86 9.88 77 238230 56087 79449994
Increased viscosity of bronchial secretion 30.84 9.88 20 238287 554 79505527
Overdose 30.83 9.88 377 237930 183829 79322252
Osteonecrosis of jaw 30.79 9.88 51 238256 43175 79462906
Proteinuria 30.73 9.88 31 238276 32471 79473610
Polyp 30.65 9.88 72 238235 8035 79498046
Eye disorder 30.65 9.88 145 238162 23267 79482814
Diabetic ketoacidosis 30.64 9.88 34 238273 34088 79471993
Acute hepatic failure 30.49 9.88 27 238280 30086 79475995
Vasculitis 30.37 9.88 152 238155 24950 79481131
Hereditary angioedema 30.30 9.88 56 238251 5279 79500802
Panic attack 30.27 9.88 148 238159 24068 79482013
Lung disorder 30.23 9.88 371 237936 80186 79425895
Cholecystitis chronic 30.14 9.88 81 238226 9825 79496256
Pharyngitis streptococcal 30.02 9.88 85 238222 10629 79495452
Respiratory arrest 30.01 9.88 81 238226 57469 79448612
Increased bronchial secretion 29.91 9.88 43 238264 3284 79502797
Snoring 29.84 9.88 57 238250 5509 79500572
Renal tubular necrosis 29.79 9.88 19 238288 25020 79481061
Oropharyngeal discomfort 29.71 9.88 66 238241 7100 79498981
Psoriatic arthropathy 29.61 9.88 126 238181 77873 79428208
Drug-induced liver injury 29.50 9.88 100 238207 66017 79440064
Inhibitory drug interaction 29.50 9.88 50 238257 4403 79501678
Cytopenia 29.42 9.88 12 238295 20371 79485710
Oral allergy syndrome 29.40 9.88 11 238296 85 79505996
Hypocalcaemia 29.38 9.88 66 238241 49858 79456223
Sinus operation 29.38 9.88 37 238270 2488 79503593
Frequent bowel movements 29.30 9.88 27 238280 29512 79476569
Forced expiratory volume abnormal 29.29 9.88 12 238295 121 79505960
Laryngeal stenosis 29.25 9.88 25 238282 1063 79505018
Morbid thoughts 29.17 9.88 22 238285 780 79505301
Metastases to lung 29.11 9.88 9 238298 18154 79487927
Vomiting 29.02 9.88 1661 236646 664167 78841914
Blood bilirubin increased 29.00 9.88 101 238206 66131 79439950
Skin necrosis 28.92 9.88 9 238298 18078 79488003
Quality of life decreased 28.54 9.88 82 238225 10338 79495743
Total lung capacity abnormal 28.54 9.88 14 238293 222 79505859
Hepatotoxicity 28.53 9.88 70 238237 51282 79454799
Self-injurious ideation 28.39 9.88 44 238263 3594 79502487
Progressive multifocal leukoencephalopathy 28.35 9.88 13 238294 20587 79485494
Swelling 28.32 9.88 466 237841 216245 79289836
Infusion site pruritus 28.29 9.88 47 238260 4071 79502010
Haematuria 28.14 9.88 108 238199 68728 79437353
Drug tolerance decreased 28.11 9.88 3 238304 12975 79493106
Immune reconstitution inflammatory syndrome 28.02 9.88 4 238303 13837 79492244
Nocturnal fear 27.95 9.88 7 238300 9 79506072
Prostate cancer 27.89 9.88 35 238272 33233 79472848
Medication error 27.87 9.88 108 238199 68534 79437547
Condition aggravated 27.84 9.88 1219 237088 499905 79006176
Spirometry abnormal 27.77 9.88 23 238284 936 79505145
Influenza like illness 27.67 9.88 332 237975 71375 79434706
Glucose tolerance impaired 27.58 9.88 69 238238 8015 79498066
Mobility decreased 27.49 9.88 233 238074 121942 79384139
Intentional product misuse 27.46 9.88 169 238138 94996 79411085
Infusion site erythema 27.43 9.88 76 238231 9384 79496697
Peritonitis 27.37 9.88 26 238281 28010 79478071
Extrapyramidal disorder 27.27 9.88 17 238290 22662 79483419
Blood alkaline phosphatase increased 27.26 9.88 98 238209 63566 79442515
Fear 27.21 9.88 134 238173 21852 79484229
Cerebral infarction 27.19 9.88 60 238247 45616 79460465
Status epilepticus 27.15 9.88 21 238286 25020 79481061
Second primary malignancy 27.14 9.88 5 238302 14345 79491736
Inappropriate schedule of product administration 27.08 9.88 555 237752 133073 79373008
Lymphopenia 26.83 9.88 31 238276 30526 79475555
Atrioventricular block first degree 26.77 9.88 3 238304 12488 79493593
Injection site pruritus 26.72 9.88 217 238090 42066 79464015
Pneumothorax spontaneous 26.67 9.88 27 238280 1427 79504654
Sputum purulent 26.50 9.88 26 238281 1323 79504758
Bronchospasm paradoxical 26.45 9.88 12 238295 158 79505923
Electrolyte imbalance 26.40 9.88 32 238275 30849 79475232
Weight decreased 26.35 9.88 1306 237001 353892 79152189
Sinus bradycardia 26.34 9.88 22 238285 25225 79480856
Upper limb fracture 26.29 9.88 115 238192 17852 79488229
Emotional distress 26.28 9.88 207 238100 39762 79466319
Neurosensory hypoacusis 25.91 9.88 13 238294 217 79505864
Haemodialysis 25.74 9.88 11 238296 18157 79487924
Jaundice 25.68 9.88 78 238229 53271 79452810
Rectal haemorrhage 25.56 9.88 129 238178 76171 79429910
Incorrect dose administered 25.42 9.88 345 237962 76285 79429796
Lip swelling 25.34 9.88 209 238098 40702 79465379
Swollen tongue 25.05 9.88 215 238092 42355 79463726
Miosis 24.99 9.88 8 238299 15781 79490300
Posterior reversible encephalopathy syndrome 24.93 9.88 25 238282 26256 79479825
Emotional disorder 24.92 9.88 97 238210 14290 79491791
Haemorrhage intracranial 24.75 9.88 25 238282 26168 79479913
Thinking abnormal 24.67 9.88 91 238216 13070 79493011
Ulcer 24.64 9.88 32 238275 29940 79476141
Dysarthria 24.59 9.88 111 238196 67511 79438570
Blood cholesterol increased 23.99 9.88 149 238158 83571 79422510
Attention-seeking behaviour 23.97 9.88 10 238297 106 79505975
Torsade de pointes 23.89 9.88 14 238293 19298 79486783
Chronic kidney disease 23.82 9.88 109 238198 66045 79440036
Stevens-Johnson syndrome 23.69 9.88 51 238256 39115 79466966
Oesophageal polyp 23.68 9.88 9 238298 73 79506008
Febrile bone marrow aplasia 23.65 9.88 5 238302 13015 79493066
Acute generalised exanthematous pustulosis 23.57 9.88 11 238296 17243 79488838
Facet joint syndrome 23.51 9.88 3 238304 11299 79494782
Diffuse large B-cell lymphoma 23.49 9.88 4 238303 12145 79493936
Embolism venous 23.46 9.88 44 238263 4195 79501886
Blebitis 23.43 9.88 6 238301 9 79506072
Coagulopathy 23.38 9.88 45 238262 35961 79470120
Haematemesis 23.35 9.88 79 238228 52185 79453896
Upper gastrointestinal haemorrhage 23.31 9.88 56 238251 41324 79464757
Tachycardia 23.31 9.88 382 237925 177386 79328695
Neurodevelopmental disorder 23.10 9.88 8 238299 48 79506033
Metastases to central nervous system 23.06 9.88 10 238297 16365 79489716
Urinary retention 23.05 9.88 89 238218 56541 79449540
Attention deficit hyperactivity disorder 23.05 9.88 38 238269 3271 79502810
Pulmonary pain 22.99 9.88 45 238262 4428 79501653
Hypoalbuminaemia 22.92 9.88 18 238289 21279 79484802
Enuresis 22.83 9.88 37 238270 3139 79502942
Liver function test abnormal 22.76 9.88 107 238200 64368 79441713
Tenosynovitis 22.71 9.88 9 238298 15545 79490536
Injection site scab 22.68 9.88 14 238293 355 79505726
Knee arthroplasty 22.45 9.88 61 238246 43187 79462894
Infusion site haemorrhage 22.34 9.88 40 238267 3680 79502401
Sputum abnormal 22.31 9.88 23 238284 1242 79504839
Nasal mucosal disorder 22.30 9.88 14 238293 366 79505715
Appetite disorder 22.27 9.88 62 238245 7677 79498404
Myoclonus 22.26 9.88 30 238277 27630 79478451
Suicidal behaviour 22.23 9.88 37 238270 3210 79502871
Aortic valve stenosis 22.22 9.88 49 238258 5245 79500836
NPM1 gene mutation 22.16 9.88 10 238297 130 79505951
Syncope 22.10 9.88 390 237917 179059 79327022
Atrioventricular block complete 22.07 9.88 11 238296 16599 79489482
Colitis ulcerative 22.06 9.88 44 238263 34698 79471383
Hospitalisation 22.02 9.88 400 237907 93836 79412245
Panniculitis 21.97 9.88 5 238302 12366 79493715
Asthma exercise induced 21.96 9.88 10 238297 133 79505948
Functional residual capacity increased 21.86 9.88 9 238298 92 79505989
Homicidal ideation 21.83 9.88 38 238269 3419 79502662
Obsessive-compulsive disorder 21.72 9.88 52 238255 5875 79500206
Upper airway obstruction 21.72 9.88 24 238283 1404 79504677
Ligament pain 21.71 9.88 12 238295 246 79505835
Joint stiffness 21.64 9.88 57 238250 40773 79465308
Overweight 21.64 9.88 42 238265 4108 79501973
Dysphemia 21.61 9.88 38 238269 3446 79502635
Subdural haematoma 21.55 9.88 38 238269 31396 79474685
Pathogen resistance 21.43 9.88 8 238299 14334 79491747
Hyposmia 21.43 9.88 18 238289 747 79505334
Endocarditis fibroplastica 21.42 9.88 6 238301 15 79506066
Myelodysplastic syndrome 21.35 9.88 36 238271 30265 79475816
Nasal turbinate abnormality 21.27 9.88 7 238300 35 79506046
Injection site swelling 21.26 9.88 225 238082 46907 79459174
Cytomegalovirus viraemia 21.19 9.88 6 238301 12815 79493266
Exposure to allergen 21.12 9.88 13 238294 328 79505753
Onychophagia 21.12 9.88 9 238298 101 79505980
Injection site urticaria 21.03 9.88 85 238222 12741 79493340
Type 2 diabetes mellitus 20.97 9.88 262 238045 56860 79449221
Choking sensation 20.94 9.88 40 238267 3866 79502215
Blood phosphorus increased 20.92 9.88 3 238304 10344 79495737
Cortisol decreased 20.90 9.88 29 238278 2143 79503938
Intervertebral disc degeneration 20.83 9.88 98 238209 15687 79490394
CFTR gene mutation 20.81 9.88 9 238298 105 79505976
Ear swelling 20.75 9.88 25 238282 1606 79504475
Cold urticaria 20.58 9.88 9 238298 108 79505973
Mental disorder 20.52 9.88 162 238145 31140 79474941
Ligament sprain 20.33 9.88 87 238220 13377 79492704
Toxic skin eruption 20.25 9.88 22 238285 22271 79483810
Hiatus hernia 20.15 9.88 129 238178 23183 79482898
Poisoning deliberate 20.15 9.88 16 238291 18812 79487269
Palpitations 20.07 9.88 508 237799 126102 79379979
Electrocardiogram QRS complex prolonged 20.01 9.88 4 238303 10829 79495252
Nasal discomfort 19.98 9.88 48 238259 5435 79500646
Glomerular filtration rate decreased 19.97 9.88 23 238284 22679 79483402
Oliguria 19.92 9.88 12 238295 16297 79489784
Pulmonary renal syndrome 19.90 9.88 16 238291 624 79505457
Prothrombin time prolonged 19.86 9.88 13 238294 16886 79489195
Blood lactate dehydrogenase increased 19.77 9.88 56 238251 39114 79466967
Intestinal perforation 19.69 9.88 14 238293 17412 79488669
Acidosis 19.67 9.88 18 238289 19744 79486337
Ocular discomfort 19.66 9.88 45 238262 4938 79501143
Blood immunoglobulin G decreased 19.63 9.88 36 238271 3373 79502708
Lung opacity 19.62 9.88 46 238261 5128 79500953
Toxic encephalopathy 19.58 9.88 5 238302 11435 79494646
Nasal septum deviation 19.53 9.88 26 238281 1847 79504234
Sputum retention 19.45 9.88 20 238287 1077 79505004
Weight increased 19.34 9.88 1014 237293 276372 79229709
Lactose intolerance 19.34 9.88 29 238278 2301 79503780
Injection site movement impairment 19.31 9.88 6 238301 24 79506057
Sinus polyp degeneration 19.30 9.88 7 238300 49 79506032
Encephalitis 19.27 9.88 10 238297 14750 79491331
Muscular weakness 19.26 9.88 351 237956 160378 79345703
Nocturnal dyspnoea 19.19 9.88 24 238283 1602 79504479
Basal cell carcinoma 19.19 9.88 53 238254 37322 79468759
Shock haemorrhagic 19.12 9.88 19 238288 20041 79486040
Pigment dispersion syndrome 18.93 9.88 6 238301 26 79506055
Adrenal suppression 18.71 9.88 22 238285 1377 79504704
Oesophageal carcinoma 18.67 9.88 5 238302 11079 79495002
Shock 18.67 9.88 67 238240 43481 79462600
Pulmonary oedema 18.66 9.88 171 238136 88083 79417998
Blood potassium increased 18.65 9.88 37 238270 29238 79476843
Muscle spasticity 18.63 9.88 22 238285 21453 79484628
Ankle fracture 18.62 9.88 100 238207 16869 79489212
Klebsiella infection 18.60 9.88 12 238295 15708 79490373
Ileus 18.60 9.88 31 238276 26180 79479901
Airway peak pressure increased 18.45 9.88 12 238295 334 79505747
Child abuse 18.40 9.88 13 238294 416 79505665
Benign prostatic hyperplasia 18.29 9.88 76 238231 11536 79494545
Splenomegaly 18.28 9.88 21 238286 20733 79485348
Ventricular fibrillation 18.14 9.88 43 238264 31883 79474198
Allergy test positive 18.10 9.88 16 238291 712 79505369
Infusion site pain 17.98 9.88 87 238220 14089 79491992
Blood calcium decreased 17.97 9.88 43 238264 31776 79474305
Increased upper airway secretion 17.91 9.88 39 238268 4138 79501943
Lung hernia 17.88 9.88 7 238300 62 79506019
Inappropriate antidiuretic hormone secretion 17.87 9.88 32 238275 26281 79479800
Proctalgia 17.84 9.88 4 238303 9997 79496084
Injection site rash 17.83 9.88 103 238204 17851 79488230
Brain oedema 17.81 9.88 30 238277 25233 79480848
Diaphragmatic disorder 17.80 9.88 24 238283 1726 79504355
Injection site hypoaesthesia 17.77 9.88 14 238293 530 79505551
Sleep talking 17.68 9.88 19 238288 1077 79505004
Hepatic cirrhosis 17.55 9.88 50 238257 34856 79471225
Blood lactic acid 17.51 9.88 13 238294 450 79505631
Ataxia 17.41 9.88 30 238277 25009 79481072
Atrial fibrillation 17.40 9.88 454 237853 197432 79308649
Product dose omission in error 17.33 9.88 57 238250 7731 79498350
Drug eruption 17.28 9.88 70 238237 43865 79462216
Respiratory failure 17.27 9.88 410 237897 180501 79325580
Mycotic allergy 17.26 9.88 22 238285 1497 79504584
Hepatitis C 17.25 9.88 7 238300 11918 79494163
Pulmonary artery stenosis congenital 17.19 9.88 5 238302 15 79506066
Meningitis eosinophilic 17.19 9.88 5 238302 15 79506066
Muscle tension dysphonia 17.18 9.88 9 238298 165 79505916
Renal disorder 17.15 9.88 197 238110 41908 79464173
Haemophilus infection 17.03 9.88 27 238280 2249 79503832
Aplastic anaemia 17.02 9.88 17 238290 17888 79488193
Hyperkaliuria 16.99 9.88 9 238298 169 79505912
Ileus paralytic 16.86 9.88 4 238303 9616 79496465
Tachypnoea 16.81 9.88 45 238262 32018 79474063
Speech disorder 16.79 9.88 242 238065 54203 79451878
Infusion site bruising 16.78 9.88 31 238276 2921 79503160
Chest pain 16.77 9.88 1017 237290 281287 79224794
Catatonia 16.67 9.88 3 238304 8753 79497328
Prostatomegaly 16.66 9.88 34 238273 3449 79502632
Pharyngeal oedema 16.59 9.88 94 238213 16178 79489903
Hepatitis 16.58 9.88 98 238209 55629 79450452
Vasomotor rhinitis 16.53 9.88 9 238298 179 79505902
Infection 16.44 9.88 574 237733 241138 79264943
Drug use disorder 16.39 9.88 3 238304 8648 79497433
Drug ineffective for unapproved indication 16.39 9.88 88 238219 51150 79454931
Hallucination 16.35 9.88 353 237954 85392 79420689
Ejection fraction decreased 16.32 9.88 51 238256 34526 79471555
Gluten sensitivity 16.27 9.88 12 238295 411 79505670
Hypertensive crisis 16.24 9.88 23 238284 20747 79485334
Pregnancy 16.21 9.88 35 238272 26816 79479265
Decreased activity 16.20 9.88 60 238247 8634 79497447
Abdominal pain 16.18 9.88 976 237331 388593 79117488
Arthralgia 16.16 9.88 1480 236827 570323 78935758
Panic reaction 16.11 9.88 40 238267 4625 79501456
Hypercapnia 16.10 9.88 61 238246 8874 79497207
Bronchitis chronic 16.08 9.88 39 238268 4443 79501638
Fall 16.04 9.88 1247 237060 486382 79019699
Dialysis 15.92 9.88 19 238288 18443 79487638
Enterococcal infection 15.91 9.88 14 238293 15646 79490435
Bladder cancer 15.89 9.88 21 238286 19505 79486576
Vocal cord disorder 15.85 9.88 21 238286 1485 79504596
Gastric haemorrhage 15.84 9.88 13 238294 15037 79491044
Hemiparesis 15.75 9.88 50 238257 33683 79472398
Eosinophil count abnormal 15.74 9.88 15 238292 736 79505345
Allergic sinusitis 15.72 9.88 16 238291 851 79505230
Product taste abnormal 15.71 9.88 26 238281 2245 79503836
Foot deformity 15.71 9.88 30 238277 24044 79482037
Abdominal pain lower 15.63 9.88 46 238261 31736 79474345
Urosepsis 15.61 9.88 35 238272 26460 79479621
Femur fracture 15.57 9.88 61 238246 38591 79467490
Muscle rigidity 15.56 9.88 22 238285 19860 79486221
Blood parathyroid hormone decreased 15.54 9.88 6 238301 10530 79495551
Premature delivery 15.52 9.88 29 238278 23438 79482643
Hypothyroidism 15.42 9.88 231 238076 52161 79453920
Peripheral sensory neuropathy 15.35 9.88 10 238297 13023 79493058
Acute pulmonary oedema 15.35 9.88 12 238295 14218 79491863
Steroid diabetes 15.34 9.88 33 238274 3473 79502608
Injection site erythema 15.25 9.88 323 237984 77874 79428207
Gangrene 15.18 9.88 4 238303 8960 79497121
Hypothermia 15.14 9.88 28 238279 22718 79483363
Haematocrit decreased 15.14 9.88 114 238193 61198 79444883
Chimerism 15.14 9.88 10 238297 286 79505795
Seizure 15.11 9.88 439 237868 188395 79317686
Hypohidrosis 15.11 9.88 10 238297 287 79505794
Breast conserving surgery 15.10 9.88 15 238292 775 79505306
Musculoskeletal pain 15.10 9.88 215 238092 102139 79403942
Obesity 15.06 9.88 166 238141 34959 79471122
Spinal operation 15.06 9.88 55 238252 7862 79498219
Dizziness exertional 15.05 9.88 13 238294 561 79505520
Duodenal ulcer 15.04 9.88 16 238291 16353 79489728
Sputum culture 14.98 9.88 9 238298 217 79505864
Skin lesion 14.96 9.88 191 238116 41653 79464428
Pulmonary thrombosis 14.94 9.88 74 238233 12097 79493984
Mucosal discolouration 14.89 9.88 15 238292 788 79505293
Product availability issue 14.86 9.88 35 238272 3912 79502169
Body temperature abnormal 14.86 9.88 26 238281 2349 79503732
Kidney transplant rejection 14.84 9.88 6 238301 10240 79495841
Eye paraesthesia 14.83 9.88 8 238299 156 79505925
Breast neoplasm 14.76 9.88 16 238291 916 79505165
Sedation complication 14.75 9.88 15 238292 15654 79490427
Gastric cancer 14.68 9.88 6 238301 10173 79495908
Delusion 14.63 9.88 24 238283 20399 79485682
Therapeutic response unexpected 14.63 9.88 106 238201 19840 79486241
Hallucination, auditory 14.63 9.88 109 238198 20584 79485497
Tumour lysis syndrome 14.62 9.88 31 238276 23908 79482173
Hypernatraemia 14.58 9.88 13 238294 14438 79491643
Body mass index increased 14.56 9.88 23 238284 1910 79504171
Leukoencephalopathy 14.50 9.88 3 238304 7926 79498155
Skin swelling 14.48 9.88 35 238272 3979 79502102
Osteomyelitis 14.46 9.88 50 238257 32815 79473266
Pigmentary glaucoma 14.45 9.88 3 238304 0 79506081
Sleep study abnormal 14.45 9.88 3 238304 0 79506081
Hypovolaemia 14.43 9.88 19 238288 17672 79488409
Gastroenteritis viral 14.40 9.88 125 238182 24706 79481375
Psoriasis 14.36 9.88 360 237947 89227 79416854
Bronchopulmonary aspergillosis 14.36 9.88 28 238279 22266 79483815
Urinary tract infection 14.35 9.88 672 237635 273840 79232241
Pyrexia 14.32 9.88 1793 236514 676916 78829165
Blood albumin decreased 14.30 9.88 32 238275 24211 79481870
Oral pruritus 14.29 9.88 26 238281 2422 79503659
Peak expiratory flow rate increased 14.28 9.88 4 238303 10 79506071
Oxygen saturation decreased 14.24 9.88 495 237812 128552 79377529
Dermatitis acneiform 14.24 9.88 6 238301 9987 79496094
Cardiac tamponade 14.16 9.88 5 238302 9271 79496810
Mouth swelling 14.11 9.88 45 238262 6006 79500075
Endocarditis 14.10 9.88 7 238300 10590 79495491
Paternal exposure during pregnancy 14.03 9.88 6 238301 68 79506013
School refusal 13.91 9.88 5 238302 34 79506047
Bronchiolitis obliterans syndrome 13.91 9.88 10 238297 329 79505752
Obsessive thoughts 13.83 9.88 17 238290 1115 79504966
Hypervolaemia 13.83 9.88 73 238234 42617 79463464
Uveitis 13.80 9.88 18 238289 16812 79489269
Allergic respiratory disease 13.78 9.88 7 238300 120 79505961
Adenotonsillectomy 13.72 9.88 6 238301 72 79506009
Conjunctivitis allergic 13.70 9.88 21 238286 1699 79504382
Pneumonia viral 13.69 9.88 59 238248 9099 79496982
Grip strength decreased 13.62 9.88 28 238279 21841 79484240
Cystic fibrosis respiratory infection suppression 13.59 9.88 11 238296 433 79505648
Nodular vasculitis 13.55 9.88 5 238302 37 79506044
Bone density decreased 13.54 9.88 77 238230 13270 79492811
Incorrect route of product administration 13.52 9.88 56 238251 34873 79471208
Laryngospasm 13.51 9.88 34 238273 3963 79502118
Bronchiolitis 13.51 9.88 35 238272 4153 79501928
Injection site eczema 13.50 9.88 6 238301 75 79506006
Blood uric acid increased 13.50 9.88 12 238295 13348 79492733
Otorrhoea 13.47 9.88 21 238286 1724 79504357
Faecaloma 13.45 9.88 9 238298 11555 79494526
Depressive symptom 13.40 9.88 46 238261 6377 79499704
Epstein-Barr virus infection 13.35 9.88 14 238293 14402 79491679
Drug level decreased 13.32 9.88 14 238293 14388 79491693
Concussion 13.28 9.88 60 238247 9443 79496638
Nasal pruritus 13.28 9.88 12 238295 550 79505531
Device related infection 13.26 9.88 55 238252 34239 79471842
Oral mucosal blistering 13.25 9.88 45 238262 6206 79499875
Vaccination site pain 13.20 9.88 8 238299 196 79505885
Mental status changes 13.20 9.88 132 238175 66827 79439254
Abdominal distension 13.19 9.88 265 238042 119385 79386696
Granulocytopenia 13.16 9.88 9 238298 11422 79494659
Upper respiratory tract congestion 13.15 9.88 26 238281 2577 79503504
Pneumonia mycoplasmal 13.14 9.88 19 238288 1459 79504622
Functional residual capacity decreased 13.09 9.88 6 238301 81 79506000
BK virus infection 13.01 9.88 5 238302 8799 79497282
Vaccination site swelling 13.00 9.88 5 238302 42 79506039
Respiratory fume inhalation disorder 12.99 9.88 8 238299 202 79505879
Sinus headache 12.98 9.88 39 238268 5041 79501040
Fatigue 12.93 9.88 3049 235258 926678 78579403
Respiratory syncytial virus infection 12.87 9.88 59 238248 9343 79496738
Febrile convulsion 12.86 9.88 15 238292 931 79505150
Insurance issue 12.80 9.88 42 238265 5691 79500390
Cytomegalovirus infection reactivation 12.80 9.88 5 238302 8711 79497370
Bradyphrenia 12.76 9.88 8 238299 10632 79495449
Anaphylactic shock 12.74 9.88 164 238143 35832 79470249
Expiratory reserve volume decreased 12.71 9.88 6 238301 87 79505994
Pneumococcal infection 12.71 9.88 15 238292 943 79505138
Alice in wonderland syndrome 12.70 9.88 5 238302 45 79506036
Lymphostasis 12.68 9.88 4 238303 17 79506064
Duodenitis 12.67 9.88 4 238303 7963 79498118
Eosinophilic pneumonia acute 12.63 9.88 16 238291 1082 79504999
Colorectal cancer 12.63 9.88 5 238302 8642 79497439
Suspected suicide 12.62 9.88 8 238299 10568 79495513
Epilepsy 12.61 9.88 71 238236 40789 79465292
Blood pressure systolic abnormal 12.61 9.88 20 238287 17227 79488854
Product appearance confusion 12.61 9.88 5 238302 46 79506035
Enteritis 12.58 9.88 15 238292 14568 79491513
Mandibular mass 12.58 9.88 8 238299 214 79505867
Troponin increased 12.56 9.88 24 238283 19231 79486850
Acute sinusitis 12.55 9.88 36 238271 4534 79501547
Gastroenteritis eosinophilic 12.52 9.88 9 238298 296 79505785
Pulmonary congestion 12.52 9.88 130 238177 26970 79479111
Cephalo-pelvic disproportion 12.51 9.88 7 238300 147 79505934
Hepatic cancer 12.51 9.88 8 238299 10521 79495560
Eye irritation 12.46 9.88 105 238202 20576 79485505
Respiratory gas exchange disorder 12.42 9.88 14 238293 837 79505244
Hyperammonaemia 12.42 9.88 9 238298 11084 79494997
Myositis 12.41 9.88 24 238283 19144 79486937
Choking 12.40 9.88 70 238237 12031 79494050
Cachexia 12.40 9.88 9 238298 11074 79495007
Psychological trauma 12.39 9.88 18 238289 1388 79504693
Cushingoid 12.38 9.88 59 238248 9493 79496588
Platelet adhesiveness decreased 12.38 9.88 3 238304 3 79506078
Chronic rhinosinusitis with nasal polyps 12.38 9.88 3 238304 3 79506078
Fight in school 12.38 9.88 3 238304 3 79506078
Upper airway resistance syndrome 12.38 9.88 3 238304 3 79506078
Allergy to fermented products 12.38 9.88 3 238304 3 79506078
Serum ferritin increased 12.38 9.88 7 238300 9840 79496241
Periorbital swelling 12.38 9.88 27 238280 2869 79503212
Abortion 12.35 9.88 18 238289 1392 79504689
Ventricular tachycardia 12.34 9.88 74 238233 41861 79464220
Cold agglutinins positive 12.33 9.88 5 238302 49 79506032
Autophobia 12.32 9.88 4 238303 19 79506062
Malnutrition 12.24 9.88 31 238276 22471 79483610
Drug ineffective 12.23 9.88 2955 235352 1077958 78428123
Lupus-like syndrome 12.23 9.88 14 238293 13843 79492238
Drug level below therapeutic 12.20 9.88 7 238300 9763 79496318
Mycobacterial infection 12.19 9.88 31 238276 3637 79502444
Self esteem decreased 12.16 9.88 15 238292 987 79505094
Ear pain 12.16 9.88 151 238156 32718 79473363
Systemic infection 12.16 9.88 7 238300 9745 79496336
Cronobacter infection 12.16 9.88 4 238303 20 79506061
Akathisia 12.14 9.88 13 238294 13246 79492835
Gastric ulcer 12.12 9.88 56 238251 33849 79472232
Stiff person syndrome 12.08 9.88 9 238298 313 79505768
Diverticulum oesophageal 12.06 9.88 7 238300 158 79505923
Infusion site mass 12.06 9.88 19 238288 1574 79504507
Unintentional medical device removal 12.04 9.88 4 238303 7708 79498373
Renal injury 12.03 9.88 20 238287 16907 79489174
Autism spectrum disorder 12.03 9.88 16 238291 1136 79504945
Hyperreflexia 12 9.88 5 238302 8380 79497701
Breast cancer 11.99 9.88 154 238153 33627 79472454
Neuritis 11.99 9.88 20 238287 1738 79504343
Allergy to plants 11.97 9.88 13 238294 746 79505335
Therapy partial responder 11.95 9.88 21 238286 17376 79488705
Systemic inflammatory response syndrome 11.95 9.88 10 238297 11455 79494626
Transaminases increased 11.94 9.88 98 238209 51645 79454436
Red blood cell count decreased 11.92 9.88 112 238195 57401 79448680
Polyneuropathy 11.85 9.88 35 238272 24116 79481965
Sinonasal obstruction 11.84 9.88 9 238298 323 79505758
Oesophagogastroduodenoscopy 11.80 9.88 8 238299 239 79505842
Injection site bruising 11.77 9.88 180 238127 40822 79465259
Head banging 11.71 9.88 11 238296 530 79505551
Abnormal weight gain 11.70 9.88 25 238282 2619 79503462
Graft versus host disease in lung 11.64 9.88 14 238293 898 79505183
Myalgia 11.63 9.88 672 237635 184969 79321112
Acute coronary syndrome 11.59 9.88 29 238278 21104 79484977
Distal intestinal obstruction syndrome 11.58 9.88 13 238294 774 79505307
Bacterial sepsis 11.55 9.88 5 238302 8193 79497888
Blood immunoglobulin E decreased 11.55 9.88 6 238301 108 79505973
Ventricular arrhythmia 11.53 9.88 6 238301 8834 79497247
Dyskinesia oesophageal 11.51 9.88 5 238302 59 79506022
Lower gastrointestinal haemorrhage 11.51 9.88 19 238288 16106 79489975
Embolism 11.42 9.88 15 238292 13967 79492114
Defiant behaviour 11.42 9.88 4 238303 25 79506056
Enterocolitis 11.42 9.88 16 238291 14496 79491585
Constipation 11.41 9.88 711 237596 282339 79223742
Flushing 11.40 9.88 345 237962 87923 79418158
Formication 11.39 9.88 37 238270 4986 79501095
Venoocclusive liver disease 11.39 9.88 11 238296 11760 79494321
Systemic candida 11.34 9.88 3 238304 6703 79499378
Hypovolaemic shock 11.28 9.88 12 238295 12264 79493817
Anal abscess 11.26 9.88 7 238300 9348 79496733
Paranasal sinus discomfort 11.19 9.88 34 238273 4422 79501659
Cholangitis 11.18 9.88 13 238294 12763 79493318
Cough variant asthma 11.17 9.88 3 238304 6 79506075
Hyperventilation 11.13 9.88 50 238257 7849 79498232
Atrioventricular block second degree 11.06 9.88 4 238303 7308 79498773
Viral myelitis 11.03 9.88 6 238301 119 79505962
Small airways disease 11.03 9.88 4 238303 28 79506053
COVID-19 immunisation 11.03 9.88 17 238290 1382 79504699
Crepitations 10.97 9.88 59 238248 9958 79496123
Lip discolouration 10.94 9.88 12 238295 696 79505385
Female genital tract fistula 10.94 9.88 41 238266 5934 79500147
Metastases to lymph nodes 10.92 9.88 9 238298 10388 79495693
Drug withdrawal syndrome 10.90 9.88 60 238247 34658 79471423
Dry skin 10.82 9.88 273 238034 67722 79438359
Exposure to toxic agent 10.82 9.88 7 238300 9151 79496930
Blood immunoglobulin E abnormal 10.79 9.88 4 238303 30 79506051
Peripheral swelling 10.74 9.88 678 237629 268939 79237142
Blood lactic acid increased 10.70 9.88 70 238237 12674 79493407
Blood creatinine decreased 10.67 9.88 5 238302 7820 79498261
Vascular device infection 10.66 9.88 9 238298 10267 79495814
Pulmonary arterial hypertension 10.65 9.88 46 238261 28320 79477761
Heparin-induced thrombocytopenia 10.65 9.88 8 238299 9674 79496407
Violence-related symptom 10.63 9.88 12 238295 719 79505362
Gout 10.63 9.88 117 238190 24632 79481449
Diabetes mellitus inadequate control 10.62 9.88 37 238270 24227 79481854
Product container issue 10.62 9.88 16 238291 1275 79504806
Eyelid infection 10.58 9.88 9 238298 380 79505701
Aphasia 10.56 9.88 89 238218 46643 79459438
Fracture pain 10.56 9.88 12 238295 724 79505357
Photosensitivity reaction 10.55 9.88 103 238204 21024 79485057
Blood calcium increased 10.55 9.88 60 238247 10340 79495741
Growth retardation 10.54 9.88 20 238287 1923 79504158
Oral herpes 10.54 9.88 127 238180 27327 79478754
Immunosuppressant drug level increased 10.53 9.88 7 238300 9020 79497061
Dystonia 10.50 9.88 31 238276 21368 79484713
Adjustment disorder 10.50 9.88 31 238276 3969 79502112
Colitis microscopic 10.49 9.88 10 238297 10758 79495323
Occupational exposure to dust 10.46 9.88 4 238303 33 79506048
Pertussis 10.46 9.88 13 238294 862 79505219
Pulmonary toxicity 10.40 9.88 14 238293 12900 79493181
Animal scratch 10.36 9.88 17 238290 1457 79504624
Hepatitis B 10.36 9.88 6 238301 8326 79497755
Measles 10.35 9.88 9 238298 392 79505689
Paraesthesia oral 10.32 9.88 100 238207 20371 79485710
Blood immunoglobulin E 10.32 9.88 3 238304 9 79506072
Hemiplegia 10.30 9.88 18 238289 14921 79491160
Skin atrophy 10.27 9.88 39 238268 5679 79500402
Bronchitis viral 10.21 9.88 15 238292 1168 79504913
Hepatic cytolysis 10.21 9.88 44 238263 27107 79478974
Hepatic lesion 10.20 9.88 4 238303 6955 79499126
Administration site reaction 10.20 9.88 6 238301 139 79505942
Laryngitis fungal 10.16 9.88 6 238301 140 79505941
Benign renal neoplasm 10.16 9.88 4 238303 36 79506045
Hyperplastic cholecystopathy 10.13 9.88 7 238300 216 79505865
Bronchitis bacterial 10.13 9.88 17 238290 1485 79504596
Enterobiasis 10.07 9.88 4 238303 37 79506044
Ankylosing spondylitis 10.06 9.88 13 238294 12192 79493889
PCO2 increased 10.06 9.88 19 238288 1821 79504260
Retinal artery embolism 10.05 9.88 6 238301 143 79505938
Infusion site extravasation 10.05 9.88 58 238249 10050 79496031
Squamous cell carcinoma of the oral cavity 10.04 9.88 10 238297 518 79505563
Alopecia areata 10.04 9.88 19 238288 1824 79504257
Neurogenic shock 10.02 9.88 11 238296 639 79505442
Hand fracture 10.01 9.88 41 238266 6184 79499897
Euglycaemic diabetic ketoacidosis 9.93 9.88 4 238303 6840 79499241

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R03DC03 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Leukotriene receptor antagonists
ATC R03DC53 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Leukotriene receptor antagonists
FDA MoA N0000000083 Leukotriene Receptor Antagonists
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D065694 Cytochrome P-450 CYP1A2 Inducers
MeSH PA D006727 Hormone Antagonists
MeSH PA D020024 Leukotriene Antagonists
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D019141 Respiratory System Agents
FDA EPC N0000175777 Leukotriene Receptor Antagonist
CHEBI has role CHEBI:38070 antiarrhythmic agent
CHEBI has role CHEBI:49159 leukotriene antagonists
CHEBI has role CHEBI:49167 anti-asthmatic drugs

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Allergic rhinitis indication 61582004
Non-allergic asthma indication 266361008 DOID:9360
Allergic asthma indication 389145006 DOID:9415
Asthma management indication 406162001
Exercise-Induced Bronchospasm Prevention indication
Suicidal thoughts contraindication 6471006
Hallucinations contraindication 7011001
Mood swings contraindication 18963009
Feeling agitated contraindication 24199005
Depressive disorder contraindication 35489007
Anxiety contraindication 48694002
Vasculitis of the skin contraindication 53312001
Dream disorder contraindication 85418005
Eosinophil count raised contraindication 386789004
Tremors contraindication
Nervousness contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.28 acidic
pKa2 4.98 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Cysteinyl leukotriene receptor 1 GPCR ANTAGONIST Ki 9.30 CHEMBL CHEMBL
Alpha-2A adrenergic receptor GPCR Ki 5.83 DRUG MATRIX
Sodium-dependent noradrenaline transporter Transporter Ki 5.57 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 5.40 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 5.58 DRUG MATRIX
Muscarinic acetylcholine receptor M1 GPCR Ki 5.71 DRUG MATRIX
Muscarinic acetylcholine receptor M3 GPCR Ki 5.85 DRUG MATRIX
Beta-3 adrenergic receptor GPCR Ki 5.50 DRUG MATRIX
Alpha-2C adrenergic receptor GPCR Ki 6.12 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 5.69 DRUG MATRIX
Adenosine receptor A3 GPCR Ki 6.61 DRUG MATRIX
Cytochrome P450 2C8 Enzyme Ki 5.96 WOMBAT-PK
Delta-type opioid receptor GPCR Ki 5.77 DRUG MATRIX
Arachidonate 5-lipoxygenase Enzyme Ki 4.33 WOMBAT-PK
Epidermal growth factor receptor Kinase IC50 5.50 DRUG MATRIX
Tyrosine-protein kinase Fyn Kinase IC50 5.33 DRUG MATRIX
Thromboxane-A synthase Enzyme IC50 5.82 DRUG MATRIX
Cysteinyl leukotriene receptor 2 GPCR Ki 5.30 PDSP
Mitogen-activated protein kinase 14 Kinase IC50 6.07 DRUG MATRIX
Substance-K receptor GPCR Ki 5.90 DRUG MATRIX
Uracil nucleotide/cysteinyl leukotriene receptor GPCR Ki 5.18 CHEMBL
Beta-2 adrenergic receptor GPCR Ki 5.62 DRUG MATRIX
Cysteinyl leukotriene receptor 1 GPCR Ki 9.30 CHEMBL
Uracil nucleotide/cysteinyl leukotriene receptor GPCR ANTAGONIST IC50 7.21 IUPHAR

External reference:

IDSource
4024117 VUID
N0000022122 NUI
D00529 KEGG_DRUG
151767-02-1 SECONDARY_CAS_RN
4021110 VANDF
4024117 VANDF
C0298130 UMLSCUI
CHEBI:50730 CHEBI
MTK PDB_CHEM_ID
CHEMBL787 ChEMBL_ID
CHEMBL1200681 ChEMBL_ID
DB00471 DRUGBANK_ID
C093875 MESH_SUPPLEMENTAL_RECORD_UI
3340 IUPHAR_LIGAND_ID
7388 INN_ID
MHM278SD3E UNII
5281040 PUBCHEM_CID
115713 RXNORM
11578 MMSL
189710 MMSL
5134 MMSL
d04289 MMSL
007256 NDDF
007257 NDDF
108620002 SNOMEDCT_US
320883008 SNOMEDCT_US
373728005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0093-7487 GRANULE 4 mg ORAL ANDA 31 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0093-7487 GRANULE 4 mg ORAL ANDA 31 sections
MONTELUKAST HUMAN PRESCRIPTION DRUG LABEL 1 0143-9649 TABLET, FILM COATED 10 mg ORAL ANDA 25 sections
MONTELUKAST HUMAN PRESCRIPTION DRUG LABEL 1 0143-9650 TABLET, CHEWABLE 5 mg ORAL ANDA 25 sections
MONTELUKAST HUMAN PRESCRIPTION DRUG LABEL 1 0143-9651 TABLET, CHEWABLE 4 mg ORAL ANDA 25 sections
Montelukast HUMAN PRESCRIPTION DRUG LABEL 1 0781-5554 TABLET, CHEWABLE 4 mg ORAL ANDA 28 sections
Montelukast HUMAN PRESCRIPTION DRUG LABEL 1 0781-5555 TABLET, CHEWABLE 5 mg ORAL ANDA 28 sections
Montelukast HUMAN PRESCRIPTION DRUG LABEL 1 0781-5560 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Montelukast HUMAN PRESCRIPTION DRUG LABEL 1 0904-6808 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-079 TABLET, CHEWABLE 4 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-079 TABLET, CHEWABLE 4 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-079 TABLET, CHEWABLE 4 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-079 TABLET, CHEWABLE 4 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-080 TABLET, CHEWABLE 5 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-080 TABLET, CHEWABLE 5 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-080 TABLET, CHEWABLE 5 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-080 TABLET, CHEWABLE 5 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-081 TABLET 10 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-081 TABLET 10 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-081 TABLET 10 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-081 TABLET 10 mg ORAL ANDA 29 sections
MONTELUKAST SODIUM ORAL HUMAN PRESCRIPTION DRUG LABEL 1 13668-531 GRANULE 4 mg ORAL ANDA 19 sections
MONTELUKAST SODIUM ORAL HUMAN PRESCRIPTION DRUG LABEL 1 13668-531 GRANULE 4 mg ORAL ANDA 19 sections
MONTELUKAST SODIUM ORAL HUMAN PRESCRIPTION DRUG LABEL 1 13668-531 GRANULE 4 mg ORAL ANDA 19 sections
MONTELUKAST SODIUM ORAL HUMAN PRESCRIPTION DRUG LABEL 1 13668-531 GRANULE 4 mg ORAL ANDA 19 sections
MONTELUKAST SODIUM ORAL HUMAN PRESCRIPTION DRUG LABEL 1 13668-531 GRANULE 4 mg ORAL ANDA 19 sections
MONTELUKAST SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 16571-100 TABLET 10 mg ORAL ANDA 20 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 16729-119 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
SINGULAIR HUMAN PRESCRIPTION DRUG LABEL 1 21695-221 TABLET, FILM COATED 10 mg ORAL NDA 28 sections
SINGULAIR HUMAN PRESCRIPTION DRUG LABEL 1 21695-565 TABLET, CHEWABLE 5 mg ORAL NDA 28 sections