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

Stem definitionDrug idCAS RN
diphenylmethyl piperazine derivatives 581 83881-51-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • cetirizine
  • cetirizine hydrochloride
  • cetirizine dihydrochloride
  • cetirizine HCl
A potent second-generation histamine H1 antagonist that is effective in the treatment of allergic rhinitis, chronic urticaria, and pollen-induced asthma. Unlike many traditional antihistamines, it does not cause drowsiness or anticholinergic side effects.
  • Molecular weight: 388.89
  • Formula: C21H25ClN2O3
  • CLOGP: 2.08
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 53.01
  • ALOGS: -3.77
  • ROTB: 8
  • 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) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.10 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.37 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 90 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Dec. 8, 1995 FDA J AND J CONSUMER INC

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
Pemphigus 2620.44 10.29 3022 235180 117144 50249778
Systemic lupus erythematosus 2323.71 10.29 3076 235126 137546 50229376
Glossodynia 2181.01 10.29 2701 235501 112868 50254054
Hand deformity 1584.56 10.29 2147 236055 98052 50268870
Abdominal discomfort 1465.24 10.29 3309 234893 228332 50138590
Alopecia 1448.32 10.29 3408 234794 241639 50125283
Swelling 1389.36 10.29 2975 235227 197897 50169025
Wound 1360.99 10.29 2055 236147 103739 50263183
Pericarditis 1127.92 10.29 1609 236593 77080 50289842
Discomfort 1108.57 10.29 1897 236305 106483 50260439
Contraindicated product administered 1105.52 10.29 2272 235930 146686 50220236
Anti-cyclic citrullinated peptide antibody positive 1009.53 10.29 1442 236760 69145 50297777
Hypersensitivity 934.88 10.29 2668 235534 212493 50154429
Arthropathy 868.30 10.29 2138 236064 155768 50211154
Maternal exposure during pregnancy 844.52 10.29 2131 236071 157647 50209275
Pain 721.65 10.29 4919 233283 573984 49792938
Muscle injury 684.88 10.29 859 237343 36252 50330670
Duodenal ulcer perforation 675.74 10.29 948 237254 44663 50322259
Folliculitis 673.56 10.29 876 237326 38349 50328573
Infusion related reaction 664.52 10.29 2028 236174 167529 50199393
Blister 635.21 10.29 1305 236897 84113 50282809
Helicobacter infection 630.41 10.29 960 237242 48742 50318180
Synovitis 621.85 10.29 1621 236581 122244 50244678
Irritable bowel syndrome 605.56 10.29 960 237242 50481 50316441
Hepatic enzyme increased 589.25 10.29 1697 236505 135683 50231239
Death 560.48 10.29 428 237774 324951 50041971
Rash 541.49 10.29 3714 234488 433757 49933165
Rheumatoid factor positive 489.77 10.29 858 237344 49001 50317921
Pruritus 488.63 10.29 2625 235577 280943 50085979
Urticaria 487.09 10.29 1528 236674 128033 50238889
Product use issue 480.82 10.29 1672 236530 147803 50219119
Sinusitis 461.50 10.29 1804 236398 168754 50198168
Lower respiratory tract infection 443.25 10.29 1212 236990 93989 50272933
Sleep disorder due to general medical condition, insomnia type 439.70 10.29 636 237566 30811 50336111
Joint swelling 416.40 10.29 2262 235940 243024 50123898
Fatigue 406.37 10.29 5091 233111 702510 49664412
Acute kidney injury 398.71 10.29 295 237907 227763 50139159
Toxicity to various agents 396.53 10.29 256 237946 212243 50154679
Anaemia 379.90 10.29 377 237825 252079 50114843
Ill-defined disorder 364.36 10.29 799 237403 53855 50313067
Impaired healing 362.92 10.29 926 237276 68860 50298062
Therapeutic product effect decreased 339.75 10.29 1404 236798 134646 50232276
Drug intolerance 335.54 10.29 1966 236236 217138 50149784
Hip arthroplasty 301.78 10.29 526 237676 29903 50337019
Completed suicide 289.63 10.29 129 238073 131760 50235162
Fall 284.46 10.29 732 237470 334200 50032722
Drug interaction 283.38 10.29 313 237889 199308 50167614
Rheumatic fever 257.74 10.29 356 237846 16511 50350411
Knee arthroplasty 253.70 10.29 537 237665 35309 50331613
Gastrointestinal disorder 245.33 10.29 987 237215 93469 50273453
Neutropenia 241.27 10.29 205 237997 147760 50219162
Swollen joint count increased 236.45 10.29 320 237882 14553 50352369
Rheumatoid arthritis 232.55 10.29 1691 236511 200859 50166063
Hypotension 220.86 10.29 488 237714 234981 50131941
Stomatitis 220.01 10.29 1003 237199 100341 50266581
Pneumonia 211.63 10.29 989 237213 377412 49989510
Asthma 191.53 10.29 881 237321 88456 50278466
Thrombocytopenia 191.38 10.29 191 238011 127482 50239440
Food allergy 189.12 10.29 212 237990 7925 50358997
Diarrhoea 183.28 10.29 1830 236372 586646 49780276
Sepsis 174 10.29 222 237980 132703 50234219
Malignant neoplasm progression 160.24 10.29 60 238142 68064 50298858
Nausea 156.24 10.29 2361 235841 703037 49663885
Febrile neutropenia 148.78 10.29 144 238058 97523 50269399
Hyponatraemia 148.49 10.29 140 238062 95999 50270923
Type 2 diabetes mellitus 148.34 10.29 426 237776 33949 50332973
Temperature regulation disorder 145.33 10.29 136 238066 4091 50362831
Treatment failure 137.06 10.29 1112 237090 136525 50230397
Myocardial infarction 131.31 10.29 135 238067 88892 50278030
Pancytopenia 129.02 10.29 123 238079 83907 50283015
Disease progression 127.62 10.29 158 238044 95708 50271214
Septic shock 126.89 10.29 55 238147 57120 50309802
Urinary tract infection 122.33 10.29 590 237612 223430 50143492
Haemoglobin decreased 122.15 10.29 260 237942 126956 50239966
Nasopharyngitis 122.12 10.29 1417 236785 191510 50175412
Cardiac failure 121.86 10.29 107 238095 75933 50290989
Cardio-respiratory arrest 119.35 10.29 52 238150 53840 50313082
Contusion 119.14 10.29 920 237282 111263 50255659
Coeliac disease 117.49 10.29 173 238029 8512 50358410
Angioedema 116.14 10.29 416 237786 37260 50329662
Blood creatinine increased 115.16 10.29 113 238089 76047 50290875
Renal impairment 114.70 10.29 112 238090 75549 50291373
Gastrointestinal haemorrhage 114.12 10.29 106 238096 73215 50293707
Vomiting 113.74 10.29 1508 236694 459250 49907672
Peripheral swelling 111.97 10.29 1470 236732 204466 50162456
Cardiac failure congestive 109.27 10.29 142 238060 84240 50282682
Renal failure 108.25 10.29 211 237991 106422 50260500
Atrial fibrillation 107.98 10.29 196 238006 101549 50265373
Depressed level of consciousness 107.56 10.29 55 238147 51898 50315024
Dehydration 105.43 10.29 366 237836 152083 50214839
Leukopenia 102.32 10.29 100 238102 67428 50299494
Metabolic acidosis 102.28 10.29 28 238174 38797 50328125
Weight increased 101.89 10.29 1422 236780 200469 50166453
Respiratory failure 94.67 10.29 178 238024 91003 50275919
Infection 92.07 10.29 1230 236972 171724 50195198
Multiple organ dysfunction syndrome 91.88 10.29 62 238140 50275 50316647
International normalised ratio increased 88.85 10.29 46 238156 43106 50323816
Coma 87.60 10.29 83 238119 56796 50310126
Blood cholesterol increased 86.52 10.29 499 237703 54716 50312206
Platelet count decreased 84.57 10.29 221 237981 100505 50266417
Muscle spasticity 83.07 10.29 222 237980 16962 50349960
Overdose 82.82 10.29 220 237982 99507 50267415
Cerebrovascular accident 82.37 10.29 204 237998 94476 50272446
Rhabdomyolysis 81.26 10.29 41 238161 38986 50327936
Cardiac arrest 80.23 10.29 171 238031 83480 50283442
Wheezing 79.82 10.29 533 237669 61514 50305408
Interstitial lung disease 79.11 10.29 80 238122 53096 50313826
Hypokalaemia 78.59 10.29 187 238015 87805 50279117
Pleural effusion 78.55 10.29 166 238036 81288 50285634
Ear pain 76.93 10.29 300 237902 27983 50338939
Oedema peripheral 76.62 10.29 433 237769 157528 50209394
Haemorrhage 75.48 10.29 84 238118 53357 50313565
Electric shock 71.61 10.29 50 238152 978 50365944
Decreased appetite 70.71 10.29 605 237597 200318 50166604
Asthenia 69.79 10.29 1069 237133 317973 50048949
Pneumonia aspiration 68.51 10.29 30 238172 30974 50335948
Crystal urine present 67.89 10.29 56 238146 1418 50365504
Intentional product use issue 67.80 10.29 605 237597 76313 50290609
Bone marrow failure 67.21 10.29 23 238179 27601 50339321
Hypoglycaemia 66.48 10.29 93 238109 53488 50313434
Intentional overdose 65.77 10.29 121 238081 62383 50304539
Weight decreased 65.19 10.29 696 237506 220549 50146373
Pain in extremity 64.62 10.29 900 237302 271965 50094957
Respiratory disorder 64.15 10.29 304 237898 30883 50336039
Anaphylactic reaction 63.99 10.29 455 237747 53600 50313322
Seizure 63.93 10.29 311 237891 117563 50249359
Night sweats 63.85 10.29 320 237882 33254 50333668
Drug abuse 63.73 10.29 115 238087 59731 50307191
Lactic acidosis 63.72 10.29 39 238163 33316 50333606
White blood cell count decreased 62.13 10.29 310 237892 116412 50250510
Drug resistance 62.09 10.29 8 238194 18981 50347941
Urinary sediment present 60.78 10.29 60 238142 1931 50364991
Herpes zoster 59.64 10.29 155 238047 70631 50296291
Hypercalcaemia 59.37 10.29 18 238184 23334 50343588
Hyperkalaemia 59.13 10.29 84 238118 48005 50318917
Liver function test abnormal 58.02 10.29 74 238128 44265 50322657
Macular degeneration 57.94 10.29 174 238028 14214 50352708
Cytomegalovirus infection 57.70 10.29 8 238194 17954 50348968
Body temperature increased 57.70 10.29 296 237906 31045 50335877
Premature delivery 57.06 10.29 20 238182 23643 50343279
Shock 56.09 10.29 14 238188 20636 50346286
Respiratory arrest 56.06 10.29 36 238166 29973 50336949
Mucosal inflammation 55.70 10.29 64 238138 40078 50326844
Chronic kidney disease 55.63 10.29 63 238139 39708 50327214
Blood immunoglobulin E increased 54.03 10.29 61 238141 2298 50364624
Hepatic function abnormal 52.32 10.29 46 238156 32635 50334287
Therapeutic product effect incomplete 52.24 10.29 237 237965 91278 50275644
Loss of consciousness 51.69 10.29 284 237918 104069 50262853
Live birth 51.26 10.29 182 238020 16226 50350696
Haemoglobin urine present 51.07 10.29 37 238165 769 50366153
Alanine aminotransferase increased 50.93 10.29 228 237974 88131 50278791
Drug level increased 50.55 10.29 14 238188 19254 50347668
Altered state of consciousness 50.34 10.29 20 238182 21890 50345032
Unresponsive to stimuli 50.33 10.29 42 238160 30567 50336355
Immunodeficiency 50.27 10.29 169 238033 14659 50352263
Skin ulcer 49.34 10.29 56 238146 35262 50331660
Off label use 48.97 10.29 1784 236418 472642 49894280
Drug hypersensitivity 48.58 10.29 860 237342 250150 50116772
Pulmonary oedema 47.79 10.29 99 238103 48839 50318083
Osteonecrosis of jaw 47.17 10.29 50 238152 32476 50334446
Confusional state 47.11 10.29 1177 237025 184751 50182171
Dermatitis atopic 46.45 10.29 70 238132 3516 50363406
Infective pulmonary exacerbation of cystic fibrosis 46.42 10.29 110 238092 7799 50359123
Lymphocyte percentage decreased 46.34 10.29 61 238141 2699 50364223
Neurotoxicity 46.33 10.29 7 238195 14733 50352189
C-reactive protein increased 46.31 10.29 159 238043 66315 50300607
Drug ineffective 45.83 10.29 4461 233741 814872 49552050
Cellulitis 45.59 10.29 175 238027 70623 50296299
Acute myeloid leukaemia 45.50 10.29 8 238194 15066 50351856
Melaena 45.24 10.29 36 238166 26828 50340094
Hypocalcaemia 45.08 10.29 36 238166 26780 50340142
Hereditary angioedema 45.00 10.29 87 238115 5355 50361567
Urine abnormality 44.75 10.29 94 238108 6144 50360778
Neoplasm progression 44.36 10.29 43 238159 29114 50337808
Gait disturbance 43.70 10.29 473 237729 149532 50217390
Femur fracture 43.57 10.29 68 238134 37396 50329526
Rash erythematous 43.37 10.29 297 237905 34555 50332367
Hepatic failure 43.15 10.29 53 238149 32230 50334692
Ascites 42.75 10.29 64 238138 35797 50331125
Rheumatoid nodule 42.53 10.29 5 238197 12730 50354192
Aspartate aminotransferase increased 42.16 10.29 206 237996 77792 50289130
Foetal exposure during pregnancy 42.03 10.29 40 238162 27319 50339603
Blood pressure fluctuation 40.74 10.29 66 238136 35757 50331165
Disseminated intravascular coagulation 40.43 10.29 15 238187 17120 50349802
Encephalopathy 40.35 10.29 60 238142 33651 50333271
Mental status changes 40.16 10.29 68 238134 36204 50330718
White blood cells urine positive 40.09 10.29 75 238127 4503 50362419
Rectal haemorrhage 39.36 10.29 76 238126 38482 50328440
Pericardial effusion 38.63 10.29 38 238164 25551 50341371
Premature baby 38.57 10.29 19 238183 18318 50348604
Urticaria chronic 38.39 10.29 26 238176 483 50366439
Localised infection 38.29 10.29 38 238164 25447 50341475
Acute myocardial infarction 38.15 10.29 49 238153 29224 50337698
Osteonecrosis 38.14 10.29 30 238172 22487 50344435
Blood creatine phosphokinase increased 37.71 10.29 41 238161 26326 50340596
Fracture 37.65 10.29 16 238186 16817 50350105
Disease recurrence 37.63 10.29 24 238178 20057 50346865
Osteomyelitis 37.58 10.29 30 238172 22323 50344599
Red blood cells urine positive 37.14 10.29 55 238147 2720 50364202
Transaminases increased 36.85 10.29 46 238156 27778 50339144
Pneumonitis 36.82 10.29 51 238151 29459 50337463
Proteinuria 36.76 10.29 16 238186 16581 50350341
Hypomagnesaemia 36.58 10.29 33 238169 23123 50343799
Hypoxia 36.48 10.29 121 238081 51002 50315920
Neutrophil percentage increased 36.42 10.29 54 238148 2673 50364249
Palmar-plantar erythrodysaesthesia syndrome 36.34 10.29 25 238177 20073 50346849
Liver injury 36.15 10.29 220 237982 24586 50342336
Extrapyramidal disorder 36.07 10.29 6 238196 11764 50355158
Temperature intolerance 36.03 10.29 97 238105 7442 50359480
Peritonitis 35.80 10.29 14 238188 15472 50351450
Lung neoplasm malignant 35.79 10.29 14 238188 15470 50351452
Agranulocytosis 35.70 10.29 29 238173 21392 50345530
Cerebral haemorrhage 35.54 10.29 45 238157 27007 50339915
Chronic spontaneous urticaria 35.37 10.29 25 238177 499 50366423
Myelosuppression 35.13 10.29 10 238192 13507 50353415
Colitis 35.09 10.29 81 238121 38448 50328474
Musculoskeletal pain 34.88 10.29 198 238004 71979 50294943
Injury 34.83 10.29 368 237834 48557 50318365
Tubulointerstitial nephritis 34.76 10.29 14 238188 15197 50351725
Serotonin syndrome 34.72 10.29 39 238163 24674 50342248
Post-traumatic stress disorder 34.62 10.29 68 238134 4235 50362687
Wrong technique in product usage process 34.59 10.29 139 238063 55371 50311551
Hyperglycaemia 34.41 10.29 75 238127 36330 50330592
Haematuria 34.29 10.29 42 238160 25571 50341351
Red blood cell sedimentation rate abnormal 34.27 10.29 17 238185 16326 50350596
Neutrophil count decreased 34.19 10.29 107 238095 45919 50321003
Product prescribing error 34.17 10.29 29 238173 20932 50345990
Hepatotoxicity 34.02 10.29 47 238155 27179 50339743
Bursitis 33.98 10.29 199 238003 21936 50344986
Renal tubular necrosis 33.94 10.29 4 238198 10164 50356758
Intentional product misuse 33.77 10.29 110 238092 46624 50320298
C-reactive protein abnormal 33.77 10.29 49 238153 27760 50339162
Blood glucose increased 33.75 10.29 197 238005 71127 50295795
Inappropriate antidiuretic hormone secretion 33.65 10.29 10 238192 13133 50353789
Plasma cell myeloma 33.51 10.29 60 238142 31262 50335660
Hip fracture 33.18 10.29 44 238158 25887 50341035
Throat irritation 33.18 10.29 250 237952 29989 50336933
Haematochezia 33.08 10.29 88 238114 39794 50327128
Accidental exposure to product 32.82 10.29 36 238166 23021 50343901
Neonatal hypoacusis 32.74 10.29 10 238192 20 50366902
Auditory neuropathy spectrum disorder 32.42 10.29 10 238192 21 50366901
Sleep disorder 32.35 10.29 412 237790 56871 50310051
Acute respiratory distress syndrome 32.23 10.29 31 238171 21068 50345854
Thrombosis 32.21 10.29 144 238058 55689 50311233
Haematoma 32.14 10.29 59 238143 30451 50336471
Perfume sensitivity 32.05 10.29 25 238177 583 50366339
Blood bilirubin increased 31.97 10.29 64 238138 31974 50334948
Blood lactate dehydrogenase increased 31.97 10.29 27 238175 19535 50347387
Pulmonary embolism 31.94 10.29 315 237887 101389 50265533
Metastases to central nervous system 31.93 10.29 7 238195 11275 50355647
Acute hepatic failure 31.84 10.29 17 238185 15660 50351262
Bacteraemia 31.83 10.29 14 238188 14419 50352503
Intervertebral discitis 31.81 10.29 50 238152 2606 50364316
Somnolence 31.56 10.29 526 237676 154459 50212463
Cardiomyopathy 31.51 10.29 17 238185 15569 50351353
Product dose omission issue 31.19 10.29 644 237558 183194 50183728
Neuropathy peripheral 31.09 10.29 298 237904 96459 50270463
Electrocardiogram QT prolonged 31.04 10.29 132 238070 51754 50315168
Respiratory depression 31.00 10.29 9 238193 12001 50354921
Breast cancer 30.96 10.29 101 238101 42789 50324133
Posterior reversible encephalopathy syndrome 30.60 10.29 16 238186 14912 50352010
Cerebral infarction 30.45 10.29 34 238168 21570 50345352
Skin necrosis 30.23 10.29 7 238195 10860 50356062
Orthostatic hypotension 30.19 10.29 58 238144 29423 50337499
Metastases to liver 30.18 10.29 30 238172 20074 50346848
Muscular weakness 29.95 10.29 294 237908 94719 50272203
Abdominal pain 29.84 10.29 865 237337 235363 50131559
Gamma-glutamyltransferase increased 29.71 10.29 59 238143 29564 50337358
Pain in jaw 29.50 10.29 88 238114 38340 50328582
Headache 29.35 10.29 2766 235436 503769 49863153
Arthralgia 29.33 10.29 2421 235781 436281 49930641
Inflammation 29.22 10.29 153 238049 56759 50310163
Psychotic disorder 28.95 10.29 36 238166 21776 50345146
Electrolyte imbalance 28.92 10.29 23 238179 17146 50349776
Shock haemorrhagic 28.56 10.29 3 238199 8341 50358581
Eosinophilic colitis 28.53 10.29 14 238188 136 50366786
Constipation 28.50 10.29 661 237541 185047 50181875
Dizziness 28.32 10.29 1337 236865 345032 50021890
Tremor 28.21 10.29 376 237826 114527 50252395
Oral pruritus 28.04 10.29 37 238165 1641 50365281
Oliguria 28.01 10.29 3 238199 8213 50358709
Tachycardia 27.68 10.29 318 237884 99445 50267477
Upper gastrointestinal haemorrhage 27.62 10.29 21 238181 16014 50350908
Urine leukocyte esterase positive 27.49 10.29 49 238153 2834 50364088
Cardiogenic shock 27.42 10.29 20 238182 15579 50351343
Inappropriate schedule of product administration 27.19 10.29 212 237990 71619 50295303
Haematemesis 27.14 10.29 56 238146 27669 50339253
Transplant rejection 27.11 10.29 6 238196 9603 50357319
Hypertensive crisis 27.11 10.29 14 238188 13140 50353782
Creatinine renal clearance decreased 27.04 10.29 11 238191 11870 50355052
Left ventricular dysfunction 26.88 10.29 8 238194 10498 50356424
Pulmonary hypertension 26.76 10.29 75 238127 33342 50333580
Neoplasm malignant 26.68 10.29 44 238158 23671 50343251
Arthritis 26.64 10.29 270 237932 86451 50280471
Haematotoxicity 26.62 10.29 3 238199 7892 50359030
Gastric ulcer 26.40 10.29 37 238165 21268 50345654
Subdural haematoma 26.36 10.29 14 238188 12933 50353989
Anuria 26.27 10.29 10 238192 11234 50355688
Leukocytosis 26.24 10.29 41 238161 22538 50344384
Vocal cord dysfunction 26.05 10.29 18 238184 346 50366576
Cardiac disorder 25.92 10.29 109 238093 42870 50324052
Generalised tonic-clonic seizure 25.87 10.29 53 238149 26257 50340665
Thrombotic microangiopathy 25.82 10.29 5 238197 8786 50358136
Forced expiratory volume decreased 25.66 10.29 61 238141 4333 50362589
Agitation 25.49 10.29 147 238055 53237 50313685
Loss of personal independence in daily activities 25.47 10.29 209 237993 69841 50297081
Therapeutic response decreased 25.36 10.29 125 238077 47106 50319816
Tachypnoea 25.22 10.29 19 238183 14558 50352364
Tuberculosis 25.22 10.29 8 238194 10075 50356847
Urine analysis abnormal 24.99 10.29 60 238142 4290 50362632
Prescribed overdose 24.88 10.29 135 238067 14465 50352457
Drug tolerance decreased 24.77 10.29 97 238105 9063 50357859
Blood calcium decreased 24.64 10.29 37 238165 20669 50346253
Hospitalisation 24.56 10.29 203 237999 67734 50299188
Pancreatitis 24.52 10.29 110 238092 42504 50324418
Adjustment disorder with depressed mood 24.52 10.29 46 238156 2768 50364154
Diabetes mellitus 24.51 10.29 133 238069 48900 50318022
Mastocytosis 24.49 10.29 20 238182 499 50366423
Pancreatitis acute 24.25 10.29 47 238155 23765 50343157
Syncope 24.23 10.29 340 237862 102662 50264260
Stress cardiomyopathy 24.22 10.29 4 238198 7883 50359039
Blood pressure diastolic abnormal 24.19 10.29 7 238195 9354 50357568
Maternal exposure timing unspecified 24.18 10.29 53 238149 3567 50363355
Chest pain 24.04 10.29 641 237561 176241 50190681
Blood potassium increased 24.01 10.29 25 238177 16373 50350549
Basal cell carcinoma 23.87 10.29 46 238156 23310 50343612
Injection site pain 23.86 10.29 373 237829 110651 50256271
Bone disorder 23.81 10.29 32 238170 18720 50348202
Urticaria thermal 23.69 10.29 13 238189 162 50366760
Victim of chemical submission 23.66 10.29 15 238187 248 50366674
Myoclonus 23.61 10.29 20 238182 14450 50352472
Mast cell activation syndrome 23.60 10.29 17 238185 350 50366572
Enthesopathy 23.59 10.29 3 238199 7190 50359732
Metastases to bone 23.57 10.29 30 238172 17965 50348957
Bradycardia 23.52 10.29 192 238010 64234 50302688
Acute respiratory failure 23.49 10.29 64 238138 28718 50338204
Nervous system disorder 23.45 10.29 25 238177 16198 50350724
Therapy cessation 23.43 10.29 55 238147 25956 50340966
Labelled drug-drug interaction medication error 23.36 10.29 10 238192 10467 50356455
Head deformity 23.33 10.29 11 238191 97 50366825
Skin plaque 23.13 10.29 74 238128 6254 50360668
Hypophagia 23.13 10.29 61 238141 27667 50339255
Cardiotoxicity 22.88 10.29 3 238199 7024 50359898
Scratch 22.87 10.29 63 238139 4899 50362023
Sinus disorder 22.79 10.29 157 238045 18301 50348621
Cystitis 22.76 10.29 120 238082 44444 50322478
Panniculitis 22.64 10.29 6 238196 8497 50358425
Spinal compression fracture 22.54 10.29 16 238186 12640 50354282
Cestode infection 22.46 10.29 15 238187 272 50366650
Transient ischaemic attack 22.46 10.29 77 238125 32133 50334789
Eczema 22.32 10.29 183 238019 22519 50344403
Epistaxis 22.26 10.29 193 238009 63761 50303161
Accidental overdose 22.19 10.29 36 238166 19497 50347425
Allergy test positive 22.10 10.29 17 238185 388 50366534
Polyneuropathy 22.05 10.29 15 238187 12116 50354806
Nocturnal fear 22.05 10.29 6 238196 6 50366916
Influenza 21.97 10.29 293 237909 89245 50277677
Clostridium difficile colitis 21.80 10.29 31 238171 17711 50349211
Lichen sclerosus 21.76 10.29 25 238177 960 50365962
Cataract 21.66 10.29 132 238070 47168 50319754
Akathisia 21.55 10.29 6 238196 8223 50358699
Sedation 21.46 10.29 73 238129 30537 50336385
Cystic fibrosis pancreatic 21.35 10.29 9 238193 59 50366863
Status epilepticus 21.30 10.29 19 238183 13387 50353535
Bronchial neoplasm 21.10 10.29 17 238185 416 50366506
Hyper IgE syndrome 21.06 10.29 17 238185 417 50366505
Blood alkaline phosphatase increased 20.92 10.29 98 238104 37428 50329494
Hepatitis 20.72 10.29 77 238125 31376 50335546
Myalgia 20.63 10.29 437 237765 123882 50243040
Escherichia infection 20.61 10.29 13 238189 10928 50355994
Treatment noncompliance 20.40 10.29 73 238129 30077 50336845
Rib fracture 20.40 10.29 37 238165 19184 50347738
Renal disorder 20.39 10.29 64 238138 27441 50339481
Haemorrhage intracranial 20.31 10.29 17 238185 12357 50354565
Exposure via body fluid 20.23 10.29 17 238185 442 50366480
Restrictive pulmonary disease 20.18 10.29 29 238173 1395 50365527
Ventricular tachycardia 20.08 10.29 27 238175 15794 50351128
Myelodysplastic syndrome 20.06 10.29 25 238177 15107 50351815
Chronic sinusitis 19.92 10.29 69 238133 6076 50360846
Schizophreniform disorder 19.73 10.29 9 238193 73 50366849
Pneumocystis jirovecii pneumonia 19.67 10.29 24 238178 14639 50352283
Lethargy 19.60 10.29 144 238058 49288 50317634
Ileus 19.56 10.29 20 238182 13209 50353713
Adverse event 19.55 10.29 302 237900 43461 50323461
Metastases to lung 19.54 10.29 14 238188 11006 50355916
Dialysis 19.52 10.29 10 238192 9428 50357494
Therapy interrupted 19.47 10.29 41 238161 20111 50346811
Muscle rigidity 19.47 10.29 11 238191 9818 50357104
Spinal fracture 19.34 10.29 27 238175 15546 50351376
Klebsiella infection 19.30 10.29 5 238197 7189 50359733
Surgery 19.22 10.29 75 238127 30130 50336792
Retinitis 19.19 10.29 33 238169 1854 50365068
Exposure during pregnancy 19.06 10.29 723 237479 120292 50246630
Intestinal perforation 18.99 10.29 13 238189 10466 50356456
Cholestasis 18.90 10.29 59 238143 25342 50341580
Pregnancy on contraceptive 18.83 10.29 24 238178 1028 50365894
Eye pruritus 18.80 10.29 112 238090 12422 50354500
Gait inability 18.75 10.29 100 238102 36927 50329995
Angina pectoris 18.67 10.29 62 238140 26126 50340796
Obstructive airways disorder 18.66 10.29 132 238070 15520 50351402
Neuroleptic malignant syndrome 18.63 10.29 15 238187 11115 50355807
Drug level decreased 18.59 10.29 4 238198 6529 50360393
Premature labour 18.55 10.29 16 238186 11460 50355462
Hallucination, auditory 18.54 10.29 14 238188 10714 50356208
Anaphylactoid reaction 18.52 10.29 46 238156 3360 50363562
Skin laceration 18.49 10.29 38 238164 18804 50348118
Ejection fraction decreased 18.47 10.29 37 238165 18483 50348439
Blood pressure increased 18.46 10.29 481 237721 132651 50234271
Histamine level increased 18.46 10.29 6 238196 16 50366906
Urinary casts 18.44 10.29 19 238183 644 50366278
Swelling face 18.43 10.29 349 237853 52246 50314676
Lip pruritus 18.37 10.29 20 238182 723 50366199
Seronegative arthritis 18.34 10.29 34 238168 2027 50364895
Colitis ischaemic 18.23 10.29 11 238191 9472 50357450
Iron deficiency anaemia 18.23 10.29 32 238170 16802 50350120
Hyperpathia 18.20 10.29 6 238196 17 50366905
Dislocation of vertebra 18.19 10.29 43 238159 3044 50363878
Blood urea increased 18.11 10.29 54 238148 23531 50343391
Insomnia 18.04 10.29 1001 237201 173864 50193058
Low birth weight baby 18.02 10.29 3 238199 5878 50361044
Renal injury 17.99 10.29 9 238193 8602 50358320
Aphasia 17.97 10.29 71 238131 28423 50338499
Hypervolaemia 17.75 10.29 61 238141 25438 50341484
Toxic epidermal necrolysis 17.65 10.29 46 238156 20946 50345976
Malaise 17.64 10.29 1350 236852 334182 50032740
Seasonal allergy 17.63 10.29 124 238078 14552 50352370
Hemiparesis 17.58 10.29 43 238159 20005 50346917
Respiratory distress 17.36 10.29 79 238123 30410 50336512
Menstruation delayed 17.22 10.29 27 238175 1404 50365518
Intestinal obstruction 17.11 10.29 65 238137 26318 50340604
Diffuse large B-cell lymphoma 17.10 10.29 3 238199 5659 50361263
Bacterial test positive 17.05 10.29 55 238147 4668 50362254
Magnesium deficiency 17.02 10.29 16 238186 484 50366438
Eye swelling 17.00 10.29 157 238045 19987 50346935
Blood potassium decreased 16.97 10.29 103 238099 36842 50330080
Lymphocyte count decreased 16.94 10.29 194 238008 26113 50340809
Acidosis 16.85 10.29 14 238188 10213 50356709
Tooth disorder 16.83 10.29 58 238144 24170 50342752
Lichen nitidus 16.83 10.29 8 238194 72 50366850
Full blood count decreased 16.56 10.29 52 238150 22294 50344628
Nasal turbinate hypertrophy 16.51 10.29 18 238184 652 50366270
Bronchial haemorrhage 16.49 10.29 16 238186 504 50366418
Eye infection bacterial 16.41 10.29 9 238193 112 50366810
Ehlers-Danlos syndrome 16.41 10.29 9 238193 112 50366810
Clostridium difficile infection 16.29 10.29 63 238139 25376 50341546
Hypotonia 16.26 10.29 9 238193 8125 50358797
Malnutrition 16.25 10.29 23 238179 13166 50353756
Adverse drug reaction 16.23 10.29 357 237845 54865 50312057
Lip swelling 16.19 10.29 183 238019 24553 50342369
Erythema 16.06 10.29 843 237359 145571 50221351
Tricuspid valve incompetence 16 10.29 22 238180 12748 50354174
Failure to thrive 15.98 10.29 5 238197 6353 50360569
Blood pressure decreased 15.98 10.29 177 238025 55732 50311190
Deafness 15.95 10.29 31 238171 15660 50351262
Diabetic ketoacidosis 15.93 10.29 38 238164 17834 50349088
Humerus fracture 15.86 10.29 8 238194 7610 50359312
Haemorrhoids 15.83 10.29 42 238160 19011 50347911
White blood cell count increased 15.82 10.29 125 238077 42115 50324807
Caesarean section 15.81 10.29 31 238171 15608 50351314
Musculoskeletal stiffness 15.80 10.29 748 237454 127733 50239189
Coronary artery disease 15.77 10.29 79 238123 29647 50337275
Mouth ulceration 15.73 10.29 73 238129 27951 50338971
Thymus disorder 15.67 10.29 11 238191 217 50366705
Haemodialysis 15.66 10.29 10 238192 8352 50358570
Urinary retention 15.43 10.29 67 238135 26123 50340799
Oxygen saturation decreased 15.42 10.29 247 237955 73001 50293921
Liver function test increased 15.40 10.29 65 238137 25541 50341381
Femoral neck fracture 15.39 10.29 8 238194 7482 50359440
Cardiac failure acute 15.27 10.29 10 238192 8240 50358682
Delirium 15.26 10.29 111 238091 38081 50328841
Hepatic steatosis 15.22 10.29 61 238141 24323 50342599
Hypothyroidism 15.22 10.29 96 238106 34029 50332893
Gastric haemorrhage 15.20 10.29 4 238198 5692 50361230
Enteritis 15.09 10.29 7 238195 6988 50359934
Device expulsion 15.06 10.29 77 238125 28745 50338177
Mental disorder 15.04 10.29 53 238149 21938 50344984
Encephalitis 14.99 10.29 8 238194 7372 50359550
Bone density decreased 14.99 10.29 18 238184 11057 50355865
Diverticulitis 14.98 10.29 93 238109 33089 50333833
Ischaemic stroke 14.95 10.29 33 238169 15915 50351007
Arrhythmia 14.89 10.29 93 238109 33039 50333883
Drug withdrawal syndrome 14.88 10.29 64 238138 25017 50341905
Lip dry 14.87 10.29 53 238149 4734 50362188
Demyelination 14.85 10.29 62 238140 5964 50360958
Dyskinesia 14.81 10.29 74 238128 27787 50339135
Blood pressure systolic abnormal 14.73 10.29 9 238193 7697 50359225
Suicide attempt 14.69 10.29 164 238038 51568 50315354
Vision blurred 14.69 10.29 271 237931 78376 50288546
Gastroenteritis 14.69 10.29 58 238144 23223 50343699
Prevertebral soft tissue swelling of cervical space 14.67 10.29 6 238196 36 50366886
Blood pressure systolic increased 14.67 10.29 102 238100 35347 50331575
Eosinophilic granulomatosis with polyangiitis 14.66 10.29 30 238172 1925 50364997
Diarrhoea haemorrhagic 14.62 10.29 9 238193 7666 50359256
Tongue pruritus 14.61 10.29 14 238188 434 50366488
Musculoskeletal disorder 14.60 10.29 38 238164 17311 50349611
Candida infection 14.59 10.29 59 238143 23464 50343458
Systemic inflammatory response syndrome 14.56 10.29 3 238199 5046 50361876
Paraesthesia oral 14.53 10.29 103 238099 12118 50354804
Osteoporosis 14.50 10.29 138 238064 44741 50322181
Tenosynovitis 14.49 10.29 17 238185 10548 50356374
Immune reconstitution inflammatory syndrome 14.48 10.29 4 238198 5512 50361410
Haemodynamic instability 14.48 10.29 10 238192 8014 50358908
Influenza like illness 14.47 10.29 187 238015 57272 50309650
Heart rate irregular 14.38 10.29 45 238157 19315 50347607
Respirovirus test positive 14.27 10.29 5 238197 18 50366904
Cholecystitis chronic 14.24 10.29 86 238116 9583 50357339
Diabetes mellitus inadequate control 14.22 10.29 25 238177 13120 50353802
Oral pain 14.17 10.29 65 238137 24968 50341954
Spinal pain 14.16 10.29 18 238184 10785 50356137
Mitral valve incompetence 14.15 10.29 39 238163 17432 50349490
Bone pain 14.11 10.29 148 238054 47081 50319841
Lymphadenopathy 14.05 10.29 96 238106 33403 50333519
Lung infiltration 14.02 10.29 26 238176 13367 50353555
Right ventricular failure 14.00 10.29 34 238168 15859 50351063
Paraesthesia 14.00 10.29 445 237757 119798 50247124
Antinuclear antibody positive 13.96 10.29 6 238196 6266 50360656
Eosinophil count increased 13.95 10.29 80 238122 8750 50358172
Blood pressure diastolic decreased 13.93 10.29 37 238165 16744 50350178
Joint effusion 13.88 10.29 25 238177 12996 50353926
Breast cancer metastatic 13.87 10.29 17 238185 10347 50356575
Electrocardiogram QRS complex prolonged 13.80 10.29 4 238198 5340 50361582
Crepitations 13.77 10.29 6 238196 6213 50360709
Hepatocellular injury 13.74 10.29 69 238133 25878 50341044
Therapy non-responder 13.62 10.29 164 238038 50858 50316064
Therapy partial responder 13.60 10.29 7 238195 6584 50360338
Sopor 13.54 10.29 48 238154 19831 50347091
Epidermolysis bullosa 13.53 10.29 8 238194 116 50366806
Chills 13.49 10.29 349 237853 96338 50270584
Device difficult to use 13.46 10.29 16 238186 9870 50357052
Polymenorrhoea 13.42 10.29 21 238181 1090 50365832
Chronic obstructive pulmonary disease 13.42 10.29 174 238028 53261 50313661
Nasal oedema 13.41 10.29 18 238184 812 50366110
Granulocytopenia 13.35 10.29 4 238198 5227 50361695
Haematocrit decreased 13.34 10.29 103 238099 34873 50332049
Osteoarthritis 13.25 10.29 235 237967 68371 50298551
Gastric disorder 13.24 10.29 83 238119 29465 50337457
Rash pustular 13.20 10.29 7 238195 6474 50360448
Red blood cell count decreased 13.20 10.29 99 238103 33736 50333186
Psoriatic arthropathy 13.18 10.29 302 237900 46730 50320192
Monocyte count abnormal 13.16 10.29 9 238193 170 50366752
Lacrimation increased 13.13 10.29 130 238072 16862 50350060
Hyperplastic cholecystopathy 13.06 10.29 7 238195 83 50366839
Faeces discoloured 13.05 10.29 36 238166 16088 50350834
Ovarian cancer 13.03 10.29 4 238198 5145 50361777
Abnormal behaviour 13.03 10.29 48 238154 19610 50347312
Deep vein thrombosis postoperative 13.02 10.29 26 238176 1639 50365283
Bronchial disorder 12.99 10.29 21 238181 1121 50365801
Marginal zone lymphoma 12.98 10.29 5 238197 25 50366897
Deep vein thrombosis 12.95 10.29 255 237947 73049 50293873
Drug eruption 12.95 10.29 62 238140 23544 50343378
Pulmonary toxicity 12.90 10.29 5 238197 5557 50361365
Sudden death 12.84 10.29 14 238188 8977 50357945
Incorrect dose administered 12.78 10.29 156 238046 48258 50318664
Stillbirth 12.77 10.29 6 238196 5946 50360976
Dementia 12.74 10.29 36 238166 15961 50350961
Urine amphetamine positive 12.72 10.29 6 238196 53 50366869
Unevaluable event 12.71 10.29 147 238055 45919 50321003
Hallucination, visual 12.70 10.29 38 238164 16544 50350378
Premenstrual syndrome 12.63 10.29 15 238187 597 50366325
Hypernatraemia 12.63 10.29 7 238195 6314 50360608
Anti-cyclic citrullinated peptide antibody 12.62 10.29 25 238177 1567 50365355
Miosis 12.59 10.29 7 238195 6303 50360619
Cells in urine 12.55 10.29 9 238193 184 50366738
Anticipatory anxiety 12.53 10.29 11 238191 304 50366618
Dyspnoea exertional 12.44 10.29 168 238034 51065 50315857
Infusion site pain 12.39 10.29 100 238102 12246 50354676
Torsade de pointes 12.36 10.29 23 238179 11812 50355110
Prothrombin time prolonged 12.36 10.29 14 238188 8824 50358098
Burns second degree 12.35 10.29 16 238186 697 50366225
Heart rate decreased 12.32 10.29 111 238091 36386 50330536
Troponin increased 12.32 10.29 12 238190 8106 50358816
No adverse event 12.28 10.29 100 238102 33478 50333444
Multiple fractures 12.25 10.29 8 238194 6603 50360319
Food intolerance 12.24 10.29 32 238170 2412 50364510
Ovarian germ cell cancer stage II 12.23 10.29 5 238197 30 50366892
Myopathy 12.22 10.29 15 238187 9124 50357798
Mechanical urticaria 12.19 10.29 12 238190 385 50366537
Peripheral sensory neuropathy 12.18 10.29 8 238194 6583 50360339
Venous thrombosis 12.18 10.29 3 238199 4463 50362459
Autoimmune disorder 12.18 10.29 58 238144 5902 50361020
Cardiovascular disorder 12.13 10.29 19 238183 10435 50356487
Suspected suicide 12.13 10.29 5 238197 5352 50361570
Sneezing 12.12 10.29 110 238092 13934 50352988
Pallor 12.11 10.29 62 238140 23137 50343785
Malignant melanoma 12.09 10.29 18 238184 10090 50356832
Urine output decreased 12.03 10.29 19 238183 10402 50356520
Hypothermia 11.99 10.29 24 238178 11992 50354930
Blood pressure systolic decreased 11.99 10.29 6 238196 5733 50361189
Bacterial infection 11.98 10.29 38 238164 16243 50350679
Second primary malignancy 11.98 10.29 9 238193 6905 50360017
Deficiency of bile secretion 11.97 10.29 4 238198 12 50366910
Autophobia 11.97 10.29 4 238198 12 50366910
Haemoglobin abnormal 11.96 10.29 3 238199 4409 50362513
Spinal cord paralysis 11.96 10.29 5 238197 32 50366890
Syphilis 11.93 10.29 8 238194 146 50366776
Choluria 11.89 10.29 8 238194 147 50366775
Metabolic disorder 11.86 10.29 5 238197 5281 50361641
Metastasis 11.82 10.29 3 238199 4372 50362550
Device use error 11.78 10.29 5 238197 5261 50361661
Condition aggravated 11.77 10.29 1583 236619 295475 50071447
Injection site haemorrhage 11.75 10.29 56 238146 21290 50345632
Deformity 11.74 10.29 12 238190 7928 50358994
Hepatic encephalopathy 11.68 10.29 17 238185 9619 50357303
Poisoning deliberate 11.65 10.29 12 238190 7900 50359022
Visual acuity reduced 11.58 10.29 52 238150 20087 50346835
Lymphoma 11.57 10.29 17 238185 9584 50357338
Vaginal haemorrhage 11.51 10.29 68 238134 24483 50342439
Duodenal ulcer 11.51 10.29 9 238193 6766 50360156
Oesophagitis 11.50 10.29 29 238173 13354 50353568
Ventricular fibrillation 11.50 10.29 20 238182 10539 50356383
Intestinal ischaemia 11.45 10.29 9 238193 6748 50360174
Poisoning 11.42 10.29 26 238176 12403 50354519
Burning sensation 11.41 10.29 148 238054 45298 50321624
Endometrial ablation 11.40 10.29 17 238185 846 50366076
Faecaloma 11.38 10.29 10 238192 7098 50359824
Device malfunction 11.34 10.29 35 238167 15086 50351836
Abdominal distension 11.30 10.29 259 237943 72644 50294278
Fungal endocarditis 11.28 10.29 9 238193 217 50366705
Underdose 11.27 10.29 53 238149 20225 50346697
Brain oedema 11.27 10.29 26 238176 12344 50354578
Lactose intolerance 11.23 10.29 32 238170 2538 50364384
Tumour lysis syndrome 11.22 10.29 11 238191 7410 50359512
Atelectasis 11.22 10.29 46 238156 18224 50348698
Drug reaction with eosinophilia and systemic symptoms 11.17 10.29 83 238119 28341 50338581
Schizophrenia 11.15 10.29 11 238191 7386 50359536
Atopy 11.14 10.29 9 238193 221 50366701
Coagulopathy 11.13 10.29 45 238157 17899 50349023
Body temperature fluctuation 11.10 10.29 27 238175 1946 50364976
Atrial flutter 11.08 10.29 15 238187 8748 50358174
CSF volume increased 11.03 10.29 3 238199 3 50366919
Epstein-Barr virus infection 11.02 10.29 10 238192 6987 50359935
Ataxia 10.99 10.29 31 238171 13755 50353167
Cyanosis central 10.99 10.29 6 238196 74 50366848
Throat tightness 10.95 10.29 148 238054 20699 50346223
Microcytosis 10.89 10.29 8 238194 170 50366752
Urobilinogen urine increased 10.87 10.29 9 238193 229 50366693
Amylase increased 10.87 10.29 6 238196 5424 50361498
Colon cancer 10.86 10.29 15 238187 8676 50358246
Atrioventricular block first degree 10.84 10.29 8 238194 6193 50360729
Cholangitis 10.82 10.29 4 238198 4575 50362347
Autoimmune arthritis 10.81 10.29 5 238197 42 50366880
Splenomegaly 10.79 10.29 18 238184 9642 50357280
Cyst 10.79 10.29 26 238176 12161 50354761
Glycosylated haemoglobin increased 10.74 10.29 21 238181 10585 50356337
Amino acid level decreased 10.71 10.29 5 238197 43 50366879
Product administration error 10.65 10.29 52 238150 19647 50347275
Device issue 10.64 10.29 53 238149 19919 50347003
Pregnancy 10.62 10.29 197 238005 29380 50337542
X-ray abnormal 10.61 10.29 32 238170 2620 50364302
Post procedural infection 10.59 10.29 12 238190 7564 50359358
Muscle atrophy 10.56 10.29 8 238194 6113 50360809
Hyperbilirubinaemia 10.54 10.29 18 238184 9552 50357370
Head injury 10.49 10.29 68 238134 23952 50342970
Nitrite urine present 10.48 10.29 17 238185 910 50366012
Protrusion tongue 10.44 10.29 10 238192 310 50366612
Hydronephrosis 10.42 10.29 15 238187 8526 50358396
Ankylosing spondylitis 10.40 10.29 11 238191 7154 50359768
Dyshidrotic eczema 10.40 10.29 13 238189 546 50366376
Blood albumin decreased 10.38 10.29 30 238172 13206 50353716
Axillary pain 10.37 10.29 23 238179 1561 50365361
Large intestine perforation 10.34 10.29 12 238190 7482 50359440
Monocyte percentage increased 10.32 10.29 18 238184 1023 50365899
Pharyngeal oedema 10.31 10.29 101 238101 13064 50353858

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 269.31 10.56 318 52853 33531 29487825
Urticaria 263.45 10.56 402 52769 54258 29467098
Pruritus 174.31 10.56 533 52638 116316 29405040
Sleep terror 107.75 10.56 43 53128 698 29520658
Sinusitis 87.70 10.56 192 52979 34158 29487198
Dermatitis atopic 80.43 10.56 50 53121 2169 29519187
Infective pulmonary exacerbation of cystic fibrosis 76.90 10.56 74 53097 6162 29515194
Rash 75.96 10.56 592 52579 189227 29332129
Death 75.42 10.56 338 52833 341746 29179610
Forced expiratory volume decreased 71.94 10.56 51 53120 2762 29518594
Wheezing 67.60 10.56 170 53001 33070 29488286
Upper respiratory tract infection 64.35 10.56 148 53023 27201 29494155
Vital capacity decreased 63.37 10.56 24 53147 336 29521020
Hypersensitivity 58.91 10.56 219 52952 52684 29468672
Headache 53.94 10.56 513 52658 173494 29347862
Anaemia 53.43 10.56 184 52987 200767 29320589
Cough 48.26 10.56 391 52780 126336 29395020
Eczema 46.88 10.56 87 53084 13739 29507617
Lip swelling 45.78 10.56 81 53090 12329 29509027
Anaphylactic reaction 43.05 10.56 128 53043 27445 29493911
Swelling face 42.33 10.56 105 53066 20245 29501111
Potassium wasting nephropathy 42.21 10.56 13 53158 92 29521264
Parathyroid gland enlargement 39.48 10.56 13 53158 117 29521239
Migraine 39.40 10.56 76 53095 12354 29509002
Sudden infant death syndrome 38.99 10.56 14 53157 167 29521189
Mydriasis 38.46 10.56 51 53120 6034 29515322
Upper respiratory fungal infection 38.35 10.56 13 53158 129 29521227
Eye disorder 38.19 10.56 58 53113 7776 29513580
Fatigue 37.81 10.56 788 52383 316033 29205323
Angioedema 36.24 10.56 133 53038 31782 29489574
Multiple organ dysfunction syndrome 36.20 10.56 36 53135 63080 29458276
Suicidal ideation 35.57 10.56 140 53031 34576 29486780
General physical health deterioration 35.53 10.56 83 53088 102774 29418582
Chest discomfort 35.30 10.56 170 53001 45813 29475543
Forced expiratory volume 33.91 10.56 11 53160 94 29521262
Nasal congestion 33.71 10.56 92 53079 18787 29502569
Crystal urine present 33.29 10.56 16 53155 413 29520943
Blood pressure increased 32.69 10.56 236 52935 73567 29447789
Renal failure 32.55 10.56 107 53064 118492 29402864
Flushing 32.23 10.56 120 53051 28872 29492484
Obstructive airways disorder 32.07 10.56 65 53106 10951 29510405
Throat irritation 31.96 10.56 57 53114 8728 29512628
Renal impairment 31.10 10.56 62 53109 81271 29440085
Influenza 30.83 10.56 153 53018 41728 29479628
Erythema 30.78 10.56 237 52934 75369 29445987
Oral pruritus 30.70 10.56 13 53158 247 29521109
Tendon disorder 29.79 10.56 29 53142 2449 29518907
Interstitial lung disease 29.70 10.56 36 53135 57682 29463674
Pulmonary function test decreased 29.62 10.56 37 53134 4126 29517230
Product dose omission issue 29.21 10.56 283 52888 96100 29425256
Nasal oedema 28.83 10.56 13 53158 289 29521067
Completed suicide 28.68 10.56 76 53095 90170 29431186
Toxicity to various agents 28.49 10.56 189 52982 173472 29347884
Penile haemorrhage 28.13 10.56 16 53155 588 29520768
Lower respiratory tract infection 28.06 10.56 108 53063 26394 29494962
Differentiation syndrome 28.05 10.56 20 53151 1093 29520263
Bronchopulmonary aspergillosis allergic 27.62 10.56 15 53156 503 29520853
Anxiety 27.54 10.56 254 52917 85111 29436245
Penis injury 27.46 10.56 12 53159 247 29521109
Dry skin 27.20 10.56 98 53073 23209 29498147
Anticholinergic syndrome 27.10 10.56 18 53153 876 29520480
Depressed mood 26.28 10.56 77 53094 16371 29504985
Myocardial infarction 25.99 10.56 106 53065 110190 29411166
Throat tightness 25.79 10.56 46 53125 7045 29514311
Cardiac failure 25.78 10.56 66 53105 79221 29442135
Disturbance in attention 25.78 10.56 91 53080 21333 29500023
Rash erythematous 25.44 10.56 91 53080 21471 29499885
Ear infection 23.83 10.56 48 53123 8052 29513304
Rash pruritic 23.56 10.56 91 53080 22272 29499084
Anger 23.50 10.56 57 53114 10833 29510523
Bone marrow failure 23.40 10.56 10 53161 27439 29493917
Hyperleukocytosis 23.23 10.56 21 53150 1614 29519742
Victim of chemical submission 23.04 10.56 7 53164 47 29521309
Gastric ulcer perforation 22.61 10.56 16 53155 864 29520492
Sinus disorder 22.13 10.56 39 53132 5916 29515440
Malignant neoplasm progression 22.12 10.56 64 53107 73795 29447561
Sepsis 22.04 10.56 158 53013 142524 29378832
Ascites 22.03 10.56 20 53151 36599 29484757
Drug resistance 21.55 10.56 6 53165 21534 29499822
Mastocytosis 21.24 10.56 6 53165 30 29521326
Swollen tongue 21.13 10.56 59 53112 12207 29509149
Encephalopathy 21.12 10.56 15 53156 31028 29490328
Disease progression 21.04 10.56 76 53095 81840 29439516
Gastrointestinal haemorrhage 20.96 10.56 73 53098 79460 29441896
Acute kidney injury 20.70 10.56 344 52827 264923 29256433
Aspirin-exacerbated respiratory disease 20.64 10.56 11 53160 355 29521001
Cerebral dysgenesis 20.52 10.56 5 53166 12 29521344
Infusion related reaction 19.80 10.56 141 53030 43745 29477611
Drug ineffective 19.72 10.56 500 52671 362670 29158686
Malaise 19.60 10.56 399 52772 159203 29362153
Postmortem blood drug level 19.55 10.56 8 53163 139 29521217
Sinus congestion 19.51 10.56 32 53139 4580 29516776
Lymphocyte percentage decreased 19.51 10.56 21 53150 1996 29519360
Sensorimotor disorder 19.50 10.56 11 53160 398 29520958
Middle insomnia 19.45 10.56 36 53135 5672 29515684
Seizure 19.36 10.56 254 52917 92869 29428487
Tic 19.34 10.56 20 53151 1815 29519541
Mood altered 19.18 10.56 44 53127 8067 29513289
Poverty of speech 19.06 10.56 9 53162 223 29521133
Rhinorrhoea 19.06 10.56 83 53088 21436 29499920
Respiratory muscle weakness 18.95 10.56 7 53164 91 29521265
Rheumatoid arthritis 18.82 10.56 18 53153 32134 29489222
Off label use 18.57 10.56 406 52765 300394 29220962
Seasonal allergy 18.43 10.56 33 53138 5069 29516287
Nasal polyps 18.14 10.56 19 53152 1750 29519606
Cardiogenic shock 18.01 10.56 6 53165 19184 29502172
Blister 17.80 10.56 77 53094 19829 29501527
Dry eye 17.72 10.56 40 53131 7256 29514100
Oral allergy syndrome 17.70 10.56 5 53166 25 29521331
Infusion site pain 17.70 10.56 24 53147 2901 29518455
International normalised ratio increased 17.67 10.56 33 53138 44339 29477017
Platelet count decreased 17.61 10.56 113 53058 104559 29416797
Disseminated intravascular coagulation 17.48 10.56 7 53164 19973 29501383
Accidental overdose 17.25 10.56 70 53101 17523 29503833
Dystonia 16.90 10.56 47 53124 9702 29511654
Drug interaction 16.71 10.56 252 52919 197133 29324223
Cerebral infarction 16.68 10.56 12 53159 24663 29496693
Eosinophilic oesophagitis 16.49 10.56 8 53163 211 29521145
Bronchospasm 16.33 10.56 46 53125 9563 29511793
Neutrophil percentage increased 16.28 10.56 18 53153 1763 29519593
Fixed eruption 16.23 10.56 15 53156 1187 29520169
Specific gravity urine increased 16.20 10.56 7 53164 140 29521216
Product quality issue 16.19 10.56 64 53107 15831 29505525
Pancytopenia 16.00 10.56 86 53085 83082 29438274
Urine analysis abnormal 15.96 10.56 18 53153 1802 29519554
Cardio-respiratory arrest 15.77 10.56 43 53128 50558 29470798
Cardiac arrest 15.65 10.56 90 53081 85501 29435855
Illness 15.56 10.56 36 53135 6638 29514718
Pleural effusion 15.17 10.56 72 53099 71836 29449520
Skin haemorrhage 15.07 10.56 25 53146 3612 29517744
Micropenis 14.99 10.56 5 53166 47 29521309
Rash macular 14.96 10.56 47 53124 10378 29510978
Hepatic function abnormal 14.93 10.56 30 53141 39229 29482127
Palpitations 14.85 10.56 105 53066 32499 29488857
Aggression 14.78 10.56 112 53059 35429 29485927
Bronchial disorder 14.73 10.56 14 53157 1147 29520209
Increased upper airway secretion 14.62 10.56 16 53155 1550 29519806
Lymphocyte count decreased 14.60 10.56 71 53100 19200 29502156
Conjunctivitis 14.30 10.56 39 53132 7959 29513397
Dermatitis exfoliative 14.26 10.56 34 53137 6391 29514965
C-reactive protein increased 14.26 10.56 37 53134 44226 29477130
Heart rate increased 14.16 10.56 119 53052 38819 29482537
Haemoglobin urine present 14.13 10.56 5 53166 57 29521299
Brugada syndrome 14.09 10.56 11 53160 690 29520666
Injection site swelling 14.02 10.56 43 53128 9374 29511982
Reflux nephropathy 13.97 10.56 5 53166 59 29521297
Amino acid level decreased 13.90 10.56 5 53166 60 29521296
Abdominoplasty 13.90 10.56 3 53168 3 29521353
Blood creatine phosphokinase increased 13.85 10.56 33 53138 40611 29480745
Sinus operation 13.82 10.56 10 53161 559 29520797
Oropharyngeal pain 13.74 10.56 95 53076 29190 29492166
Rhinitis 13.68 10.56 28 53143 4750 29516606
Myocardial oedema 13.60 10.56 7 53164 210 29521146
Pseudoporphyria 13.57 10.56 8 53163 315 29521041
Sleep apnoea syndrome 13.45 10.56 65 53106 17534 29503822
Hereditary angioedema 13.30 10.56 11 53160 750 29520606
Chronic spontaneous urticaria 13.14 10.56 5 53166 71 29521285
Leukopenia 13.02 10.56 53 53118 55150 29466206
Myelosuppression 13.01 10.56 3 53168 12224 29509132
Septic shock 12.98 10.56 63 53108 62497 29458859
Insomnia 12.98 10.56 228 52943 88533 29432823
Respiratory failure 12.92 10.56 112 53059 97019 29424337
Amino acid level increased 12.70 10.56 8 53163 355 29521001
Crying 12.62 10.56 29 53142 5322 29516034
Periorbital discomfort 12.56 10.56 4 53167 32 29521324
Shock 12.51 10.56 12 53159 21392 29499964
Secretion discharge 12.44 10.56 25 53146 4185 29517171
Infusion site mass 12.44 10.56 7 53164 252 29521104
Swelling 12.40 10.56 107 53064 35176 29486180
Irritability 12.31 10.56 75 53096 22077 29499279
Adenocarcinoma pancreas 12.23 10.56 13 53158 1218 29520138
Gastroenteritis viral 12.23 10.56 30 53141 5742 29515614
Eye movement disorder 12.21 10.56 23 53148 3673 29517683
Erythema multiforme 12.20 10.56 36 53135 7681 29513675
Urine ketone body present 12.10 10.56 12 53159 1036 29520320
Penile erythema 12.10 10.56 6 53165 166 29521190
Urethritis noninfective 12.09 10.56 3 53168 8 29521348
Neuroleptic malignant syndrome 12.08 10.56 7 53164 16141 29505215
Hypercapnic coma 12.07 10.56 6 53165 167 29521189
Pruritus genital 12.01 10.56 9 53162 531 29520825
Temperature intolerance 12.00 10.56 20 53151 2901 29518455
Phonophobia 11.97 10.56 6 53165 170 29521186
Urine abnormality 11.96 10.56 15 53156 1679 29519677
Cerebral haemorrhage 11.96 10.56 24 53147 31402 29489954
Full blood count abnormal 11.87 10.56 56 53115 14957 29506399
Aplastic anaemia 11.84 10.56 35 53136 7475 29513881
Drug-induced liver injury 11.83 10.56 73 53098 21582 29499774
Urine albumin/creatinine ratio 11.83 10.56 3 53168 9 29521347
Treatment failure 11.81 10.56 31 53140 36908 29484448
Psychomotor hyperactivity 11.76 10.56 37 53134 8176 29513180
Congenital genital malformation 11.71 10.56 5 53166 97 29521259
Peritonitis 11.71 10.56 6 53165 14818 29506538
Scratch 11.69 10.56 19 53152 2699 29518657
Neutropenia 11.53 10.56 167 53004 131544 29389812
Tonsillitis 11.51 10.56 16 53155 1979 29519377
Respiratory tract infection 11.38 10.56 57 53114 15594 29505762
Ocular hyperaemia 11.18 10.56 39 53132 9088 29512268
Oculogyric crisis 11.16 10.56 13 53158 1348 29520008
Ileus 11.12 10.56 6 53165 14396 29506960
Haematochezia 11.10 10.56 32 53139 36951 29484405
Pharyngitis streptococcal 11.09 10.56 16 53155 2048 29519308
Accident 11.02 10.56 22 53149 3666 29517690
Febrile neutropenia 11.02 10.56 139 53032 112101 29409255
Affective disorder 11.01 10.56 20 53151 3106 29518250
Pharyngeal paraesthesia 10.98 10.56 8 53163 452 29520904
Genital haemorrhage 10.97 10.56 5 53166 114 29521242
Post-tussive vomiting 10.97 10.56 3 53168 13 29521343
Mycobacterial infection 10.88 10.56 15 53156 1841 29519515
Hyperventilation 10.83 10.56 17 53154 2345 29519011
Fibromyalgia 10.80 10.56 18 53153 2611 29518745
Infusion site swelling 10.80 10.56 15 53156 1855 29519501
Poor quality sleep 10.74 10.56 33 53138 7200 29514156
Hypertrichosis 10.64 10.56 7 53164 335 29521021
Physiotherapy chest 10.62 10.56 3 53168 15 29521341
Eye swelling 10.61 10.56 37 53134 8620 29512736

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
Pemphigus 1439.89 9.88 1361 213395 59340 64224636
Systemic lupus erythematosus 1269.57 9.88 1425 213331 76187 64207789
Glossodynia 1265.82 9.88 1306 213450 63390 64220586
Hand deformity 1119.10 9.88 1206 213550 61565 64222411
Pericarditis 927.95 9.88 1092 213664 61424 64222552
Anti-cyclic citrullinated peptide antibody positive 905.75 9.88 965 213791 48597 64235379
Hypersensitivity 890.23 9.88 1997 212759 194455 64089521
Wound 860.06 9.88 1163 213593 75314 64208662
Swelling 838.59 9.88 1727 213029 158491 64125485
Urticaria 819.79 9.88 1629 213127 145688 64138288
Alopecia 760.06 9.88 1693 213063 163997 64119979
Discomfort 717.49 9.88 1099 213657 79779 64204197
Pruritus 701.54 9.88 2459 212297 309941 63974035
Abdominal discomfort 694.91 9.88 1733 213023 180589 64103387
Duodenal ulcer perforation 619.82 9.88 667 214089 33958 64250018
Helicobacter infection 578.83 9.88 676 214080 37686 64246290
Synovitis 569.26 9.88 1111 213645 97979 64185997
Arthropathy 558.78 9.88 1240 213516 119727 64164249
Blister 546.58 9.88 973 213783 79994 64203982
Muscle injury 546.29 9.88 550 214206 25887 64258089
Contraindicated product administered 539.91 9.88 1142 213614 106687 64177289
Folliculitis 530.63 9.88 575 214181 29502 64254474
Irritable bowel syndrome 508.79 9.88 625 214131 36744 64247232
Sinusitis 499.85 9.88 1333 213423 144595 64139381
Hepatic enzyme increased 494.52 9.88 1235 213521 128708 64155268
Sleep disorder due to general medical condition, insomnia type 489.48 9.88 517 214239 25753 64258223
Maternal exposure during pregnancy 486.36 9.88 1021 213735 94863 64189113
Infusion related reaction 475.75 9.88 1413 213343 163054 64120922
Rash 473.05 9.88 2871 211885 455678 63828298
Lower respiratory tract infection 419.01 9.88 954 213802 93660 64190316
Death 411.51 9.88 607 214149 482098 63801878
Asthma 410.49 9.88 950 213806 94275 64189701
Rheumatoid factor positive 388.93 9.88 529 214227 34409 64249567
Pain 384.92 9.88 3149 211607 550362 63733614
Acute kidney injury 357.91 9.88 591 214165 448649 63835327
Joint swelling 349.57 9.88 1532 213224 213850 64070126
Toxicity to various agents 343.06 9.88 424 214332 363089 63920887
Anaemia 337.52 9.88 461 214295 378219 63905757
Drug intolerance 331.95 9.88 1372 213384 186620 64097356
Completed suicide 280.37 9.88 203 214553 224211 64059765
Drug interaction 279.27 9.88 486 214270 361597 63922379
Fatigue 273.21 9.88 3739 211017 744991 63538985
Therapeutic product effect decreased 265.78 9.88 917 213839 114434 64169542
Impaired healing 264.55 9.88 607 214149 59866 64224110
Ill-defined disorder 262.62 9.88 502 214254 43550 64240426
Food allergy 255.86 9.88 211 214545 7640 64276336
Neutropenia 189.72 9.88 316 214440 239308 64044668
Temperature regulation disorder 184.79 9.88 135 214621 4076 64279900
Hip arthroplasty 175.03 9.88 280 214476 21071 64262905
Gastrointestinal disorder 174.34 9.88 675 214081 89034 64194942
Product use issue 172.47 9.88 976 213780 150739 64133237
Sepsis 166.83 9.88 321 214435 230020 64053956
Hypotension 164.71 9.88 681 214075 380293 63903683
Rheumatic fever 164.42 9.88 178 214578 9116 64274860
Thrombocytopenia 161.98 9.88 312 214444 223489 64060487
Knee arthroplasty 157.61 9.88 305 214451 26694 64257282
Coeliac disease 154.53 9.88 155 214601 7257 64276719
Pneumonia 151.34 9.88 1167 213589 558409 63725567
Stomatitis 149.09 9.88 741 214015 108864 64175112
Myocardial infarction 146.29 9.88 203 214553 165618 64118358
Fall 145.74 9.88 804 213952 416022 63867954
Headache 145.35 9.88 2522 212234 526945 63757031
Wheezing 141.11 9.88 587 214169 79992 64203984
Febrile neutropenia 139.82 9.88 257 214499 187400 64096576
Renal impairment 138.45 9.88 147 214609 134870 64149106
Multiple organ dysfunction syndrome 138.35 9.88 83 214673 101330 64182646
Contusion 138.05 9.88 746 214010 113219 64170757
Swollen joint count increased 137.31 9.88 148 214608 7541 64276435
Malignant neoplasm progression 133.31 9.88 108 214648 112763 64171213
Cardiac failure 131.44 9.88 148 214608 132225 64151751
Angioedema 129.05 9.88 476 214280 61345 64222631
Renal failure 127.37 9.88 258 214498 181430 64102546
Pancytopenia 125.84 9.88 176 214580 143133 64140843
Nasopharyngitis 124.08 9.88 1094 213662 194979 64088997
Cardio-respiratory arrest 122.76 9.88 89 214667 98304 64185672
Gastrointestinal haemorrhage 120.72 9.88 158 214598 132154 64151822
Septic shock 119.47 9.88 105 214651 105332 64178644
Peripheral swelling 113.82 9.88 1130 213626 208023 64075953
Interstitial lung disease 112.34 9.88 96 214660 97636 64186340
Weight increased 110.97 9.88 1142 213614 212206 64071770
Crystal urine present 108.44 9.88 72 214684 1857 64282119
Respiratory failure 102.14 9.88 242 214514 160941 64123035
International normalised ratio increased 100.87 9.88 70 214686 79097 64204879
Disease progression 100.29 9.88 200 214556 141480 64142496
Hyponatraemia 99.44 9.88 216 214540 148123 64135853
Blood creatinine increased 98.43 9.88 189 214567 135593 64148383
Anaphylactic reaction 97.47 9.88 470 214286 68194 64215782
Infective pulmonary exacerbation of cystic fibrosis 97.09 9.88 155 214601 11641 64272335
Cardiac arrest 96.28 9.88 233 214523 153831 64130145
Rhabdomyolysis 96.12 9.88 98 214658 91628 64192348
Platelet count decreased 94.61 9.88 267 214489 167444 64116532
Ear pain 94.49 9.88 238 214518 24898 64259078
Metabolic acidosis 91.39 9.88 62 214694 70896 64213080
Rash erythematous 89.64 9.88 360 214396 48273 64235703
Cardiac failure congestive 89.30 9.88 188 214568 130392 64153584
Swelling face 88.35 9.88 411 214345 58755 64225221
Bone marrow failure 88.35 9.88 25 214731 47927 64236049
Haemoglobin decreased 84.55 9.88 348 214408 194715 64089261
Leukopenia 83.33 9.88 130 214626 101112 64182864
Drug resistance 82.32 9.88 10 214746 35092 64248884
Electric shock 80.58 9.88 49 214707 1080 64282896
Muscle spasticity 79.21 9.88 173 214583 16496 64267480
Hepatic function abnormal 79.14 9.88 59 214697 64254 64219722
Urinary sediment present 79.04 9.88 63 214693 2171 64281805
Throat irritation 78.71 9.88 264 214492 32447 64251529
Immunodeficiency 78.52 9.88 169 214587 15955 64268021
Type 2 diabetes mellitus 76.99 9.88 269 214487 33751 64250225
Urine abnormality 76.69 9.88 108 214648 7254 64276722
Atrial fibrillation 74.91 9.88 304 214452 170785 64113191
White blood cells urine positive 74.59 9.88 91 214665 5307 64278669
Lymphocyte percentage decreased 73.56 9.88 84 214672 4565 64279411
Haemoglobin urine present 73.53 9.88 42 214714 821 64283155
Depressed level of consciousness 73.49 9.88 98 214658 81338 64202638
Dermatitis atopic 71.67 9.88 76 214680 3800 64280176
Infection 71.21 9.88 934 213822 183946 64100030
Diarrhoea 70.40 9.88 1851 212905 720853 63563123
Night sweats 69.79 9.88 271 214485 35775 64248201
Hypoglycaemia 69.70 9.88 120 214636 89772 64194204
Respiratory disorder 69.52 9.88 271 214485 35840 64248136
Arthralgia 69.30 9.88 1945 212811 440315 63843661
Forced expiratory volume decreased 68.97 9.88 99 214657 6768 64277208
Hyperkalaemia 68.80 9.88 146 214610 100983 64182993
Pleural effusion 68.79 9.88 205 214551 126354 64157622
Erythema 68.31 9.88 936 213820 186134 64097842
Sleep terror 68.07 9.88 45 214711 1152 64282824
Type I hypersensitivity 67.72 9.88 71 214685 3503 64280473
Temperature intolerance 65.93 9.88 107 214649 8148 64275828
Treatment failure 65.35 9.88 635 214121 116181 64167795
Shock 64.99 9.88 23 214733 38217 64245759
Pneumonia aspiration 64.77 9.88 61 214695 59210 64224766
Ascites 64.09 9.88 67 214689 61934 64222042
Respiratory arrest 62.16 9.88 51 214705 52934 64231042
Blood creatine phosphokinase increased 61.98 9.88 62 214694 58496 64225480
Drug abuse 61.92 9.88 229 214527 132145 64151831
Neurotoxicity 61.41 9.88 9 214747 27395 64256581
Neutrophil percentage increased 59.91 9.88 74 214682 4371 64279605
Cytomegalovirus infection 58.88 9.88 25 214731 37174 64246802
Red blood cells urine positive 57.87 9.88 73 214683 4405 64279571
Haemorrhage 57.00 9.88 111 214645 79240 64204736
Bursitis 56.74 9.88 179 214577 21306 64262670
Haematuria 56.38 9.88 71 214685 60400 64223576
Urine analysis abnormal 56.37 9.88 82 214674 5674 64278302
Lactic acidosis 56.32 9.88 73 214683 61337 64222639
Lip swelling 56.26 9.88 233 214523 31674 64252302
Disseminated intravascular coagulation 55.76 9.88 19 214737 32329 64251647
Encephalopathy 54.90 9.88 69 214687 58750 64225226
Blood cholesterol increased 54.78 9.88 319 214437 49747 64234229
Eczema 53.96 9.88 219 214537 29501 64254475
Oral pruritus 53.63 9.88 46 214710 1759 64282217
Cerebrovascular accident 52.65 9.88 257 214499 137326 64146650
Urine leukocyte esterase positive 51.35 9.88 60 214696 3343 64280633
Body temperature increased 51.31 9.88 250 214506 36416 64247560
Acute myeloid leukaemia 51.18 9.88 14 214742 27449 64256527
Cardiogenic shock 50.99 9.88 22 214734 32405 64251571
Chest discomfort 50.88 9.88 601 214155 115505 64168471
Hereditary angioedema 49.80 9.88 63 214693 3813 64280163
Melaena 48.75 9.88 64 214692 53484 64230492
Hepatic failure 48.62 9.88 68 214688 55326 64228650
Upper respiratory tract infection 48.51 9.88 411 214345 72374 64211602
Acute myocardial infarction 47.96 9.88 100 214656 69618 64214358
Coma 47.54 9.88 142 214614 87473 64196503
Dehydration 47.33 9.88 477 214279 216286 64067690
Serotonin syndrome 47.09 9.88 37 214719 39245 64244731
Blood immunoglobulin E increased 47.06 9.88 61 214695 3783 64280193
Overdose 46.66 9.88 325 214431 159241 64124735
Insomnia 46.57 9.88 921 213835 196915 64087061
Post-traumatic stress disorder 45.76 9.88 63 214693 4142 64279834
Obstructive airways disorder 45.44 9.88 175 214581 23010 64260966
Hypercalcaemia 45.29 9.88 24 214732 31392 64252584
Altered state of consciousness 45.06 9.88 36 214720 37866 64246110
Off label use 44.93 9.88 1689 213067 631117 63652859
Myelosuppression 44.69 9.88 12 214744 23818 64260158
Blood bilirubin increased 44.46 9.88 77 214679 57476 64226500
Mastocytosis 44.17 9.88 24 214732 424 64283552
Victim of chemical submission 43.96 9.88 21 214735 279 64283697
Lymphocyte count decreased 43.67 9.88 258 214498 40441 64243535
Renal tubular necrosis 43.66 9.88 10 214746 22100 64261876
Injury 43.22 9.88 327 214429 55665 64228311
Cerebral infarction 42.82 9.88 44 214712 41000 64242976
Skin ulcer 42.72 9.88 50 214706 43924 64240052
Cerebral haemorrhage 42.60 9.88 65 214691 51025 64232951
Decreased appetite 41.99 9.88 671 214085 280618 64003358
Haematochezia 41.73 9.88 100 214656 66273 64217703
Chronic spontaneous urticaria 41.57 9.88 24 214732 479 64283497
Maternal exposure timing unspecified 41.30 9.88 48 214708 2659 64281317
Rheumatoid arthritis 40.74 9.88 771 213985 163523 64120453
Oedema peripheral 40.63 9.88 476 214280 209841 64074135
Osteonecrosis of jaw 40.08 9.88 44 214712 39781 64244195
Skin plaque 39.35 9.88 90 214666 8850 64275126
Neuroleptic malignant syndrome 39.24 9.88 17 214739 24979 64258997
Throat tightness 39.18 9.88 167 214589 22993 64260983
Hypocalcaemia 38.94 9.88 49 214707 41704 64242272
Shock haemorrhagic 38.84 9.88 5 214751 16786 64267190
Eye swelling 38.73 9.88 162 214594 22119 64261857
Mental status changes 38.57 9.88 92 214664 61070 64222906
Sinus disorder 38.52 9.88 134 214622 16774 64267202
C-reactive protein increased 38.23 9.88 174 214582 94735 64189241
Pregnancy 38.08 9.88 154 214602 20711 64263265
Perfume sensitivity 38.02 9.88 25 214731 634 64283342
Live birth 37.91 9.88 102 214654 11102 64272874
Peritonitis 37.75 9.88 18 214738 25005 64258971
Blood pressure fluctuation 37.74 9.88 72 214684 51799 64232177
Upper gastrointestinal haemorrhage 37.60 9.88 37 214719 35183 64248793
Pneumocystis jirovecii pneumonia 37.13 9.88 23 214733 27611 64256365
Inappropriate antidiuretic hormone secretion 36.87 9.88 14 214742 22275 64261701
Pulmonary oedema 36.84 9.88 136 214620 78538 64205438
Rectal haemorrhage 36.64 9.88 96 214660 61721 64222255
Intentional product misuse 36.52 9.88 121 214635 72174 64211802
Labelled drug-drug interaction medication error 36.26 9.88 14 214742 22048 64261928
Lacrimation increased 35.57 9.88 138 214618 18208 64265768
Agranulocytosis 35.51 9.88 45 214711 38184 64245792
Ventricular tachycardia 35.44 9.88 37 214719 34228 64249748
Neoplasm progression 35.24 9.88 51 214705 40913 64243063
Urinary tract infection 34.70 9.88 552 214204 231044 64052932
Sudden infant death syndrome 34.64 9.88 15 214741 156 64283820
Mucosal inflammation 34.26 9.88 101 214655 62483 64221493
Thrombotic microangiopathy 33.97 9.88 7 214749 16648 64267328
Flushing 33.95 9.88 406 214350 78242 64205734
Scratch 33.90 9.88 70 214686 6419 64277557
Posterior reversible encephalopathy syndrome 33.86 9.88 17 214739 22929 64261047
Adverse event 33.56 9.88 236 214520 39253 64244723
Exposure during pregnancy 33.54 9.88 401 214355 77274 64206702
Hypokalaemia 33.35 9.88 253 214503 121650 64162326
Neutrophil count decreased 33.24 9.88 138 214618 77058 64206918
Unresponsive to stimuli 33.23 9.88 74 214682 50319 64233657
Asthenia 33.14 9.88 1130 213626 426914 63857062
Neonatal hypoacusis 32.88 9.88 9 214747 17 64283959
Pericardial effusion 32.67 9.88 50 214706 39204 64244772
Hyperglycaemia 32.22 9.88 100 214656 60868 64223108
Orthostatic hypotension 32.18 9.88 67 214689 46671 64237305
Loss of consciousness 32.15 9.88 327 214429 148038 64135938
Head deformity 31.94 9.88 10 214746 36 64283940
Auditory neuropathy spectrum disorder 31.91 9.88 9 214747 20 64283956
Blood lactate dehydrogenase increased 31.71 9.88 38 214718 33040 64250936
Exposure via body fluid 31.71 9.88 16 214740 241 64283735
Paraesthesia oral 31.60 9.88 106 214650 13025 64270951
Vomiting 31.49 9.88 1507 213249 549610 63734366
Bacteraemia 31.44 9.88 26 214730 26885 64257091
Bacterial test positive 31.29 9.88 69 214687 6621 64277355
Abdominal pain upper 31.11 9.88 783 213973 174247 64109729
Ileus 31.02 9.88 19 214737 22947 64261029
Liver function test abnormal 30.99 9.88 98 214658 59303 64224673
Respiratory depression 30.83 9.88 20 214736 23423 64260553
Intervertebral discitis 30.81 9.88 50 214706 3807 64280169
Chronic sinusitis 30.69 9.88 66 214690 6226 64277750
Disease recurrence 30.42 9.88 36 214720 31474 64252502
Eye pruritus 30.30 9.88 102 214654 12557 64271419
Tachypnoea 29.44 9.88 27 214729 26544 64257432
Left ventricular dysfunction 29.15 9.88 10 214746 16944 64267032
Nasal congestion 28.91 9.88 315 214441 59343 64224633
Potassium wasting nephropathy 28.76 9.88 13 214743 151 64283825
Prostate cancer 28.71 9.88 15 214741 19780 64264196
Premature delivery 28.61 9.88 13 214743 18576 64265400
Adjustment disorder with depressed mood 28.54 9.88 38 214718 2419 64281557
Feeling hot 28.41 9.88 254 214502 45409 64238567
White blood cell count decreased 28.28 9.88 363 214393 157474 64126502
Anuria 28.06 9.88 14 214742 18950 64265026
Oliguria 27.98 9.88 7 214749 14569 64269407
Cestode infection 27.71 9.88 15 214741 263 64283713
Seasonal allergy 27.64 9.88 94 214662 11632 64272344
Penis injury 27.61 9.88 12 214744 126 64283850
Urticaria thermal 27.60 9.88 13 214743 167 64283809
Acute respiratory distress syndrome 27.49 9.88 55 214701 38880 64245096
Transaminases increased 27.39 9.88 68 214688 44526 64239450
Haematotoxicity 27.19 9.88 5 214751 12891 64271085
Myelodysplastic syndrome 27.17 9.88 31 214725 27548 64256428
Alanine aminotransferase increased 27.09 9.88 314 214442 138717 64145259
Transplant rejection 27.05 9.88 12 214744 17389 64266587
Plasma cell myeloma 26.96 9.88 72 214684 46003 64237973
Parathyroid gland enlargement 26.96 9.88 12 214744 134 64283842
Lichen sclerosus 26.94 9.88 23 214733 874 64283102
Renal injury 26.70 9.88 9 214747 15420 64268556
Vocal cord dysfunction 26.68 9.88 17 214739 408 64283568
Extrapyramidal disorder 26.65 9.88 16 214740 19536 64264440
Nasal oedema 26.57 9.88 24 214732 984 64282992
Chronic kidney disease 26.54 9.88 101 214655 57818 64226158
Nasal turbinate hypertrophy 26.52 9.88 19 214737 556 64283420
Adverse drug reaction 26.32 9.88 249 214507 45215 64238761
Haemodialysis 26.20 9.88 12 214744 17065 64266911
Mast cell activation syndrome 26.14 9.88 16 214740 357 64283619
Psychotic disorder 26.03 9.88 47 214709 34531 64249445
Nausea 25.91 9.88 2259 212497 783541 63500435
Restrictive pulmonary disease 25.86 9.88 34 214722 2138 64281838
Sneezing 25.82 9.88 110 214646 15141 64268835
Urticaria chronic 25.76 9.88 17 214739 434 64283542
Metastases to liver 25.73 9.88 25 214731 23916 64260060
Palmar-plantar erythrodysaesthesia syndrome 25.67 9.88 35 214721 28784 64255192
Menstruation delayed 25.57 9.88 25 214731 1134 64282842
Cardiomyopathy 25.53 9.88 28 214728 25328 64258648
Coronary artery disease 25.42 9.88 109 214647 60324 64223652
Proteinuria 25.37 9.88 33 214723 27690 64256286
Hepatotoxicity 25.28 9.88 60 214696 39902 64244074
Forced expiratory volume 25.27 9.88 10 214746 81 64283895
Lip pruritus 25.20 9.88 20 214736 685 64283291
Blood urine present 24.91 9.88 124 214632 18216 64265760
Aspartate aminotransferase increased 24.73 9.88 267 214489 119521 64164455
Thrombosis 24.73 9.88 136 214620 70506 64213470
Ventricular fibrillation 24.41 9.88 26 214730 23834 64260142
Cystic fibrosis pancreatic 24.37 9.88 9 214747 59 64283917
Hyper IgE syndrome 24.32 9.88 17 214739 478 64283498
Ear infection 24.23 9.88 147 214609 23257 64260719
Electrolyte imbalance 24.20 9.88 29 214727 25214 64258762
Haematemesis 24.19 9.88 78 214678 46921 64237055
Red blood cell sedimentation rate abnormal 24.18 9.88 12 214744 16294 64267682
Pathogen resistance 24.13 9.88 6 214750 12537 64271439
Osteomyelitis 24.07 9.88 34 214722 27553 64256423
Acute hepatic failure 23.98 9.88 31 214725 26081 64257895
Cardiotoxicity 23.91 9.88 3 214753 10271 64273705
Prescribed overdose 23.85 9.88 132 214624 20199 64263777
Allergy test positive 23.85 9.88 16 214740 420 64283556
Retinitis 23.84 9.88 32 214724 2053 64281923
Bronchial neoplasm 23.62 9.88 16 214740 427 64283549
Localised infection 23.61 9.88 40 214716 30121 64253855
Drug level increased 23.56 9.88 49 214707 34147 64249829
Specific gravity urine increased 23.52 9.88 16 214740 430 64283546
Monocyte percentage increased 23.34 9.88 31 214725 1969 64282007
Pregnancy on contraceptive 23.18 9.88 20 214736 771 64283205
Dry mouth 23.13 9.88 305 214451 60113 64223863
Subdural haematoma 23.09 9.88 36 214720 28018 64255958
Gastric haemorrhage 23.09 9.88 8 214748 13473 64270503
Product prescribing error 23.08 9.88 52 214704 35217 64248759
Haematoma 22.95 9.88 78 214678 46172 64237804
Demyelination 22.91 9.88 62 214694 6772 64277204
Dialysis 22.85 9.88 14 214742 16906 64267070
Status epilepticus 22.85 9.88 23 214733 21640 64262336
Hyperammonaemia 22.79 9.88 3 214753 9901 64274075
Escherichia infection 22.74 9.88 11 214745 15157 64268819
Polymenorrhoea 22.69 9.88 21 214735 889 64283087
Crying 22.62 9.88 129 214627 19961 64264015
Metastases to central nervous system 22.58 9.88 9 214747 13903 64270073
Nocturnal fear 22.40 9.88 6 214750 10 64283966
Creatinine renal clearance decreased 22.33 9.88 10 214746 14411 64269565
Cytokine release syndrome 22.32 9.88 132 214624 20697 64263279
C-reactive protein abnormal 22.30 9.88 39 214717 29008 64254968
Basal cell carcinoma 22.26 9.88 43 214713 30795 64253181
Fracture 22.06 9.88 18 214738 18737 64265239
Immune reconstitution inflammatory syndrome 22.06 9.88 7 214749 12463 64271513
Bronchial disorder 21.99 9.88 31 214725 2084 64281892
Diffuse large B-cell lymphoma 21.88 9.88 4 214752 10357 64273619
Bradycardia 21.88 9.88 270 214486 117949 64166027
Migraine 21.79 9.88 311 214445 62366 64221610
Penile haemorrhage 21.67 9.88 16 214740 491 64283485
Infusion site pain 21.64 9.88 80 214676 10317 64273659
Cholecystitis chronic 21.50 9.88 74 214682 9213 64274763
Bacterial test 21.14 9.88 23 214733 1184 64282792
Middle insomnia 21.12 9.88 92 214664 12785 64271191
Lip dry 21.09 9.88 49 214707 4869 64279107
Neoplasm malignant 20.98 9.88 31 214725 24657 64259319
Rhinitis 20.89 9.88 81 214675 10684 64273292
Graft versus host disease 20.74 9.88 10 214746 13803 64270173
Hyperbilirubinaemia 20.71 9.88 24 214732 21181 64262795
Tubulointerstitial nephritis 20.70 9.88 45 214711 30864 64253112
Sinus congestion 20.70 9.88 104 214652 15335 64268641
Eosinophilic oesophagitis 20.64 9.88 15 214741 449 64283527
Anxiety 20.62 9.88 848 213908 201801 64082175
Cellulitis 20.46 9.88 206 214550 93451 64190525
Hepatic encephalopathy 20.41 9.88 24 214732 21042 64262934
Dislocation of vertebra 20.35 9.88 37 214719 3087 64280889
Gastric ulcer 20.26 9.88 44 214712 30190 64253786
Tuberculosis 20.25 9.88 9 214747 13029 64270947
Hip fracture 20.25 9.88 37 214719 27062 64256914
Hallucination, auditory 20.25 9.88 16 214740 16923 64267053
Lung neoplasm malignant 20.18 9.88 25 214731 21423 64262553
Eosinophilic colitis 20.17 9.88 14 214742 389 64283587
Metastases to lung 20.10 9.88 13 214743 15251 64268725
Cardiac failure acute 20.09 9.88 15 214741 16329 64267647
Urine ketone body present 20.08 9.88 38 214718 3269 64280707
Intentional overdose 19.99 9.88 197 214559 89747 64194229
Tongue pruritus 19.97 9.88 15 214741 473 64283503
Myoclonus 19.95 9.88 33 214723 25085 64258891
Eosinophilic granulomatosis with polyangiitis 19.89 9.88 35 214721 2847 64281129
Cough 19.88 9.88 1212 213544 300936 63983040
Leukocytosis 19.87 9.88 62 214694 37678 64246298
Nitrite urine present 19.79 9.88 21 214735 1051 64282925
Enthesopathy 19.76 9.88 4 214752 9634 64274342
Urinary casts 19.62 9.88 21 214735 1061 64282915
Intestinal ischaemia 19.53 9.88 7 214749 11542 64272434
Swollen tongue 19.52 9.88 190 214566 34764 64249212
Therapy partial responder 19.52 9.88 5 214751 10243 64273733
Colitis 19.44 9.88 115 214641 58559 64225417
Klebsiella infection 19.36 9.88 10 214746 13271 64270705
Coagulopathy 19.35 9.88 49 214707 31871 64252105
Haemorrhage intracranial 19.33 9.88 31 214725 23853 64260123
Mechanical urticaria 19.25 9.88 13 214743 345 64283631
Haemodynamic instability 19.23 9.88 13 214743 14899 64269077
Skin burning sensation 19.22 9.88 78 214678 10505 64273471
Lichen nitidus 19.20 9.88 8 214748 75 64283901
Skin necrosis 19.15 9.88 12 214744 14317 64269659
Thymus disorder 19.12 9.88 11 214745 218 64283758
Muscle rigidity 19.07 9.88 18 214738 17455 64266521
Arrhythmia 19.04 9.88 101 214655 52843 64231133
Metastases to bone 19.04 9.88 24 214732 20411 64263565
Premenstrual syndrome 19.02 9.88 15 214741 509 64283467
Blood urea increased 18.96 9.88 79 214677 44074 64239902
Aspergillus infection 18.92 9.88 16 214740 16363 64267613
Gamma-glutamyltransferase increased 18.90 9.88 90 214666 48420 64235556
Syncope 18.78 9.88 391 214365 157244 64126732
Substance abuse 18.76 9.88 4 214752 9288 64274688
Depressed mood 18.71 9.88 214 214542 40798 64243178
Musculoskeletal stiffness 18.69 9.88 540 214216 122666 64161310
Fixed eruption 18.64 9.88 29 214727 2130 64281846
Generalised tonic-clonic seizure 18.59 9.88 69 214687 39788 64244188
Weight decreased 18.59 9.88 770 213986 284969 63999007
Seronegative arthritis 18.53 9.88 33 214723 2710 64281266
Heparin-induced thrombocytopenia 18.51 9.88 3 214753 8476 64275500
Second primary malignancy 18.42 9.88 9 214747 12328 64271648
Multiple sclerosis 18.38 9.88 117 214639 18824 64265152
Pharyngeal oedema 18.33 9.88 101 214655 15430 64268546
Ejection fraction decreased 18.24 9.88 43 214713 28664 64255312
Ehlers-Danlos syndrome 18.11 9.88 9 214747 131 64283845
Dyshidrotic eczema 18.09 9.88 15 214741 547 64283429
Magnesium deficiency 18.07 9.88 15 214741 548 64283428
Hypoxia 17.98 9.88 197 214559 87952 64196024
Sedation 17.92 9.88 74 214682 41388 64242588
Bilirubin urine present 17.79 9.88 12 214744 318 64283658
Herpes zoster 17.78 9.88 173 214583 79014 64204962
Gait disturbance 17.69 9.88 437 214319 171718 64112258
Cytomegalovirus viraemia 17.58 9.88 7 214749 10821 64273155
Encephalitis 17.54 9.88 10 214746 12561 64271415
Sudden death 17.30 9.88 25 214731 20071 64263905
Lactose intolerance 17.29 9.88 27 214729 1989 64281987
Violence-related symptom 17.25 9.88 16 214740 679 64283297
Intentional product use issue 17.04 9.88 427 214329 94937 64189039
Tumour lysis syndrome 16.92 9.88 24 214732 19416 64264560
Pulmonary embolism 16.86 9.88 365 214391 145991 64137985
Loss of personal independence in daily activities 16.82 9.88 157 214599 72297 64211679
Angina pectoris 16.78 9.88 85 214671 44996 64238980
Diabetes mellitus 16.77 9.88 141 214615 66333 64217643
Treatment noncompliance 16.75 9.88 81 214675 43401 64240575
Stress cardiomyopathy 16.73 9.88 5 214751 9252 64274724
Prevertebral soft tissue swelling of cervical space 16.69 9.88 6 214750 36 64283940
Oral allergy syndrome 16.69 9.88 6 214750 36 64283940
Pulmonary artery stenosis congenital 16.66 9.88 5 214751 15 64283961
Osteonecrosis 16.60 9.88 44 214712 28185 64255791
Fibromyalgia 16.55 9.88 187 214569 35544 64248432
Blood potassium increased 16.44 9.88 39 214717 25941 64258035
Pulmonary function test decreased 16.30 9.88 53 214703 6408 64277568
Photosensitivity reaction 16.26 9.88 110 214646 18063 64265913
Pharyngeal swelling 16.25 9.88 48 214708 5511 64278465
Pulmonary hypertension 16.25 9.88 81 214675 43058 64240918
Myopathy 16.23 9.88 21 214735 17659 64266317
Hyperplastic cholecystopathy 16.19 9.88 8 214748 115 64283861
Upper respiratory fungal infection 16.16 9.88 11 214745 296 64283680
Pulmonary haemorrhage 16.16 9.88 12 214744 13097 64270879
Pulmonary pain 16.08 9.88 30 214726 2554 64281422
Therapeutic product effect incomplete 16.03 9.88 245 214511 103237 64180739
Circulatory collapse 15.99 9.88 58 214698 33674 64250302
Femur fracture 15.98 9.88 59 214697 34076 64249900
Anaphylactoid reaction 15.90 9.88 43 214713 4695 64279281
Pulse absent 15.87 9.88 5 214751 8941 64275035
Protrusion tongue 15.79 9.88 12 214744 385 64283591
Oesophagitis 15.75 9.88 30 214726 21600 64262376
Diabetic ketoacidosis 15.73 9.88 49 214707 29796 64254180
Panniculitis 15.68 9.88 5 214751 8874 64275102
Epistaxis 15.66 9.88 231 214525 97900 64186076
Swelling of eyelid 15.62 9.88 27 214729 2165 64281811
Deep vein thrombosis postoperative 15.61 9.88 21 214735 1350 64282626
Duodenal ulcer 15.60 9.88 15 214741 14420 64269556
Respiratory distress 15.57 9.88 106 214650 52225 64231751
Hypervolaemia 15.52 9.88 70 214686 38215 64245761
Anti-cyclic citrullinated peptide antibody 15.48 9.88 21 214735 1361 64282615
Injection site urticaria 15.47 9.88 76 214680 11105 64272871
Hypertensive crisis 15.42 9.88 23 214733 18225 64265751
Neuropathy peripheral 15.36 9.88 287 214469 117238 64166738
Endometrial ablation 15.33 9.88 16 214740 785 64283191
Intestinal perforation 15.32 9.88 17 214739 15296 64268680
Dermatitis contact 15.30 9.88 65 214691 8935 64275041
Pruritus genital 15.25 9.88 18 214738 1014 64282962
Reaction to excipient 15.24 9.88 21 214735 1382 64282594
Cells in urine 15.14 9.88 9 214747 190 64283786
Gangrene 15.14 9.88 3 214753 7335 64276641
Ischaemic stroke 15.07 9.88 48 214708 28987 64254989
Poor feeding infant 15.05 9.88 8 214748 135 64283841
Rhinorrhoea 15.04 9.88 282 214474 59687 64224289
Candida infection 14.91 9.88 54 214702 31365 64252611
Toxic encephalopathy 14.90 9.88 7 214749 9808 64274168
Anticipatory anxiety 14.82 9.88 10 214746 265 64283711
Epstein-Barr virus infection 14.67 9.88 12 214744 12476 64271500
Faecaloma 14.67 9.88 7 214749 9721 64274255
Therapy cessation 14.66 9.88 57 214699 32432 64251544
Myocardial ischaemia 14.64 9.88 35 214721 23216 64260760
Axillary pain 14.59 9.88 23 214733 1709 64282267
Marginal zone lymphoma 14.52 9.88 6 214750 55 64283921
Delirium 14.37 9.88 154 214602 69040 64214936
Blood alkaline phosphatase increased 14.37 9.88 119 214637 56160 64227816
Activated partial thromboplastin time prolonged 14.26 9.88 13 214743 12818 64271158
Sensitivity to weather change 14.26 9.88 52 214704 6662 64277314
Schizophreniform disorder 14.25 9.88 8 214748 151 64283825
Metabolic disorder 14.20 9.88 4 214752 7693 64276283
Dyspnoea 14.12 9.88 2656 212100 716018 63567958
Haemophagocytic lymphohistiocytosis 14.11 9.88 23 214733 17586 64266390
Kidney transplant rejection 14.10 9.88 7 214749 9504 64274472
Biliary dyskinesia 14.09 9.88 27 214729 2345 64281631
Eye infection bacterial 14.09 9.88 9 214747 217 64283759
Urinary retention 13.98 9.88 101 214655 49100 64234876
Specific gravity urine decreased 13.86 9.88 15 214741 768 64283208
Acute graft versus host disease in skin 13.74 9.88 3 214753 6852 64277124
Wrong technique in product usage process 13.74 9.88 144 214612 64830 64219146
Cardiac tamponade 13.72 9.88 5 214751 8159 64275817
Enteritis 13.70 9.88 12 214744 12065 64271911
White blood cell count increased 13.68 9.88 147 214609 65867 64218109
Drug level decreased 13.58 9.88 11 214745 11492 64272484
Enterocolitis 13.57 9.88 12 214744 12006 64271970
Paternal exposure timing unspecified 13.56 9.88 6 214750 66 64283910
Hepatic cancer 13.50 9.88 4 214752 7444 64276532
Pain in extremity 13.50 9.88 849 213907 302236 63981740
Arteriosclerosis 13.43 9.88 20 214736 15857 64268119
Ventricular arrhythmia 13.41 9.88 4 214752 7411 64276565
Poisoning deliberate 13.40 9.88 15 214741 13443 64270533
Toxic epidermal necrolysis 13.31 9.88 71 214685 37095 64246881
Culture urine positive 13.26 9.88 37 214719 4114 64279862
Laryngitis 13.20 9.88 72 214684 10959 64273017
Bundle branch block right 13.18 9.88 9 214747 10260 64273716
Vital capacity decreased 13.10 9.88 17 214739 1055 64282921
Pancreatitis 13.06 9.88 131 214625 59476 64224500
Food intolerance 13.05 9.88 29 214727 2797 64281179
Blood pressure decreased 13.04 9.88 205 214551 85994 64197982
Hemiparesis 13.04 9.88 53 214703 29774 64254202
Autoimmune arthritis 13.02 9.88 7 214749 121 64283855
Febrile bone marrow aplasia 12.99 9.88 11 214745 11244 64272732
Hyperhidrosis 12.99 9.88 524 214232 124396 64159580
Immunosuppressant drug level increased 12.98 9.88 4 214752 7255 64276721
Adenovirus infection 12.96 9.88 4 214752 7251 64276725
Diarrhoea haemorrhagic 12.93 9.88 11 214745 11216 64272760
Cardiac failure chronic 12.89 9.88 7 214749 9034 64274942
Urine amphetamine positive 12.81 9.88 6 214750 76 64283900
Hypernatraemia 12.79 9.88 13 214743 12176 64271800
Ileus paralytic 12.77 9.88 6 214750 8409 64275567
Blood calcium decreased 12.74 9.88 43 214713 25511 64258465
Accidental exposure to product 12.72 9.88 45 214711 26319 64257657
Rhinitis allergic 12.71 9.88 57 214699 8021 64275955
Red blood cell count increased 12.67 9.88 33 214723 3522 64280454
Dry skin 12.63 9.88 240 214516 50921 64233055
Intestinal obstruction 12.62 9.88 70 214686 36216 64247760
Venoocclusive liver disease 12.56 9.88 9 214747 10006 64273970
Pulmonary fibrosis 12.49 9.88 54 214702 29824 64254152
Pneumonia fungal 12.48 9.88 7 214749 8870 64275106
Hallucination, visual 12.45 9.88 49 214707 27785 64256191
Hypothermia 12.41 9.88 30 214726 19826 64264150
Akathisia 12.39 9.88 12 214744 11498 64272478
Granulocytopenia 12.30 9.88 10 214746 10430 64273546
Bruxism 12.27 9.88 33 214723 3591 64280385
Prothrombin time prolonged 12.21 9.88 21 214735 15720 64268256
Enterococcal infection 12.19 9.88 17 214739 13849 64270127
Blood pressure diastolic abnormal 12.17 9.88 13 214743 11904 64272072
Urine bilirubin decreased 12.16 9.88 7 214749 139 64283837
Splenomegaly 12.15 9.88 26 214730 17935 64266041
Inflammation 12.13 9.88 149 214607 65151 64218825
Peripheral sensory neuropathy 12.09 9.88 12 214744 11366 64272610
Walking aid user 11.97 9.88 47 214709 6234 64277742
Lung infiltration 11.95 9.88 33 214723 20856 64263120
Cachexia 11.94 9.88 8 214748 9209 64274767
Autophobia 11.90 9.88 4 214752 19 64283957
Pulmonary alveolar haemorrhage 11.89 9.88 9 214747 9729 64274247
Epidermolysis bullosa 11.86 9.88 8 214748 212 64283764
Ataxia 11.82 9.88 36 214720 22048 64261928
Eosinophil count increased 11.79 9.88 84 214672 14028 64269948
Ear swelling 11.72 9.88 18 214738 1307 64282669
Hyperuricaemia 11.72 9.88 10 214746 10181 64273795
Post viral fatigue syndrome 11.68 9.88 9 214747 295 64283681
Burns second degree 11.64 9.88 15 214741 925 64283051
Schizophrenia 11.62 9.88 12 214744 11156 64272820
Cardiovascular disorder 11.59 9.88 22 214734 15859 64268117
Idiopathic angioedema 11.57 9.88 4 214752 21 64283955
Autoimmune disorder 11.48 9.88 44 214712 5772 64278204
Musculoskeletal pain 11.42 9.88 196 214560 81098 64202878
Hypophagia 11.38 9.88 81 214675 39506 64244470
Tachyarrhythmia 11.36 9.88 3 214753 6023 64277953
Hepatitis 11.36 9.88 97 214659 45485 64238491
Cystic fibrosis 11.35 9.88 31 214725 3403 64280573
Renal disorder 11.35 9.88 70 214686 35295 64248681
Tarsal tunnel syndrome 11.34 9.88 11 214745 494 64283482
Red cell distribution width increased 11.31 9.88 75 214681 12234 64271742
Parkinsonism 11.31 9.88 19 214737 14354 64269622
Haemoglobin abnormal 11.30 9.88 3 214753 6001 64277975
Colitis ischaemic 11.24 9.88 17 214739 13397 64270579
Bronchospasm 11.21 9.88 116 214640 21566 64262410
Spinal compression fracture 11.20 9.88 20 214736 14755 64269221
Blood glucose increased 11.17 9.88 245 214511 97828 64186148
Skin toxicity 11.17 9.88 4 214752 6598 64277378
Hypoaesthesia 11.08 9.88 568 214188 138540 64145436
Escherichia sepsis 11.04 9.88 5 214751 7160 64276816
Acidosis 11.03 9.88 27 214729 17768 64266208
Urobilinogen urine increased 11.00 9.88 12 214744 620 64283356
Pregnancy with injectable contraceptive 10.99 9.88 6 214750 107 64283869
Rhinovirus infection 10.89 9.88 45 214711 6111 64277865
Hemiplegia 10.88 9.88 16 214740 12752 64271224
Post-tussive vomiting 10.86 9.88 4 214752 26 64283950
Hepatic lesion 10.79 9.88 3 214753 5821 64278155
Poisoning 10.79 9.88 37 214719 21842 64262134
Uterine pain 10.77 9.88 7 214749 174 64283802
Coronary artery bypass 10.77 9.88 3 214753 5812 64278164
Microcytosis 10.75 9.88 9 214747 333 64283643
Oropharyngeal pain 10.73 9.88 379 214377 88488 64195488
Venous thrombosis 10.57 9.88 4 214752 6377 64277599
Atopy 10.55 9.88 8 214748 256 64283720
Differentiation syndrome 10.54 9.88 22 214734 2032 64281944
Large intestine perforation 10.54 9.88 16 214740 12588 64271388
Benign prostatic hyperplasia 10.53 9.88 9 214747 9156 64274820
Deafness 10.51 9.88 29 214727 18330 64265646
Pneumonitis 10.49 9.88 112 214644 50253 64233723
Postmortem blood drug level 10.49 9.88 8 214748 258 64283718
Bacterial infection 10.49 9.88 45 214711 24905 64259071
Renal cyst 10.47 9.88 16 214740 12554 64271422
Lower gastrointestinal haemorrhage 10.44 9.88 19 214737 13920 64270056
Anal abscess 10.44 9.88 6 214750 7502 64276474
Generalised anxiety disorder 10.41 9.88 21 214735 1894 64282082
Neutropenic sepsis 10.39 9.88 41 214715 23231 64260745
Breast cancer stage III 10.39 9.88 27 214729 2878 64281098
Pulmonary toxicity 10.34 9.88 8 214748 8553 64275423
Alanine aminotransferase abnormal 10.32 9.88 5 214751 6883 64277093
Hypoaesthesia oral 10.30 9.88 70 214686 11510 64272466
Nystagmus 10.30 9.88 9 214747 9059 64274917
Emotional distress 10.29 9.88 173 214583 35865 64248111
Agitation 10.28 9.88 220 214536 88147 64195829
Sleep disorder 10.27 9.88 266 214490 59443 64224533
Bicuspid aortic valve 10.26 9.88 4 214752 31 64283945
Urticaria pressure 10.25 9.88 3 214753 8 64283968
Urine output decreased 10.24 9.88 25 214731 16467 64267509
Exposure to allergen 10.23 9.88 7 214749 190 64283786
Tendon disorder 10.20 9.88 45 214711 6287 64277689
Laryngeal stenosis 10.18 9.88 13 214743 794 64283182
Spinal fusion surgery 10.18 9.88 31 214725 3620 64280356
Periorbital discomfort 10.15 9.88 4 214752 32 64283944
Prosopagnosia 10.15 9.88 4 214752 32 64283944
Blood albumin decreased 10.14 9.88 36 214720 21037 64262939
Transient ischaemic attack 10.14 9.88 96 214660 44086 64239890
Iron deficiency anaemia 10.14 9.88 38 214718 21851 64262125
Papule 10.14 9.88 45 214711 6305 64277671
Portal hypertension 10.13 9.88 4 214752 6215 64277761
Cardiac disorder 10.12 9.88 128 214628 55688 64228288
Pneumothorax 10.11 9.88 44 214712 24254 64259722
Nail dystrophy 10.11 9.88 13 214743 800 64283176
Cholestasis 10.09 9.88 98 214658 44774 64239202
Pulmonary congestion 10.08 9.88 43 214713 23837 64260139
Acute pulmonary oedema 10.01 9.88 17 214739 12792 64271184
Bronchial haemorrhage 9.98 9.88 16 214740 1206 64282770
Acute coronary syndrome 9.97 9.88 32 214724 19278 64264698
Angina unstable 9.96 9.88 23 214733 15444 64268532
Apnoea 9.96 9.88 12 214744 10410 64273566
Sunburn 9.96 9.88 29 214727 3303 64280673
Strabismus 9.95 9.88 22 214734 2115 64281861
Hydronephrosis 9.93 9.88 20 214736 14105 64269871
Pancreatitis acute 9.89 9.88 93 214663 42762 64241214

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R06AE07 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Piperazine derivatives
ATC S01GX12 SENSORY ORGANS
OPHTHALMOLOGICALS
DECONGESTANTS AND ANTIALLERGICS
Other antiallergics
FDA MoA N0000000190 Histamine H1 Receptor Antagonists
FDA EPC N0000175587 Histamine-1 Receptor Antagonist
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:37955 H1 receptor antagonists
CHEBI has role CHEBI:50857 anti-allergic drugs
CHEBI has role CHEBI:78298 environmental contaminants
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D039563 Histamine H1 Antagonists, Non-Sedating
MeSH PA D018377 Neurotransmitter Agents

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

DiseaseRelationSNOMED_IDDOID
Vasomotor rhinitis indication 8229003 DOID:4730
Allergic rhinitis indication 61582004
Nasal discharge indication 64531003
Nasal congestion indication 68235000
Sneezing indication 76067001
Common cold indication 82272006 DOID:10459
Chronic idiopathic urticaria indication 302162004
Seasonal allergic rhinitis indication 367498001
Allergic conjunctivitis indication 473460002 DOID:11204
Atopic dermatitis off-label use 24079001 DOID:3310
Urticaria off-label use 126485001
Glaucoma contraindication 23986001 DOID:1686
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Diabetes mellitus contraindication 73211009 DOID:9351
Chronic renal failure syndrome contraindication 90688005
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Drowsy contraindication 271782001
Angle-closure glaucoma contraindication 392291006 DOID:13550
Hypertensive urgency contraindication 443482000
Hemodialysis with High-Flux Membrane contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.03 acidic
pKa2 8.21 Basic
pKa3 3.72 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
5MG;120MG ZYRTEC-D 12 HOUR J AND J CONSUMER INC N021150 Nov. 9, 2007 OTC TABLET, EXTENDED RELEASE ORAL 7226614 June 10, 2022 TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
10MG/ML (10MG/ML) QUZYTTIR JDP N211415 Oct. 4, 2019 RX SOLUTION INTRAVENOUS 8513259 Feb. 11, 2030 METHOD OF INCREASING PEAK PLASMA OR ONSET OF PLASMA CONCENTRATION BY INTRAVENOUS INJECTION IN INDIVIDUALS IN NEED OF TREATMENT FOR ACUTE URTICARIA
10MG/ML (10MG/ML) QUZYTTIR JDP N211415 Oct. 4, 2019 RX SOLUTION INTRAVENOUS 9119771 Feb. 11, 2030 TREATMENT OF ACUTE URTICARIA
10MG/ML (10MG/ML) QUZYTTIR JDP N211415 Oct. 4, 2019 RX SOLUTION INTRAVENOUS 9180090 Feb. 11, 2030 TREATMENT OF ACUTE URTICARIA
10MG/ML (10MG/ML) QUZYTTIR JDP N211415 Oct. 4, 2019 RX SOLUTION INTRAVENOUS 8263581 Feb. 28, 2030 TREATMENT OF ACUTE URTICARIA
10MG/ML (10MG/ML) QUZYTTIR JDP N211415 Oct. 4, 2019 RX SOLUTION INTRAVENOUS 8314083 Feb. 28, 2030 METHOD OF TREATMENT IN PATIENTS WITH CONCOMITANT ANGIOEDEMA
EQ 0.24% BASE ZERVIATE EYEVANCE N208694 May 30, 2017 RX SOLUTION/DROPS OPHTHALMIC 8829005 March 15, 2030 TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
EQ 0.24% BASE ZERVIATE EYEVANCE N208694 May 30, 2017 RX SOLUTION/DROPS OPHTHALMIC 9993471 March 15, 2030 TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG/ML (10MG/ML) QUZYTTIR JDP N211415 Oct. 4, 2019 RX SOLUTION INTRAVENOUS Oct. 4, 2022 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Histamine H1 receptor GPCR ANTAGONIST Ki 7.91 WOMBAT-PK CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 4.52 CHEMBL
Angiopoietin-1 receptor Kinase Kd 4.05 CHEMBL

External reference:

IDSource
4024005 VUID
N0000022010 NUI
D00664 KEGG_DRUG
83881-52-1 SECONDARY_CAS_RN
203150 RXNORM
4020943 VANDF
4024005 VANDF
C0055147 UMLSCUI
CHEBI:3561 CHEBI
CHEMBL1000 ChEMBL_ID
CHEMBL1607273 ChEMBL_ID
CHEMBL1201113 ChEMBL_ID
DB00341 DRUGBANK_ID
D017332 MESH_DESCRIPTOR_UI
2678 PUBCHEM_CID
1222 IUPHAR_LIGAND_ID
5520 INN_ID
YO7261ME24 UNII
130140 MMSL
38293 MMSL
4399 MMSL
4400 MMSL
d03827 MMSL
003803 NDDF
003804 NDDF
108655000 SNOMEDCT_US
108656004 SNOMEDCT_US
372523007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
good sense all day allergy d HUMAN OTC DRUG LABEL 2 0113-0147 TABLET, FILM COATED, EXTENDED RELEASE 5 mg ORAL ANDA 16 sections
Good Sense All Day Allergy D HUMAN OTC DRUG LABEL 2 0113-0176 TABLET, EXTENDED RELEASE 5 mg ORAL ANDA 16 sections
Good Sense Childrens All Day Allergy HUMAN OTC DRUG LABEL 1 0113-0189 SOLUTION 5 mg ORAL ANDA 16 sections
Good Sense Childrens All Day Allergy HUMAN OTC DRUG LABEL 1 0113-0503 SOLUTION 5 mg ORAL ANDA 16 sections
good sense all day allergy HUMAN OTC DRUG LABEL 1 0113-1036 CAPSULE, LIQUID FILLED 10 mg ORAL ANDA 16 sections
All Day Allergy-D HUMAN OTC DRUG LABEL 2 0113-2176 TABLET, EXTENDED RELEASE 5 mg ORAL ANDA 16 sections
Basic Care All Day Allergy HUMAN OTC DRUG LABEL 1 0113-7002 TABLET, FILM COATED 10 mg ORAL ANDA 16 sections
BASIC CARE ALL DAY ALLERGY HUMAN OTC DRUG LABEL 1 0113-7036 CAPSULE, LIQUID FILLED 10 mg ORAL ANDA 16 sections
basic care childrens all day allergy HUMAN OTC DRUG LABEL 1 0113-7189 SOLUTION 5 mg ORAL ANDA 16 sections
basic care childrens all day allergy HUMAN OTC DRUG LABEL 1 0113-7475 SOLUTION 5 mg ORAL ANDA 16 sections
Good Sense all day allergy HUMAN OTC DRUG LABEL 1 0113-9458 TABLET, FILM COATED 10 mg ORAL ANDA 16 sections
Cetirizine Hydrochloride HUMAN OTC DRUG LABEL 1 0121-4780 SYRUP 5 mg ORAL ANDA 17 sections
Cetirizine Hydrochloride (Allergy) Human OTC Drug Label 1 0363-0068 CAPSULE 10 mg ORAL ANDA 16 sections
Cetirizine Hydrochloride Human OTC Drug Label 1 0363-0471 TABLET, ORALLY DISINTEGRATING 10 mg ORAL ANDA 14 sections
Wal Zyr HUMAN OTC DRUG LABEL 1 0363-0495 TABLET, FILM COATED 10 mg ORAL ANDA 16 sections
Wal-Zyr HUMAN OTC DRUG LABEL 1 0363-0606 TABLET 10 mg ORAL ANDA 17 sections
Wal-Zyr HUMAN OTC DRUG LABEL 1 0363-0606 TABLET 10 mg ORAL ANDA 17 sections
Wal-Zyr HUMAN OTC DRUG LABEL 1 0363-0741 CAPSULE 10 mg ORAL ANDA 16 sections
Wal-Zyr HUMAN OTC DRUG LABEL 1 0363-0921 CAPSULE 10 mg ORAL NDA 17 sections
Childrens Dye Free Wal Zyr HUMAN OTC DRUG LABEL 1 0363-0953 SOLUTION 5 mg ORAL ANDA 16 sections
Wal-Zyr D HUMAN OTC DRUG LABEL 2 0363-0989 TABLET, FILM COATED, EXTENDED RELEASE 5 mg ORAL ANDA 17 sections
Cetirizine HUMAN OTC DRUG LABEL 1 0363-1040 CAPSULE, LIQUID FILLED 10 mg ORAL ANDA 16 sections
WAL ZYR D HUMAN OTC DRUG LABEL 2 0363-1147 TABLET, FILM COATED, EXTENDED RELEASE 5 mg ORAL ANDA 16 sections
24 HOUR ALLERGY HUMAN OTC DRUG LABEL 1 0363-1219 CAPSULE 10 mg ORAL NDA 17 sections
childrens dye free wal zyr HUMAN OTC DRUG LABEL 1 0363-1475 SOLUTION 5 mg ORAL ANDA 16 sections
Wal-Zyr Cetirizine Hydrochloride HUMAN OTC DRUG LABEL 1 0363-2088 SOLUTION 5 mg ORAL ANDA 17 sections
Wal-Zyr Cetirizine Hydrochloride HUMAN OTC DRUG LABEL 1 0363-2102 SOLUTION 5 mg ORAL ANDA 17 sections
Wal-Zyr All Day Allergy HUMAN OTC DRUG LABEL 1 0363-2106 SOLUTION 5 mg ORAL ANDA 17 sections
Childrens Cetirizine Hydrochloride Human OTC Drug Label 1 0363-4025 TABLET, ORALLY DISINTEGRATING 10 mg ORAL ANDA 14 sections
Childrens Cetirizine Hydrochloride Human OTC Drug Label 1 0363-4025 TABLET, ORALLY DISINTEGRATING 10 mg ORAL ANDA 14 sections