cetirizine ๐Ÿถ 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 ยตM/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 2890.05 10.37 3813 289059 153399 55845796
Systemic lupus erythematosus 2579.61 10.37 3876 288996 176202 55822993
Glossodynia 2475.99 10.37 3483 289389 148975 55850220
Hand deformity 1832.00 10.37 2830 290042 131662 55867533
Abdominal discomfort 1721.42 10.37 4179 288693 273095 55726100
Alopecia 1692.47 10.37 4300 288572 289158 55710037
Wound 1608.12 10.37 2714 290158 136090 55863105
Swelling 1590.40 10.37 3709 289163 236062 55763133
Pericarditis 1371.70 10.37 2212 290660 106711 55892484
Discomfort 1326.71 10.37 2526 290346 139235 55859960
Contraindicated product administered 1282.78 10.37 2926 289946 183360 55815835
Anti-cyclic citrullinated peptide antibody positive 1233.98 10.37 1997 290875 96603 55902592
Hypersensitivity 1128.93 10.37 3407 289465 253001 55746194
Arthropathy 1128.71 10.37 2912 289960 197363 55801832
Maternal exposure during pregnancy 910.17 10.37 2599 290273 186954 55812241
Duodenal ulcer perforation 869.30 10.37 1395 291477 66947 55932248
Infusion related reaction 847.08 10.37 2699 290173 206232 55792963
Synovitis 834.52 10.37 2273 290599 159032 55840163
Helicobacter infection 823.91 10.37 1415 291457 71853 55927342
Muscle injury 805.14 10.37 1169 291703 51331 55947864
Folliculitis 799.59 10.37 1194 291678 53785 55945410
Blister 775.78 10.37 1735 291137 107152 55892043
Hepatic enzyme increased 759.31 10.37 2284 290588 169100 55830095
Pain 753.41 10.37 5950 286922 657234 55341961
Irritable bowel syndrome 733.05 10.37 1294 291578 67164 55932031
Death 707.36 10.37 453 292419 340973 55658222
Rheumatoid arthritis 675.55 10.37 3834 289038 378770 55620425
Product use issue 624.64 10.37 2257 290615 183784 55815411
Rash 620.90 10.37 4535 288337 488512 55510683
Rheumatoid factor positive 597.97 10.37 1192 291680 67868 55931327
Urticaria 555.82 10.37 1836 291036 142840 55856355
Pruritus 534.75 10.37 3137 289735 313486 55685709
Sleep disorder due to general medical condition, insomnia type 533.64 10.37 872 292000 42466 55956729
Lower respiratory tract infection 529.89 10.37 1553 291319 113241 55885954
Toxicity to various agents 502.73 10.37 271 292601 224293 55774902
Joint swelling 500.72 10.37 2889 289983 286911 55712284
Acute kidney injury 490.62 10.37 325 292547 240438 55758757
Anaemia 484.80 10.37 408 292464 267103 55732092
Therapeutic product effect decreased 475.18 10.37 1942 290930 167510 55831685
Sinusitis 474.78 10.37 2161 290711 195420 55803775
Impaired healing 467.83 10.37 1243 291629 85598 55913597
Drug intolerance 461.92 10.37 2647 290225 262171 55737024
Fatigue 435.26 10.37 6115 286757 782437 55216758
Ill-defined disorder 428.41 10.37 1038 291834 67505 55931690
Fall 362.10 10.37 830 292042 356680 55642515
Drug interaction 359.28 10.37 337 292535 209418 55789777
Rheumatic fever 348.02 10.37 575 292297 28252 55970943
Completed suicide 343.67 10.37 133 292739 133700 55865495
Hip arthroplasty 327.38 10.37 661 292211 37962 55961233
Neutropenia 315.95 10.37 218 292654 157949 55841246
Hypotension 314.95 10.37 511 292361 249997 55749198
Swollen joint count increased 311.80 10.37 497 292375 23687 55975508
Gastrointestinal disorder 309.60 10.37 1284 291588 111418 55887777
Stomatitis 293.26 10.37 1326 291546 119484 55879711
Knee arthroplasty 278.33 10.37 672 292200 43587 55955608
Pneumonia 256.99 10.37 1167 291705 405931 55593264
Thrombocytopenia 248.63 10.37 206 292666 136018 55863177
Sepsis 231.95 10.37 231 292641 139609 55859586
Type 2 diabetes mellitus 228.53 10.37 647 292225 46215 55952980
Diarrhoea 225.93 10.37 2180 290692 636327 55362868
Treatment failure 210.06 10.37 1562 291310 168830 55830365
Hyponatraemia 198.33 10.37 145 292727 101994 55897201
Febrile neutropenia 198.33 10.37 155 292717 105390 55893805
Nausea 195.43 10.37 2803 290069 761375 55237820
Malignant neoplasm progression 194.08 10.37 70 292802 73517 55925678
Food allergy 175.42 10.37 223 292649 8601 55990594
Disease progression 175.22 10.37 173 292699 105000 55894195
Liver injury 174.82 10.37 547 292325 41301 55957894
Nasopharyngitis 171.17 10.37 1830 291042 219129 55780066
Pancytopenia 170.87 10.37 127 292745 88588 55910607
Urinary tract infection 167.79 10.37 663 292209 239850 55759345
Haemoglobin decreased 167.08 10.37 275 292597 133862 55865333
Cardiac failure 166.71 10.37 111 292761 81982 55917213
Blood cholesterol increased 157.95 10.37 772 292100 71807 55927388
Myocardial infarction 156.74 10.37 151 292721 92719 55906476
Dehydration 155.40 10.37 375 292497 158450 55840745
Blood creatinine increased 152.89 10.37 116 292756 80075 55919120
Atrial fibrillation 150.36 10.37 208 292664 108689 55890506
Gastrointestinal haemorrhage 147.20 10.37 108 292764 75843 55923352
Renal impairment 146.05 10.37 123 292749 80590 55918605
Septic shock 145.59 10.37 67 292805 60768 55938427
Contusion 144.62 10.37 1153 291719 127277 55871918
Renal failure 143.79 10.37 220 292652 110280 55888915
Cardio-respiratory arrest 143.55 10.37 54 292818 55267 55943928
Vomiting 143.47 10.37 1782 291090 496446 55502749
Depressed level of consciousness 143.27 10.37 57 292815 56376 55942819
Cardiac failure congestive 143.01 10.37 147 292725 87573 55911622
Temperature regulation disorder 136.44 10.37 141 292731 4327 55994868
Leukopenia 136.03 10.37 102 292770 70838 55928357
Infection 135.46 10.37 1615 291257 198591 55800604
Respiratory failure 133.83 10.37 179 292693 94883 55904312
Asthma 132.23 10.37 1022 291850 111748 55887447
Weight increased 127.23 10.37 1786 291086 227917 55771278
Peripheral swelling 124.41 10.37 1811 291061 232915 55766280
Metabolic acidosis 124.05 10.37 29 292843 40425 55958770
Platelet count decreased 120.81 10.37 231 292641 106152 55893043
Multiple organ dysfunction syndrome 120.37 10.37 62 292810 52708 55946487
Angioedema 118.21 10.37 478 292394 40975 55958220
Coeliac disease 117.79 10.37 201 292671 10138 55989057
Intentional product use issue 117.55 10.37 905 291967 98828 55900367
Coma 116.67 10.37 84 292788 59571 55939624
Cerebrovascular accident 114.09 10.37 214 292658 99056 55900139
Hypokalaemia 110.82 10.37 201 292671 94236 55904959
Interstitial lung disease 108.18 10.37 83 292789 56980 55942215
Overdose 106.56 10.37 246 292626 105584 55893611
Cardiac arrest 105.55 10.37 179 292693 86135 55913060
Seizure 103.20 10.37 321 292551 124798 55874397
International normalised ratio increased 101.56 10.37 51 292821 43990 55955205
Pleural effusion 101.13 10.37 181 292691 85299 55913896
Plasma cell myeloma 98.90 10.37 60 292812 46586 55952609
White blood cell count decreased 98.51 10.37 331 292541 125659 55873536
Rhabdomyolysis 98.49 10.37 44 292828 40614 55958581
Haemorrhage 97.13 10.37 90 292782 56307 55942888
Intentional overdose 94.11 10.37 130 292742 67987 55931208
Dermatitis atopic 91.47 10.37 159 292713 8140 55991055
Chronic spontaneous urticaria 89.74 10.37 61 292811 1026 55998169
Weight decreased 89.30 10.37 811 292061 239903 55759292
Hypoglycaemia 88.19 10.37 96 292776 55719 55943476
Asthenia 87.83 10.37 1256 291616 341717 55657478
Wheezing 86.27 10.37 677 292195 74349 55924846
Lactic acidosis 84.45 10.37 39 292833 35307 55963888
Psoriatic arthropathy 84.10 10.37 666 292206 73342 55925853
Hyperkalaemia 83.16 10.37 85 292787 50780 55948415
Pneumonia aspiration 81.83 10.37 33 292839 32378 55966817
Oedema peripheral 81.29 10.37 539 292333 170715 55828480
Premature delivery 79.85 10.37 21 292851 27039 55972156
Bone marrow failure 79.67 10.37 24 292848 28262 55970933
Night sweats 78.90 10.37 423 292449 40790 55958405
Macular degeneration 78.80 10.37 247 292625 18661 55980534
Herpes zoster 78.34 10.37 174 292698 75715 55923480
Drug resistance 78.15 10.37 8 292864 20534 55978661
Drug abuse 77.45 10.37 146 292726 67464 55931731
Liver function test abnormal 77.33 10.37 74 292798 45597 55953598
Pain in extremity 76.90 10.37 1087 291785 296344 55702851
Hypercalcaemia 74.46 10.37 20 292852 25391 55973804
Mucosal inflammation 74.09 10.37 68 292804 42742 55956453
Confusional state 73.22 10.37 1504 291368 206651 55792544
Muscle spasticity 72.64 10.37 249 292623 19711 55979484
Loss of consciousness 71.42 10.37 309 292563 109040 55890155
Ear pain 71.09 10.37 334 292538 30556 55968639
Injury 70.98 10.37 544 292328 59307 55939888
Skin ulcer 70.85 10.37 58 292814 38550 55960645
Cytomegalovirus infection 69.70 10.37 9 292863 19287 55979908
Chronic kidney disease 69.07 10.37 70 292802 41986 55957209
Electric shock 68.69 10.37 52 292820 1043 55998152
Constipation 67.83 10.37 697 292175 201246 55797949
Cellulitis 67.82 10.37 184 292688 74765 55924430
Alanine aminotransferase increased 65.96 10.37 257 292615 93405 55905790
Drug ineffective 64.55 10.37 5581 287291 913408 55085787
Pulmonary oedema 64.43 10.37 104 292768 51039 55948156
Prescribed overdose 64.27 10.37 258 292614 22038 55977157
Shock 63.85 10.37 17 292855 21711 55977484
Hepatic function abnormal 63.31 10.37 52 292820 34506 55964689
Drug level increased 63.25 10.37 15 292857 20710 55978485
Crystal urine present 63.14 10.37 58 292814 1535 55997660
Decreased appetite 62.52 10.37 785 292087 218446 55780749
Femur fracture 61.62 10.37 68 292804 39227 55959968
Respiratory arrest 61.36 10.37 42 292830 30583 55968612
Acute myeloid leukaemia 61.10 10.37 8 292864 16964 55982231
Melaena 60.51 10.37 36 292836 28254 55970941
Altered state of consciousness 60.51 10.37 22 292850 22999 55976196
Unresponsive to stimuli 60.31 10.37 46 292826 31679 55967516
Osteonecrosis of jaw 60.12 10.37 51 292821 33307 55965888
Ascites 59.95 10.37 64 292808 37480 55961715
Pulmonary embolism 58.78 10.37 322 292550 106802 55892393
Somnolence 58.64 10.37 555 292317 162858 55836337
Rheumatoid nodule 58.62 10.37 5 292867 14852 55984343
Urticaria chronic 58.47 10.37 37 292835 548 55998647
Neoplasm progression 57.64 10.37 49 292823 31967 55967228
Breast cancer 57.21 10.37 104 292768 48729 55950466
Hepatic failure 56.99 10.37 54 292818 33432 55965763
Urinary sediment present 56.95 10.37 62 292810 2022 55997173
Respiratory disorder 56.70 10.37 336 292536 33621 55965574
Live birth 55.82 10.37 226 292646 19379 55979816
Body temperature increased 54.11 10.37 334 292538 33908 55965287
Foetal exposure during pregnancy 53.62 10.37 58 292814 33765 55965430
Pericardial effusion 53.47 10.37 38 292834 27137 55972058
Encephalopathy 53.36 10.37 63 292809 35262 55963933
Aspartate aminotransferase increased 52.97 10.37 235 292637 82367 55916828
Blood creatine phosphokinase increased 52.54 10.37 41 292831 27911 55971284
Pneumonitis 52.44 10.37 52 292820 31512 55967683
Tremor 52.11 10.37 392 292480 120697 55878498
Hypomagnesaemia 51.88 10.37 33 292839 24982 55974213
Hypocalcaemia 51.79 10.37 44 292828 28716 55970479
Acute myocardial infarction 51.74 10.37 49 292823 30344 55968851
Sleep disorder 51.60 10.37 559 292313 67104 55932091
Thrombosis 51.46 10.37 149 292723 59278 55939917
Haematochezia 51.31 10.37 93 292779 43625 55955570
Disseminated intravascular coagulation 50.69 10.37 15 292857 17870 55981325
Rectal haemorrhage 50.67 10.37 86 292786 41381 55957814
Osteomyelitis 50.66 10.37 32 292840 24314 55974881
Therapeutic product effect incomplete 50.64 10.37 333 292539 105698 55893497
Hypoxia 50.52 10.37 130 292742 53767 55945428
Orthostatic hypotension 50.37 10.37 59 292813 33140 55966055
Mental status changes 50.37 10.37 73 292799 37428 55961767
Hepatotoxicity 49.86 10.37 53 292819 31100 55968095
Serotonin syndrome 49.60 10.37 39 292833 26451 55972744
Anticipatory anxiety 49.41 10.37 42 292830 1000 55998195
Neuropathy peripheral 49.22 10.37 323 292549 102570 55896625
Neutrophil count decreased 49.18 10.37 117 292755 49705 55949490
Neurotoxicity 49.07 10.37 11 292861 15784 55983411
Blood pressure fluctuation 49.05 10.37 84 292788 40276 55958919
Hyperglycaemia 49.02 10.37 77 292795 38204 55960991
Product prescribing error 48.90 10.37 30 292842 23156 55976039
Cerebral haemorrhage 48.84 10.37 46 292826 28560 55970635
Electrocardiogram QT prolonged 48.64 10.37 135 292737 54453 55944742
Transaminases increased 48.26 10.37 47 292825 28723 55970472
Colitis 48.13 10.37 90 292782 41721 55957474
Premature baby 47.76 10.37 20 292852 19185 55980010
Fracture 47.73 10.37 17 292855 18001 55981194
Palmar-plantar erythrodysaesthesia syndrome 47.66 10.37 25 292847 21040 55978155
Haemoglobin urine present 47.56 10.37 37 292835 774 55998421
Proteinuria 47.54 10.37 16 292856 17554 55981641
Blood immunoglobulin E increased 47.53 10.37 68 292804 2941 55996254
Lung neoplasm malignant 46.79 10.37 16 292856 17380 55981815
Immunodeficiency 46.60 10.37 187 292685 15970 55983225
Abdominal pain 46.55 10.37 1009 291863 257796 55741399
Haematuria 46.54 10.37 43 292829 26944 55972251
Product dose omission issue 46.47 10.37 767 292105 203986 55795209
Tachycardia 45.91 10.37 342 292530 105534 55893661
Lymphocyte percentage decreased 45.82 10.37 65 292807 2789 55996406
Blood bilirubin increased 45.71 10.37 64 292808 33290 55965905
Blood glucose increased 45.69 10.37 218 292654 74933 55924262
Arthralgia 45.34 10.37 3109 289763 498560 55500635
Hip fracture 45.32 10.37 44 292828 26929 55972266
Adverse event 45.28 10.37 464 292408 54912 55944283
Bursitis 44.82 10.37 271 292601 27311 55971884
Anaphylactic reaction 44.80 10.37 487 292385 58508 55940687
Localised infection 44.58 10.37 46 292826 27366 55971829
Accidental exposure to product 44.03 10.37 38 292834 24609 55974586
Creatinine renal clearance decreased 43.53 10.37 11 292861 14548 55984647
C-reactive protein increased 43.44 10.37 236 292636 78448 55920747
Peritonitis 43.41 10.37 15 292857 16187 55983008
Blood lactate dehydrogenase increased 43.26 10.37 27 292845 20648 55978547
Retinitis 42.79 10.37 78 292794 4146 55995049
Bacteraemia 42.70 10.37 14 292858 15617 55983578
Acute respiratory distress syndrome 42.70 10.37 31 292841 21895 55977300
Pulmonary hypertension 42.60 10.37 76 292796 35868 55963327
Musculoskeletal stiffness 42.59 10.37 1088 291784 154919 55844276
Osteonecrosis 42.44 10.37 35 292837 23180 55976015
Myelosuppression 42.10 10.37 19 292853 17436 55981759
Gait disturbance 42.09 10.37 597 292275 162724 55836471
Wrong technique in product usage process 41.98 10.37 158 292714 58010 55941185
Inappropriate antidiuretic hormone secretion 41.89 10.37 10 292862 13746 55985449
Skin necrosis 41.79 10.37 7 292865 12354 55986841
Renal tubular necrosis 41.76 10.37 4 292868 10824 55988371
White blood cells urine positive 41.64 10.37 83 292789 4719 55994476
Adjustment disorder with depressed mood 41.63 10.37 86 292786 5017 55994178
Dizziness 41.54 10.37 1569 291303 374571 55624624
Drug hypersensitivity 41.48 10.37 1102 291770 274103 55725092
Myalgia 41.35 10.37 463 292409 131562 55867633
Urine abnormality 41.32 10.37 101 292771 6598 55992597
Blood pressure increased 41.29 10.37 520 292352 144656 55854539
Pain in jaw 41.14 10.37 92 292780 39944 55959251
Neoplasm malignant 41.13 10.37 48 292824 27007 55972188
Metastases to central nervous system 40.75 10.37 7 292865 12129 55987066
Syncope 40.73 10.37 363 292509 107836 55891359
Posterior reversible encephalopathy syndrome 40.70 10.37 16 292856 15944 55983251
Bradycardia 40.35 10.37 197 292675 67307 55931888
Acute hepatic failure 40.06 10.37 18 292854 16560 55982635
Gamma-glutamyltransferase increased 40.04 10.37 62 292810 30943 55968252
Muscular weakness 39.07 10.37 351 292521 104101 55895094
Psychotic disorder 38.92 10.37 39 292833 23519 55975676
Chest pain 38.89 10.37 724 292148 189073 55810122
Cardiomyopathy 38.74 10.37 18 292854 16240 55982955
Cerebral infarction 38.64 10.37 36 292836 22469 55976726
Haematoma 38.58 10.37 67 292805 31952 55967243
Victim of chemical submission 38.56 10.37 25 292847 387 55998808
Blood calcium decreased 38.53 10.37 40 292832 23729 55975466
Infective pulmonary exacerbation of cystic fibrosis 38.17 10.37 111 292761 8046 55991149
Agranulocytosis 38.02 10.37 37 292835 22622 55976573
Agitation 38.02 10.37 156 292716 55880 55943315
Respiratory depression 37.95 10.37 9 292863 12426 55986769
Musculoskeletal pain 37.68 10.37 257 292615 80895 55918300
Generalised tonic-clonic seizure 37.67 10.37 53 292819 27513 55971682
Extrapyramidal disorder 37.60 10.37 9 292863 12347 55986848
Drug use disorder 37.29 10.37 78 292794 4591 55994604
Electrolyte imbalance 37.11 10.37 24 292848 18009 55981186
Red blood cells urine positive 37.06 10.37 60 292812 2896 55996299
Breast cancer metastatic 37.06 10.37 17 292855 15452 55983743
General physical health deterioration 37.01 10.37 1152 291720 168858 55830337
Epistaxis 37.01 10.37 201 292671 66822 55932373
Maternal exposure timing unspecified 36.96 10.37 85 292787 5338 55993857
Rash erythematous 36.96 10.37 325 292547 36896 55962299
Haematemesis 36.67 10.37 58 292814 28700 55970495
Metastases to liver 36.51 10.37 35 292837 21551 55977644
Cataract 36.46 10.37 140 292732 51107 55948088
Neutrophil percentage increased 36.46 10.37 58 292814 2758 55996437
Leukocytosis 36.40 10.37 42 292830 23749 55975446
Cardiogenic shock 36.02 10.37 20 292852 16305 55982890
Basal cell carcinoma 35.98 10.37 47 292825 25174 55974021
Dislocation of vertebra 35.95 10.37 84 292788 5331 55993864
Lip dry 35.87 10.37 122 292750 9618 55989577
Cardiac disorder 35.53 10.37 121 292751 45766 55953429
Acute respiratory failure 35.42 10.37 67 292805 30927 55968268
Exposure during pregnancy 35.22 10.37 944 291928 135398 55863797
Diabetes mellitus 35.04 10.37 148 292724 52587 55946608
Auditory neuropathy spectrum disorder 34.93 10.37 11 292861 22 55999173
Upper gastrointestinal haemorrhage 34.68 10.37 23 292849 17031 55982164
Drug tolerance decreased 34.59 10.37 150 292722 13261 55985934
Adverse drug reaction 34.59 10.37 503 292369 64629 55934566
Influenza 34.38 10.37 323 292549 94938 55904257
Gastric ulcer 34.34 10.37 40 292832 22523 55976672
Hypophagia 34.27 10.37 61 292811 28815 55970380
Cystitis 34.23 10.37 135 292737 48903 55950292
Mechanical urticaria 34.15 10.37 24 292848 427 55998768
Hereditary angioedema 33.92 10.37 95 292777 6740 55992455
Tuberculosis 33.62 10.37 8 292864 11021 55988174
Sedation 33.49 10.37 83 292789 34771 55964424
Shock haemorrhagic 33.14 10.37 4 292868 9029 55990166
Anuria 33.08 10.37 10 292862 11750 55987445
Anti-cyclic citrullinated peptide antibody 33.07 10.37 65 292807 3658 55995537
Therapy cessation 32.89 10.37 57 292815 27207 55971988
Oliguria 32.86 10.37 3 292869 8437 55990758
Blood potassium increased 32.84 10.37 25 292847 17236 55981959
Transplant rejection 32.77 10.37 6 292866 9928 55989267
Status epilepticus 32.76 10.37 19 292853 15122 55984073
Haematotoxicity 32.59 10.37 3 292869 8380 55990815
Metastases to bone 32.57 10.37 32 292840 19476 55979719
Thrombotic microangiopathy 32.56 10.37 5 292867 9406 55989789
Perfume sensitivity 32.51 10.37 28 292844 679 55998516
Panniculitis 32.34 10.37 6 292866 9836 55989359
Hospitalisation 32.15 10.37 243 292629 74757 55924438
Renal disorder 32.11 10.37 66 292806 29539 55969656
Subdural haematoma 32.08 10.37 15 292857 13484 55985711
Neonatal hypoacusis 31.76 10.37 10 292862 20 55999175
Temperature intolerance 31.65 10.37 103 292769 7937 55991258
Bone disorder 31.55 10.37 33 292839 19510 55979685
Enthesopathy 31.04 10.37 3 292869 8060 55991135
Eye pruritus 30.80 10.37 151 292721 14055 55985140
Post-traumatic stress disorder 30.79 10.37 71 292801 4467 55994728
Urine leukocyte esterase positive 30.73 10.37 57 292815 3071 55996124
Transient ischaemic attack 30.69 10.37 82 292790 33495 55965700
Blood pressure diastolic abnormal 30.62 10.37 11 292861 11587 55987608
Labelled drug-drug interaction medication error 30.57 10.37 11 292861 11575 55987620
Injection site pain 30.56 10.37 427 292445 116691 55882504
Left ventricular dysfunction 30.32 10.37 10 292862 11113 55988082
Eczema 30.05 10.37 236 292636 25917 55973278
Cholestasis 30.04 10.37 59 292813 26854 55972341
Clostridium difficile colitis 29.85 10.37 32 292840 18706 55980489
Stress cardiomyopathy 29.84 10.37 4 292868 8332 55990863
Myelodysplastic syndrome 29.66 10.37 25 292847 16381 55982814
Red blood cell sedimentation rate abnormal 29.62 10.37 32 292840 18641 55980554
Accidental overdose 29.32 10.37 38 292834 20423 55978772
Blood alkaline phosphatase increased 29.28 10.37 104 292768 38841 55960354
Facet joint syndrome 29.15 10.37 89 292783 6628 55992567
Hepatitis 29.14 10.37 91 292781 35350 55963845
Deep vein thrombosis 29.08 10.37 258 292614 76719 55922476
Ventricular tachycardia 29.06 10.37 27 292845 16874 55982321
Cardiotoxicity 29.05 10.37 3 292869 7647 55991548
Pancreatitis 29.04 10.37 128 292744 44952 55954243
Oxygen saturation decreased 28.99 10.37 267 292605 78800 55920395
Pancreatitis acute 28.99 10.37 54 292818 25070 55974125
Intervertebral discitis 28.64 10.37 52 292820 2755 55996440
Hypertensive crisis 28.45 10.37 19 292853 14017 55985178
Inappropriate schedule of product administration 28.29 10.37 287 292585 83100 55916095
Angina pectoris 28.16 10.37 65 292807 27911 55971284
Intentional product misuse 28.13 10.37 155 292717 51349 55947846
Blood pressure systolic increased 28.13 10.37 113 292759 40723 55958472
Hypothyroidism 28.05 10.37 103 292769 38093 55961102
Aphasia 28.01 10.37 74 292798 30341 55968854
Suicide attempt 27.93 10.37 181 292691 57655 55941540
Urine analysis abnormal 27.92 10.37 70 292802 4647 55994548
Escherichia infection 27.80 10.37 13 292859 11686 55987509
Myoclonus 27.69 10.37 23 292849 15180 55984015
Spinal compression fracture 27.69 10.37 17 292855 13117 55986078
Influenza like illness 27.39 10.37 195 292677 60793 55938402
Vocal cord dysfunction 27.34 10.37 20 292852 380 55998815
Ejection fraction decreased 27.26 10.37 38 292834 19803 55979392
Pneumocystis jirovecii pneumonia 27.09 10.37 25 292847 15676 55983519
Therapy interrupted 27.06 10.37 58 292814 25567 55973628
Mast cell activation syndrome 27.05 10.37 25 292847 667 55998528
Akathisia 26.93 10.37 6 292866 8646 55990549
Blood pressure decreased 26.91 10.37 188 292684 58862 55940333
Rib fracture 26.82 10.37 40 292832 20269 55978926
Diverticulitis 26.78 10.37 96 292776 35756 55963439
Nervous system disorder 26.73 10.37 29 292843 16860 55982335
Muscle rigidity 26.72 10.37 11 292861 10660 55988535
Ileus 26.55 10.37 20 292852 13862 55985333
Respiratory distress 26.26 10.37 81 292791 31586 55967609
Spinal fracture 26.22 10.37 28 292844 16396 55982799
Haemorrhage intracranial 26.21 10.37 17 292855 12738 55986457
Hypervolaemia 26.21 10.37 62 292810 26396 55972799
Eosinophilic colitis 26.18 10.37 14 292858 148 55999047
Arrhythmia 26.16 10.37 94 292778 34989 55964206
Tachypnoea 26.12 10.37 25 292847 15405 55983790
Urinary retention 26.08 10.37 68 292804 28006 55971189
Tooth disorder 26.02 10.37 59 292813 25494 55973701
Diffuse large B-cell lymphoma 26.01 10.37 3 292869 7013 55992182
Polyneuropathy 26.00 10.37 18 292854 13032 55986163
Schizophrenia 26.00 10.37 11 292861 10488 55988707
Iron deficiency anaemia 25.96 10.37 33 292839 17886 55981309
Treatment noncompliance 25.96 10.37 85 292787 32538 55966657
Lethargy 25.86 10.37 159 292713 51282 55947913
Intestinal obstruction 25.80 10.37 68 292804 27903 55971292
Toxic epidermal necrolysis 25.76 10.37 47 292825 21995 55977200
Surgery 25.60 10.37 85 292787 32401 55966794
Chronic obstructive pulmonary disease 25.58 10.37 184 292688 57231 55941964
Pulmonary arterial hypertension 25.55 10.37 63 292809 26440 55972755
Pulmonary toxicity 25.49 10.37 5 292867 7878 55991317
Skin laceration 25.37 10.37 41 292831 20115 55979080
Blood urea increased 25.34 10.37 56 292816 24417 55974778
Clostridium difficile infection 25.18 10.37 66 292806 27132 55972063
Chills 25.05 10.37 379 292493 102225 55896970
Deep vein thrombosis postoperative 25.00 10.37 61 292811 3980 55995215
Musculoskeletal disorder 25.00 10.37 38 292834 19109 55980086
Chronic sinusitis 24.99 10.37 98 292774 8280 55990915
Hemiparesis 24.96 10.37 46 292826 21444 55977751
Klebsiella infection 24.91 10.37 5 292867 7751 55991444
Throat irritation 24.90 10.37 270 292602 32413 55966782
Restrictive pulmonary disease 24.86 10.37 35 292837 1491 55997704
Blood potassium decreased 24.79 10.37 110 292762 38562 55960633
Head deformity 24.78 10.37 12 292860 101 55999094
Seasonal allergy 24.64 10.37 163 292709 16945 55982250
Blood pressure systolic abnormal 24.60 10.37 10 292862 9767 55989428
Oral pruritus 24.37 10.37 38 292834 1776 55997419
Vision blurred 24.36 10.37 295 292577 82648 55916547
Drug eruption 24.25 10.37 62 292810 25701 55973494
Premature labour 24.20 10.37 16 292856 11866 55987329
Red blood cell count decreased 24.18 10.37 103 292769 36514 55962681
Hallucination, auditory 24.18 10.37 15 292857 11509 55987686
Mastocytosis 24.15 10.37 21 292851 516 55998679
Diabetic ketoacidosis 24.12 10.37 38 292834 18833 55980362
Urticaria thermal 24.11 10.37 16 292856 258 55998937
Colitis ischaemic 24.02 10.37 11 292861 10009 55989186
Neuroleptic malignant syndrome 24.00 10.37 15 292857 11463 55987732
Febrile bone marrow aplasia 23.89 10.37 3 292869 6569 55992626
Tubulointerstitial nephritis 23.83 10.37 31 292841 16634 55982561
Balance disorder 23.69 10.37 269 292603 76251 55922944
Loss of personal independence in daily activities 23.67 10.37 290 292582 81079 55918116
Hyper IgE syndrome 23.65 10.37 19 292853 417 55998778
Intestinal perforation 23.36 10.37 14 292858 10945 55988250
Allergic reaction to excipient 23.28 10.37 17 292855 322 55998873
Hepatic steatosis 23.22 10.37 65 292807 26149 55973046
Dyskinesia 23.05 10.37 76 292796 29032 55970163
No adverse event 23.00 10.37 104 292768 36270 55962925
Drug withdrawal syndrome 22.99 10.37 64 292808 25793 55973402
Headache 22.89 10.37 3279 289593 555765 55443430
Pregnancy on contraceptive 22.86 10.37 29 292843 1116 55998079
Haemorrhoids 22.81 10.37 44 292828 20162 55979033
Dialysis 22.72 10.37 11 292861 9691 55989504
Oral pain 22.70 10.37 66 292806 26227 55972968
Autoimmune disorder 22.65 10.37 100 292772 8909 55990286
Coronary artery disease 22.64 10.37 83 292789 30713 55968482
Allergy test positive 22.52 10.37 18 292854 392 55998803
Tenosynovitis 22.52 10.37 19 292853 12442 55986753
Renal injury 22.51 10.37 9 292863 8878 55990317
Device expulsion 22.43 10.37 82 292790 30367 55968828
Low birth weight baby 22.41 10.37 3 292869 6255 55992940
Ischaemic stroke 22.40 10.37 33 292839 16809 55982386
Bone density decreased 22.40 10.37 20 292852 12740 55986455
Forced expiratory volume decreased 22.37 10.37 64 292808 4596 55994599
Deafness 22.25 10.37 32 292840 16462 55982733
Malnutrition 22.23 10.37 24 292848 13984 55985211
Ankylosing spondylitis 22.15 10.37 12 292860 9918 55989277
Full blood count decreased 22.12 10.37 56 292816 23293 55975902
Therapeutic response decreased 22.11 10.37 172 292700 52586 55946609
Lymphadenopathy 22.06 10.37 101 292771 35107 55964088
Off label use 21.85 10.37 2547 290325 553633 55445562
Drug level decreased 21.78 10.37 5 292867 7059 55992136
Mouth ulceration 21.72 10.37 80 292792 29560 55969635
Dyspnoea exertional 21.68 10.37 181 292691 54508 55944687
Hypotonia 21.63 10.37 9 292863 8668 55990527
Acidosis 21.57 10.37 14 292858 10487 55988708
Skin plaque 21.54 10.37 83 292789 6955 55992240
Nocturnal fear 21.46 10.37 6 292866 6 55999189
Lupus vulgaris 21.31 10.37 37 292835 1892 55997303
Gastroenteritis 21.28 10.37 61 292811 24351 55974844
X-ray abnormal 21.21 10.37 60 292812 4281 55994914
Hepatocellular injury 21.15 10.37 69 292803 26445 55972750
Haematocrit decreased 21.13 10.37 109 292763 36720 55962475
Cestode infection 21.10 10.37 15 292857 272 55998923
Metastases to lung 21.01 10.37 18 292854 11700 55987495
Mitral valve incompetence 20.96 10.37 39 292833 18114 55981081
Caesarean section 20.95 10.37 32 292840 16059 55983136
Breast cancer female 20.87 10.37 20 292852 12318 55986877
Cardiac failure acute 20.87 10.37 10 292862 8863 55990332
Bone pain 20.85 10.37 164 292708 50021 55949174
Humerus fracture 20.84 10.37 8 292864 8089 55991106
Encephalitis 20.81 10.37 8 292864 8082 55991113
Arthritis 20.71 10.37 380 292492 99472 55899723
Tricuspid valve incompetence 20.70 10.37 23 292849 13230 55985965
Unevaluable event 20.68 10.37 154 292718 47533 55951662
Cognitive disorder 20.68 10.37 160 292712 48973 55950222
Cystic fibrosis pancreatic 20.48 10.37 9 292863 59 55999136
Scratch 20.47 10.37 70 292802 5533 55993662
Bronchial neoplasm 20.44 10.37 18 292854 450 55998745
Incorrect dose administered 20.34 10.37 175 292697 52372 55946823
Lichen sclerosus 20.30 10.37 26 292846 1010 55998185
Heart rate decreased 20.30 10.37 125 292747 40302 55958893
Malaise 20.12 10.37 1644 291228 366216 55632979
Psoriasis 20.10 10.37 350 292522 92342 55906853
Ovarian cancer 20.08 10.37 4 292868 6234 55992961
Ear infection 20.04 10.37 250 292622 31045 55968150
Diabetes mellitus inadequate control 19.99 10.37 26 292846 13954 55985241
Victim of sexual abuse 19.96 10.37 20 292852 591 55998604
Device difficult to use 19.95 10.37 16 292856 10745 55988450
Pallor 19.86 10.37 62 292810 24087 55975108
Burning sensation 19.83 10.37 160 292712 48536 55950659
Unintentional medical device removal 19.76 10.37 3 292869 5691 55993504
Enteritis 19.75 10.37 7 292865 7436 55991759
Hallucination, visual 19.75 10.37 38 292834 17430 55981765
Haemodialysis 19.73 10.37 10 292862 8581 55990614
Fibromyalgia 19.72 10.37 427 292445 59176 55940019
Failure to thrive 19.57 10.37 5 292867 6565 55992630
Crepitations 19.53 10.37 6 292866 6978 55992217
Femoral neck fracture 19.47 10.37 8 292864 7763 55991432
Heart rate irregular 19.28 10.37 50 292822 20629 55978566
Faeces discoloured 19.19 10.37 37 292835 16959 55982236
Sopor 19.19 10.37 51 292821 20871 55978324
Right ventricular failure 19.08 10.37 35 292837 16344 55982851
Candida infection 18.99 10.37 69 292803 25598 55973597
Schizophreniform disorder 18.87 10.37 9 292863 73 55999122
Abdominal distension 18.85 10.37 287 292585 77339 55921856
Seronegative arthritis 18.77 10.37 43 292829 2693 55996502
Gastric haemorrhage 18.77 10.37 4 292868 5946 55993249
Product use in unapproved indication 18.47 10.37 903 291969 139919 55859276
Condition aggravated 18.46 10.37 2057 290815 342841 55656354
Drug reaction with eosinophilia and systemic symptoms 18.36 10.37 88 292784 30216 55968979
Lung infiltration 18.19 10.37 27 292845 13711 55985484
Liver function test increased 18.05 10.37 80 292792 28053 55971142
Dementia 17.98 10.37 39 292833 17119 55982076
Therapy partial responder 17.97 10.37 9 292863 7776 55991419
Torsade de pointes 17.93 10.37 23 292849 12417 55986778
Visual acuity reduced 17.91 10.37 52 292820 20674 55978521
Histamine level increased 17.87 10.37 6 292866 16 55999179
Systemic inflammatory response syndrome 17.82 10.37 3 292869 5275 55993920
Multiple fractures 17.69 10.37 8 292864 7333 55991862
Coagulopathy 17.64 10.37 45 292827 18671 55980524
Hyperpathia 17.61 10.37 6 292866 17 55999178
Hallucination 17.57 10.37 167 292705 48982 55950213
Immune reconstitution inflammatory syndrome 17.53 10.37 4 292868 5670 55993525
Device malfunction 17.47 10.37 36 292836 16100 55983095
Nasal turbinate hypertrophy 17.41 10.37 20 292852 693 55998502
Haemodynamic instability 17.25 10.37 11 292861 8318 55990877
Bacterial test positive 17.23 10.37 61 292811 4907 55994288
Antinuclear antibody positive 17.21 10.37 7 292865 6834 55992361
Mental disorder 17.10 10.37 64 292808 23540 55975655
Spinal pain 17.10 10.37 22 292850 11862 55987333
Troponin increased 17.09 10.37 12 292860 8623 55990572
Vaginal haemorrhage 17.08 10.37 72 292800 25601 55973594
Gastric disorder 17.03 10.37 102 292770 33108 55966087
Atelectasis 17.01 10.37 48 292824 19260 55979935
Sudden death 17.00 10.37 15 292857 9610 55989585
Exposure via body fluid 16.98 10.37 17 292855 502 55998693
Nephrolithiasis 16.95 10.37 119 292753 37216 55961979
White blood cell count increased 16.90 10.37 150 292722 44609 55954586
Head injury 16.86 10.37 70 292802 24996 55974199
Device issue 16.79 10.37 55 292817 21051 55978144
Brain oedema 16.70 10.37 27 292845 13244 55985951
Circulatory collapse 16.69 10.37 54 292818 20749 55978446
Grip strength decreased 16.69 10.37 143 292729 16113 55983082
Anaphylactoid reaction 16.68 10.37 48 292824 3458 55995737
Electrocardiogram QRS complex prolonged 16.60 10.37 4 292868 5463 55993732
Rash pustular 16.47 10.37 7 292865 6656 55992539
Second primary malignancy 16.43 10.37 9 292863 7393 55991802
Hepatic encephalopathy 16.40 10.37 17 292855 10093 55989102
Lymphoma 16.40 10.37 18 292854 10410 55988785
Back pain 16.34 10.37 1039 291833 236131 55763064
Blood pressure diastolic decreased 16.32 10.37 49 292823 19274 55979921
Malignant melanoma 16.31 10.37 19 292853 10700 55988495
Cytopenia 16.29 10.37 16 292856 9739 55989456
Stillbirth 16.23 10.37 6 292866 6208 55992987
Injection site haemorrhage 16.21 10.37 60 292812 22141 55977054
Diarrhoea haemorrhagic 16.15 10.37 11 292861 8032 55991163
Prothrombin time prolonged 16.14 10.37 14 292858 9046 55990149
Peripheral sensory neuropathy 16.12 10.37 8 292864 6948 55992247
Atopy 16.09 10.37 12 292860 235 55998960
Lichen nitidus 16.06 10.37 8 292864 72 55999123
Staphylococcal infection 16.06 10.37 122 292750 37496 55961699
Granulocytopenia 16.05 10.37 4 292868 5340 55993855
Ventricular fibrillation 16.04 10.37 20 292852 10932 55988263
Hypothermia 16.04 10.37 25 292847 12445 55986750
Bronchial haemorrhage 15.98 10.37 17 292855 540 55998655
Monocyte count abnormal 15.93 10.37 11 292861 190 55999005
Poisoning deliberate 15.85 10.37 17 292855 9936 55989259
Peripheral venous disease 15.72 10.37 98 292774 9981 55989214
Ataxia 15.71 10.37 32 292840 14371 55984824
Tumour lysis syndrome 15.69 10.37 11 292861 7912 55991283
Product administration error 15.65 10.37 56 292816 20873 55978322
Hydronephrosis 15.61 10.37 15 292857 9227 55989968
Metastasis 15.54 10.37 3 292869 4781 55994414
Sinus tachycardia 15.53 10.37 62 292810 22382 55976813
Splenomegaly 15.50 10.37 18 292854 10150 55989045
Eating disorder 15.46 10.37 42 292830 17063 55982132
Duodenal ulcer 15.45 10.37 9 292863 7146 55992049
Menstruation delayed 15.44 10.37 28 292844 1482 55997713
Dysphagia 15.42 10.37 317 292555 81630 55917565
Urinary casts 15.39 10.37 19 292853 711 55998484
Atrioventricular block first degree 15.35 10.37 8 292864 6757 55992438
Oral allergy syndrome 15.32 10.37 6 292866 28 55999167
Lip pruritus 15.30 10.37 20 292852 793 55998402
Epstein-Barr virus infection 15.26 10.37 10 292862 7453 55991742
Foot fracture 15.24 10.37 60 292812 21749 55977446
Faecaloma 15.18 10.37 10 292862 7431 55991764
Cyst 15.15 10.37 27 292845 12751 55986444
Blood pressure systolic decreased 15.15 10.37 7 292865 6336 55992859
Blood albumin decreased 15.10 10.37 30 292842 13598 55985597
Urinary incontinence 15.10 10.37 91 292781 29494 55969701
Laryngitis 15.07 10.37 124 292748 13806 55985389
Gangrene 15.07 10.37 5 292867 5535 55993660
Disorientation 15.05 10.37 120 292752 36493 55962702
Walking aid user 15.04 10.37 85 292787 8358 55990837
Hemiplegia 14.96 10.37 13 292859 8391 55990804
Hepatic cytolysis 14.87 10.37 21 292851 10885 55988310
Pregnancy 14.82 10.37 248 292624 32785 55966410
Cardiovascular disorder 14.81 10.37 21 292851 10868 55988327
Paraesthesia oral 14.78 10.37 127 292745 14322 55984873
Device use error 14.71 10.37 5 292867 5451 55993744
Oesophagitis 14.69 10.37 32 292840 14025 55985170
Breast cancer stage I 14.69 10.37 7 292865 6223 55992972
Hyperbilirubinaemia 14.67 10.37 19 292853 10216 55988979
Intestinal ischaemia 14.66 10.37 9 292863 6946 55992249
Magnesium deficiency 14.62 10.37 16 292856 525 55998670
Osteopenia 14.62 10.37 47 292825 18094 55981101
Venous thrombosis 14.61 10.37 3 292869 4577 55994618
Gastritis 14.60 10.37 113 292759 34589 55964606
Bacterial infection 14.60 10.37 44 292828 17286 55981909
Pulmonary mass 14.51 10.37 56 292816 20414 55978781
Colon cancer 14.49 10.37 17 292855 9544 55989651
Urine output decreased 14.45 10.37 21 292851 10756 55988439
Pancreatic carcinoma 14.41 10.37 10 292862 7231 55991964
Muscle atrophy 14.37 10.37 8 292864 6513 55992682
Cholangitis 14.30 10.37 4 292868 4945 55994250
Tongue pruritus 14.29 10.37 15 292857 469 55998726
Myocarditis 14.25 10.37 15 292857 8843 55990352
Fistula 14.24 10.37 15 292857 8840 55990355
Atrial flutter 14.23 10.37 16 292856 9153 55990042
Female genital tract fistula 14.21 10.37 3 292869 4489 55994706
Injection site erythema 14.16 10.37 301 292571 77147 55922048
Large intestine perforation 14.15 10.37 12 292860 7839 55991356
Prevertebral soft tissue swelling of cervical space 14.10 10.37 6 292866 36 55999159
Eye infection bacterial 14.07 10.37 9 292863 136 55999059
Flatulence 14.07 10.37 100 292772 31188 55968007
Abdominal pain lower 14.02 10.37 67 292805 23025 55976170
Food intolerance 14 10.37 39 292833 2758 55996437
Aspergillus infection 13.96 10.37 11 292861 7454 55991741
Sinus node dysfunction 13.95 10.37 3 292869 4431 55994764
Dysarthria 13.88 10.37 135 292737 39415 55959780
Hypoalbuminaemia 13.87 10.37 21 292851 10578 55988617
Kidney infection 13.87 10.37 58 292814 20667 55978528
Glomerular filtration rate decreased 13.78 10.37 27 292845 12302 55986893
Glycosylated haemoglobin increased 13.78 10.37 23 292849 11142 55988053
Respirovirus test positive 13.78 10.37 5 292867 18 55999177
Renal cyst 13.64 10.37 17 292855 9292 55989903
Speech disorder 13.57 10.37 127 292745 37366 55961829
Colitis ulcerative 13.54 10.37 73 292799 24318 55974877
Abdominal pain upper 13.48 10.37 1090 291782 177223 55821972
Ehlers-Danlos syndrome 13.47 10.37 9 292863 147 55999048
Muscle spasms 13.40 10.37 581 292291 136790 55862405
Parkinsonism 13.40 10.37 18 292854 9528 55989667
Abnormal behaviour 13.40 10.37 57 292815 20215 55978980
Hypernatraemia 13.37 10.37 9 292863 6611 55992584
Eye swelling 13.36 10.37 170 292702 21206 55977989
Apathy 13.33 10.37 13 292859 7941 55991254
Tumour marker increased 13.31 10.37 3 292869 4290 55994905
Cholelithiasis 13.31 10.37 136 292736 39328 55959867
Pyelonephritis 13.27 10.37 41 292831 15983 55983212
Toothache 13.27 10.37 48 292824 17832 55981363
Miosis 13.26 10.37 9 292863 6583 55992612
Neutropenic sepsis 13.19 10.37 38 292834 15147 55984048
Paraesthesia 13.15 10.37 550 292322 129964 55869231
Myocardial ischaemia 13.15 10.37 27 292845 12089 55987106
Pollakiuria 13.14 10.37 77 292795 25125 55974070
Acute coronary syndrome 13.13 10.37 19 292853 9749 55989446
Drug ineffective for unapproved indication 13.13 10.37 79 292793 25614 55973581
Metabolic disorder 13.08 10.37 6 292866 5455 55993740
Polyuria 13.06 10.37 12 292860 7539 55991656
Blood glucose decreased 13.03 10.37 53 292819 19034 55980161
Congestive cardiomyopathy 13.03 10.37 7 292865 5812 55993383
Cells in urine 12.98 10.37 10 292862 206 55998989
Nail operation 12.93 10.37 18 292854 759 55998436
Arterial occlusive disease 12.87 10.37 6 292866 5404 55993791
Aphthous ulcer 12.86 10.37 27 292845 11992 55987203
Necrosis 12.84 10.37 5 292867 5011 55994184
Amylase increased 12.83 10.37 7 292865 5764 55993431
Lip swelling 12.82 10.37 200 292672 26072 55973123
Pulmonary congestion 12.81 10.37 42 292830 16073 55983122
Obstructive airways disorder 12.81 10.37 142 292730 17140 55982055
Lacrimation increased 12.81 10.37 149 292723 18199 55980996
Epidermolysis bullosa 12.79 10.37 8 292864 116 55999079
Blood pressure abnormal 12.76 10.37 33 292839 13627 55985568
Rash maculo-papular 12.70 10.37 93 292779 28814 55970381
Intentional self-injury 12.69 10.37 77 292795 24915 55974280
Post procedural haemorrhage 12.69 10.37 12 292860 7437 55991758
Pulmonary haemorrhage 12.68 10.37 10 292862 6773 55992422
Ulcer 12.65 10.37 67 292805 22418 55976777
Enterocolitis 12.63 10.37 11 292861 7093 55992102
Sinus disorder 12.58 10.37 164 292708 20570 55978625
Gait inability 12.55 10.37 148 292724 41670 55957525
Cachexia 12.53 10.37 5 292867 4937 55994258
Tardive dyskinesia 12.48 10.37 14 292858 8017 55991178
Post procedural infection 12.43 10.37 15 292857 8317 55990878
Device related infection 12.42 10.37 65 292807 21815 55977380
Leukoencephalopathy 12.37 10.37 3 292869 4079 55995116
Pneumothorax 12.34 10.37 38 292834 14829 55984366
Escherichia urinary tract infection 12.30 10.37 24 292848 10951 55988244
Neurological symptom 12.25 10.37 5 292867 4871 55994324
Thymus disorder 12.20 10.37 11 292861 284 55998911
Bronchial disorder 12.18 10.37 22 292850 1161 55998034
Vertigo CNS origin 12.18 10.37 5 292867 27 55999168
Epilepsy 12.16 10.37 79 292793 25152 55974043
Urine amphetamine positive 12.14 10.37 6 292866 53 55999142
Motor dysfunction 12.13 10.37 19 292853 9438 55989757
Toxic encephalopathy 12.09 10.37 8 292864 5930 55993265
Bedridden 12.08 10.37 22 292850 10303 55988892
Poor venous access 12.06 10.37 29 292843 12277 55986918
Poisoning 11.93 10.37 31 292841 12782 55986413
Gastric cancer 11.93 10.37 3 292869 3980 55995215
Pre-eclampsia 11.91 10.37 16 292856 8470 55990725
Hyperthyroidism 11.91 10.37 33 292839 13319 55985876
Glaucoma 11.90 10.37 48 292824 17281 55981914
Lymphocyte count decreased 11.90 10.37 208 292664 27731 55971464
Tendonitis 11.89 10.37 51 292821 18046 55981149
Respiratory tract infection 11.88 10.37 125 292747 35946 55963249
Diplopia 11.85 10.37 60 292812 20309 55978886
Delirium 11.81 10.37 153 292719 42364 55956831
Demyelination 11.79 10.37 64 292808 6198 55992997
Insomnia 11.76 10.37 1155 291717 190705 55808490
Lower gastrointestinal haemorrhage 11.75 10.37 12 292860 7175 55992020
Ovarian germ cell cancer stage II 11.75 10.37 5 292867 30 55999165
Normochromic normocytic anaemia 11.70 10.37 4 292868 4345 55994850
Swelling face 11.68 10.37 378 292494 55691 55943504
Prescribed underdose 11.65 10.37 161 292711 20456 55978739
Limb injury 11.63 10.37 68 292804 22202 55976993
Suspected suicide 11.63 10.37 7 292865 5459 55993736
Eosinophilic granulomatosis with polyangiitis 11.59 10.37 30 292842 2031 55997164
Hyperplastic cholecystopathy 11.59 10.37 7 292865 95 55999100
Autophobia 11.57 10.37 4 292868 12 55999183
Deficiency of bile secretion 11.57 10.37 4 292868 12 55999183
Lipase increased 11.55 10.37 18 292854 8961 55990234
Alanine aminotransferase abnormal 11.55 10.37 4 292868 4311 55994884
Spinal stenosis 11.51 10.37 36 292836 13978 55985217
Hyperuricaemia 11.51 10.37 6 292866 5067 55994128
Upper limb fracture 11.48 10.37 48 292824 17107 55982088
Spinal cord paralysis 11.48 10.37 5 292867 32 55999163
Metastases to lymph nodes 11.47 10.37 13 292859 7410 55991785
Osteoporosis 11.45 10.37 196 292676 51856 55947339
Intervertebral disc degeneration 11.44 10.37 37 292835 14217 55984978
Soft tissue disorder 11.41 10.37 4 292868 4278 55994917
Pneumonia bacterial 11.41 10.37 15 292857 8013 55991182
Hypogammaglobulinaemia 11.36 10.37 10 292862 6416 55992779
Skin discolouration 11.34 10.37 119 292753 34237 55964958
Hyperlipidaemia 11.31 10.37 52 292820 18057 55981138
Polymenorrhoea 11.31 10.37 21 292851 1132 55998063
Hepatic lesion 11.29 10.37 4 292868 4251 55994944
Decubitus ulcer 11.28 10.37 21 292851 9754 55989441
Embolism 11.26 10.37 13 292859 7351 55991844
Hyperthermia 11.25 10.37 16 292856 8269 55990926
Feeling abnormal 11.25 10.37 574 292298 133028 55866167
Tinnitus 11.20 10.37 101 292771 29941 55969254
Syphilis 11.16 10.37 8 292864 147 55999048
Dysuria 11.16 10.37 104 292768 30625 55968570
Haemoglobin abnormal 11.12 10.37 5 292867 4599 55994596
Eosinophil count increased 11.09 10.37 87 292785 9550 55989645
Choluria 11.07 10.37 8 292864 149 55999046
Ileus paralytic 11.04 10.37 4 292868 4191 55995004
Haemolysis 11.01 10.37 10 292862 6318 55992877
Oligohydramnios 11.00 10.37 9 292863 5985 55993210
Acute pulmonary oedema 11.00 10.37 14 292858 7583 55991612
Uveitis 10.99 10.37 26 292846 11069 55988126
Oligoarthritis 10.98 10.37 12 292860 393 55998802
Flank pain 10.93 10.37 38 292834 14287 55984908
Transfusion 10.91 10.37 35 292837 13485 55985710
Renal cancer 10.90 10.37 7 292865 5272 55993923
Bacterial sepsis 10.89 10.37 3 292869 3746 55995449
Activated partial thromboplastin time prolonged 10.86 10.37 11 292861 6601 55992594
Blood magnesium decreased 10.85 10.37 29 292843 11845 55987350
Endometrial ablation 10.85 10.37 18 292854 887 55998308
Gastrooesophageal reflux disease 10.84 10.37 340 292532 82917 55916278
Hypomania 10.82 10.37 6 292866 4896 55994299
Blood pressure inadequately controlled 10.79 10.37 5 292867 4519 55994676
Musculoskeletal chest pain 10.78 10.37 59 292813 19582 55979613
Escherichia sepsis 10.73 10.37 5 292867 4504 55994691
CSF volume increased 10.73 10.37 3 292869 3 55999192
Scleritis 10.72 10.37 3 292869 3708 55995487
Epigastric discomfort 10.72 10.37 10 292862 6238 55992957
Cholecystitis chronic 10.67 10.37 87 292785 9661 55989534
Atrioventricular block complete 10.65 10.37 14 292858 7480 55991715
Enterococcal infection 10.65 10.37 13 292859 7171 55992024
Axillary pain 10.63 10.37 26 292846 1699 55997496
Affect lability 10.62 10.37 23 292849 10102 55989093
Pathological fracture 10.61 10.37 16 292856 8073 55991122
Uterine cancer 10.61 10.37 5 292867 4474 55994721
Injection site bruising 10.56 10.37 139 292733 38382 55960813
Nephrogenic systemic fibrosis 10.55 10.37 5 292867 4460 55994735
Delusion 10.54 10.37 27 292845 11188 55988007
Myopathy 10.53 10.37 22 292850 9790 55989405
Inflammation 10.53 10.37 276 292596 68795 55930400
Wrist fracture 10.52 10.37 30 292842 11996 55987199
Blood creatine increased 10.49 10.37 7 292865 5166 55994029
Proctalgia 10.45 10.37 8 292864 5501 55993694
Presyncope 10.44 10.37 84 292788 25498 55973697
Immobile 10.43 10.37 8 292864 5494 55993701
Cyanosis central 10.43 10.37 6 292866 74 55999121
Nitrite urine present 10.42 10.37 19 292853 1010 55998185
Red cell distribution width decreased 10.42 10.37 25 292847 1614 55997581
Joint effusion 10.40 10.37 41 292831 14857 55984338
Eye disorder 10.39 10.37 63 292809 20389 55978806
Post procedural complication 10.38 10.37 44 292828 15622 55983573
Nystagmus 10.38 10.37 9 292863 5816 55993379

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
Urticaria 340.55 10.45 467 56691 57050 31583136
Asthma 271.98 10.45 359 56799 42252 31597934
Pruritus 236.64 10.45 623 56535 124544 31515642
Dermatitis atopic 126.09 10.45 89 57069 4773 31635413
Sleep terror 106.73 10.45 43 57115 714 31639472
Sinusitis 95.42 10.45 207 56951 36489 31603697
Rash 92.72 10.45 651 56507 200835 31439351
Infective pulmonary exacerbation of cystic fibrosis 81.76 10.45 78 57080 6406 31633780
Death 80.53 10.45 356 56802 360213 31279973
Hypersensitivity 77.58 10.45 249 56909 55494 31584692
Forced expiratory volume decreased 73.75 10.45 53 57105 2924 31637262
Upper respiratory tract infection 69.77 10.45 160 56998 29262 31610924
Wheezing 68.65 10.45 180 56978 35806 31604380
Vital capacity decreased 62.22 10.45 24 57134 353 31639833
Anaemia 60.46 10.45 191 56967 213331 31426855
Lip swelling 56.94 10.45 93 57065 13230 31626956
Headache 55.58 10.45 540 56618 183112 31457074
Eczema 54.58 10.45 99 57059 15318 31624868
Eye disorder 53.19 10.45 71 57087 8431 31631755
Product dose omission issue 51.89 10.45 347 56811 105239 31534947
Cough 50.30 10.45 415 56743 134399 31505787
Pruritus genital 46.62 10.45 22 57136 543 31639643
Swelling face 44.95 10.45 111 57047 21279 31618907
Nasal congestion 43.07 10.45 106 57052 20275 31619911
Angioedema 43.01 10.45 146 57012 33472 31606714
Lower respiratory tract infection 42.82 10.45 130 57028 28107 31612079
Parathyroid gland enlargement 42.57 10.45 14 57144 125 31640061
Potassium wasting nephropathy 42.17 10.45 13 57145 92 31640094
Upper respiratory fungal infection 41.43 10.45 14 57144 137 31640049
General physical health deterioration 40.78 10.45 90 57068 113345 31526841
Multiple organ dysfunction syndrome 40.42 10.45 38 57120 68165 31572021
Anaphylactic reaction 40.17 10.45 131 57027 29422 31610764
Dry skin 39.29 10.45 118 57040 25363 31614823
Fatigue 39.07 10.45 833 56325 334373 31305813
Sudden infant death syndrome 37.79 10.45 14 57144 183 31640003
Illness 37.29 10.45 63 57095 9214 31630972
Chest discomfort 37.25 10.45 182 56976 49187 31590999
Renal failure 37.23 10.45 107 57051 123223 31516963
Mydriasis 36.89 10.45 52 57106 6500 31633686
Migraine 36.85 10.45 80 57078 14100 31626086
Forced expiratory volume 36.70 10.45 12 57146 105 31640081
Rheumatoid arthritis 35.59 10.45 21 57137 47788 31592398
Suicidal ideation 34.81 10.45 144 57014 36262 31603924
Throat irritation 34.49 10.45 61 57097 9253 31630933
Renal impairment 34.00 10.45 65 57093 86284 31553902
Erythema 33.51 10.45 254 56904 80151 31560035
Throat tightness 33.40 10.45 54 57104 7615 31632571
Influenza 33.15 10.45 163 56995 44162 31596024
Crystal urine present 32.96 10.45 16 57142 421 31639765
Toxicity to various agents 32.50 10.45 193 56965 181294 31458892
Blood pressure increased 32.31 10.45 250 56908 79383 31560803
Cardiac failure 31.04 10.45 68 57090 85885 31554301
Tendon disorder 30.89 10.45 30 57128 2518 31637668
Penis injury 30.61 10.45 13 57145 248 31639938
Bronchopulmonary aspergillosis allergic 30.29 10.45 17 57141 607 31639579
Penile haemorrhage 30.01 10.45 17 57141 618 31639568
Oral pruritus 29.65 10.45 13 57145 269 31639917
Pulmonary function test decreased 29.57 10.45 38 57120 4347 31635839
Flushing 29.46 10.45 120 57038 30008 31610178
Differentiation syndrome 28.35 10.45 21 57137 1214 31638972
Anxiety 28.11 10.45 269 56889 90764 31549422
Seasonal allergy 28.04 10.45 42 57116 5546 31634640
Obstructive airways disorder 27.97 10.45 67 57091 12597 31627589
Completed suicide 27.89 10.45 79 57079 91435 31548751
Nasal oedema 27.73 10.45 13 57145 316 31639870
Patient elopement 27.33 10.45 7 57151 22 31640164
Interstitial lung disease 27.09 10.45 43 57115 61360 31578826
Myocardial infarction 27.04 10.45 109 57049 113345 31526841
Disturbance in attention 26.54 10.45 95 57063 22355 31617831
Ascites 26.54 10.45 21 57137 40992 31599194
Malignant neoplasm progression 26.51 10.45 65 57093 78933 31561253
Disease progression 26.19 10.45 80 57078 90384 31549802
Rash pruritic 25.54 10.45 98 57060 23840 31616346
Rash erythematous 25.28 10.45 94 57064 22533 31617653
Depressed mood 24.87 10.45 79 57079 17496 31622690
Drug resistance 24.59 10.45 6 57152 23447 31616739
Sepsis 24.40 10.45 167 56991 151762 31488424
Sinus disorder 24.31 10.45 42 57116 6253 31633933
Acute kidney injury 24.20 10.45 357 56801 279357 31360829
Ear infection 24.10 10.45 51 57107 8830 31631356
Malaise 24.01 10.45 432 56726 168079 31472107
Aplastic anaemia 24.00 10.45 52 57106 9151 31631035
Anticholinergic syndrome 23.86 10.45 18 57140 1070 31639116
Infusion related reaction 23.60 10.45 158 57000 47897 31592289
Infusion site pain 23.55 10.45 29 57129 3177 31637009
Gastrointestinal haemorrhage 23.19 10.45 74 57084 82475 31557711
Encephalopathy 23.15 10.45 15 57143 32459 31607727
Cardiogenic shock 22.97 10.45 6 57152 22402 31617784
Bone marrow failure 22.75 10.45 11 57147 27997 31612189
Dry eye 22.66 10.45 47 57111 8025 31632161
Middle insomnia 22.65 10.45 40 57118 6059 31634127
Victim of chemical submission 22.65 10.45 7 57151 50 31640136
Aspirin-exacerbated respiratory disease 22.60 10.45 12 57146 383 31639803
Anger 22.50 10.45 57 57101 11096 31629090
Prostate cancer 22.21 10.45 21 57137 37580 31602606
Hyperleukocytosis 22.18 10.45 21 57137 1708 31638478
Swollen tongue 22.17 10.45 62 57096 12800 31627386
Rash macular 21.72 10.45 57 57101 11338 31628848
Sinus congestion 21.58 10.45 35 57123 4948 31635238
Chronic spontaneous urticaria 21.32 10.45 9 57149 169 31640017
Platelet count decreased 21.06 10.45 115 57043 110320 31529866
Gastric ulcer perforation 20.88 10.45 16 57142 974 31639212
Mastocytosis 20.60 10.45 6 57152 34 31640152
Rhinorrhoea 20.43 10.45 89 57069 22923 31617263
Tic 20.31 10.45 21 57137 1900 31638286
Cerebral dysgenesis 20.22 10.45 5 57153 13 31640173
Ocular hyperaemia 20.04 10.45 51 57107 9958 31630228
Eye pruritus 19.93 10.45 34 57124 5011 31635175
Drug ineffective 19.77 10.45 553 56605 395020 31245166
Postmortem blood drug level 19.52 10.45 8 57150 139 31640047
Nasal polyps 19.49 10.45 21 57137 1992 31638194
Conjunctivitis 19.45 10.45 46 57112 8577 31631609
Neurotoxicity 19.43 10.45 3 57155 16223 31623963
Plasma cell myeloma 19.36 10.45 46 57112 56485 31583701
Mood altered 19.35 10.45 45 57113 8301 31631885
Lymphocyte percentage decreased 19.20 10.45 21 57137 2026 31638160
Seizure 19.19 10.45 269 56889 99499 31540687
Poverty of speech 19.04 10.45 9 57149 223 31639963
Sensorimotor disorder 18.95 10.45 11 57147 419 31639767
Respiratory muscle weakness 18.93 10.45 7 57151 91 31640095
International normalised ratio increased 18.71 10.45 33 57125 45190 31594996
Radiation inflammation 18.56 10.45 12 57146 556 31639630
Cerebral infarction 18.51 10.45 12 57146 25965 31614221
Disseminated intravascular coagulation 18.38 10.45 7 57151 20530 31619656
Pancytopenia 18.30 10.45 88 57070 87228 31552958
Off label use 17.97 10.45 483 56675 346791 31293395
C-reactive protein increased 17.96 10.45 38 57120 48612 31591574
Cardiac arrest 17.95 10.45 91 57067 88971 31551215
Sinus operation 17.90 10.45 12 57146 591 31639595
Injection site swelling 17.76 10.45 49 57109 10038 31630148
Oral allergy syndrome 17.69 10.45 5 57153 25 31640161
Accident 17.66 10.45 28 57130 3883 31636303
Scratch 17.41 10.45 24 57134 2937 31637249
Myelosuppression 17.33 10.45 3 57155 14917 31625269
Injection 17.25 10.45 4 57154 7 31640179
Skin haemorrhage 17.17 10.45 28 57130 3976 31636210
Hepatic function abnormal 17.13 10.45 30 57128 41192 31598994
Bronchospasm 17.12 10.45 48 57110 9924 31630262
Blister 17.10 10.45 79 57079 20857 31619329
Pulmonary pain 16.88 10.45 13 57145 797 31639389
Pleural effusion 16.59 10.45 74 57084 74846 31565340
COVID-19 16.42 10.45 161 56997 54660 31585526
Product quality issue 16.41 10.45 65 57093 16046 31624140
Specific gravity urine increased 16.18 10.45 7 57151 140 31640046
Neutrophil percentage increased 16.17 10.45 18 57140 1771 31638415
Dermatitis exfoliative 16.15 10.45 36 57122 6456 31633730
Rhinitis 16.03 10.45 31 57127 5033 31635153
Adenoidal hypertrophy 15.96 10.45 7 57151 145 31640041
Oropharyngeal pain 15.75 10.45 104 57054 31379 31608807
Accidental overdose 15.55 10.45 70 57088 18280 31621906
Swelling 15.53 10.45 118 57040 37240 31602946
Leukopenia 15.43 10.45 53 57105 57775 31582411
Dystonia 15.42 10.45 47 57111 10178 31630008
Drug interaction 15.40 10.45 274 56884 208269 31431917
Urine analysis abnormal 15.31 10.45 18 57140 1879 31638307
Micropenis 14.98 10.45 5 57153 47 31640139
Eosinophilic oesophagitis 14.88 10.45 8 57150 262 31639924
Septic shock 14.85 10.45 65 57093 66093 31574093
Bronchial disorder 14.72 10.45 15 57143 1334 31638852
Blood creatine phosphokinase increased 14.50 10.45 34 57124 41940 31598246
Sleep apnoea syndrome 14.28 10.45 69 57089 18556 31621630
Shock 14.15 10.45 12 57146 22633 31617553
Haemoglobin urine present 14.11 10.45 5 57153 57 31640129
Skin fissures 14.09 10.45 27 57131 4353 31635833
Temperature intolerance 14.06 10.45 22 57136 3017 31637169
Aggression 13.97 10.45 115 57043 37176 31603010
Reflux nephropathy 13.96 10.45 5 57153 59 31640127
Tonsillitis 13.92 10.45 18 57140 2072 31638114
Increased upper airway secretion 13.91 10.45 16 57142 1632 31638554
Abdominoplasty 13.89 10.45 3 57155 3 31640183
Crying 13.88 10.45 31 57127 5566 31634620
Amino acid level decreased 13.88 10.45 5 57153 60 31640126
Brugada syndrome 13.83 10.45 11 57147 707 31639479
Fixed eruption 13.79 10.45 15 57143 1438 31638748
Infusion site swelling 13.71 10.45 18 57140 2103 31638083
Respiratory failure 13.68 10.45 117 57041 101332 31538854
Eye swelling 13.68 10.45 42 57116 9134 31631052
Gastroenteritis viral 13.63 10.45 33 57125 6244 31633942
Thrombocytopenia 13.44 10.45 179 56979 142568 31497618
Myocardial oedema 13.43 10.45 7 57151 215 31639971
Insomnia 13.43 10.45 243 56915 94593 31545593
Pseudoporphyria 13.41 10.45 8 57150 321 31639865
Treatment failure 13.33 10.45 34 57124 40758 31599428
Neuroleptic malignant syndrome 13.14 10.45 7 57151 16862 31623324
Erythema multiforme 13.03 10.45 38 57120 8033 31632153
Heart rate increased 12.93 10.45 122 57036 40988 31599198
Pharyngitis streptococcal 12.86 10.45 18 57140 2235 31637951
Neutropenia 12.85 10.45 177 56981 140187 31499999
Periorbital discomfort 12.55 10.45 4 57154 32 31640154
Peritonitis 12.48 10.45 6 57152 15321 31624865
Complex regional pain syndrome 12.37 10.45 9 57149 506 31639680
Irritability 12.30 10.45 77 57081 22812 31617374
Palpitations 12.08 10.45 105 57053 34478 31605708
Urethritis noninfective 12.08 10.45 3 57155 8 31640178
Lymphocyte count decreased 12.07 10.45 71 57087 20578 31619608
Hypotension 12.06 10.45 279 56879 204339 31435847
Phonophobia 11.95 10.45 6 57152 170 31640016
Hypercapnic coma 11.92 10.45 6 57152 171 31640015
Urine albumin/creatinine ratio 11.82 10.45 3 57155 9 31640177
Food allergy 11.82 10.45 12 57146 1063 31639123
Cerebral haemorrhage 11.80 10.45 26 57132 32786 31607400
Penile erythema 11.76 10.45 6 57152 176 31640010
Urine ketone body present 11.73 10.45 12 57146 1072 31639114
Swelling of eyelid 11.73 10.45 11 57147 884 31639302
Pharyngeal paraesthesia 11.73 10.45 9 57149 549 31639637
Acute myeloid leukaemia 11.54 10.45 10 57148 18662 31621524
Amino acid level increased 11.53 10.45 8 57150 417 31639769
Eye movement disorder 11.45 10.45 23 57135 3838 31636348
Full blood count abnormal 11.43 10.45 59 57099 16288 31623898
Hyperventilation 11.43 10.45 18 57140 2483 31637703
Adenocarcinoma pancreas 11.42 10.45 13 57145 1311 31638875
Skin exfoliation 11.42 10.45 78 57080 23796 31616390
Cardiac failure congestive 11.41 10.45 90 57068 79297 31560889
Respiratory tract infection 11.33 10.45 62 57096 17499 31622687
Sleep disorder due to a general medical condition 11.28 10.45 23 57135 3879 31636307
Injection site reaction 11.06 10.45 46 57112 11605 31628581
Croup infectious 11.05 10.45 7 57151 313 31639873
Urine abnormality 11.01 10.45 15 57143 1816 31638370
Congenital genital malformation 11.00 10.45 5 57153 113 31640073
Post-tussive vomiting 10.96 10.45 3 57155 13 31640173
Labelled drug-drug interaction medication error 10.95 10.45 5 57153 13158 31627028
Secretion discharge 10.77 10.45 26 57132 4911 31635275
Frustration tolerance decreased 10.76 10.45 17 57141 2351 31637835
Viral infection 10.71 10.45 56 57102 15537 31624649
Infusion site erythema 10.68 10.45 15 57143 1868 31638318
Infusion site mass 10.68 10.45 7 57151 332 31639854
Febrile neutropenia 10.67 10.45 155 57003 121694 31518492
Deep vein thrombosis 10.63 10.45 65 57093 60671 31579515
Physiotherapy chest 10.61 10.45 3 57155 15 31640171
Ventricular fibrillation 10.58 10.45 11 57147 18837 31621349
Forced expiratory volume increased 10.45 10.45 3 57155 16 31640170

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 1710.95 9.99 1795 256113 81241 70589295
Glossodynia 1532.82 9.99 1727 256181 84760 70585776
Systemic lupus erythematosus 1528.72 9.99 1868 256040 100034 70570502
Hand deformity 1373.24 9.99 1632 256276 84850 70585686
Pericarditis 1201.35 9.99 1510 256398 83195 70587341
Anti-cyclic citrullinated peptide antibody positive 1146.35 9.99 1344 256564 68841 70601695
Hypersensitivity 1136.29 9.99 2550 255358 227262 70443274
Wound 1096.56 9.99 1562 256346 97170 70573366
Swelling 1056.35 9.99 2201 255707 186338 70484198
Alopecia 995.98 9.99 2216 255692 196274 70474262
Urticaria 971.72 9.99 1953 255955 161096 70509440
Discomfort 954.07 9.99 1516 256392 103920 70566616
Abdominal discomfort 914.71 9.99 2248 255660 212410 70458126
Duodenal ulcer perforation 831.43 9.99 977 256931 50135 70620401
Synovitis 819.29 9.99 1589 256319 127639 70542897
Pruritus 811.84 9.99 2929 254979 342631 70327905
Helicobacter infection 793.25 9.99 995 256913 54661 70615875
Arthropathy 760.86 9.99 1683 256225 148374 70522162
Blister 720.45 9.99 1303 256605 99223 70571313
Contraindicated product administered 709.89 9.99 1534 256374 133078 70537458
Muscle injury 704.14 9.99 782 257126 37712 70632824
Folliculitis 696.11 9.99 816 257092 41754 70628782
Irritable bowel syndrome 677.17 9.99 879 257029 49971 70620565
Hepatic enzyme increased 671.25 9.99 1647 256261 155343 70515193
Infusion related reaction 658.53 9.99 1889 256019 195645 70474891
Sleep disorder due to general medical condition, insomnia type 611.12 9.99 701 257207 35031 70635505
Maternal exposure during pregnancy 581.38 9.99 1291 256617 114054 70556482
Rash 574.01 9.99 3489 254419 507073 70163463
Sinusitis 568.59 9.99 1623 256285 167572 70502964
Lower respiratory tract infection 551.03 9.99 1241 256667 110672 70559864
Death 536.59 9.99 640 257268 509421 70161115
Rheumatoid factor positive 509.51 9.99 747 257161 47653 70622883
Drug intolerance 487.16 9.99 1863 256045 223824 70446712
Acute kidney injury 461.26 9.99 632 257276 473992 70196544
Joint swelling 459.76 9.99 1981 255927 251230 70419306
Toxicity to various agents 443.08 9.99 442 257466 381730 70288806
Anaemia 440.38 9.99 491 257417 402932 70267604
Pain 425.96 9.99 3809 254099 625007 70045529
Therapeutic product effect decreased 417.83 9.99 1306 256602 141712 70528824
Impaired healing 392.22 9.99 848 257060 73526 70597010
Rheumatoid arthritis 376.39 9.99 2070 255838 289735 70380801
Asthma 352.70 9.99 1103 256805 119690 70550846
Drug interaction 348.55 9.99 530 257378 380911 70289625
Ill-defined disorder 339.04 9.99 667 257241 54074 70616462
Completed suicide 331.83 9.99 208 257700 226927 70443609
Fatigue 298.10 9.99 4420 253488 819899 69850637
Rheumatic fever 259.90 9.99 321 257587 17339 70653197
Neutropenia 253.82 9.99 338 257570 256818 70413718
Product use issue 250.41 9.99 1304 256604 178633 70491903
Gastrointestinal disorder 248.56 9.99 896 257012 104531 70566005
Food allergy 248.12 9.99 223 257685 8301 70662235
Hypotension 246.09 9.99 708 257200 403673 70266863
Stomatitis 235.56 9.99 1009 256899 127502 70543034
Hip arthroplasty 228.66 9.99 385 257523 27655 70642881
Sepsis 227.78 9.99 335 257573 244210 70426326
Thrombocytopenia 221.29 9.99 329 257579 238781 70431755
Swollen joint count increased 209.66 9.99 254 257654 13446 70657090
Knee arthroplasty 208.79 9.99 415 257493 33886 70636650
Pneumonia 192.46 9.99 1324 256584 594908 70075628
Nasopharyngitis 191.68 9.99 1424 256484 220782 70449754
Febrile neutropenia 188.17 9.99 282 257626 204036 70466500
Fall 184.44 9.99 909 256999 443187 70227349
Cardiac failure 180.23 9.99 154 257754 143387 70527149
Multiple organ dysfunction syndrome 179.28 9.99 85 257823 108430 70562106
Temperature regulation disorder 178.47 9.99 140 257768 4304 70666232
Myocardial infarction 175.05 9.99 220 257688 171425 70499111
Renal impairment 174.02 9.99 160 257748 143777 70526759
Renal failure 169.26 9.99 266 257642 188804 70481732
Pancytopenia 167.73 9.99 181 257727 150926 70519610
Coeliac disease 167.67 9.99 185 257723 8848 70661688
Malignant neoplasm progression 167.54 9.99 119 257789 121620 70548916
Contusion 164.49 9.99 908 257000 127128 70543408
Gastrointestinal haemorrhage 156.53 9.99 161 257747 137247 70533289
Wheezing 152.63 9.99 713 257195 93457 70577079
Weight increased 152.01 9.99 1446 256462 240885 70429651
Headache 148.11 9.99 2945 254963 577460 70093076
Type 2 diabetes mellitus 147.91 9.99 423 257485 43657 70626879
Hyponatraemia 146.35 9.99 222 257686 159865 70510671
Septic shock 142.67 9.99 119 257789 112139 70558397
Disease progression 142.52 9.99 218 257690 156454 70514082
Respiratory failure 142.07 9.99 247 257661 168488 70502048
Peripheral swelling 139.74 9.99 1394 256514 235169 70435367
Interstitial lung disease 139.28 9.99 106 257802 104579 70565957
Platelet count decreased 136.73 9.99 276 257632 177946 70492590
Dermatitis atopic 136.21 9.99 166 257742 8841 70661695
Treatment failure 132.98 9.99 939 256969 143203 70527333
Cardio-respiratory arrest 130.08 9.99 105 257803 100572 70569964
Cardiac arrest 130.04 9.99 239 257669 159595 70510941
Infection 128.81 9.99 1251 256657 209534 70461002
Blood cholesterol increased 127.48 9.99 519 257389 64085 70606451
Blood creatinine increased 127.18 9.99 202 257706 142799 70527737
Angioedema 126.62 9.99 529 257379 66081 70604455
Rhabdomyolysis 122.32 9.99 101 257807 95659 70574877
Haemoglobin decreased 121.08 9.99 364 257544 204795 70465741
Atrial fibrillation 119.20 9.99 313 257595 184035 70486501
International normalised ratio increased 119.05 9.99 73 257835 80653 70589883
Cardiac failure congestive 117.96 9.99 194 257714 135263 70535273
Metabolic acidosis 115.66 9.99 63 257845 74283 70596253
Leukopenia 113.46 9.99 132 257776 106428 70564108
Chronic spontaneous urticaria 108.64 9.99 61 257847 1050 70669486
Arthralgia 105.68 9.99 2484 255424 500906 70169630
Crystal urine present 102.93 9.99 74 257834 1988 70668548
Drug resistance 102.59 9.99 10 257898 38180 70632356
Depressed level of consciousness 102.35 9.99 100 257808 87331 70583205
Night sweats 100.95 9.99 369 257539 43315 70627221
Bone marrow failure 100.30 9.99 27 257881 48983 70621553
Plasma cell myeloma 98.81 9.99 73 257835 73128 70597408
Hyperkalaemia 96.25 9.99 149 257759 106442 70564094
Hepatic function abnormal 95.47 9.99 65 257843 67931 70602605
Ear pain 92.73 9.99 265 257643 27334 70643202
Ascites 90.35 9.99 68 257840 67479 70603057
Pleural effusion 90.19 9.99 220 257688 132644 70537892
Infective pulmonary exacerbation of cystic fibrosis 90.04 9.99 160 257748 11998 70658538
Hypoglycaemia 89.99 9.99 127 257781 94237 70576299
Diarrhoea 86.53 9.99 2179 255729 781162 69889374
Injury 83.26 9.99 462 257446 64783 70605753
Bursitis 80.93 9.99 247 257661 26426 70644110
Rash erythematous 80.43 9.99 387 257521 51331 70619205
Dehydration 80.40 9.99 487 257421 225655 70444881
Blood creatine phosphokinase increased 80.25 9.99 63 257845 61200 70609336
Electric shock 78.95 9.99 51 257857 1144 70669392
Pneumonia aspiration 77.94 9.99 67 257841 62222 70608314
Immunodeficiency 77.86 9.99 187 257721 17368 70653168
Shock 77.73 9.99 25 257883 40400 70630136
Lactic acidosis 77.70 9.99 73 257835 64951 70605585
White blood cells urine positive 77.38 9.99 99 257809 5541 70664995
Swelling face 76.46 9.99 441 257467 62723 70607813
Anaphylactic reaction 75.99 9.99 500 257408 74474 70596062
Haemorrhage 75.82 9.99 117 257791 83698 70586838
Cytomegalovirus infection 75.72 9.99 25 257883 39733 70630803
Urinary sediment present 75.51 9.99 65 257843 2282 70668254
Haematuria 75.23 9.99 72 257836 63501 70607035
Urine abnormality 73.94 9.99 115 257793 7723 70662813
Throat irritation 73.13 9.99 288 257620 35016 70635520
Muscle spasticity 73.02 9.99 196 257712 19493 70651043
Lymphocyte percentage decreased 72.14 9.99 88 257820 4691 70665845
Cerebrovascular accident 71.36 9.99 274 257634 143196 70527340
Cardiogenic shock 70.62 9.99 22 257886 36285 70634251
Encephalopathy 70.47 9.99 72 257836 61589 70608947
Haemoglobin urine present 69.91 9.99 42 257866 825 70669711
Coma 69.74 9.99 143 257765 91701 70578835
Acute myeloid leukaemia 69.35 9.99 14 257894 30926 70639610
Prostate cancer 68.00 9.99 15 257893 31148 70639388
Disseminated intravascular coagulation 67.83 9.99 19 257889 33579 70636957
Adverse event 67.68 9.99 357 257551 49104 70621432
Respiratory disorder 67.65 9.99 302 257606 38821 70631715
Respiratory arrest 67.49 9.99 58 257850 53875 70616661
Neurotoxicity 65.81 9.99 14 257894 29812 70640724
Melaena 65.32 9.99 65 257843 56290 70614246
Eczema 64.74 9.99 269 257639 33512 70637024
Acute myocardial infarction 64.73 9.99 103 257805 72784 70597752
Forced expiratory volume decreased 64.43 9.99 104 257804 7210 70663326
Overdose 64.35 9.99 358 257550 169387 70501149
Prescribed overdose 63.98 9.99 231 257677 26950 70643586
Hepatic failure 63.93 9.99 69 257839 57556 70612980
Sleep terror 63.87 9.99 45 257863 1170 70669366
Serotonin syndrome 63.61 9.99 37 257871 42077 70628459
Temperature intolerance 63.57 9.99 114 257794 8609 70661927
Victim of chemical submission 63.30 9.99 31 257877 397 70670139
Maternal exposure timing unspecified 63.29 9.99 79 257829 4312 70666224
Fibromyalgia 63.09 9.99 342 257566 47532 70623004
Anticipatory anxiety 62.04 9.99 41 257867 957 70669579
Drug abuse 60.61 9.99 302 257606 146954 70523582
Urine analysis abnormal 60.45 9.99 92 257816 6062 70664474
Type I hypersensitivity 60.07 9.99 71 257837 3661 70666875
Skin ulcer 59.97 9.99 52 257856 48093 70622443
Blood bilirubin increased 59.75 9.99 78 257830 59823 70610713
Neutrophil percentage increased 59.61 9.99 78 257830 4464 70666072
Red blood cells urine positive 57.40 9.99 78 257830 4631 70665905
Haematochezia 57.01 9.99 112 257796 72969 70597567
Lip dry 56.68 9.99 116 257792 9669 70660867
Adverse drug reaction 56.65 9.99 360 257548 52984 70617552
Urine leukocyte esterase positive 56.46 9.99 68 257840 3577 70666959
Lip swelling 55.99 9.99 259 257649 33795 70636741
Cerebral haemorrhage 55.95 9.99 68 257840 53796 70616740
Body temperature increased 55.52 9.99 289 257619 39545 70630991
Retinitis 55.47 9.99 72 257836 4088 70666448
Hypercalcaemia 55.15 9.99 28 257880 34357 70636179
Hypokalaemia 54.59 9.99 268 257640 130920 70539616
Eye pruritus 54.51 9.99 146 257762 14501 70656035
Cerebral infarction 54.12 9.99 46 257862 42963 70627573
Myelosuppression 53.93 9.99 21 257887 30124 70640412
Exposure during pregnancy 53.69 9.99 521 257387 87196 70583340
Renal tubular necrosis 52.95 9.99 10 257898 23161 70647375
Pregnancy 52.53 9.99 198 257710 23583 70646953
Pulmonary oedema 52.16 9.99 141 257767 82137 70588399
White blood cell count decreased 52.11 9.99 383 257525 169758 70500778
Orthostatic hypotension 50.97 9.99 68 257840 51675 70618861
Urinary tract infection 50.53 9.99 620 257288 248149 70422387
Erythema 50.42 9.99 1012 256896 198551 70471985
Osteonecrosis of jaw 50.21 9.99 45 257863 40957 70629579
Mental status changes 49.83 9.99 96 257812 63005 70607531
Neutrophil count decreased 49.42 9.99 148 257760 83408 70587128
Ear infection 49.19 9.99 219 257689 28117 70642419
Live birth 48.93 9.99 135 257773 13644 70656892
Abdominal pain upper 48.65 9.99 981 256927 192621 70477915
Oral pruritus 48.56 9.99 47 257861 1924 70668612
Upper gastrointestinal haemorrhage 48.50 9.99 39 257869 37438 70633098
Neuroleptic malignant syndrome 48.40 9.99 17 257891 25990 70644546
Rectal haemorrhage 47.88 9.99 105 257803 65726 70604810
Musculoskeletal stiffness 47.79 9.99 779 257129 146981 70523555
Altered state of consciousness 47.73 9.99 45 257863 39977 70630559
Mechanical urticaria 47.68 9.99 25 257883 373 70670163
Facet joint syndrome 47.28 9.99 82 257826 6031 70664505
Adjustment disorder with depressed mood 47.07 9.99 67 257841 4156 70666380
Ventricular tachycardia 47.01 9.99 38 257870 36385 70634151
Loss of consciousness 46.98 9.99 352 257556 155364 70515172
Blood pressure fluctuation 46.41 9.99 90 257818 58922 70611614
Pericardial effusion 46.36 9.99 50 257858 41726 70628810
Hyperglycaemia 46.34 9.99 104 257804 64568 70605968
Vomiting 46.32 9.99 1727 256181 591384 70079152
Labelled drug-drug interaction medication error 46.25 9.99 15 257893 24112 70646424
Liver injury 46.12 9.99 281 257627 40754 70629782
Pneumocystis jirovecii pneumonia 46.04 9.99 26 257882 30056 70640480
Peritonitis 45.53 9.99 19 257889 26140 70644396
Shock haemorrhagic 45.47 9.99 6 257902 18100 70652436
Inappropriate antidiuretic hormone secretion 45.46 9.99 14 257894 23262 70647274
Blood immunoglobulin E increased 45.30 9.99 70 257838 4674 70665862
Hypocalcaemia 45.16 9.99 58 257850 44801 70625735
Neoplasm progression 45.00 9.99 59 257849 45169 70625367
Insomnia 44.37 9.99 1071 256837 216735 70453801
Anti-cyclic citrullinated peptide antibody 44.22 9.99 58 257850 3327 70667209
Mastocytosis 44.18 9.99 25 257883 437 70670099
Liver function test abnormal 44.08 9.99 98 257810 61048 70609488
Urticaria chronic 43.81 9.99 26 257882 499 70670037
Blood lactate dehydrogenase increased 43.68 9.99 38 257870 35089 70635447
Post-traumatic stress disorder 43.45 9.99 66 257842 4341 70666195
Bacteraemia 42.51 9.99 27 257881 29282 70641254
Thrombotic microangiopathy 42.32 9.99 7 257901 17841 70652695
Chest discomfort 42.19 9.99 661 257247 123720 70546816
Intentional product use issue 42.10 9.99 642 257266 119500 70551036
Posterior reversible encephalopathy syndrome 42.03 9.99 18 257890 24384 70646152
Upper respiratory tract infection 41.91 9.99 457 257451 78817 70591719
Unresponsive to stimuli 41.89 9.99 78 257830 51853 70618683
Chronic sinusitis 41.84 9.99 94 257814 8357 70662179
Oedema peripheral 41.71 9.99 581 257327 227510 70443026
Thrombosis 40.79 9.99 139 257769 75266 70595270
Hereditary angioedema 40.62 9.99 69 257839 4990 70665546
Respiratory depression 40.15 9.99 20 257888 24811 70645725
Skin plaque 39.98 9.99 101 257807 9682 70660854
Perfume sensitivity 39.91 9.99 28 257880 723 70669813
Asthenia 39.74 9.99 1315 256593 456351 70214185
Agranulocytosis 39.65 9.99 53 257855 40245 70630291
Premature delivery 39.52 9.99 14 257894 21290 70649246
Bradycardia 39.37 9.99 278 257630 124337 70546199
Seasonal allergy 39.17 9.99 123 257785 13361 70657175
Acute respiratory distress syndrome 38.85 9.99 56 257852 41198 70629338
Mucosal inflammation 38.83 9.99 122 257786 67728 70602808
Myelodysplastic syndrome 38.54 9.99 31 257877 29754 70640782
Transaminases increased 38.48 9.99 70 257838 46948 70623588
Ileus 38.48 9.99 20 257888 24217 70646319
Dislocation of vertebra 38.25 9.99 66 257842 4834 70665702
Dry mouth 38.09 9.99 408 257500 70049 70600487
Ventricular fibrillation 37.94 9.99 26 257882 27085 70643451
Alanine aminotransferase increased 37.85 9.99 348 257560 147132 70523404
Scratch 37.73 9.99 82 257826 7128 70663408
Psychotic disorder 37.69 9.99 49 257859 37652 70632884
Off label use 37.59 9.99 2266 255642 740794 69929742
Intentional overdose 37.07 9.99 208 257700 98227 70572309
Nausea 36.77 9.99 2636 255272 849452 69821084
Pruritus genital 36.68 9.99 31 257877 1061 70669475
Hepatotoxicity 36.43 9.99 65 257843 43921 70626615
Lacrimation increased 36.22 9.99 156 257752 19743 70650793
Eye swelling 36.20 9.99 176 257732 23438 70647098
Decreased appetite 36.15 9.99 838 257070 303942 70366594
Throat tightness 35.88 9.99 183 257725 24839 70645697
Pulmonary embolism 35.72 9.99 378 257530 155489 70515047
Deep vein thrombosis postoperative 35.54 9.99 54 257854 3553 70666983
Chronic kidney disease 35.50 9.99 109 257799 60948 70609588
Coronary artery disease 35.07 9.99 114 257794 62622 70607914
Proteinuria 35.06 9.99 33 257875 29341 70641195
Status epilepticus 35.02 9.99 23 257885 24503 70646033
Obstructive airways disorder 34.71 9.99 187 257721 25926 70644610
Mast cell activation syndrome 34.71 9.99 24 257884 605 70669931
C-reactive protein increased 34.69 9.99 247 257661 110270 70560266
Anuria 34.65 9.99 14 257894 19639 70650897
Cellulitis 34.62 9.99 214 257694 98714 70571822
Paraesthesia oral 34.58 9.99 129 257779 15288 70655248
Creatinine renal clearance decreased 34.22 9.99 10 257898 17190 70653346
Osteomyelitis 33.96 9.99 36 257872 30282 70640254
Drug level increased 33.85 9.99 50 257858 36419 70634117
Palmar-plantar erythrodysaesthesia syndrome 33.79 9.99 36 257872 30211 70640325
Haematemesis 33.73 9.99 80 257828 48717 70621819
Transplant rejection 33.61 9.99 12 257896 18159 70652377
Lymphocyte count decreased 33.55 9.99 272 257636 43267 70627269
Oliguria 33.34 9.99 7 257901 15044 70655492
Haematotoxicity 33.24 9.99 5 257903 13669 70656867
Laryngitis 33.06 9.99 117 257791 13514 70657022
Left ventricular dysfunction 32.97 9.99 12 257896 17945 70652591
Allergic reaction to excipient 32.89 9.99 18 257890 294 70670242
Product prescribing error 32.77 9.99 57 257851 38895 70631641
Renal injury 32.68 9.99 9 257899 16085 70654451
Nasal congestion 32.63 9.99 374 257534 65298 70605238
Constipation 32.53 9.99 685 257223 251753 70418783
Basal cell carcinoma 32.47 9.99 45 257863 33653 70636883
Electrolyte imbalance 32.27 9.99 30 257878 26831 70643705
Cardiomyopathy 32.22 9.99 29 257879 26344 70644192
Neonatal hypoacusis 32.10 9.99 9 257899 17 70670519
Aspartate aminotransferase increased 31.99 9.99 301 257607 126677 70543859
Acute hepatic failure 31.97 9.99 32 257876 27640 70642896
Bacterial test positive 31.29 9.99 75 257833 6956 70663580
Haemodialysis 31.22 9.99 12 257896 17354 70653182
Auditory neuropathy spectrum disorder 31.13 9.99 9 257899 20 70670516
Head deformity 31.08 9.99 10 257898 36 70670500
Syncope 31.03 9.99 420 257488 165289 70505247
Colitis 30.99 9.99 123 257785 63691 70606845
Restrictive pulmonary disease 30.88 9.99 40 257868 2266 70668270
Sleep disorder 30.81 9.99 389 257519 69483 70601053
Sudden infant death syndrome 30.77 9.99 15 257893 190 70670346
Arrhythmia 30.70 9.99 103 257805 56040 70614496
Autoimmune disorder 30.68 9.99 85 257823 8611 70661925
Extrapyramidal disorder 30.26 9.99 19 257889 20731 70649805
Neoplasm malignant 30.23 9.99 36 257872 28738 70641798
Intentional product misuse 30.07 9.99 168 257740 79427 70591109
Tachypnoea 29.90 9.99 36 257872 28602 70641934
Escherichia infection 29.84 9.99 11 257897 16320 70654216
Metastases to liver 29.81 9.99 30 257878 25848 70644688
Pathogen resistance 29.78 9.99 6 257902 13273 70657263
Penis injury 29.72 9.99 13 257895 126 70670410
Pregnancy on contraceptive 29.67 9.99 25 257883 852 70669684
Cardiotoxicity 29.47 9.99 3 257905 11067 70659469
Metastases to central nervous system 29.43 9.99 9 257899 15025 70655511
Subdural haematoma 29.37 9.99 38 257870 29260 70641276
Urticaria thermal 29.36 9.99 16 257892 259 70670277
Localised infection 29.30 9.99 47 257861 33111 70637425
Psoriatic arthropathy 29.16 9.99 362 257546 64409 70606127
Drug use disorder 29.08 9.99 80 257828 8071 70662465
Epistaxis 29.07 9.99 236 257672 102391 70568145
Leukocytosis 29.07 9.99 63 257845 39605 70630931
Exposure via body fluid 28.99 9.99 16 257892 266 70670270
Vocal cord dysfunction 28.77 9.99 19 257889 443 70670093
Gastric haemorrhage 28.67 9.99 8 257900 14177 70656359
Haematoma 28.46 9.99 86 257822 48332 70622204
Parathyroid gland enlargement 28.36 9.99 13 257895 142 70670394
Neuropathy peripheral 28.17 9.99 310 257598 126586 70543950
Hypoxia 28.15 9.99 211 257697 93133 70577403
Skin necrosis 28.08 9.99 12 257896 16279 70654257
Fracture 28.08 9.99 19 257889 19925 70650611
Hip fracture 27.98 9.99 37 257871 28226 70642310
Diffuse large B-cell lymphoma 27.84 9.99 7 257901 13295 70657241
Pulmonary hypertension 27.82 9.99 82 257826 46454 70624082
Hypoaesthesia 27.76 9.99 744 257164 152995 70517541
Oral allergy syndrome 27.69 9.99 10 257898 55 70670481
Coagulopathy 27.66 9.99 49 257859 33200 70637336
Graft versus host disease 27.65 9.99 10 257898 15013 70655523
Hyper IgE syndrome 27.51 9.99 19 257889 478 70670058
Sedation 27.47 9.99 83 257825 46648 70623888
Generalised tonic-clonic seizure 27.46 9.99 70 257838 41591 70628945
Hepatic encephalopathy 27.41 9.99 24 257884 22094 70648442
Blood urea increased 27.37 9.99 81 257827 45828 70624708
Intervertebral discitis 27.33 9.99 52 257856 4109 70666427
Potassium wasting nephropathy 27.22 9.99 13 257895 157 70670379
Tuberculosis 27.13 9.99 10 257898 14838 70655698
Grip strength decreased 27.05 9.99 121 257787 15564 70654972
Gamma-glutamyltransferase increased 27.03 9.99 94 257814 50591 70619945
Cardiac failure acute 26.93 9.99 15 257893 17472 70653064
Immune reconstitution inflammatory syndrome 26.87 9.99 7 257901 12983 70657553
Forced expiratory volume 26.87 9.99 11 257897 89 70670447
Hyperammonaemia 26.86 9.99 3 257905 10290 70660246
Sinus disorder 26.73 9.99 138 257770 18821 70651715
Dialysis 26.69 9.99 15 257893 17387 70653149
Aspergillus infection 26.55 9.99 16 257892 17852 70652684
Cestode infection 26.47 9.99 15 257893 263 70670273
Hallucination, auditory 26.42 9.99 17 257891 18311 70652225
Enthesopathy 26.36 9.99 4 257904 10865 70659671
Gastric ulcer 26.31 9.99 47 257861 31743 70638793
Weight decreased 26.23 9.99 895 257013 309593 70360943
Hyperbilirubinaemia 26.18 9.99 26 257882 22542 70647994
Lichen sclerosus 26.17 9.99 24 257884 917 70669619
Nasal turbinate hypertrophy 26.17 9.99 20 257888 591 70669945
Haemorrhage intracranial 26.03 9.99 31 257877 24746 70645790
Victim of sexual abuse 25.99 9.99 18 257890 455 70670081
Muscle rigidity 25.94 9.99 18 257890 18632 70651904
Ejection fraction decreased 25.89 9.99 45 257863 30717 70639819
Metastases to bone 25.71 9.99 26 257882 22350 70648186
Angina pectoris 25.62 9.99 90 257818 48293 70622243
Klebsiella infection 25.49 9.99 10 257898 14282 70656254
Tumour lysis syndrome 25.49 9.99 24 257884 21336 70649200
Diabetes mellitus 25.32 9.99 155 257753 71669 70598867
Therapy partial responder 25.28 9.99 7 257901 12467 70658069
Femur fracture 25.16 9.99 59 257849 36073 70634463
Herpes zoster 25.07 9.99 194 257714 85041 70585495
Circulatory collapse 24.64 9.99 58 257850 35416 70635120
Myoclonus 24.59 9.99 36 257872 26319 70644217
Allergy test positive 24.57 9.99 17 257891 429 70670107
Peripheral venous disease 24.45 9.99 90 257818 10597 70659939
Urinary retention 24.40 9.99 103 257805 52417 70618119
Respiratory distress 24.27 9.99 109 257799 54541 70615995
Diabetic ketoacidosis 23.97 9.99 49 257859 31463 70639073
Middle insomnia 23.93 9.99 108 257800 13945 70656591
Hypervolaemia 23.71 9.99 70 257838 39636 70630900
Pulmonary pain 23.65 9.99 44 257864 3418 70667118
Cystic fibrosis pancreatic 23.60 9.99 9 257899 59 70670477
Panniculitis 23.58 9.99 5 257903 10671 70659865
Bronchial neoplasm 23.57 9.99 17 257891 459 70670077
Second primary malignancy 23.50 9.99 9 257899 13042 70657494
Encephalitis 23.43 9.99 10 257898 13575 70656961
Ischaemic stroke 23.38 9.99 48 257860 30772 70639764
Haemodynamic instability 23.30 9.99 14 257894 15644 70654892
Substance abuse 23.01 9.99 4 257904 9833 70660703
Blood potassium increased 22.97 9.99 40 257868 27286 70643250
Seizure 22.88 9.99 483 257425 177479 70493057
Cytomegalovirus viraemia 22.87 9.99 7 257901 11678 70658858
Heparin-induced thrombocytopenia 22.68 9.99 3 257905 9034 70661502
Blood pressure decreased 22.59 9.99 218 257690 91297 70579239
Menstruation delayed 22.51 9.99 25 257883 1204 70669332
Hepatic cancer 22.51 9.99 4 257904 9679 70660857
Sudden death 22.51 9.99 26 257882 21038 70649498
Walking aid user 22.45 9.99 72 257836 7909 70662627
Feeling hot 22.33 9.99 273 257635 48397 70622139
Intestinal ischaemia 22.26 9.99 8 257900 12056 70658480
Specific gravity urine increased 22.25 9.99 16 257892 430 70670106
Bladder cancer 22.24 9.99 18 257890 17224 70653312
Confusional state 22.16 9.99 1255 256653 283143 70387393
Monocyte percentage increased 22.14 9.99 32 257876 2013 70668523
Infusion site pain 22.09 9.99 92 257816 11472 70659064
Lung neoplasm malignant 21.93 9.99 35 257873 24707 70645829
Lip pruritus 21.90 9.99 20 257888 760 70669776
Penile haemorrhage 21.88 9.99 17 257891 515 70670021
Nocturnal fear 21.87 9.99 6 257902 10 70670526
Treatment noncompliance 21.84 9.99 91 257817 46483 70624053
Metastases to lung 21.52 9.99 17 257891 16467 70654069
Oesophageal carcinoma 21.49 9.99 4 257904 9362 70661174
Rhinitis 21.38 9.99 91 257817 11456 70659080
Toxic epidermal necrolysis 21.34 9.99 73 257835 39484 70631052
Stress cardiomyopathy 21.01 9.99 5 257903 9857 70660679
Blood calcium decreased 20.98 9.99 46 257862 28800 70641736
Deep vein thrombosis 20.94 9.99 281 257627 110761 70559775
Duodenal ulcer 20.92 9.99 15 257893 15265 70655271
Flushing 20.82 9.99 417 257491 81755 70588781
Blood alkaline phosphatase increased 20.78 9.99 126 257782 58395 70612141
Lupus-like syndrome 20.75 9.99 90 257818 11425 70659111
Polymenorrhoea 20.36 9.99 21 257887 929 70669607
Gangrene 20.29 9.99 3 257905 8306 70662230
Gait disturbance 20.26 9.99 515 257393 184591 70485945
Blood urine present 20.17 9.99 130 257778 19223 70651313
Haemophagocytic lymphohistiocytosis 20.11 9.99 25 257883 19587 70650949
Bronchial disorder 20.09 9.99 33 257875 2321 70668215
Intestinal obstruction 20.04 9.99 73 257835 38752 70631784
Nitrite urine present 20.04 9.99 23 257885 1149 70669387
Exostosis 19.93 9.99 104 257804 14241 70656295
Hemiparesis 19.88 9.99 54 257854 31415 70639121
Catatonia 19.71 9.99 3 257905 8130 70662406
Therapy cessation 19.66 9.99 60 257848 33616 70636920
Hypophagia 19.63 9.99 81 257827 41489 70629047
Sneezing 19.63 9.99 117 257791 16834 70653702
Nasal oedema 19.62 9.99 24 257884 1283 70669253
Seronegative arthritis 19.50 9.99 40 257868 3339 70667197
Epstein-Barr virus infection 19.36 9.99 12 257896 13186 70657350
Pulmonary haemorrhage 19.28 9.99 13 257895 13660 70656876
Renal disorder 19.27 9.99 72 257836 37937 70632599
Bacterial test 19.24 9.99 23 257885 1200 70669336
Osteonecrosis 19.21 9.99 49 257859 29111 70641425
Cholestasis 19.21 9.99 99 257809 47773 70622763
Demyelination 19.20 9.99 64 257844 7172 70663364
Intestinal perforation 19.18 9.99 18 257890 16026 70654510
Cholecystitis chronic 19.02 9.99 76 257832 9300 70661236
Enterocolitis 19 9.99 12 257896 13054 70657482
Myocardial ischaemia 18.95 9.99 37 257871 24163 70646373
Activated partial thromboplastin time prolonged 18.83 9.99 13 257895 13492 70657044
Swelling of eyelid 18.82 9.99 37 257871 2995 70667541
Agitation 18.82 9.99 233 257675 93142 70577394
Pain in extremity 18.79 9.99 988 256920 327094 70343442
Hallucination, visual 18.79 9.99 50 257858 29287 70641249
Hypothyroidism 18.72 9.99 94 257814 45661 70624875
Schizophrenia 18.68 9.99 20 257888 16748 70653788
Colorectal cancer 18.64 9.99 4 257904 8466 70662070
Cardiac failure chronic 18.62 9.99 7 257901 10262 70660274
Eosinophilic oesophagitis 18.53 9.99 15 257893 483 70670053
Lichen nitidus 18.52 9.99 8 257900 75 70670461
Tremor 18.39 9.99 428 257480 155196 70515340
Enteritis 18.36 9.99 12 257896 12819 70657717
Renal cancer 18.33 9.99 10 257898 11786 70658750
Eosinophilic colitis 18.22 9.99 14 257894 417 70670119
Blood glucose increased 18.21 9.99 264 257644 102718 70567818
Skin burning sensation 18.12 9.99 86 257822 11340 70659196
Tongue pruritus 18.08 9.99 15 257893 500 70670036
Swollen tongue 17.96 9.99 210 257698 36836 70633700
Joint dislocation 17.93 9.99 102 257806 14429 70656107
Somnolence 17.84 9.99 623 257285 214983 70455553
Blood pressure diastolic abnormal 17.83 9.99 18 257890 15486 70655050
Drug level decreased 17.81 9.99 12 257896 12612 70657924
Kidney transplant rejection 17.72 9.99 7 257901 9954 70660582
Candida infection 17.67 9.99 65 257843 34408 70636128
Faecaloma 17.54 9.99 8 257900 10443 70660093
Pulse absent 17.53 9.99 6 257902 9324 70661212
Oesophagitis 17.42 9.99 35 257873 22617 70647919
Toxic encephalopathy 17.41 9.99 8 257900 10398 70660138
Red blood cell sedimentation rate abnormal 17.40 9.99 27 257881 19276 70651260
Splenomegaly 17.39 9.99 26 257882 18844 70651692
Dry skin 17.37 9.99 293 257615 55638 70614898
Acute respiratory failure 17.29 9.99 119 257789 53546 70616990
Metabolic disorder 17.28 9.99 4 257904 8036 70662500
Pancreatic carcinoma 17.24 9.99 13 257895 12891 70657645
Premenstrual syndrome 17.20 9.99 15 257893 536 70670000
Tubulointerstitial nephritis 17.20 9.99 62 257846 33014 70637522
Urine ketone body present 17.19 9.99 38 257870 3341 70667195
Migraine 17.12 9.99 363 257545 71875 70598661
Upper respiratory fungal infection 17.10 9.99 12 257896 310 70670226
Cardiac tamponade 17.09 9.99 5 257903 8590 70661946
Accidental exposure to product 17.08 9.99 49 257859 28002 70642534
Pulmonary toxicity 17.01 9.99 9 257899 10789 70659747
Ehlers-Danlos syndrome 17.01 9.99 9 257899 137 70670399
Red cell distribution width decreased 16.92 9.99 25 257883 1604 70668932
Akathisia 16.92 9.99 12 257896 12281 70658255
Ataxia 16.90 9.99 37 257871 23180 70647356
Immunosuppressant drug level increased 16.86 9.99 4 257904 7903 70662633
Cataract 16.67 9.99 126 257782 55519 70615017
Crying 16.64 9.99 133 257775 21066 70649470
Ventricular arrhythmia 16.62 9.99 4 257904 7826 70662710
Magnesium deficiency 16.60 9.99 15 257893 562 70669974
Urinary casts 16.58 9.99 21 257887 1163 70669373
Tachycardia 16.58 9.99 444 257464 158102 70512434
Dyshidrotic eczema 16.54 9.99 15 257893 565 70669971
Bundle branch block right 16.48 9.99 9 257899 10601 70659935
Acute graft versus host disease in skin 16.48 9.99 3 257905 7134 70663402
Unintentional medical device removal 16.44 9.99 3 257905 7121 70663415
Peripheral sensory neuropathy 16.44 9.99 12 257896 12098 70658438
Adenovirus infection 16.43 9.99 4 257904 7764 70662772
Gastric cancer 16.42 9.99 6 257902 8949 70661587
Wrong technique in product usage process 16.39 9.99 165 257743 68533 70602003
Hypertensive crisis 16.37 9.99 28 257880 19234 70651302
Food intolerance 16.31 9.99 36 257872 3162 70667374
Parkinsonism 16.28 9.99 19 257889 15306 70655230
Arteriosclerosis 16.25 9.99 22 257886 16616 70653920
Prothrombin time prolonged 16.23 9.99 21 257887 16169 70654367
Pulmonary artery stenosis congenital 16.23 9.99 5 257903 15 70670521
Prevertebral soft tissue swelling of cervical space 16.18 9.99 6 257902 36 70670500
Bilirubin urine present 16.17 9.99 12 257896 339 70670197
Hemiplegia 16.13 9.99 16 257892 13879 70656657
Lung infiltration 16.13 9.99 34 257874 21590 70648946
Febrile bone marrow aplasia 16.12 9.99 12 257896 11979 70658557
Pulmonary congestion 16.02 9.99 43 257865 25111 70645425
Pancreatitis 16.01 9.99 148 257760 62520 70608016
Clostridium difficile colitis 15.99 9.99 53 257855 28943 70641593
Cachexia 15.97 9.99 8 257900 9892 70660644
Cells in urine 15.89 9.99 10 257898 214 70670322
Sinus congestion 15.89 9.99 113 257795 17260 70653276
Delirium 15.87 9.99 184 257724 74430 70596106
Ileus paralytic 15.84 9.99 6 257902 8755 70661781
Cytopenia 15.83 9.99 24 257884 17299 70653237
Pulmonary alveolar haemorrhage 15.81 9.99 9 257899 10360 70660176
Transient ischaemic attack 15.75 9.99 100 257808 45844 70624692
Violence-related symptom 15.73 9.99 16 257892 696 70669840
Thymus disorder 15.71 9.99 11 257897 283 70670253
Colitis ischaemic 15.60 9.99 17 257891 14120 70656416
Alanine aminotransferase abnormal 15.46 9.99 5 257903 8054 70662482
Hepatic steatosis 15.28 9.99 67 257841 33746 70636790
Diverticulitis 15.27 9.99 89 257819 41645 70628891
Pneumonitis 15.25 9.99 126 257782 54471 70616065
Endometrial ablation 15.24 9.99 17 257891 823 70669713
Axillary pain 15.22 9.99 26 257882 1889 70668647
Ankylosing spondylitis 15.22 9.99 12 257896 11634 70658902
Granulocytopenia 15.18 9.99 10 257898 10637 70659899
Acidosis 15.11 9.99 27 257881 18236 70652300
Eosinophilic granulomatosis with polyangiitis 15.09 9.99 35 257873 3178 70667358
Hepatitis 15.05 9.99 113 257795 49867 70620669
Hydronephrosis 15.04 9.99 20 257888 15222 70655314
Iron deficiency anaemia 15.02 9.99 39 257869 23033 70647503
Myopathy 14.97 9.99 28 257880 18584 70651952
Lower gastrointestinal haemorrhage 14.85 9.99 19 257889 14701 70655835
Hypothermia 14.85 9.99 33 257875 20561 70649975
Muscular weakness 14.84 9.99 386 257522 137950 70532586
Patient elopement 14.82 9.99 6 257902 47 70670489
Faeces discoloured 14.78 9.99 49 257859 26760 70643776
Renal cyst 14.78 9.99 16 257892 13329 70657207
Visual acuity reduced 14.76 9.99 52 257856 27878 70642658
Spinal compression fracture 14.75 9.99 21 257887 15532 70655004
Atopy 14.75 9.99 11 257897 313 70670223
Blood albumin decreased 14.72 9.99 37 257871 22090 70648446
Hyperuricaemia 14.71 9.99 11 257897 10955 70659581
Suicide attempt 14.70 9.99 202 257706 79308 70591228
Deafness 14.69 9.99 30 257878 19273 70651263
Pneumonia fungal 14.67 9.99 9 257899 9944 70660592
Joint range of motion decreased 14.67 9.99 152 257756 25874 70644662
Skin toxicity 14.66 9.99 4 257904 7194 70663342
Anal abscess 14.66 9.99 6 257902 8352 70662184
Protrusion tongue 14.65 9.99 12 257896 393 70670143
White blood cell count increased 14.63 9.99 172 257736 69401 70601135
Reaction to excipient 14.61 9.99 22 257886 1436 70669100
Enterococcal infection 14.53 9.99 19 257889 14563 70655973
Pulmonary function test decreased 14.50 9.99 56 257852 6745 70663791
Hypernatraemia 14.46 9.99 15 257893 12746 70657790
Hepatic cytolysis 14.46 9.99 30 257878 19162 70651374
Electrocardiogram QT prolonged 14.45 9.99 215 257693 83302 70587234
Pneumothorax 14.42 9.99 47 257861 25799 70644737
Cardiovascular disorder 14.38 9.99 24 257884 16646 70653890
Poor feeding infant 14.34 9.99 8 257900 136 70670400
Poisoning deliberate 14.32 9.99 25 257883 17035 70653501
Pancreatitis acute 14.22 9.99 101 257807 45123 70625413
Lactose intolerance 14.21 9.99 27 257881 2131 70668405
Diarrhoea haemorrhagic 14.21 9.99 13 257895 11717 70658819
Chronic obstructive pulmonary disease 14.09 9.99 198 257710 77443 70593093
Tachyarrhythmia 14.07 9.99 3 257905 6379 70664157
Neutropenic sepsis 13.96 9.99 45 257863 24785 70645751
Venoocclusive liver disease 13.96 9.99 11 257897 10667 70659869
Anaphylactoid reaction 13.93 9.99 45 257863 4962 70665574
Torsade de pointes 13.92 9.99 28 257880 18088 70652448
Escherichia sepsis 13.92 9.99 5 257903 7538 70662998
Hyperplastic cholecystopathy 13.88 9.99 8 257900 145 70670391
Acute pulmonary oedema 13.86 9.99 17 257891 13395 70657141
Red blood cell count decreased 13.84 9.99 122 257786 52039 70618497
Hypomagnesaemia 13.83 9.99 89 257819 40675 70629861
Acute coronary syndrome 13.81 9.99 33 257875 20046 70650490
Fixed eruption 13.77 9.99 29 257879 2467 70668069
Pharyngeal oedema 13.73 9.99 101 257807 15595 70654941
Condition aggravated 13.67 9.99 1765 256143 425870 70244666
Endophthalmitis 13.67 9.99 3 257905 6252 70664284
Urine bilirubin decreased 13.64 9.99 8 257900 150 70670386
Abdominal pain 13.61 9.99 1065 256843 341062 70329474
Angina unstable 13.60 9.99 23 257885 15870 70654666
Schizophreniform disorder 13.60 9.99 8 257900 151 70670385
Glomerular filtration rate decreased 13.58 9.99 35 257873 20721 70649815
Bacterial infection 13.55 9.99 50 257858 26442 70644094
Injection 13.51 9.99 4 257904 10 70670526
Right ventricular failure 13.50 9.99 39 257869 22235 70648301
Malnutrition 13.49 9.99 34 257874 20283 70650253
Brain oedema 13.47 9.99 42 257866 23376 70647160
Diabetes mellitus inadequate control 13.47 9.99 40 257868 22605 70647931
Sensitivity to weather change 13.43 9.99 58 257850 7347 70663189
Product monitoring error 13.37 9.99 4 257904 6772 70663764
Troponin increased 13.36 9.99 25 257883 16589 70653947
Benign prostatic hyperplasia 13.35 9.99 11 257897 10432 70660104
Large intestine perforation 13.34 9.99 17 257891 13178 70657358
Mitral valve incompetence 13.31 9.99 51 257857 26677 70643859
Product use in unapproved indication 13.26 9.99 900 257008 206578 70463958
Hepatic lesion 13.23 9.99 3 257905 6114 70664422
Device related infection 13.23 9.99 66 257842 32119 70638417
Tenosynovitis 13.13 9.99 19 257889 13957 70656579
Paternal exposure timing unspecified 13.05 9.99 6 257902 66 70670470
Depressed mood 13.04 9.99 228 257680 43592 70626944
Venous thrombosis 12.98 9.99 4 257904 6645 70663891
Vertigo CNS origin 12.96 9.99 5 257903 34 70670502
Lethargy 12.92 9.99 194 257714 75056 70595480
Colon cancer 12.90 9.99 20 257888 14286 70656250
Euglycaemic diabetic ketoacidosis 12.89 9.99 3 257905 6004 70664532
Loss of personal independence in daily activities 12.89 9.99 224 257684 84686 70585850
Pharyngeal swelling 12.85 9.99 52 257856 6401 70664135
Cardiac disorder 12.84 9.99 146 257762 59269 70611267
Myocarditis 12.83 9.99 31 257877 18762 70651774
Systemic inflammatory response syndrome 12.82 9.99 12 257896 10700 70659836
Cystitis 12.81 9.99 109 257799 46832 70623704
Anxiety 12.75 9.99 948 256960 219382 70451154
Drug level below therapeutic 12.70 9.99 8 257900 8715 70661821
Blood pressure systolic abnormal 12.68 9.99 17 257891 12892 70657644
Rhinitis allergic 12.65 9.99 67 257841 9228 70661308
Breast cancer stage III 12.64 9.99 53 257855 6628 70663908
Injection site urticaria 12.64 9.99 79 257829 11559 70658977
Myositis 12.63 9.99 28 257880 17461 70653075
Coronary artery bypass 12.62 9.99 3 257905 5917 70664619
Pulmonary arterial hypertension 12.60 9.99 69 257839 32786 70637750
Blood pressure systolic decreased 12.59 9.99 10 257898 9661 70660875
Pneumonia bacterial 12.55 9.99 26 257882 16615 70653921
Coronary arterial stent insertion 12.51 9.99 3 257905 5884 70664652
C-reactive protein 12.49 9.99 25 257883 2051 70668485
Gastritis erosive 12.45 9.99 11 257897 10084 70660452
Spinal fracture 12.41 9.99 25 257883 16142 70654394
Dermatitis contact 12.41 9.99 69 257839 9680 70660856
Urine output decreased 12.39 9.99 27 257881 16943 70653593
Cytokine release syndrome 12.37 9.99 149 257759 26318 70644218
Tooth disorder 12.36 9.99 45 257863 23893 70646643
Urine amphetamine positive 12.31 9.99 6 257902 76 70670460
Femoral neck fracture 12.30 9.99 9 257899 9064 70661472
Gastroenteritis 12.27 9.99 65 257843 31148 70639388
Biliary dyskinesia 12.23 9.99 27 257881 2372 70668164
Congestive cardiomyopathy 12.21 9.99 13 257895 10913 70659623
Eye infection bacterial 12.20 9.99 9 257899 252 70670284
Hypertriglyceridaemia 12.17 9.99 15 257893 11796 70658740
Premature labour 12.12 9.99 7 257901 7993 70662543
Cerebral ischaemia 12.07 9.99 12 257896 10400 70660136
Sinus headache 12.05 9.99 40 257868 4473 70666063
Oligoarthritis 11.97 9.99 12 257896 513 70670023
Apnoea 11.92 9.99 13 257895 10796 70659740
Specific gravity urine decreased 11.91 9.99 15 257893 826 70669710
Staphylococcal sepsis 11.89 9.99 19 257889 13408 70657128
Photosensitivity reaction 11.89 9.99 115 257793 19225 70651311
Atrioventricular block first degree 11.84 9.99 15 257893 11658 70658878
Marginal zone lymphoma 11.84 9.99 6 257902 83 70670453
Pulmonary thrombosis 11.80 9.99 14 257894 11194 70659342
Coronavirus infection 11.78 9.99 4 257904 6248 70664288
Obesity 11.78 9.99 149 257759 26622 70643914
Nystagmus 11.78 9.99 10 257898 9345 70661191
Mixed liver injury 11.78 9.99 4 257904 6245 70664291
Humerus fracture 11.77 9.99 8 257900 8370 70662166
Autoimmune arthritis 11.77 9.99 7 257901 135 70670401
Electrocardiogram QRS complex prolonged 11.72 9.99 11 257897 9795 70660741
Blood lactic acid increased 11.71 9.99 14 257894 11159 70659377
Hepatocellular injury 11.71 9.99 109 257799 45982 70624554
Tricuspid valve incompetence 11.69 9.99 30 257878 17787 70652749
Pain in jaw 11.68 9.99 99 257809 42570 70627966
Oxygen saturation decreased 11.67 9.99 328 257580 116101 70554435
Multiple fractures 11.63 9.99 5 257903 6760 70663776
Rib fracture 11.61 9.99 50 257858 25306 70645230
Rash macular 11.59 9.99 143 257765 25401 70645135
Embolic stroke 11.59 9.99 6 257902 7283 70663253
Supraventricular tachycardia 11.59 9.99 35 257873 19675 70650861
Red blood cell count increased 11.59 9.99 36 257872 3888 70666648
Hyperthyroidism 11.58 9.99 36 257872 20055 70650481
Illness 11.56 9.99 171 257737 31620 70638916
Autophobia 11.55 9.99 4 257904 19 70670517
Ketoacidosis 11.54 9.99 6 257902 7263 70663273
Nail operation 11.48 9.99 12 257896 539 70669997
Drug ineffective 11.48 9.99 3699 254209 936053 69734483
Therapeutic product effect incomplete 11.44 9.99 340 257568 119542 70550994
Arterial occlusive disease 11.41 9.99 7 257901 7735 70662801
Crepitations 11.36 9.99 9 257899 8705 70661831
Head injury 11.35 9.99 75 257833 34066 70636470
Peritonitis bacterial 11.34 9.99 10 257898 9174 70661362
Cytomegalovirus test positive 11.33 9.99 3 257905 5505 70665031
Retinal haemorrhage 11.32 9.99 7 257901 7703 70662833
Partial seizures 11.31 9.99 8 257900 8197 70662339
Hypotonia 11.27 9.99 16 257892 11849 70658687
Dysarthria 11.27 9.99 159 257749 62154 70608382
Hypoalbuminaemia 11.21 9.99 34 257874 19088 70651448
Blood uric acid increased 11.20 9.99 10 257898 9119 70661417
Radiation inflammation 11.18 9.99 12 257896 556 70669980
Motor dysfunction 11.11 9.99 19 257889 13051 70657485
Hepatitis fulminant 11.10 9.99 5 257903 6576 70663960
Malignant melanoma 11.10 9.99 21 257887 13879 70656657
Blepharospasm 11.10 9.99 35 257873 3810 70666726
Intestinal haemorrhage 11.09 9.99 4 257904 6016 70664520
Generalised oedema 11.08 9.99 41 257867 21667 70648869
Hepatitis B 11.06 9.99 8 257900 8106 70662430
Sinus tachycardia 11.03 9.99 75 257833 33838 70636698
Fistula 11.02 9.99 14 257894 10867 70659669
Adenoidal hypertrophy 11.00 9.99 7 257901 153 70670383
Chest pain 10.97 9.99 776 257132 250484 70420052
Decompression sickness 10.96 9.99 5 257903 54 70670482
Tendon disorder 10.90 9.99 50 257858 6501 70664035
Squamous cell carcinoma 10.86 9.99 23 257885 14581 70655955
Portal hypertension 10.85 9.99 5 257903 6487 70664049
Culture urine positive 10.82 9.99 37 257871 4200 70666336
Bruxism 10.82 9.99 34 257874 3695 70666841
Laryngeal stenosis 10.80 9.99 15 257893 909 70669627
Rhinorrhoea 10.80 9.99 317 257591 66054 70604482
Epidermolysis bullosa 10.69 9.99 8 257900 229 70670307
Ear swelling 10.66 9.99 19 257889 1428 70669108
Idiopathic angioedema 10.65 9.99 4 257904 25 70670511
Drug abuser 10.63 9.99 4 257904 5860 70664676
Heart rate decreased 10.60 9.99 160 257748 61855 70608681
Post viral fatigue syndrome 10.60 9.99 9 257899 310 70670226
Product lot number issue 10.57 9.99 7 257901 164 70670372
Blood culture positive 10.57 9.99 8 257900 7918 70662618
Cholangitis 10.56 9.99 16 257892 11533 70659003
Hypogammaglobulinaemia 10.53 9.99 16 257892 11522 70659014
Tarsal tunnel syndrome 10.53 9.99 11 257897 494 70670042
Blood pressure diastolic decreased 10.52 9.99 53 257855 25727 70644809
Haemoglobin abnormal 10.52 9.99 5 257903 6372 70664164
Post-tussive vomiting 10.52 9.99 4 257904 26 70670510
Haemoptysis 10.51 9.99 128 257780 51324 70619212
Pregnancy with injectable contraceptive 10.50 9.99 6 257902 107 70670429
Nephrotic syndrome 10.46 9.99 14 257894 10626 70659910
Full blood count decreased 10.44 9.99 48 257860 23870 70646666
Breast cancer metastatic 10.33 9.99 13 257895 10133 70660403
Drug withdrawal syndrome 10.32 9.99 73 257835 32642 70637894
Lung consolidation 10.31 9.99 9 257899 8297 70662239
Spinal fusion surgery 10.30 9.99 35 257873 3962 70666574
Malaise 10.29 9.99 1757 256151 431175 70239361
Urticaria pressure 10.27 9.99 4 257904 28 70670508
Tendinous contracture 10.26 9.99 6 257902 112 70670424
Sopor 10.24 9.99 69 257839 31198 70639338
Tonsillar hypertrophy 10.21 9.99 18 257890 1341 70669195
Hepatitis cholestatic 10.20 9.99 19 257889 12631 70657905
Left ventricular failure 10.19 9.99 10 257898 8718 70661818
Nasal pruritus 10.18 9.99 10 257898 417 70670119
Lymphoma 10.17 9.99 26 257882 15436 70655100
Periorbital swelling 10.15 9.99 24 257884 2206 70668330
Blood phosphorus increased 10.15 9.99 6 257902 6764 70663772
Uterine pain 10.14 9.99 7 257901 176 70670360
Therapy interrupted 10.12 9.99 51 257857 24751 70645785
Organising pneumonia 10.11 9.99 13 257895 10037 70660499
Eosinophil count increased 10.10 9.99 92 257816 15130 70655406
Gastrointestinal perforation 10.09 9.99 4 257904 5677 70664859
Polyuria 10.06 9.99 21 257887 13385 70657151
Heart rate irregular 10.06 9.99 65 257843 29678 70640858
Embolism 10.04 9.99 20 257888 12968 70657568
Microcytosis 10.03 9.99 9 257899 334 70670202
Gastrointestinal inflammation 10.02 9.99 6 257902 6717 70663819

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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
DB00341 DRUGBANK_ID
CHEMBL1201113 ChEMBL_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 0113-0981 CAPSULE, LIQUID FILLED 10 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
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