allopurinol ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
124 315-30-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • zyloprim
  • allopurinol
  • tautomeric mixture of 1H-pyrazolo[3,4-d]pyrimidin-4-ol and 1,5-dihydro-4H-pyrazolo[3,4-d]pyrimidin-4-one
  • allopurinol sodium
A XANTHINE OXIDASE inhibitor that decreases URIC ACID production. It also acts as an antimetabolite on some simpler organisms.
  • Molecular weight: 136.11
  • Formula: C5H4N4O
  • CLOGP: 0.63
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 74.69
  • ALOGS: -0.79
  • ROTB: 0

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.40 g O
0.40 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.57 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 12 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 97.71 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 53 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.58 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 11 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.97 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.80 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 19, 1966 FDA PROMETHEUS LABS

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
Drug reaction with eosinophilia and systemic symptoms 1982.54 9.77 1059 112723 27365 50463977
Acute kidney injury 738.69 9.77 1600 112182 226458 50264884
Drug ineffective 494.56 9.77 676 113106 818657 49672685
Toxic epidermal necrolysis 386.86 9.77 344 113438 20648 50470694
Stevens-Johnson syndrome 358.87 9.77 335 113447 21417 50469925
Febrile neutropenia 341.47 9.77 708 113074 96959 50394383
Renal failure 332.60 9.77 738 113044 105895 50385447
Anaemia 310.47 9.77 1255 112527 251201 50240141
Hyperkalaemia 287.55 9.77 441 113341 47648 50443694
Pemphigus 254.00 9.77 3 113779 120163 50371179
Rash maculo-papular 233.87 9.77 294 113488 26347 50464995
Tumour lysis syndrome 229.86 9.77 165 113617 7256 50484086
Maternal exposure during pregnancy 205.24 9.77 53 113729 159725 50331617
Glossodynia 205.22 9.77 14 113768 115555 50375787
Melaena 203.96 9.77 276 113506 26588 50464754
Systemic lupus erythematosus 200.14 9.77 37 113745 140585 50350757
Pain 195.91 9.77 659 113123 578244 49913098
Pancytopenia 194.86 9.77 519 113263 83511 50407831
Cytokine release syndrome 186.50 9.77 155 113627 8479 50482863
Cardiac failure 184.83 9.77 478 113304 75562 50415780
Gout 184.07 9.77 174 113608 11296 50480046
Arthropathy 183.48 9.77 63 113719 157843 50333499
Hand deformity 178.30 9.77 12 113770 100187 50391155
Rheumatoid arthritis 175.87 9.77 120 113662 202430 50288912
Thrombocytopenia 174.65 9.77 657 113125 127016 50364326
Joint swelling 169.45 9.77 181 113601 245105 50246237
Alopecia 169.09 9.77 181 113601 244866 50246476
Therapeutic product effect decreased 165.63 9.77 50 113732 136000 50355342
Renal impairment 165.08 9.77 457 113325 75204 50416138
Blood creatinine increased 160.26 9.77 454 113328 75706 50415636
Contraindicated product administered 158.82 9.77 68 113714 148890 50342452
Atrial fibrillation 153.85 9.77 541 113241 101204 50390138
Plasma cell myeloma 152.80 9.77 262 113520 31060 50460282
Abdominal discomfort 151.17 9.77 179 113603 231462 50259880
Completed suicide 149.13 9.77 55 113727 131834 50359508
Sepsis 145.95 9.77 639 113143 132286 50359056
Exposure during pregnancy 139.31 9.77 49 113733 120966 50370376
Eosinophilia 128.64 9.77 183 113599 18469 50472873
Drug interaction 126.05 9.77 824 112958 198797 50292545
Discomfort 124.55 9.77 44 113738 108336 50383006
General physical health deterioration 124.51 9.77 641 113141 141793 50349549
Treatment failure 124.21 9.77 78 113704 137559 50353783
Chronic kidney disease 121.27 9.77 273 113509 39498 50451844
Drug intolerance 121.07 9.77 191 113591 218913 50272429
Platelet count decreased 120.42 9.77 497 113285 100229 50391113
Pericarditis 117.90 9.77 18 113764 78671 50412671
Dehydration 116.95 9.77 662 113120 151787 50339555
Synovitis 116.24 9.77 67 113715 123798 50367544
Haemoglobin decreased 115.01 9.77 578 113204 126638 50364704
Bradycardia 113.70 9.77 361 113421 64065 50427277
Toxic skin eruption 106.50 9.77 129 113653 11122 50480220
Lactic acidosis 106.24 9.77 233 113549 33122 50458220
Product prescribing error 103.10 9.77 176 113606 20785 50470557
Blood urea increased 100.52 9.77 186 113596 23399 50467943
International normalised ratio increased 100.43 9.77 267 113515 42885 50448457
Hypotension 99.17 9.77 884 112898 234585 50256757
Rheumatoid factor positive 98.29 9.77 3 113779 49856 50441486
Arthralgia 97.53 9.77 583 113199 438119 50053223
Infusion related reaction 97.29 9.77 144 113638 169413 50321929
Hyperuricaemia 94.86 9.77 81 113701 4599 50486743
Swelling 94.85 9.77 193 113589 200679 50290663
Product use issue 91.68 9.77 121 113661 149354 50341988
Pyrexia 91.15 9.77 1277 112505 378926 50112416
Oedema peripheral 90.06 9.77 636 113146 157325 50334017
Injection site pain 88.25 9.77 72 113710 110952 50380390
Drug hypersensitivity 87.77 9.77 281 113501 250729 50240613
Neutropenia 87.43 9.77 601 113181 147364 50343978
Duodenal ulcer perforation 85.62 9.77 4 113778 45607 50445735
Headache 85.41 9.77 729 113053 505806 49985536
Sinusitis 84.73 9.77 159 113623 170399 50320943
Neutropenic sepsis 83.46 9.77 129 113653 14018 50477324
Off label use 83.04 9.77 676 113106 473750 50017592
Hyponatraemia 82.79 9.77 431 113351 95708 50395634
Hypoglycaemia 81.00 9.77 285 113497 53296 50438046
Wound 79.95 9.77 72 113710 105722 50385620
Gastrointestinal haemorrhage 78.51 9.77 350 113432 72971 50418371
Nasopharyngitis 71.66 9.77 210 113572 192717 50298625
Hypersensitivity 71.66 9.77 246 113536 214915 50276427
Labelled drug-drug interaction medication error 71.07 9.77 102 113680 10375 50480967
Injection site erythema 71.04 9.77 40 113742 74896 50416446
Blood uric acid increased 70.94 9.77 63 113719 3771 50487571
Helicobacter infection 70.83 9.77 13 113769 49689 50441653
Muscle injury 70.49 9.77 3 113779 37108 50454234
Acute myeloid leukaemia 68.19 9.77 122 113660 14952 50476390
Irritable bowel syndrome 66.11 9.77 17 113765 51424 50439918
Folliculitis 66.10 9.77 6 113776 39219 50452123
Hepatic enzyme increased 65.66 9.77 131 113651 137249 50354093
Fatigue 65.65 9.77 1159 112623 706442 49784900
Dilatation intrahepatic duct acquired 65.38 9.77 31 113751 614 50490728
Hypokalaemia 65.36 9.77 379 113403 87613 50403729
Intentional overdose 64.26 9.77 30 113752 62474 50428868
Multiple sclerosis relapse 61.73 9.77 11 113771 42953 50448389
Gastrointestinal disorder 61.51 9.77 73 113709 94383 50396959
Haematoma 61.33 9.77 179 113603 30331 50461011
Injection site reaction 57.99 9.77 20 113762 50012 50441330
Pneumonia 57.58 9.77 1181 112601 377220 50114122
Dermatitis exfoliative 57.09 9.77 64 113718 5078 50486264
Ill-defined disorder 56.55 9.77 26 113756 54628 50436714
Syncope 56.49 9.77 411 113371 102591 50388751
Abortion spontaneous 53.30 9.77 14 113768 41758 50449584
Anxiety 53.25 9.77 212 113570 177394 50313948
Face oedema 52.74 9.77 121 113661 17718 50473624
Chronic lymphocytic leukaemia 52.72 9.77 43 113739 2290 50489052
Injection site pruritus 52.61 9.77 13 113769 40398 50450944
Asthenia 52.27 9.77 1007 112775 318035 50173307
Blood lactate dehydrogenase increased 51.68 9.77 127 113655 19435 50471907
Tubulointerstitial nephritis 51.57 9.77 109 113673 15102 50476240
Multiple drug therapy 50.86 9.77 39 113743 1898 50489444
Tumour flare 50.36 9.77 20 113762 252 50491090
Sopor 50.35 9.77 127 113655 19752 50471590
Purpura 49.76 9.77 84 113698 9827 50481515
Intentional product use issue 49.48 9.77 60 113722 76858 50414484
Multiple organ dysfunction syndrome 49.21 9.77 234 113548 50103 50441239
Diarrhoea 48.06 9.77 1693 112089 586783 49904559
Cardioactive drug level increased 47.87 9.77 38 113744 1946 50489396
Suicidal ideation 47.74 9.77 33 113749 55352 50435990
Psoriatic arthropathy 47.69 9.77 23 113759 47009 50444333
Impaired healing 47.53 9.77 52 113730 69734 50421608
Therapeutic product effect incomplete 45.68 9.77 85 113697 91430 50399912
Epistaxis 45.24 9.77 272 113510 63682 50427660
Dialysis 44.77 9.77 78 113704 9360 50481982
Splenomegaly 44.74 9.77 79 113703 9581 50481761
Loss of personal independence in daily activities 44.68 9.77 55 113727 69995 50421347
Rash morbilliform 43.43 9.77 42 113740 2804 50488538
Anuria 43.37 9.77 85 113697 11159 50480183
Hip arthroplasty 43.26 9.77 8 113774 30421 50460921
Sleep disorder due to general medical condition, insomnia type 43.17 9.77 9 113773 31438 50459904
Injection site swelling 43.01 9.77 20 113762 41753 50449589
Allergic reaction to excipient 42.38 9.77 18 113764 272 50491070
Pleural effusion 42.36 9.77 321 113461 81133 50410209
Blast crisis in myelogenous leukaemia 41.13 9.77 21 113761 491 50490851
Skin exfoliation 41.02 9.77 167 113615 33445 50457897
Depression 40.88 9.77 212 113570 165211 50326131
Dermatitis bullous 40.35 9.77 64 113718 7109 50484233
Drug abuse 39.22 9.77 46 113736 59800 50431542
Shock haemorrhagic 38.34 9.77 68 113714 8276 50483066
Electrolyte imbalance 37.69 9.77 104 113678 17065 50474277
Pregnancy 37.57 9.77 10 113772 29567 50461775
Musculoskeletal stiffness 37.46 9.77 155 113627 128326 50363016
Respiratory failure 37.09 9.77 340 113442 90841 50400501
Septic shock 36.58 9.77 237 113545 56938 50434404
Diabetes mellitus inadequate control 36.50 9.77 87 113695 13058 50478284
Toxicity to various agents 36.47 9.77 304 113478 212195 50279147
Acute motor-sensory axonal neuropathy 35.96 9.77 16 113766 272 50491070
Injection site bruising 35.75 9.77 19 113763 36749 50454593
Intentional self-injury 35.27 9.77 5 113777 23107 50468235
Mucosal inflammation 35.24 9.77 181 113601 39961 50451381
Sleep disorder 34.45 9.77 47 113735 57236 50434106
Agranulocytosis 34.15 9.77 116 113666 21305 50470037
Rash erythematous 33.32 9.77 161 113621 34691 50456651
Dermatitis exfoliative generalised 33.16 9.77 38 113744 3088 50488254
Anti-neutrophil cytoplasmic antibody positive vasculitis 33.07 9.77 33 113749 2289 50489053
Sinoatrial block 33.02 9.77 21 113761 754 50490588
Metabolic acidosis 32.66 9.77 173 113609 38652 50452690
Erythema multiforme 32.02 9.77 66 113716 8984 50482358
White blood cell count decreased 31.95 9.77 402 113380 116320 50375022
Gravitational oedema 31.78 9.77 24 113758 1141 50490201
Enanthema 31.77 9.77 16 113766 363 50490979
Product monitoring error 31.71 9.77 35 113747 2729 50488613
Right ventricular failure 31.70 9.77 93 113689 15800 50475542
Dyspnoea 31.64 9.77 1519 112263 546089 49945253
Suicide attempt 31.56 9.77 42 113740 51690 50439652
Rhabdomyolysis 31.54 9.77 172 113610 38855 50452487
Product dose omission issue 31.54 9.77 263 113519 183575 50307767
Knee arthroplasty 31.37 9.77 21 113761 35825 50455517
Insomnia 30.98 9.77 248 113534 174617 50316725
Seizure 30.86 9.77 148 113634 117726 50373616
HLA-B*5801 assay positive 30.60 9.77 6 113776 0 50491342
Throat irritation 30.33 9.77 15 113767 30224 50461118
Azotaemia 30.13 9.77 41 113741 3967 50487375
Fibromyalgia 30.09 9.77 34 113748 44944 50446398
Device dislocation 29.92 9.77 6 113776 21540 50469802
Sight disability 29.88 9.77 11 113771 111 50491231
Blood creatine phosphokinase increased 29.83 9.77 128 113654 26239 50465103
Thermohypoaesthesia 29.79 9.77 11 113771 112 50491230
Petechiae 29.69 9.77 78 113704 12434 50478908
Leukopenia 29.62 9.77 256 113526 67272 50424070
Differentiation syndrome 29.48 9.77 21 113761 912 50490430
Lip erosion 29.44 9.77 20 113762 804 50490538
Disseminated intravascular coagulation 29.28 9.77 95 113687 17040 50474302
Rectal haemorrhage 29.21 9.77 167 113615 38391 50452951
Glomerular filtration rate decreased 29.05 9.77 74 113708 11578 50479764
Blood potassium increased 29.01 9.77 92 113690 16306 50475036
Subdural haematoma 28.99 9.77 79 113703 12868 50478474
Anaemia macrocytic 28.67 9.77 32 113750 2527 50488815
Haemodialysis 28.43 9.77 60 113722 8302 50483040
Foetal exposure during pregnancy 28.32 9.77 13 113769 27346 50463996
Pemphigoid 28.25 9.77 49 113733 5858 50485484
Inappropriate schedule of product administration 28.25 9.77 76 113706 71755 50419587
Human herpesvirus 6 infection 28.19 9.77 32 113750 2574 50488768
Breast cancer 28.07 9.77 33 113749 42857 50448485
Sternal fracture 27.68 9.77 28 113754 1974 50489368
Hyperphosphataemia 27.41 9.77 27 113755 1844 50489498
Wrong technique in product usage process 27.31 9.77 52 113730 55458 50435884
Klebsiella infection 27.28 9.77 54 113728 7140 50484202
Pulmonary arterial hypertension 27.25 9.77 104 113678 20215 50471127
Chemical burn of oral cavity 27.20 9.77 9 113773 64 50491278
Medication error 27.10 9.77 156 113626 35948 50455394
Accidental exposure to product 27.09 9.77 9 113773 23048 50468294
Live birth 26.37 9.77 3 113779 16405 50474937
Hypercalcaemia 26.13 9.77 113 113669 23239 50468103
Hypovolaemic shock 26.08 9.77 44 113738 5144 50486198
Red blood cell sedimentation rate increased 26.06 9.77 17 113765 29399 50461943
Hypervolaemia 25.98 9.77 120 113662 25379 50465963
Alanine aminotransferase increased 25.77 9.77 308 113474 88051 50403291
Mood swings 25.43 9.77 3 113779 15951 50475391
Conjunctivitis 25.36 9.77 87 113695 16058 50475284
Adverse event 25.23 9.77 37 113745 43726 50447616
Blood pressure fluctuation 25.16 9.77 26 113756 35797 50455545
Oral mucosa erosion 25.01 9.77 20 113762 1035 50490307
Arrhythmia 24.77 9.77 143 113639 32989 50458353
Oedema 24.75 9.77 254 113528 69927 50421415
Weight increased 24.67 9.77 313 113469 201578 50289764
Feeling abnormal 24.58 9.77 173 113609 125319 50366023
Hyperglycaemia 24.58 9.77 153 113629 36252 50455090
Hepatocellular injury 24.18 9.77 119 113663 25828 50465514
Hyperpyrexia 24.16 9.77 32 113750 3017 50488325
Paraesthesia 23.93 9.77 165 113617 120078 50371264
Osteoarthritis 23.78 9.77 77 113705 68529 50422813
Cerebellar stroke 23.66 9.77 11 113771 208 50491134
Coagulation test abnormal 23.18 9.77 16 113766 660 50490682
Condition aggravated 22.97 9.77 501 113281 296557 50194785
Vessel puncture site haemorrhage 22.91 9.77 9 113773 110 50491232
Prerenal failure 22.72 9.77 22 113760 1471 50489871
Acute generalised exanthematous pustulosis 22.53 9.77 57 113725 8881 50482461
Platelet disorder 22.42 9.77 22 113760 1495 50489847
Tonsillar haemorrhage 22.40 9.77 11 113771 236 50491106
Dementia 22.38 9.77 83 113699 15914 50475428
Hepatitis 22.38 9.77 134 113648 31319 50460023
Injection site haemorrhage 22.32 9.77 10 113772 21336 50470006
Pulmonary oedema 22.23 9.77 187 113595 48751 50442591
Product quality issue 22.12 9.77 22 113760 30836 50460506
Leukocytosis 22.09 9.77 105 113677 22474 50468868
Papillary muscle rupture 22.04 9.77 5 113777 5 50491337
Mucosal ulceration 21.89 9.77 17 113765 843 50490499
Hepatic function abnormal 21.84 9.77 137 113645 32544 50458798
Drug eruption 21.81 9.77 108 113674 23498 50467844
Cerebral haemorrhage 21.70 9.77 119 113663 26933 50464409
Blood pressure increased 21.68 9.77 193 113589 132939 50358403
Administration site discomfort 21.53 9.77 8 113774 83 50491259
Pericardial effusion 21.50 9.77 114 113668 25475 50465867
Injection site rash 21.46 9.77 5 113777 16172 50475170
Necrotising ulcerative gingivostomatitis 21.41 9.77 6 113776 22 50491320
Blood alkaline phosphatase increased 21.28 9.77 151 113631 37375 50453967
Cardiac failure acute 21.20 9.77 53 113729 8197 50483145
Hypoglycaemic coma 20.87 9.77 26 113756 2307 50489035
Dyspnoea exertional 20.80 9.77 191 113591 51042 50440300
Ecchymosis 20.76 9.77 60 113722 10109 50481233
Acute respiratory failure 20.72 9.77 123 113659 28659 50462683
Hypoaesthesia 20.50 9.77 185 113597 127072 50364270
Ear infection 20.42 9.77 17 113765 25953 50465389
Cardiac failure congestive 20.33 9.77 284 113498 84098 50407244
Intentional product misuse 20.28 9.77 47 113735 46687 50444655
Libido increased 20.21 9.77 19 113763 1224 50490118
Renal disorder 20.10 9.77 118 113664 27387 50463955
Lip oedema 20.08 9.77 30 113752 3163 50488179
Cardiomegaly 20.07 9.77 80 113702 15865 50475477
Transfusion 19.80 9.77 69 113713 12836 50478506
Mucosal erosion 19.65 9.77 19 113763 1268 50490074
Tachyarrhythmia 19.57 9.77 34 113748 4071 50487271
Hypocalcaemia 19.56 9.77 115 113667 26701 50464641
Ear pain 19.33 9.77 21 113761 28262 50463080
Multimorbidity 19.28 9.77 13 113769 516 50490826
Mandibular mass 19.23 9.77 9 113773 173 50491169
Cholestasis 19.23 9.77 110 113672 25291 50466051
Soft tissue injury 19.15 9.77 20 113762 1464 50489878
Amaurosis 19.04 9.77 13 113769 527 50490815
Urine output decreased 18.92 9.77 59 113723 10362 50480980
Abdominal wall wound 18.90 9.77 7 113775 72 50491270
Back pain 18.80 9.77 365 113417 219665 50271677
Mantle cell lymphoma 18.79 9.77 12 113770 434 50490908
Arthritis 18.77 9.77 116 113666 86605 50404737
Hepatotoxicity 18.74 9.77 115 113667 27111 50464231
Heart rate increased 18.50 9.77 100 113682 77150 50414192
Full blood count decreased 18.40 9.77 99 113683 22247 50469095
Myeloblast percentage decreased 18.34 9.77 6 113776 41 50491301
Fracture blisters 18.32 9.77 7 113775 79 50491263
Hyperbilirubinaemia 18.14 9.77 55 113727 9515 50481827
Pseudomonal bacteraemia 18.13 9.77 18 113764 1241 50490101
Atrioventricular block complete 18.01 9.77 46 113736 7209 50484133
Diverticulum oesophageal 17.93 9.77 8 113774 137 50491205
Neutrophil count decreased 17.89 9.77 170 113612 45856 50445486
Blood bilirubin increased 17.63 9.77 128 113654 31910 50459432
Cardiac failure chronic 17.62 9.77 30 113752 3533 50487809
Autoimmune haemolytic anaemia 17.62 9.77 32 113750 3967 50487375
Immune effector cell-associated neurotoxicity syndrome 17.60 9.77 17 113765 1133 50490209
Wrist deformity 17.54 9.77 21 113761 1788 50489554
Neovascularisation 17.47 9.77 16 113766 997 50490345
Therapeutic drug monitoring analysis incorrectly performed 17.32 9.77 8 113774 149 50491193
Lymphocytosis 17.28 9.77 23 113759 2179 50489163
Hyperthermia 17.27 9.77 47 113735 7649 50483693
Psoriasis 17.27 9.77 88 113694 68912 50422430
Rash pruritic 17.26 9.77 174 113608 47672 50443670
Injection site mass 16.94 9.77 7 113775 15673 50475669
Injury 16.89 9.77 55 113727 48870 50442472
Nephrogenic anaemia 16.87 9.77 20 113762 1685 50489657
Influenza 16.77 9.77 125 113657 89413 50401929
Bone erosion 16.77 9.77 3 113779 11684 50479658
Bone marrow failure 16.75 9.77 113 113669 27511 50463831
Limb discomfort 16.74 9.77 18 113764 24339 50467003
Migraine 16.66 9.77 100 113682 75180 50416162
Hepatic failure 16.65 9.77 127 113655 32156 50459186
Glomerulonephritis 16.62 9.77 19 113763 1540 50489802
Disturbance in social behaviour 16.52 9.77 26 113756 2868 50488474
Metastases to bone 16.49 9.77 10 113772 17985 50473357
Burning sensation 16.46 9.77 50 113732 45396 50445946
Aplasia pure red cell 16.42 9.77 32 113750 4183 50487159
Uveitic glaucoma 16.37 9.77 4 113778 7 50491335
Hypersensitivity vasculitis 16.28 9.77 31 113751 3984 50487358
Aplastic anaemia 16.26 9.77 46 113736 7657 50483685
Stress 16.23 9.77 64 113718 53729 50437613
Chronic myeloid leukaemia 16.13 9.77 22 113760 2134 50489208
Anger 16.07 9.77 3 113779 11330 50480012
Nodal arrhythmia 16.06 9.77 16 113766 1108 50490234
Pain in extremity 16.04 9.77 479 113303 272386 50218956
No adverse event 16.04 9.77 32 113750 33546 50457796
B-cell unclassifiable lymphoma high grade 16.02 9.77 4 113778 8 50491334
Therapeutic drug monitoring analysis not performed 15.94 9.77 13 113769 692 50490650
Diabetic hyperosmolar coma 15.72 9.77 10 113772 359 50490983
Influenza like illness 15.71 9.77 71 113711 57388 50433954
Cholestatic liver injury 15.69 9.77 21 113761 2000 50489342
Neuroleptic malignant syndrome 15.66 9.77 3 113779 11127 50480215
Staphylococcal scalded skin syndrome 15.63 9.77 7 113775 121 50491221
Neutropenic colitis 15.62 9.77 23 113759 2394 50488948
Blood pressure inadequately controlled 15.56 9.77 32 113750 4348 50486994
Lower respiratory tract infection 15.50 9.77 138 113644 95063 50396279
Erythema 15.48 9.77 435 113347 145979 50345363
Generalised tonic-clonic seizure 15.40 9.77 22 113760 26288 50465054
Musculoskeletal disorder 15.40 9.77 10 113772 17339 50474003
Eye oedema 15.40 9.77 17 113765 1326 50490016
Stenosis 15.37 9.77 16 113766 1167 50490175
Oliguria 15.37 9.77 47 113735 8169 50483173
Pulmonary hypertension 15.34 9.77 128 113654 33289 50458053
Emphysematous cystitis 15.32 9.77 7 113775 127 50491215
Drug-induced liver injury 15.32 9.77 112 113670 27983 50463359
Duodenal stenosis 15.29 9.77 11 113771 485 50490857
Disorientation 15.28 9.77 134 113648 35350 50455992
Streptococcal sepsis 15.23 9.77 19 113763 1688 50489654
Renal infarct 15.22 9.77 17 113765 1343 50489999
Dermatitis 15.22 9.77 68 113714 14183 50477159
Rhinorrhoea 15.16 9.77 62 113720 51521 50439821
Post-traumatic neck syndrome 15.06 9.77 20 113762 1890 50489452
Eosinopenia 15.06 9.77 5 113777 36 50491306
Chronic myeloid leukaemia recurrent 14.97 9.77 8 113774 206 50491136
Acute myeloid leukaemia recurrent 14.92 9.77 17 113765 1373 50489969
Gouty arthritis 14.83 9.77 11 113771 509 50490833
Mucocutaneous haemorrhage 14.80 9.77 6 113776 80 50491262
Foot fracture 14.78 9.77 14 113768 20077 50471265
Subdural haemorrhage 14.74 9.77 24 113758 2725 50488617
Erosive oesophagitis 14.68 9.77 18 113764 1571 50489771
Proteinuria 14.68 9.77 75 113707 16522 50474820
Transaminases increased 14.65 9.77 110 113672 27714 50463628
Paraneoplastic syndrome 14.59 9.77 11 113771 522 50490820
Hostility 14.58 9.77 19 113763 1763 50489579
Infection 14.43 9.77 288 113494 172666 50318676
Performance enhancing product use 14.41 9.77 4 113778 14 50491328
Poisoning 14.34 9.77 5 113777 12424 50478918
Multiple sclerosis 14.25 9.77 15 113767 20478 50470864
Presyncope 14.09 9.77 98 113684 24100 50467242
Shock 14.07 9.77 87 113695 20563 50470779
Orthopnoea 14.05 9.77 36 113746 5653 50485689
Serum ferritin increased 13.98 9.77 34 113748 5168 50486174
Upper gastrointestinal haemorrhage 13.86 9.77 72 113710 15963 50475379
Venoocclusive liver disease 13.83 9.77 30 113752 4231 50487111
Pulmonary fibrosis 13.75 9.77 21 113761 24416 50466926
Blood uric acid abnormal 13.71 9.77 5 113777 49 50491293
Capillary leak syndrome 13.71 9.77 19 113763 1871 50489471
Aspartate aminotransferase increased 13.68 9.77 249 113533 77749 50413593
Fluid retention 13.66 9.77 174 113608 50475 50440867
Complication associated with device 13.63 9.77 8 113774 14647 50476695
Platelet dysfunction 13.59 9.77 6 113776 100 50491242
Foot deformity 13.42 9.77 14 113768 19196 50472146
Gamma-glutamyltransferase increased 13.35 9.77 113 113669 29510 50461832
Haemoperitoneum 13.29 9.77 22 113760 2533 50488809
Adult failure to thrive 13.28 9.77 6 113776 106 50491236
Gastritis erosive 13.21 9.77 33 113749 5101 50486241
Blood phosphorus increased 13.12 9.77 22 113760 2560 50488782
Urosepsis 13.06 9.77 69 113713 15396 50475946
Chronic lymphocytic leukaemia recurrent 13.04 9.77 7 113775 182 50491160
Haematocrit decreased 13.01 9.77 128 113654 34848 50456494
Blood cholesterol increased 12.93 9.77 72 113710 55143 50436199
Respiratory tract congestion 12.86 9.77 8 113774 14191 50477151
Haemoptysis 12.85 9.77 100 113682 25473 50465869
Eye pain 12.84 9.77 28 113754 28421 50462921
Renal function test abnormal 12.81 9.77 23 113759 2826 50488516
Cholecystitis chronic 12.80 9.77 3 113779 9666 50481676
Abdominal pain upper 12.78 9.77 267 113515 159042 50332300
Hypocoagulable state 12.78 9.77 13 113769 923 50490419
Overdose 12.77 9.77 153 113629 99574 50391768
Trichiasis 12.74 9.77 5 113777 61 50491281
Nephropathy 12.70 9.77 33 113749 5225 50486117
Prurigo 12.64 9.77 12 113770 783 50490559
Surgery 12.61 9.77 31 113751 30174 50461168
Oral contusion 12.52 9.77 5 113777 64 50491278
Electrocardiogram QT shortened 12.47 9.77 6 113776 123 50491219
Gait disturbance 12.45 9.77 250 113532 149755 50341587
Device issue 12.40 9.77 16 113766 19956 50471386
Rash macular 12.38 9.77 80 113702 19197 50472145
HLA marker study positive 12.38 9.77 7 113775 202 50491140
Insulin-requiring type 2 diabetes mellitus 12.31 9.77 5 113777 67 50491275
Tachypnoea 12.29 9.77 65 113717 14512 50476830
Serotonin syndrome 12.28 9.77 23 113759 24690 50466652
Eosinophilic pustular folliculitis 12.27 9.77 4 113778 27 50491315
Cutaneous vasculitis 12.25 9.77 29 113753 4333 50487009
Extensor plantar response 12.19 9.77 14 113768 1140 50490202
Venoocclusive disease 12.19 9.77 18 113764 1878 50489464
Nasal mucosal erosion 12.18 9.77 5 113777 69 50491273
Lung infiltration 12.18 9.77 61 113721 13332 50478010
Grip strength decreased 12.18 9.77 6 113776 12115 50479227
Chorea 12.09 9.77 15 113767 1325 50490017
Fixed eruption 12.09 9.77 12 113770 827 50490515
Drug resistance 12.01 9.77 15 113767 18974 50472368
Lymphocytic infiltration 12.01 9.77 12 113770 834 50490508
Wrong drug 12.00 9.77 6 113776 134 50491208
Joint stiffness 11.96 9.77 32 113750 30276 50461066
Epidermolysis 11.96 9.77 7 113775 216 50491126
Blood electrolytes increased 11.91 9.77 4 113778 30 50491312
Bicytopenia 11.91 9.77 18 113764 1918 50489424
Drug withdrawal syndrome 11.90 9.77 24 113758 25057 50466285
End stage renal disease 11.85 9.77 34 113748 5703 50485639
Asthma 11.85 9.77 136 113646 89201 50402141
Dystonia 11.83 9.77 6 113776 11920 50479422
Ileal ulcer 11.81 9.77 9 113773 434 50490908
Haematochezia 11.61 9.77 139 113643 39743 50451599
Calciphylaxis 11.48 9.77 21 113761 2617 50488725
Spigelian hernia 11.47 9.77 4 113778 34 50491308
Blood pressure systolic increased 11.46 9.77 41 113741 35408 50455934
Diabetic ketoacidosis 11.43 9.77 14 113768 17858 50473484
Strangury 11.42 9.77 3 113779 8 50491334
Hypertensive crisis 11.32 9.77 59 113723 13095 50478247
Pneumonia pseudomonal 11.31 9.77 18 113764 2005 50489337
Acid base balance abnormal 11.29 9.77 7 113775 240 50491102
Heart rate decreased 11.28 9.77 43 113739 36454 50454888
Balance disorder 11.19 9.77 103 113679 70487 50420855
Neutropenic infection 11.17 9.77 13 113769 1074 50490268
Diffuse large B-cell lymphoma 11.17 9.77 33 113749 5629 50485713
Atrioventricular block first degree 11.16 9.77 35 113747 6166 50485176
Psychotic disorder 11.11 9.77 20 113762 21792 50469550
Proteus test positive 11.11 9.77 6 113776 158 50491184
Hypertensive heart disease 11.08 9.77 19 113763 2251 50489091
Eosinophilic myocarditis 11.04 9.77 8 113774 357 50490985
Urticaria 11.03 9.77 215 113567 129346 50361996
Cytopenia 11.02 9.77 44 113738 8731 50482611
Lip haemorrhage 11.01 9.77 9 113773 481 50490861
Hyperviscosity syndrome 10.97 9.77 6 113776 162 50491180
Procedural pain 10.94 9.77 9 113773 13823 50477519
Conjunctival hyperaemia 10.93 9.77 18 113764 2064 50489278
Premature delivery 10.92 9.77 23 113759 23640 50467702
Paraesthesia oral 10.91 9.77 7 113775 12214 50479128
Cardiac murmur functional 10.90 9.77 4 113778 40 50491302
Spontaneous haematoma 10.88 9.77 11 113771 775 50490567
Pupillary reflex impaired 10.88 9.77 17 113765 1864 50489478
Underdose 10.87 9.77 18 113764 20260 50471082
Mixed liver injury 10.86 9.77 24 113758 3427 50487915
Bradyarrhythmia 10.82 9.77 17 113765 1873 50489469
Parakeratosis 10.79 9.77 7 113775 260 50491082
Hepatic necrosis 10.75 9.77 31 113751 5217 50486125
Throat tightness 10.72 9.77 19 113763 20828 50470514
Therapeutic response unexpected 10.68 9.77 12 113770 15903 50475439
Muscle necrosis 10.66 9.77 9 113773 503 50490839
Bone marrow transplant 10.64 9.77 10 113772 644 50490698
Constipation 10.62 9.77 515 113267 185193 50306149
Device malfunction 10.59 9.77 11 113771 15110 50476232
Allergy to chemicals 10.59 9.77 14 113768 1318 50490024
Pelvic venous thrombosis 10.57 9.77 14 113768 1320 50490022
Panic attack 10.52 9.77 17 113765 19325 50472017
Maternal condition affecting foetus 10.52 9.77 6 113776 176 50491166
Peripheral arterial occlusive disease 10.46 9.77 24 113758 3513 50487829
Subarachnoid haemorrhage 10.46 9.77 50 113732 10726 50480616
Abnormal dreams 10.44 9.77 4 113778 9373 50481969
Rheumatoid nodule 10.43 9.77 8 113774 12727 50478615
Neuromyelitis optica spectrum disorder 10.43 9.77 11 113771 815 50490527
Corneal thinning 10.41 9.77 5 113777 102 50491240
Leukostasis syndrome 10.32 9.77 4 113778 47 50491295
Vision blurred 10.32 9.77 120 113662 78527 50412815
Potentiating drug interaction 10.32 9.77 25 113757 3791 50487551
Halo vision 10.31 9.77 8 113774 396 50490946
Haemorrhage intracranial 10.31 9.77 55 113727 12319 50479023
Left ventricular failure 10.30 9.77 29 113753 4812 50486530
Bronchopulmonary aspergillosis 10.30 9.77 39 113743 7553 50483789
Lichenoid keratosis 10.26 9.77 14 113768 1358 50489984
Staphylococcal sepsis 10.26 9.77 37 113745 6999 50484343
Visual impairment 10.24 9.77 101 113681 68174 50423168
Pulmonary congestion 10.24 9.77 64 113718 15183 50476159
Acute febrile neutrophilic dermatosis 10.22 9.77 20 113762 2622 50488720
Retroperitoneal haematoma 10.22 9.77 20 113762 2623 50488719
Localised oedema 10.21 9.77 29 113753 4838 50486504
Pulmonary haemorrhage 10.21 9.77 35 113747 6457 50484885
Chronic myeloid leukaemia transformation 10.19 9.77 5 113777 107 50491235
Optic ischaemic neuropathy 10.18 9.77 12 113770 1005 50490337
Hypozincaemia 10.13 9.77 3 113779 14 50491328
Head banging 10.12 9.77 8 113774 407 50490935
Cardiopulmonary failure 10.10 9.77 23 113759 3350 50487992
Death 10.09 9.77 856 112926 324523 50166819
Generalised oedema 10.09 9.77 59 113723 13672 50477670
Bacteriuria 10.05 9.77 10 113772 691 50490651
Drug tolerance decreased 10.04 9.77 4 113778 9156 50482186
Bloody peritoneal effluent 10.03 9.77 4 113778 51 50491291
Carpal tunnel syndrome 10.01 9.77 14 113768 16879 50474463
Aortic valve sclerosis 9.96 9.77 12 113770 1028 50490314
Haemorrhoidal haemorrhage 9.89 9.77 24 113758 3643 50487699
Rebound acid hypersecretion 9.83 9.77 7 113775 304 50491038
Idiosyncratic drug reaction 9.82 9.77 10 113772 711 50490631
Deficiency anaemia 9.80 9.77 3 113779 16 50491326
Chest discomfort 9.79 9.77 148 113634 92574 50398768

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
Drug reaction with eosinophilia and systemic symptoms 1136.60 10.57 1154 196197 26838 29350338
Drug ineffective 509.38 10.57 1039 196312 362131 29015045
Acute kidney injury 381.05 10.57 3045 194306 262222 29114954
Drug abuse 358.30 10.57 53 197298 79830 29297346
Toxicity to various agents 318.06 10.57 416 196935 173245 29203931
Gout 271.84 10.57 440 196911 16471 29360705
Tumour lysis syndrome 232.41 10.57 368 196983 13516 29363660
Off label use 229.97 10.57 1130 196221 299670 29077506
Completed suicide 191.16 10.57 192 197159 90054 29287122
Hyperkalaemia 186.46 10.57 858 196493 60534 29316642
Stevens-Johnson syndrome 179.17 10.57 362 196989 16135 29361041
Renal failure 162.63 10.57 1349 196002 117250 29259926
Anaemia 158.55 10.57 2041 195310 198910 29178266
Foetal exposure during pregnancy 150.54 10.57 23 197328 33844 29343332
Cardiac failure 148.76 10.57 972 196379 78315 29298861
General physical health deterioration 130.44 10.57 1150 196201 101707 29275469
Product use in unapproved indication 130.13 10.57 238 197113 86637 29290539
Eosinophilia 127.60 10.57 381 196970 21780 29355396
Toxic epidermal necrolysis 112.09 10.57 320 197031 17833 29359343
Febrile neutropenia 106.29 10.57 1181 196170 111059 29266117
Hyperuricaemia 97.03 10.57 169 197182 6720 29370456
Intentional overdose 96.12 10.57 70 197281 38458 29338718
Blood creatinine increased 93.03 10.57 922 196429 84180 29292996
Treatment failure 89.72 10.57 69 197282 36870 29340306
Drug dependence 89.34 10.57 16 197335 20965 29356211
Cytokine release syndrome 88.64 10.57 239 197112 12880 29364296
Chronic lymphocytic leukaemia 86.74 10.57 114 197237 3519 29373657
Oedema peripheral 84.46 10.57 1059 196292 102498 29274678
Renal impairment 83.54 10.57 870 196481 80463 29296713
Product monitoring error 80.89 10.57 94 197257 2551 29374625
Chronic kidney disease 78.60 10.57 463 196888 35953 29341223
Atrial fibrillation 77.63 10.57 1060 196291 104586 29272590
Toxic skin eruption 77.56 10.57 189 197162 9568 29367608
Suicide attempt 77.53 10.57 68 197283 34042 29343134
Overdose 74.69 10.57 277 197074 79542 29297634
Seizure 70.68 10.57 350 197001 92773 29284403
Dermatitis exfoliative generalised 70.39 10.57 92 197259 2824 29374352
Premature baby 67.73 10.57 16 197335 17264 29359912
Headache 66.86 10.57 791 196560 173216 29203960
Dermatitis exfoliative 66.22 10.57 138 197213 6287 29370889
Suicidal ideation 64.56 10.57 82 197269 34634 29342542
Product dose omission issue 63.90 10.57 379 196972 96004 29281172
Blood uric acid increased 63.12 10.57 127 197224 5641 29371535
Injection site pain 63.12 10.57 74 197277 32372 29344804
Drug withdrawal syndrome 62.43 10.57 21 197330 17963 29359213
Drug resistance 60.75 10.57 34 197317 21506 29355670
Drug intolerance 60.27 10.57 147 197204 48232 29328944
Thrombocytopenia 56.84 10.57 1237 196114 133586 29243590
Rash maculo-papular 55.79 10.57 314 197037 23975 29353201
Intentional product misuse 55.46 10.57 91 197260 34570 29342606
Ventricular enlargement 55.42 10.57 36 197315 428 29376748
Blood lactate dehydrogenase increased 54.97 10.57 264 197087 18945 29358231
Sepsis 53.89 10.57 1289 196062 141393 29235783
Intentional product use issue 53.83 10.57 128 197223 42370 29334806
Aggression 51.72 10.57 99 197252 35442 29341734
Death 50.30 10.57 1823 195528 340261 29036915
Melaena 50.00 10.57 368 196983 30808 29346368
Face oedema 49.29 10.57 166 197185 10117 29367059
Anxiety 49.29 10.57 350 197001 85015 29292161
Pain 48.90 10.57 827 196524 170605 29206571
Pyrexia 48.45 10.57 2364 194987 285258 29091918
Splenomegaly 48.24 10.57 196 197155 13083 29364093
Serotonin syndrome 47.46 10.57 29 197322 17483 29359693
Inferior vena cava dilatation 47.45 10.57 38 197313 639 29376537
Hypotension 46.49 10.57 1658 195693 192696 29184480
Plasma cell myeloma 45.93 10.57 413 196938 36702 29340474
Depression 45.40 10.57 357 196994 84790 29292386
Neuroleptic malignant syndrome 44.81 10.57 26 197325 16122 29361054
Product use issue 44.60 10.57 184 197167 51260 29325916
Infective exacerbation of chronic obstructive airways disease 44.48 10.57 55 197296 1595 29375581
Inappropriate schedule of product administration 43.79 10.57 151 197200 44321 29332855
Right atrial hypertrophy 43.58 10.57 33 197318 509 29376667
Therapeutic product effect incomplete 42.50 10.57 128 197223 39177 29337999
Purpura 42.47 10.57 147 197204 9085 29368091
Insomnia 42.00 10.57 384 196967 88377 29288799
Syncope 41.38 10.57 768 196583 80603 29296573
Appendicolith 40.95 10.57 79 197272 3401 29373775
Gouty arthritis 40.91 10.57 41 197310 936 29376240
Aortic valve stenosis 40.40 10.57 61 197290 2147 29375029
Sedation 40.39 10.57 34 197317 17371 29359805
Blood urea increased 40.15 10.57 323 197028 27789 29349387
Synovitis 39.07 10.57 12 197339 10878 29366298
Somnolence 38.81 10.57 420 196931 93535 29283641
Respiratory depression 38.63 10.57 21 197330 13502 29363674
Epistaxis 38.01 10.57 519 196832 51185 29325991
Febrile infection 37.58 10.57 56 197295 1948 29375228
Blood pressure fluctuation 36.97 10.57 47 197304 19847 29357329
Platelet count decreased 36.90 10.57 937 196414 103735 29273441
Tumour flare 36.61 10.57 30 197321 522 29376654
Cardio-respiratory arrest 36.20 10.57 194 197157 50407 29326769
Rheumatoid arthritis 36.00 10.57 103 197248 32049 29345127
Respiratory arrest 35.83 10.57 74 197277 25759 29351417
Neutropenic sepsis 34.88 10.57 163 197188 11564 29365612
Musculoskeletal stiffness 34.36 10.57 131 197220 37327 29339849
Cardiac failure chronic 34.24 10.57 108 197243 6359 29370817
Drug hypersensitivity 34.08 10.57 292 197059 68114 29309062
Gouty tophus 33.84 10.57 17 197334 118 29377058
Normocytic anaemia 33.60 10.57 53 197298 1939 29375237
Degenerative mitral valve disease 33.37 10.57 20 197331 204 29376972
Immune reconstitution inflammatory syndrome 33.10 10.57 6 197345 7796 29369380
Psychotic disorder 32.96 10.57 53 197298 20301 29356875
Nasopharyngitis 32.80 10.57 248 197103 59417 29317759
Glomerular filtration rate abnormal 32.60 10.57 32 197319 712 29376464
Device interaction 32.35 10.57 28 197323 527 29376649
Irritability 31.97 10.57 62 197289 22090 29355086
Labelled drug-drug interaction medication error 31.87 10.57 163 197188 11996 29365180
Pulmonary function test abnormal 31.86 10.57 53 197298 2029 29375147
Pelvic mass 31.77 10.57 19 197332 193 29376983
Rhabdomyolysis 31.63 10.57 576 196775 60232 29316944
Abnormal behaviour 31.44 10.57 67 197284 23060 29354116
Full blood count abnormal 31.17 10.57 189 197162 14824 29362352
Dermatitis allergic 31.05 10.57 96 197255 5592 29371584
Acute myeloid leukaemia 30.64 10.57 202 197149 16311 29360865
Incorrect route of product administration 30.53 10.57 17 197334 10784 29366392
Coma 30.05 10.57 148 197203 39302 29337874
Eczema 29.95 10.57 176 197175 13650 29363526
Intentional self-injury 29.34 10.57 24 197327 12437 29364739
Substance abuse 29.28 10.57 5 197346 6782 29370394
Hyponatraemia 29.23 10.57 623 196728 67010 29310166
Haemoglobin decreased 29.00 10.57 937 196414 107438 29269738
Bronchial secretion retention 28.80 10.57 37 197314 1116 29376060
Drug ineffective for unapproved indication 28.09 10.57 32 197319 14182 29362994
Hypercreatininaemia 28.02 10.57 24 197327 445 29376731
Blood electrolytes abnormal 27.63 10.57 32 197319 865 29376311
Generalised tonic-clonic seizure 27.24 10.57 54 197297 19085 29358091
Therapeutic product effect decreased 27.00 10.57 103 197248 29348 29347828
Arthralgia 27.00 10.57 717 196634 138900 29238276
Dyspnoea 26.97 10.57 2530 194821 324202 29052974
Poisoning 26.46 10.57 17 197334 9976 29367200
Blood potassium increased 26.44 10.57 178 197173 14473 29362703
Drug interaction 26.11 10.57 1587 195764 195798 29181378
Haematochezia 25.86 10.57 368 196983 36615 29340561
Multiple sclerosis relapse 25.66 10.57 23 197328 11396 29365780
Haematoma 25.56 10.57 252 197099 22960 29354216
Hepatic vein dilatation 25.28 10.57 17 197334 215 29376961
Erythema multiforme 24.99 10.57 110 197241 7607 29369569
Hospitalisation 24.87 10.57 192 197159 45796 29331380
International normalised ratio increased 24.74 10.57 425 196926 43947 29333229
Vascular purpura 24.60 10.57 38 197313 1365 29375811
No adverse event 24.29 10.57 50 197301 17428 29359748
Dyskinesia 24.16 10.57 62 197289 19999 29357177
Electrolyte depletion 24.00 10.57 15 197336 166 29377010
Malignant neoplasm progression 23.80 10.57 348 197003 73511 29303665
Post transplant lymphoproliferative disorder 23.80 10.57 4 197347 5489 29371687
Accidental exposure to product 23.75 10.57 22 197329 10731 29366445
Atrial enlargement 23.75 10.57 19 197332 319 29376857
Diastolic dysfunction 23.61 10.57 81 197270 4983 29372193
Bronchial wall thickening 23.57 10.57 32 197319 1020 29376156
Atrial septal defect 23.44 10.57 8 197343 6781 29370395
Blood urea abnormal 23.43 10.57 27 197324 726 29376450
Blood lactic acid 23.36 10.57 19 197332 327 29376849
Therapeutic drug monitoring analysis not performed 23.21 10.57 22 197329 468 29376708
Azotaemia 23.12 10.57 75 197276 4482 29372694
Product prescribing error 22.73 10.57 201 197150 17775 29359401
Pathogen resistance 22.61 10.57 13 197338 8103 29369073
Right ventricular hypertrophy 22.57 10.57 33 197318 1128 29376048
Withdrawal syndrome 22.54 10.57 24 197327 10968 29366208
Electrolyte imbalance 22.19 10.57 140 197211 11134 29366042
Agitation 22.11 10.57 227 197124 51077 29326099
Rash 21.98 10.57 1509 195842 188310 29188866
Oligoasthenozoospermia 21.97 10.57 7 197344 10 29377166
Diabetic ketoacidosis 21.49 10.57 47 197304 16026 29361150
Pleural effusion 21.43 10.57 630 196721 71278 29305898
Dehydration 21.33 10.57 953 196398 113795 29263381
Bradycardia 21.22 10.57 581 196770 65048 29312128
Narrow anterior chamber angle 21.19 10.57 12 197339 109 29377067
Acute graft versus host disease in skin 21.11 10.57 3 197348 4661 29372515
Anger 21.00 10.57 25 197326 10865 29366311
Hypertrophy 20.89 10.57 20 197331 431 29376745
Renal function test abnormal 20.88 10.57 46 197305 2178 29374998
Accidental overdose 20.71 10.57 55 197296 17538 29359638
Hyperphosphataemia 20.69 10.57 46 197305 2192 29374984
Unresponsive to stimuli 20.46 10.57 92 197259 25034 29352142
Eye injury 20.44 10.57 23 197328 602 29376574
C-reactive protein abnormal 20.41 10.57 9 197342 6527 29370649
Skin exfoliation 20.34 10.57 236 197115 22409 29354767
Pulmonary vascular disorder 20.20 10.57 22 197329 555 29376621
Haematuria 20.18 10.57 410 196941 43729 29333447
Dyspnoea exertional 20.15 10.57 349 197002 36141 29341035
Thrombotic microangiopathy 20.09 10.57 17 197334 8664 29368512
Orthostatic hypotension 19.96 10.57 235 197116 22394 29354782
Heart rate increased 19.93 10.57 165 197186 38773 29338403
Pancytopenia 19.69 10.57 709 196642 82459 29294717
Coating in mouth 19.60 10.57 10 197341 72 29377104
Subacute hepatic failure 19.60 10.57 10 197341 72 29377104
Nicotine dependence 19.59 10.57 20 197331 467 29376709
Pneumonia aspiration 19.57 10.57 154 197197 36583 29340593
Abnormal loss of weight 19.52 10.57 61 197290 3573 29373603
Dependence on oxygen therapy 19.43 10.57 13 197338 163 29377013
Prostate cancer recurrent 19.25 10.57 27 197324 888 29376288
Base excess decreased 19.16 10.57 14 197337 204 29376972
Tooth deposit 19.15 10.57 10 197341 76 29377100
Gravitational oedema 18.96 10.57 21 197330 540 29376636
Hypocalcaemia 18.85 10.57 216 197135 20449 29356727
Pruritus allergic 18.84 10.57 13 197338 172 29377004
Oedema 18.82 10.57 377 196974 40106 29337070
Intestinal haemorrhage 18.73 10.57 54 197297 3025 29374151
Paranoia 18.70 10.57 23 197328 9854 29367322
Graft versus host disease 18.68 10.57 22 197329 9606 29367570
Lymphocytopenia neonatal 18.66 10.57 6 197345 9 29377167
Blood uric acid abnormal 18.62 10.57 10 197341 81 29377095
Serum ferritin abnormal 18.38 10.57 14 197337 218 29376958
Asthenia 18.34 10.57 1671 195680 213579 29163597
Erysipelas 18.33 10.57 66 197285 4159 29373017
Obstruction 18.27 10.57 40 197311 1886 29375290
Condition aggravated 18.26 10.57 794 196557 145501 29231675
Depressed mood 18.18 10.57 53 197298 16395 29360781
Myocardial infarction 18.15 10.57 579 196772 109717 29267459
Restlessness 18.09 10.57 81 197270 22064 29355112
Tremor 18.03 10.57 364 196987 73174 29304002
Mucormycosis 17.94 10.57 6 197345 5152 29372024
Low birth weight baby 17.83 10.57 11 197340 6597 29370579
Poisoning deliberate 17.73 10.57 8 197343 5723 29371453
Liver palpable 17.65 10.57 15 197336 275 29376901
Gastrointestinal haemorrhage 17.62 10.57 673 196678 78860 29298316
Hallucination, auditory 17.48 10.57 23 197328 9570 29367606
Oroantral fistula 17.36 10.57 13 197338 197 29376979
Crying 17.30 10.57 7 197344 5344 29371832
Cardiogenic shock 17.24 10.57 200 197151 18990 29358186
Dialysis 17.22 10.57 122 197229 10086 29367090
Aptyalism 17.17 10.57 15 197336 286 29376890
Wrong technique in product usage process 17.09 10.57 131 197220 31297 29345879
Renal atrophy 17.08 10.57 28 197323 1059 29376117
Speech disorder 16.90 10.57 90 197261 23426 29353750
Post-traumatic amnestic disorder 16.88 10.57 8 197343 48 29377128
Transplant rejection 16.87 10.57 22 197329 9190 29367986
Tubulointerstitial nephritis 16.81 10.57 186 197165 17457 29359719
Acute graft versus host disease 16.70 10.57 9 197342 5815 29371361
Skin swelling 16.66 10.57 27 197324 1011 29376165
Sexual dysfunction 16.65 10.57 9 197342 5805 29371371
Neck pain 16.60 10.57 80 197271 21367 29355809
Differentiation syndrome 16.59 10.57 28 197323 1085 29376091
Epidermolysis 16.42 10.57 14 197337 258 29376918
Decreased gait velocity 16.37 10.57 11 197340 139 29377037
Product quality issue 16.30 10.57 53 197298 15842 29361334
COVID-19 pneumonia 16.18 10.57 114 197237 9408 29367768
Drug therapeutic incompatibility 16.13 10.57 10 197341 109 29377067
Stag horn calculus 16.07 10.57 4 197347 0 29377176
Mantle cell lymphoma 16.01 10.57 28 197323 1117 29376059
Presyncope 15.97 10.57 171 197180 15918 29361258
Device issue 15.94 10.57 17 197334 7763 29369413
Therapeutic response shortened 15.93 10.57 6 197345 4785 29372391
White blood cell count decreased 15.84 10.57 694 196657 82668 29294508
Glomerular filtration rate decreased 15.84 10.57 129 197222 11137 29366039
Maternal exposure during pregnancy 15.80 10.57 4 197347 4119 29373057
Mantle cell lymphoma refractory 15.78 10.57 9 197342 83 29377093
Feeling abnormal 15.69 10.57 262 197089 54183 29322993
Haemodialysis 15.67 10.57 117 197234 9837 29367339
Vomiting 15.62 10.57 1212 196139 211048 29166128
Bronchospasm 15.58 10.57 25 197326 9584 29367592
Cardiac failure congestive 15.55 10.57 642 196709 75939 29301237
Cardiac aneurysm 15.46 10.57 23 197328 799 29376377
Gastritis erosive 15.34 10.57 74 197277 5319 29371857
Mucosal necrosis 15.30 10.57 8 197343 61 29377115
Nephrogenic anaemia 15.30 10.57 38 197313 1947 29375229
Influenza like illness 15.27 10.57 98 197253 24372 29352804
Genital ulceration 15.01 10.57 11 197340 161 29377015
Urate nephropathy 14.99 10.57 5 197346 9 29377167
Respiratory fatigue 14.98 10.57 8 197343 64 29377112
N-terminal prohormone brain natriuretic peptide increased 14.90 10.57 37 197314 1895 29375281
Lens dislocation 14.84 10.57 9 197342 94 29377082
Sarcopenia 14.81 10.57 15 197336 347 29376829
Diverticulum intestinal 14.80 10.57 52 197299 3238 29373938
Sinusitis 14.79 10.57 152 197199 34198 29342978
Obsessive-compulsive disorder 14.77 10.57 6 197345 4570 29372606
Injection site reaction 14.72 10.57 33 197318 11155 29366021
Mental disorder 14.69 10.57 41 197310 12864 29364312
Injection site erythema 14.69 10.57 46 197305 13910 29363266
Small for dates baby 14.66 10.57 3 197348 3576 29373600
Treatment noncompliance 14.62 10.57 98 197253 24129 29353047
Rales 14.62 10.57 93 197258 7417 29369759
Joint swelling 14.57 10.57 238 197113 49392 29327784
Ejection fraction decreased 14.57 10.57 167 197184 15811 29361365
Therapy non-responder 14.48 10.57 134 197217 30777 29346399
Heart rate decreased 14.43 10.57 102 197249 24810 29352366
Psoriatic arthropathy 14.38 10.57 50 197301 14641 29362535
Device leakage 14.34 10.57 6 197345 4489 29372687
Benign prostatic hyperplasia 14.32 10.57 130 197221 11580 29365596
Appendicitis 14.28 10.57 104 197247 8675 29368501
Blood pressure increased 14.25 10.57 379 196972 73424 29303752
Hypoglycaemia 14.24 10.57 423 196928 47923 29329253
Catatonia 14.20 10.57 6 197345 4462 29372714
Cardioactive drug level increased 14.20 10.57 33 197318 1620 29375556
Multimorbidity 14.16 10.57 18 197333 537 29376639
Oxygen consumption decreased 14.09 10.57 11 197340 178 29376998
Adenovirus infection 14.09 10.57 6 197345 4441 29372735
Acquired epidermolysis bullosa 14.04 10.57 5 197346 12 29377164
Ichthyosis acquired 14.04 10.57 5 197346 12 29377164
Neonatal respiratory distress syndrome 14.03 10.57 4 197347 3806 29373370
Acne 14.01 10.57 25 197326 9195 29367981
Hypoaesthesia 13.91 10.57 262 197089 53205 29323971
Paroxysmal arrhythmia 13.85 10.57 4 197347 3 29377173
Brain oedema 13.78 10.57 39 197312 12181 29364995
Blood phosphorus increased 13.77 10.57 46 197305 2791 29374385
Pulmonary hypertension 13.75 10.57 187 197164 18421 29358755
Carcinoma in situ of skin 13.74 10.57 8 197343 77 29377099
Unevaluable event 13.73 10.57 130 197221 29721 29347455
Soft tissue mass 13.72 10.57 19 197332 617 29376559
Lip erosion 13.70 10.57 17 197334 495 29376681
Human herpesvirus 6 infection 13.66 10.57 35 197316 1828 29375348
Dysarthria 13.63 10.57 136 197215 30775 29346401
Leukostasis syndrome 13.55 10.57 6 197345 30 29377146
Rash morbilliform 13.53 10.57 42 197309 2451 29374725
Flushing 13.45 10.57 126 197225 28866 29348310
Dizziness 13.44 10.57 1454 195897 188230 29188946
Tricuspid valve incompetence 13.40 10.57 99 197252 8295 29368881
Left ventricular enlargement 13.36 10.57 19 197332 633 29376543
Reactive gastropathy 13.33 10.57 10 197341 152 29377024
Aplasia pure red cell 13.28 10.57 72 197279 5419 29371757
Portal vein flow decreased 13.25 10.57 5 197346 15 29377161
Device malfunction 12.99 10.57 23 197328 8484 29368692
Eczema nummular 12.99 10.57 9 197342 120 29377056
Light chain disease 12.99 10.57 9 197342 120 29377056
Dyspnoea at rest 12.93 10.57 49 197302 3165 29374011
Ascites 12.93 10.57 328 197023 36291 29340885
Metabolic acidosis 12.91 10.57 336 197015 37326 29339850
Rash macular 12.88 10.57 116 197235 10309 29366867
Hypervolaemia 12.83 10.57 176 197175 17369 29359807
Nervousness 12.81 10.57 36 197315 11270 29365906
Colitis ulcerative 12.81 10.57 43 197308 12726 29364450
Cardiac failure acute 12.79 10.57 105 197246 9087 29368089
Respiratory tract haemorrhage 12.74 10.57 23 197328 941 29376235
Epididymitis 12.66 10.57 38 197313 2177 29374999
Activated partial thromboplastin time shortened 12.65 10.57 15 197336 416 29376760
Strangury 12.62 10.57 9 197342 126 29377050
Cardiac autonomic neuropathy 12.61 10.57 7 197344 61 29377115
Thrombin time prolonged 12.59 10.57 10 197341 166 29377010
Underdose 12.58 10.57 39 197312 11830 29365346
Productive cough 12.56 10.57 285 197066 30974 29346202
Fear 12.53 10.57 28 197323 9476 29367700
Subcutaneous haematoma 12.50 10.57 22 197329 882 29376294
Jugular vein distension 12.49 10.57 18 197333 607 29376569
Type V hyperlipidaemia 12.39 10.57 19 197332 678 29376498
Diverticulum intestinal haemorrhagic 12.39 10.57 36 197315 2026 29375150
Drug abuser 12.39 10.57 5 197346 3822 29373354
Myelofibrosis 12.35 10.57 29 197322 1433 29375743
Apparent death 12.32 10.57 4 197347 3500 29373676
Anaphylactic reaction 12.29 10.57 121 197230 27452 29349724
Drug screen positive 12.25 10.57 5 197346 3796 29373380
Ventricular internal diameter abnormal 12.18 10.57 8 197343 97 29377079
Pneumocystis jirovecii pneumonia 12.18 10.57 64 197287 16715 29360461
Cardiovascular insufficiency 12.17 10.57 28 197323 1365 29375811
Scrotal erythema 12.17 10.57 5 197346 20 29377156
Chronic myeloid leukaemia 12.16 10.57 35 197316 1959 29375217
Mitral valve incompetence 12.15 10.57 139 197212 13154 29364022
Syringe issue 12.12 10.57 5 197346 3773 29373403
Arrhythmia 12.12 10.57 284 197067 31029 29346147
Systolic dysfunction 12.11 10.57 37 197314 2141 29375035
Oesophageal mucosal blister 12.05 10.57 3 197348 0 29377176
Surgical vascular shunt 12.05 10.57 3 197348 0 29377176
HLA-B*5801 assay positive 12.05 10.57 3 197348 0 29377176
Gastrointestinal adenocarcinoma 12.05 10.57 3 197348 0 29377176
Memory impairment 12.03 10.57 171 197180 36299 29340877
Injection site bruising 12.03 10.57 20 197331 7560 29369616
Jaundice cholestatic 12.03 10.57 58 197293 4168 29373008
Amnesia 12.02 10.57 95 197256 22548 29354628
Hepatitis C 11.95 10.57 26 197325 8884 29368292
Transfusion reaction 11.93 10.57 21 197330 842 29376334
Lymphadenopathy 11.89 10.57 234 197117 24815 29352361
Cytopenia 11.83 10.57 109 197242 9750 29367426
Hypersensitivity vasculitis 11.77 10.57 48 197303 3209 29373967
Injection site pruritus 11.74 10.57 13 197338 5836 29371340
Hyperamylasaemia 11.74 10.57 16 197335 512 29376664
Tachyarrhythmia 11.73 10.57 45 197306 2924 29374252
Helicobacter test positive 11.70 10.57 18 197333 644 29376532
Mood swings 11.63 10.57 19 197332 7232 29369944
Retroperitoneal fibrosis 11.63 10.57 12 197339 284 29376892
Asphyxia 11.59 10.57 11 197340 5304 29371872
Tooth loss 11.57 10.57 5 197346 3669 29373507
Microphthalmos 11.52 10.57 10 197341 189 29376987
Hypomagnesaemia 11.49 10.57 172 197179 17296 29359880
Vasculitis necrotising 11.48 10.57 17 197334 588 29376588
Drooling 11.45 10.57 3 197348 3018 29374158
Adrenal insufficiency 11.44 10.57 37 197314 11077 29366099
Skin reaction 11.42 10.57 59 197292 4358 29372818
Oesophagobronchial fistula 11.35 10.57 9 197342 149 29377027
Sleep disorder 11.30 10.57 106 197245 24280 29352896
Brain natriuretic peptide increased 11.29 10.57 57 197294 4173 29373003
Malignant transformation 11.15 10.57 20 197331 814 29376362
Intestinal angioedema 11.14 10.57 10 197341 198 29376978
Acute cutaneous lupus erythematosus 11.08 10.57 7 197344 79 29377097
Nightmare 11.07 10.57 39 197312 11378 29365798
Therapy partial responder 11.06 10.57 11 197340 5188 29371988
Paraesthesia 11.06 10.57 274 197077 53571 29323605
Respiratory tract infection 11.04 10.57 156 197195 15495 29361681
Cytomegalovirus nephritis 11.04 10.57 8 197343 115 29377061
Vision blurred 11.03 10.57 195 197156 39981 29337195
Hypercalcaemia 11.03 10.57 132 197219 12627 29364549
Organic brain syndrome 11.02 10.57 11 197340 250 29376926
Ventricular arrhythmia 10.89 10.57 60 197291 4544 29372632
Gastritis haemorrhagic 10.88 10.57 25 197326 1218 29375958
Oxygen saturation decreased 10.84 10.57 223 197128 44714 29332462
Microcytic anaemia 10.83 10.57 34 197317 1997 29375179
Impaired work ability 10.82 10.57 13 197338 5627 29371549
Bone marrow reticulin fibrosis 10.78 10.57 9 197342 161 29377015
Hepatitis acute 10.77 10.57 77 197274 6385 29370791
Eyelid oedema 10.68 10.57 60 197291 4576 29372600
Mydriasis 10.67 10.57 15 197336 6070 29371106
Injection site swelling 10.66 10.57 30 197321 9387 29367789
Retinitis viral 10.65 10.57 7 197344 85 29377091
Body temperature decreased 10.63 10.57 36 197315 10628 29366548
Peripheral arterial occlusive disease 10.60 10.57 64 197287 5012 29372164
Exercise tolerance decreased 10.59 10.57 56 197295 4175 29373001
Hepatosplenomegaly 10.57 10.57 51 197300 3666 29373510

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
Drug reaction with eosinophilia and systemic symptoms 3040.72 9.87 2195 264989 52022 64179526
Acute kidney injury 1147.41 9.87 4269 262915 444971 63786577
Drug ineffective 869.29 9.87 1341 265843 838906 63392642
Toxic epidermal necrolysis 535.96 9.87 714 266470 36452 64195096
Hyperkalaemia 472.42 9.87 1190 265994 99939 64131609
Renal failure 471.01 9.87 1738 265446 179950 64051598
Tumour lysis syndrome 452.36 9.87 477 266707 18963 64212585
Stevens-Johnson syndrome 442.58 9.87 624 266560 33625 64197923
Anaemia 436.19 9.87 2871 264313 375809 63855739
Febrile neutropenia 388.17 9.87 1673 265511 185984 64045564
Gout 377.88 9.87 455 266729 20958 64210590
Completed suicide 360.13 9.87 244 266940 224170 64007378
Cardiac failure 335.89 9.87 1258 265926 131115 64100433
Pain 307.20 9.87 1217 265967 552294 63679254
General physical health deterioration 293.97 9.87 1643 265541 202782 64028766
Toxicity to various agents 291.33 9.87 674 266510 362839 63868709
Drug abuse 290.73 9.87 93 267091 132281 64099267
Eosinophilia 283.81 9.87 541 266643 37535 64194013
Joint swelling 283.80 9.87 284 266900 215098 64016450
Maternal exposure during pregnancy 263.33 9.87 41 267143 95843 64135705
Rheumatoid arthritis 260.33 9.87 181 267003 164113 64067435
Cytokine release syndrome 250.75 9.87 367 266817 20462 64211086
Blood creatinine increased 242.06 9.87 1159 266025 134623 64096925
Off label use 239.45 9.87 1588 265596 631218 63600330
Drug intolerance 234.03 9.87 260 266924 187732 64043816
Renal impairment 232.44 9.87 1141 266043 133876 64097672
Atrial fibrillation 230.72 9.87 1352 265832 169737 64061811
Rash maculo-papular 228.50 9.87 562 266622 46464 64185084
Sepsis 225.54 9.87 1680 265504 228661 64002887
Alopecia 223.38 9.87 214 266970 165476 64066072
Exposure during pregnancy 220.75 9.87 30 267154 77645 64153903
Headache 220.69 9.87 1289 265895 528178 63703370
Thrombocytopenia 217.24 9.87 1629 265555 222172 64009376
Therapeutic product effect decreased 213.99 9.87 105 267079 115246 64116302
Arthralgia 213.60 9.87 1024 266160 441236 63790312
Melaena 212.19 9.87 593 266591 52955 64178593
Hand deformity 211.23 9.87 12 267172 62759 64168789
Pemphigus 209.32 9.87 10 267174 60691 64170857
Synovitis 206.51 9.87 76 267108 99014 64132534
Systemic lupus erythematosus 202.51 9.87 38 267146 77574 64153974
Arthropathy 195.95 9.87 130 267054 120837 64110711
Glossodynia 193.64 9.87 21 267163 64675 64166873
Chronic kidney disease 190.13 9.87 600 266584 57319 64174229
Injection site pain 185.54 9.87 116 267068 111292 64120256
Drug hypersensitivity 181.52 9.87 452 266732 237363 63994185
Toxic skin eruption 180.93 9.87 303 266881 18981 64212567
Drug interaction 177.96 9.87 2285 264899 359798 63871750
Treatment failure 176.79 9.87 135 267049 116681 64114867
Nasopharyngitis 173.09 9.87 344 266840 195729 64035819
Hyperuricaemia 167.57 9.87 209 266975 9982 64221566
Oedema peripheral 166.18 9.87 1461 265723 208856 64022692
Sinusitis 164.44 9.87 218 266966 145710 64085838
Pancytopenia 155.62 9.87 1072 266112 142237 64089311
Intentional overdose 154.88 9.87 90 267094 89854 64141694
Plasma cell myeloma 152.77 9.87 479 266705 45596 64185952
Pyrexia 151.14 9.87 3195 263989 555449 63676099
Hypotension 137.19 9.87 2278 264906 378696 63852852
Abdominal discomfort 134.08 9.87 353 266831 181969 64049579
Blood urea increased 130.15 9.87 441 266743 43712 64187836
Platelet count decreased 127.76 9.87 1156 266028 166555 64064993
Product use issue 125.59 9.87 276 266908 151439 64080109
Discomfort 125.54 9.87 91 267093 80787 64150761
Dermatitis exfoliative 125.46 9.87 183 267001 10169 64221379
Chronic lymphocytic leukaemia 122.59 9.87 118 267066 4197 64227351
Injection site erythema 120.26 9.87 72 267112 70728 64160820
Bradycardia 119.37 9.87 869 266315 117350 64114198
Contraindicated product administered 118.51 9.87 164 267020 107665 64123883
Product monitoring error 118.35 9.87 129 267055 5325 64226223
Dehydration 114.02 9.87 1386 265798 215377 64016171
Musculoskeletal stiffness 113.17 9.87 211 266973 122995 64108553
Labelled drug-drug interaction medication error 112.85 9.87 269 266915 21793 64209755
Rhabdomyolysis 112.17 9.87 707 266477 91019 64140529
Product prescribing error 111.74 9.87 361 266823 34908 64196640
International normalised ratio increased 110.08 9.87 631 266553 78536 64153012
Blood lactate dehydrogenase increased 109.75 9.87 344 266840 32734 64198814
Product dose omission issue 109.62 9.87 425 266759 194322 64037226
Syncope 108.78 9.87 1064 266120 156571 64074977
Dermatitis exfoliative generalised 108.12 9.87 128 267056 5788 64225760
Swelling 106.15 9.87 326 266858 159892 64071656
Blood uric acid increased 105.81 9.87 149 267035 8014 64223534
Anxiety 101.83 9.87 462 266722 202187 64029361
Haemoglobin decreased 99.86 9.87 1241 265943 193822 64037726
Purpura 98.93 9.87 220 266964 17026 64214522
Infusion related reaction 98.38 9.87 350 266834 164117 64067431
Injection site pruritus 97.64 9.87 19 267165 37807 64193741
Intentional product use issue 97.02 9.87 153 267031 95211 64136337
Hypoglycaemia 96.67 9.87 671 266513 89221 64142327
Face oedema 95.89 9.87 272 266912 24489 64207059
Multiple sclerosis relapse 95.56 9.87 26 267158 41109 64190439
Pericarditis 94.87 9.87 72 267112 62444 64169104
Suicide attempt 91.85 9.87 95 267089 70912 64160636
Hyponatraemia 91.70 9.87 979 266205 147360 64084188
Helicobacter infection 89.58 9.87 24 267160 38338 64193210
Irritable bowel syndrome 87.98 9.87 23 267161 37346 64194202
Suicidal ideation 87.24 9.87 88 267096 66454 64165094
Abortion spontaneous 87.14 9.87 4 267180 25139 64206409
Epistaxis 86.56 9.87 699 266485 97432 64134116
Neutropenic sepsis 84.68 9.87 250 266934 23022 64208526
Gastrointestinal haemorrhage 84.48 9.87 879 266305 131433 64100115
Injection site reaction 84.22 9.87 44 267140 46620 64184928
Duodenal ulcer perforation 84.06 9.87 20 267164 34605 64196943
Hepatic enzyme increased 82.82 9.87 269 266915 129674 64101874
Blood pressure fluctuation 82.28 9.87 57 267127 51814 64179734
Splenomegaly 81.30 9.87 209 266975 17752 64213796
Product use in unapproved indication 80.95 9.87 416 266768 176202 64055346
Therapeutic product effect incomplete 79.39 9.87 196 266988 103286 64128262
Insomnia 78.23 9.87 489 266695 197347 64034201
Hypersensitivity 75.92 9.87 489 266695 195963 64035585
Haematoma 73.26 9.87 382 266802 45868 64185680
Lactic acidosis 71.77 9.87 468 266716 60942 64170606
Device expulsion 71.22 9.87 4 267180 21132 64210416
Tumour flare 71.18 9.87 43 267141 744 64230804
Injection site bruising 70.69 9.87 31 267153 36342 64195206
Inappropriate schedule of product administration 70.63 9.87 175 267009 92111 64139437
Sleep disorder due to general medical condition, insomnia type 70.38 9.87 12 267172 26258 64205290
Acute myeloid leukaemia 70.37 9.87 262 266922 27201 64204347
Injection site swelling 70.29 9.87 42 267142 41311 64190237
Appendicolith 70.02 9.87 79 267105 3390 64228158
Depression 69.93 9.87 458 266726 182833 64048715
Pleural effusion 69.88 9.87 817 266367 125742 64105806
Fatigue 69.70 9.87 2471 264713 746259 63485289
Muscle injury 68.83 9.87 13 267171 26424 64205124
Asthenia 68.65 9.87 2287 264897 425757 63805791
Pneumonia 67.35 9.87 2896 264288 556680 63674868
Neutropenia 66.60 9.87 1377 265807 238247 63993301
Tubulointerstitial nephritis 66.39 9.87 279 266905 30630 64200918
Ventricular enlargement 64.55 9.87 35 267149 488 64231060
Intentional product misuse 64.45 9.87 126 267058 72169 64159379
Breast cancer 63.03 9.87 21 267163 29127 64202421
Pregnancy 61.85 9.87 7 267177 20858 64210690
Fibromyalgia 61.14 9.87 36 267148 35695 64195853
Multiple organ dysfunction syndrome 61.10 9.87 666 266518 100747 64130801
Paraesthesia 60.97 9.87 318 266866 134204 64097344
Wound 60.91 9.87 142 267042 76335 64155213
Psoriatic arthropathy 60.52 9.87 54 267130 43227 64188321
Overdose 60.21 9.87 400 266784 159166 64072382
Skin exfoliation 59.93 9.87 354 266830 44531 64187017
Seizure 59.21 9.87 426 266758 166466 64065082
Gastrointestinal disorder 59.05 9.87 183 267001 89526 64142022
Haematuria 57.86 9.87 439 266745 60032 64171516
Right atrial hypertrophy 57.77 9.87 33 267151 512 64231036
Inferior vena cava dilatation 57.59 9.87 37 267147 717 64230831
Feeling abnormal 57.15 9.87 322 266862 133280 64098268
Accidental exposure to product 57.00 9.87 19 267165 26345 64205203
Haematochezia 56.47 9.87 469 266715 65904 64165644
Drug resistance 56.44 9.87 38 267146 35064 64196484
Serotonin syndrome 56.15 9.87 48 267136 39234 64192314
Cardioactive drug level increased 55.27 9.87 70 267114 3395 64228153
Infective exacerbation of chronic obstructive airways disease 55.24 9.87 59 267125 2379 64229169
Hypoaesthesia 54.88 9.87 344 266840 138764 64092784
Weight increased 54.73 9.87 592 266592 212756 64018792
Metabolic acidosis 54.42 9.87 490 266694 70468 64161080
Dialysis 54.32 9.87 174 267010 16746 64214802
C-reactive protein abnormal 53.00 9.87 27 267157 29020 64202528
Intentional self-injury 52.99 9.87 27 267157 29017 64202531
Electrolyte imbalance 52.77 9.87 226 266958 25017 64206531
Erythema multiforme 52.74 9.87 164 267020 15537 64216011
Hip arthroplasty 52.49 9.87 12 267172 21339 64210209
Peripheral swelling 51.80 9.87 585 266599 208568 64022980
Dyspnoea 51.28 9.87 3543 263641 715131 63516417
Impaired healing 50.84 9.87 109 267075 60364 64171184
Loss of personal independence in daily activities 50.43 9.87 144 267040 72310 64159238
Cardiac failure chronic 50.36 9.87 114 267070 8927 64222621
Heart rate increased 50.09 9.87 224 266960 98451 64133097
Haemodialysis 48.94 9.87 169 267015 16908 64214640
Rash morbilliform 48.51 9.87 81 267103 5060 64226488
Pain in extremity 48.44 9.87 924 266260 302161 63929387
Azotaemia 47.96 9.87 100 267084 7402 64224146
Respiratory arrest 47.52 9.87 92 267092 52893 64178655
Drug withdrawal syndrome 47.52 9.87 36 267148 31255 64200293
Blood potassium increased 47.11 9.87 223 266961 25757 64205791
Rhinorrhoea 46.44 9.87 113 267071 59856 64171692
Migraine 46.29 9.87 121 267063 62556 64168992
Condition aggravated 46.16 9.87 1182 266002 371244 63860304
Red blood cell sedimentation rate increased 46.09 9.87 37 267147 31198 64200350
Gouty arthritis 45.02 9.87 40 267144 1282 64230266
Glomerular filtration rate decreased 44.66 9.87 180 267004 19392 64212156
Blood pressure increased 44.56 9.87 478 266706 172074 64059474
Gravitational oedema 44.28 9.87 44 267140 1628 64229920
Arthritis 43.92 9.87 188 266996 83626 64147922
Differentiation syndrome 43.56 9.87 48 267136 2006 64229542
Dilatation intrahepatic duct acquired 43.23 9.87 30 267154 664 64230884
Benign prostatic hyperplasia 42.88 9.87 108 267076 9057 64222491
Pulmonary function test abnormal 42.87 9.87 59 267125 3105 64228443
Back pain 42.35 9.87 755 266429 249416 63982132
Hyperphosphataemia 42.03 9.87 66 267118 3915 64227633
Injection site warmth 41.23 9.87 4 267180 13458 64218090
Subdural haematoma 41.22 9.87 227 266957 27827 64203721
HLA-B*5801 assay positive 40.42 9.87 9 267175 0 64231548
Degenerative mitral valve disease 39.73 9.87 20 267164 237 64231311
Cardiac failure congestive 39.44 9.87 760 266424 129820 64101728
Injection site haemorrhage 39.41 9.87 26 267158 24252 64207296
Somnolence 39.26 9.87 600 266584 203045 64028503
Febrile infection 39.16 9.87 54 267130 2847 64228701
Neuroleptic malignant syndrome 38.94 9.87 28 267156 24968 64206580
Wrong technique in product usage process 38.33 9.87 139 267045 64835 64166713
Rectal haemorrhage 38.16 9.87 408 266776 61409 64170139
Eczema 38.14 9.87 232 266952 29488 64202060
Leukopenia 38.00 9.87 610 266574 100632 64130916
Therapeutic drug monitoring analysis not performed 37.99 9.87 35 267149 1177 64230371
Poisoning 37.50 9.87 22 267162 21857 64209691
Sleep disorder 37.06 9.87 125 267059 59584 64171964
Folliculitis 36.94 9.87 42 267142 30035 64201513
Blast crisis in myelogenous leukaemia 36.93 9.87 29 267155 780 64230768
Throat irritation 36.68 9.87 49 267135 32662 64198886
Hypervolaemia 36.65 9.87 278 266906 38007 64193541
Generalised tonic-clonic seizure 35.92 9.87 69 267115 39788 64191760
Burning sensation 35.82 9.87 97 267087 49567 64181981
Human herpesvirus 6 infection 35.74 9.87 67 267117 4587 64226961
Live birth 35.20 9.87 3 267181 11201 64220347
Knee arthroplasty 35.05 9.87 36 267148 26963 64204585
Glomerular filtration rate abnormal 34.96 9.87 34 267150 1225 64230323
Infective pulmonary exacerbation of cystic fibrosis 34.86 9.87 4 267180 11792 64219756
Gouty tophus 34.37 9.87 20 267164 322 64231226
Allergic reaction to excipient 34.30 9.87 18 267166 234 64231314
Ill-defined disorder 34.11 9.87 83 267101 43969 64187579
Device dislocation 33.95 9.87 23 267161 21155 64210393
Right ventricular hypertrophy 33.60 9.87 34 267150 1286 64230262
Drug dependence 33.34 9.87 54 267130 33258 64198290
Shock haemorrhagic 33.32 9.87 148 267036 16643 64214905
Osteoarthritis 33.22 9.87 142 267042 63194 64168354
Oedema 33.04 9.87 550 266634 91385 64140163
Influenza like illness 32.57 9.87 138 267046 61564 64169984
Hypercreatininaemia 32.51 9.87 27 267157 788 64230760
Prostate cancer recurrent 32.50 9.87 26 267158 719 64230829
Sopor 32.21 9.87 222 266962 29439 64202109
Crying 31.96 9.87 22 267162 20068 64211480
Agranulocytosis 31.91 9.87 269 266915 37960 64193588
Full blood count abnormal 31.89 9.87 222 266962 29535 64202013
Aortic valve stenosis 31.59 9.87 63 267121 4517 64227031
Hypovolaemic shock 31.54 9.87 104 267080 10162 64221386
Sedation 31.42 9.87 79 267105 41383 64190165
White blood cell count decreased 31.29 9.87 866 266318 156971 64074577
Normocytic anaemia 31.16 9.87 52 267132 3247 64228301
Dyspnoea exertional 31.03 9.87 453 266731 73277 64158271
Neck pain 31.03 9.87 140 267044 61393 64170155
Presyncope 30.95 9.87 250 266934 34839 64196709
Acute motor-sensory axonal neuropathy 30.93 9.87 20 267164 392 64231156
Adverse event 30.90 9.87 74 267110 39415 64192133
Influenza 30.87 9.87 287 266897 106244 64125304
Lip erosion 30.85 9.87 32 267152 1247 64230301
Device issue 30.78 9.87 29 267155 22619 64208929
Respiratory depression 30.72 9.87 31 267153 23412 64208136
Blood phosphorus increased 30.54 9.87 65 267119 4881 64226667
Epidermolysis 30.49 9.87 21 267163 459 64231089
Septic shock 30.26 9.87 609 266575 104828 64126720
Renal function test abnormal 30.26 9.87 57 267127 3917 64227631
Nausea 30.26 9.87 2824 264360 782976 63448572
Cardiogenic shock 30.23 9.87 234 266950 32193 64199355
Injection site urticaria 30.19 9.87 5 267179 11176 64220372
Diastolic dysfunction 30.08 9.87 93 267091 8782 64222766
Foot fracture 30.08 9.87 19 267165 18138 64213410
Dermatitis bullous 30.05 9.87 114 267070 11940 64219608
Red blood cell sedimentation rate abnormal 29.98 9.87 15 267169 16291 64215257
Hypersensitivity vasculitis 29.90 9.87 78 267106 6683 64224865
Hypokalaemia 29.82 9.87 688 266496 121215 64110333
Anuria 29.59 9.87 156 267028 18808 64212740
Rheumatoid nodule 29.37 9.87 8 267176 12643 64218905
Multimorbidity 29.37 9.87 28 267156 984 64230564
Hypocalcaemia 29.33 9.87 283 266901 41470 64190078
Pemphigoid 29.28 9.87 119 267065 12867 64218681
Flushing 29.22 9.87 198 266986 78450 64153098
Epididymitis 28.88 9.87 36 267148 1718 64229830
Blood lactic acid 28.81 9.87 20 267164 443 64231105
Renal atrophy 28.76 9.87 35 267149 1629 64229919
Cardiac failure acute 28.70 9.87 139 267045 16205 64215343
Cytopenia 28.20 9.87 133 267051 15338 64216210
Nasal congestion 28.17 9.87 139 267045 59519 64172029
Diarrhoea 28.14 9.87 3411 263773 719293 63512255
COVID-19 pneumonia 28.01 9.87 139 267045 16365 64215183
Mood swings 27.96 9.87 19 267165 17449 64214099
Urticaria 27.71 9.87 436 266748 146881 64084667
Foot deformity 27.71 9.87 17 267167 16487 64215061
Device interaction 27.59 9.87 23 267161 675 64230873
Withdrawal syndrome 27.57 9.87 34 267150 23458 64208090
Gastritis erosive 27.53 9.87 95 267089 9500 64222048
Premature delivery 27.45 9.87 22 267162 18567 64212981
Ear infection 27.33 9.87 34 267150 23370 64208178
Tachyarrhythmia 27.15 9.87 70 267114 5956 64225592
Aplasia pure red cell 27.10 9.87 77 267107 6937 64224611
Blood cholesterol increased 27.03 9.87 111 267073 49955 64181593
Blood urea abnormal 26.96 9.87 29 267155 1179 64230369
Immune reconstitution inflammatory syndrome 26.93 9.87 9 267175 12461 64219087
Heart rate decreased 26.75 9.87 127 267057 54940 64176608
Cardiomegaly 26.75 9.87 179 267005 23505 64208043
Depressed mood 26.74 9.87 84 267100 40928 64190620
Atrial enlargement 26.61 9.87 22 267162 638 64230910
Therapeutic response shortened 26.48 9.87 5 267179 10165 64221383
Atrioventricular block complete 26.32 9.87 124 267060 14294 64217254
Hepatic vein dilatation 26.24 9.87 15 267169 233 64231315
Multiple drug therapy 26.09 9.87 39 267145 2215 64229333
Petechiae 25.57 9.87 148 267036 18478 64213070
HLA marker study positive 25.52 9.87 12 267172 121 64231427
Prerenal failure 25.52 9.87 47 267137 3175 64228373
Acne 25.45 9.87 35 267149 23046 64208502
Substance abuse 25.44 9.87 4 267180 9288 64222260
Limb discomfort 25.41 9.87 46 267138 27129 64204419
Oligoasthenozoospermia 25.27 9.87 7 267177 10 64231538
Vascular purpura 25.10 9.87 41 267143 2515 64229033
Abdominal pain upper 24.83 9.87 544 266640 174486 64057062
Mantle cell lymphoma 24.64 9.87 27 267157 1121 64230427
Mucosal ulceration 24.61 9.87 33 267151 1694 64229854
Psychotic disorder 24.59 9.87 68 267116 34510 64197038
Coma 24.54 9.87 238 266946 87377 64144171
Cardio-respiratory arrest 24.41 9.87 275 266909 98118 64133430
Muscle spasticity 24.27 9.87 20 267164 16649 64214899
Hepatitis 24.14 9.87 292 266892 45290 64186258
Blood pressure systolic increased 24.06 9.87 114 267070 49339 64182209
Myelofibrosis 24.05 9.87 37 267147 2156 64229392
Obstruction 24.01 9.87 46 267138 3202 64228346
Anaemia macrocytic 23.99 9.87 55 267129 4343 64227205
Hypertrophy 23.92 9.87 22 267162 738 64230810
Poisoning deliberate 23.83 9.87 13 267171 13445 64218103
Multiple sclerosis 23.75 9.87 26 267158 18915 64212633
Ecchymosis 23.73 9.87 118 267066 13904 64217644
Aggression 23.42 9.87 105 267079 46127 64185421
Oral mucosa erosion 23.38 9.87 32 267152 1675 64229873
Dermatitis allergic 23.37 9.87 124 267060 14985 64216563
Blood uric acid abnormal 23.35 9.87 12 267172 149 64231399
Immune effector cell-associated neurotoxicity syndrome 23.31 9.87 40 267144 2555 64228993
Hyperbilirubinaemia 23.20 9.87 159 267025 21046 64210502
Product quality issue 23.19 9.87 56 267128 29743 64201805
Base excess decreased 23.10 9.87 16 267168 353 64231195
Joint stiffness 22.98 9.87 58 267126 30346 64201202
Sarcopenia 22.79 9.87 16 267168 361 64231187
Blood creatine phosphokinase increased 22.79 9.87 355 266829 58203 64173345
Injection site rash 22.78 9.87 19 267165 15723 64215825
Therapeutic response decreased 22.72 9.87 125 267059 52063 64179485
Memory impairment 22.65 9.87 236 266948 85446 64146102
Narrow anterior chamber angle 22.60 9.87 12 267172 160 64231388
Vision blurred 22.57 9.87 252 266932 90064 64141484
Diabetic ketoacidosis 22.51 9.87 57 267127 29788 64201760
Heavy menstrual bleeding 22.37 9.87 11 267173 12066 64219482
Drug ineffective for unapproved indication 22.31 9.87 61 267123 31072 64200476
Ear pain 22.23 9.87 44 267140 25092 64206456
Post transplant lymphoproliferative disorder 22.23 9.87 6 267178 9538 64222010
Bronchial wall thickening 22.08 9.87 33 267151 1874 64229674
Autoimmune haemolytic anaemia 22.02 9.87 72 267112 7004 64224544
Musculoskeletal disorder 21.99 9.87 25 267159 17881 64213667
Pulmonary vascular disorder 21.97 9.87 23 267161 906 64230642
Lichenoid keratosis 21.97 9.87 45 267139 3289 64228259
Chemical burn of oral cavity 21.96 9.87 9 267175 63 64231485
Cardiac aneurysm 21.93 9.87 27 267157 1272 64230276
Eye pain 21.89 9.87 63 267121 31562 64199986
Erosive oesophagitis 21.89 9.87 39 267145 2567 64228981
Gastric disorder 21.84 9.87 56 267128 29141 64202407
Rash pustular 21.83 9.87 90 267094 9795 64221753
Exercise tolerance decreased 21.83 9.87 76 267108 7634 64223914
Intestinal haemorrhage 21.76 9.87 61 267123 5453 64226095
Vaginal haemorrhage 21.66 9.87 29 267155 19315 64212233
Strangury 21.66 9.87 12 267172 175 64231373
Liver palpable 21.62 9.87 15 267169 332 64231216
Body temperature decreased 21.57 9.87 47 267137 25881 64205667
Mydriasis 21.53 9.87 19 267165 15293 64216255
Bronchial secretion retention 21.46 9.87 38 267146 2489 64229059
Aplastic anaemia 21.37 9.87 114 267070 13806 64217742
Hypocoagulable state 21.36 9.87 32 267152 1821 64229727
Device breakage 21.36 9.87 5 267179 8750 64222798
Underdose 21.34 9.87 47 267137 25782 64205766
Device difficult to use 21.29 9.87 7 267177 9791 64221757
Psoriasis 21.27 9.87 192 266992 71511 64160037
Device malfunction 21.24 9.87 25 267159 17608 64213940
Disability 21.20 9.87 12 267172 12160 64219388
Gamma-glutamyltransferase increased 21.19 9.87 300 266884 48210 64183338
Thermohypoaesthesia 21.17 9.87 10 267174 102 64231446
Hypercalcaemia 21.12 9.87 211 266973 31205 64200343
Arrhythmia 21.00 9.87 322 266862 52622 64178926
Pulmonary hypertension 20.98 9.87 272 266912 42867 64188681
Gastroenteritis viral 20.68 9.87 31 267153 19698 64211850
Escherichia sepsis 20.61 9.87 71 267113 7094 64224454
Right ventricular failure 20.60 9.87 156 267028 21315 64210233
Full blood count decreased 20.52 9.87 162 267022 22420 64209128
Sight disability 20.36 9.87 10 267174 112 64231436
Decreased gait velocity 20.31 9.87 11 267173 153 64231395
Injury 20.29 9.87 142 267042 55850 64175698
Diverticulum intestinal haemorrhagic 20.23 9.87 43 267141 3226 64228322
Conjunctivitis 20.16 9.87 149 267035 20205 64211343
Ascites 20.14 9.87 365 266819 61636 64169912
Lipase increased 20.14 9.87 115 267069 14287 64217261
Respiratory failure 20.13 9.87 838 266346 160345 64071203
Left ventricular enlargement 19.99 9.87 19 267165 665 64230883
Infection 19.96 9.87 598 266586 184282 64047266
N-terminal prohormone brain natriuretic peptide increased 19.96 9.87 45 267139 3514 64228034
Mitral valve incompetence 19.90 9.87 177 267007 25361 64206187
Illness 19.75 9.87 38 267146 21900 64209648
Pericardial effusion 19.72 9.87 249 266935 39005 64192543
Brain natriuretic peptide increased 19.70 9.87 73 267111 7560 64223988
Systolic dysfunction 19.68 9.87 42 267142 3160 64228388
Duodenitis 19.57 9.87 67 267117 6674 64224874
Acute generalised exanthematous pustulosis 19.49 9.87 112 267072 13946 64217602
Lymphocytosis 19.25 9.87 45 267139 3599 64227949
Electrolyte depletion 19.23 9.87 14 267170 335 64231213
Injection site mass 19.23 9.87 26 267158 17244 64214304
Pulmonary oedema 19.22 9.87 444 266740 78230 64153318
Lip oedema 19.12 9.87 56 267128 5133 64226415
Angioedema 19.06 9.87 361 266823 61460 64170088
Genital ulceration 19.06 9.87 18 267166 625 64230923
Hyperpyrexia 18.91 9.87 55 267129 5022 64226526
Irritability 18.89 9.87 83 267101 36663 64194885
Blood alkaline phosphatase increased 18.88 9.87 333 266851 55946 64175602
Enanthema 18.71 9.87 19 267165 722 64230826
Atrial flutter 18.70 9.87 141 267043 19239 64212309
Unresponsive to stimuli 18.65 9.87 127 267057 50266 64181282
Cholestasis 18.60 9.87 275 266909 44597 64186951
Haemoptysis 18.57 9.87 296 266888 48752 64182796
Throat tightness 18.44 9.87 43 267141 23117 64208431
Caesarean section 18.40 9.87 12 267172 11262 64220286
Mantle cell lymphoma refractory 18.38 9.87 9 267175 100 64231448
Upper gastrointestinal haemorrhage 18.38 9.87 225 266959 34995 64196553
Hallucination, auditory 18.36 9.87 26 267158 16913 64214635
Anger 18.24 9.87 23 267161 15718 64215830
Eosinophilic pustular folliculitis 18.15 9.87 9 267175 103 64231445
Hepatitis acute 18.13 9.87 106 267078 13283 64218265
Appendicitis 18.10 9.87 107 267077 13462 64218086
Mental disorder 18.07 9.87 53 267131 26392 64205156
Bone marrow failure 18.01 9.87 289 266895 47663 64183885
Unevaluable event 17.82 9.87 129 267055 50360 64181188
Decreased appetite 17.76 9.87 1374 265810 279915 63951633
Neutrophil count decreased 17.75 9.87 432 266752 76764 64154784
Osteopenia 17.71 9.87 23 267161 15517 64216031
Acute respiratory failure 17.67 9.87 298 266886 49636 64181912
Platelet disorder 17.66 9.87 33 267151 2254 64229294
Activated partial thromboplastin time prolonged 17.64 9.87 102 267082 12729 64218819
Renal disorder 17.63 9.87 224 266960 35141 64196407
Blood loss anaemia 17.54 9.87 108 267076 13784 64217764
Asthma 17.51 9.87 283 266901 94942 64136606
Carpal tunnel syndrome 17.45 9.87 24 267160 15804 64215744
Aptyalism 17.36 9.87 18 267166 701 64230847
Nicotine dependence 17.22 9.87 19 267165 795 64230753
Urinary retention 17.18 9.87 293 266891 48908 64182640
Blood bilirubin increased 17.03 9.87 334 266850 57219 64174329
Papillary muscle rupture 17.00 9.87 5 267179 10 64231538
Type V hyperlipidaemia 16.93 9.87 20 267164 902 64230646
Abortion induced 16.93 9.87 3 267181 6385 64225163
Surgery 16.87 9.87 60 267124 28153 64203395
Post-traumatic amnestic disorder 16.84 9.87 7 267177 51 64231497
Hepatocellular injury 16.76 9.87 272 266912 44963 64186585
Leukocytosis 16.72 9.87 234 266950 37506 64194042
Skin oedema 16.68 9.87 25 267159 1423 64230125
Lymphadenopathy 16.66 9.87 279 266905 46407 64185141
Lung consolidation 16.63 9.87 70 267114 7688 64223860
Gait disturbance 16.62 9.87 565 266619 171590 64059958
Anaphylactic reaction 16.60 9.87 193 266991 68471 64163077
Therapy partial responder 16.60 9.87 11 267173 10237 64221311
Panniculitis 16.58 9.87 8 267176 8871 64222677
Interstitial lung disease 16.58 9.87 526 266658 97206 64134342
Lens dislocation 16.57 9.87 9 267175 126 64231422
Anaphylactic shock 16.52 9.87 67 267117 30261 64201287
Vomiting 16.52 9.87 2015 265169 549102 63682446
Coronary artery stenosis 16.51 9.87 91 267093 11157 64220391
Actinic keratosis 16.47 9.87 53 267131 5112 64226436
Fistula 16.47 9.87 10 267174 9751 64221797
Fear 16.42 9.87 37 267147 20134 64211414
Therapy non-responder 16.42 9.87 184 267000 65715 64165833
Cholecystitis chronic 16.40 9.87 9 267175 9278 64222270
Rash macular 16.37 9.87 160 267024 23525 64208023
Respiratory tract haemorrhage 16.22 9.87 25 267159 1459 64230089
Sinoatrial block 16.19 9.87 22 267162 1144 64230404
Emotional disorder 16.15 9.87 17 267167 12590 64218958
Oxygen saturation decreased 16.10 9.87 330 266854 106846 64124702
Exposure to toxic agent 16.09 9.87 3 267181 6156 64225392
Colon cancer 16.06 9.87 99 267085 12640 64218908
Abnormal loss of weight 16.05 9.87 67 267117 7333 64224215
Organic brain syndrome 15.88 9.87 14 267170 444 64231104
Necrotising ulcerative gingivostomatitis 15.85 9.87 6 267178 33 64231515
Scrotal erythema 15.84 9.87 5 267179 14 64231534
Hyperamylasaemia 15.82 9.87 19 267165 872 64230676
Mobility decreased 15.82 9.87 255 266929 85585 64145963
Tongue disorder 15.80 9.87 16 267168 12064 64219484
Extravasation blood 15.75 9.87 13 267171 376 64231172
Confusional state 15.73 9.87 1271 265913 259873 63971675
Serum ferritin abnormal 15.67 9.87 13 267171 379 64231169
Nervousness 15.66 9.87 66 267118 29490 64202058
Pelvic mass 15.64 9.87 21 267163 1079 64230469
Cardiovascular insufficiency 15.64 9.87 34 267150 2590 64228958
No adverse event 15.62 9.87 63 267121 28498 64203050
Drug eruption 15.59 9.87 223 266961 35913 64195635
Mucosal necrosis 15.59 9.87 8 267176 99 64231449
Soft tissue mass 15.52 9.87 19 267165 890 64230658
Sinus congestion 15.48 9.87 25 267159 15414 64216134
Respiratory tract congestion 15.44 9.87 27 267157 16138 64215410
Metastases to bone 15.43 9.87 39 267145 20396 64211152
Rales 15.38 9.87 112 267072 15117 64216431
Nephrogenic anaemia 15.37 9.87 39 267145 3286 64228262
Urate nephropathy 15.35 9.87 9 267175 147 64231401
White blood cell count increased 15.35 9.87 370 266814 65644 64165904
Blood electrolytes abnormal 15.30 9.87 27 267157 1764 64229784
Anti-neutrophil cytoplasmic antibody positive vasculitis 15.23 9.87 36 267148 2900 64228648
Mandibular mass 15.20 9.87 10 267174 202 64231346
Head discomfort 15.11 9.87 16 267168 11818 64219730
Incorrect product administration duration 15.11 9.87 11 267173 9747 64221801
Cystitis 15.08 9.87 109 267075 42566 64188982
Subacute hepatic failure 15.08 9.87 10 267174 205 64231343
Chronic myeloid leukaemia 15.00 9.87 39 267145 3335 64228213
Human herpes virus 6 serology positive 14.99 9.87 10 267174 207 64231341
Coeliac disease 14.91 9.87 6 267178 7406 64224142
Road traffic accident 14.88 9.87 71 267113 30674 64200874
Upper respiratory tract infection 14.86 9.87 212 266972 72573 64158975
Subdural haemorrhage 14.78 9.87 52 267132 5251 64226297
Food allergy 14.77 9.87 7 267177 7844 64223704
Myeloblast percentage decreased 14.76 9.87 6 267178 41 64231507
Adrenal insufficiency 14.70 9.87 46 267138 22441 64209107
Hypoglycaemic coma 14.68 9.87 45 267139 4229 64227319
Dermatosis 14.68 9.87 14 267170 492 64231056
Diffuse large B-cell lymphoma 14.66 9.87 83 267101 10278 64221270
Blood blister 14.65 9.87 33 267151 2575 64228973
Dry eye 14.64 9.87 66 267118 28953 64202595
Device leakage 14.61 9.87 8 267176 8258 64223290
Ventricular tachycardia 14.60 9.87 211 266973 34054 64197494
Hepatic function abnormal 14.51 9.87 359 266825 63954 64167594
Colitis ulcerative 14.43 9.87 48 267136 22980 64208568
Diverticulum intestinal 14.42 9.87 65 267119 7355 64224193
Prothrombin time prolonged 14.34 9.87 113 267071 15628 64215920
Blood pressure inadequately controlled 14.32 9.87 52 267132 5332 64226216
Panic attack 14.31 9.87 42 267142 20911 64210637
Blood pressure diastolic decreased 14.31 9.87 46 267138 22255 64209293
Incorrect route of product administration 14.30 9.87 49 267135 23249 64208299
Dyspnoea at rest 14.27 9.87 58 267126 6271 64225277
Coating in mouth 14.27 9.87 10 267174 225 64231323
Tooth deposit 14.27 9.87 10 267174 225 64231323
Diabetic nephropathy 14.27 9.87 33 267151 2621 64228927
Sensitivity to weather change 14.23 9.87 5 267179 6709 64224839
Dyskinesia 14.21 9.87 100 267084 39288 64192260
Fracture blisters 14.20 9.87 7 267177 79 64231469
Administration site discomfort 14.18 9.87 8 267176 121 64231427
Urosepsis 14.18 9.87 147 267037 21947 64209601
Acute coronary syndrome 14.11 9.87 132 267052 19178 64212370
Transplant rejection 14.10 9.87 32 267152 17369 64214179
Injection site extravasation 14.04 9.87 8 267176 8078 64223470
Oliguria 14.04 9.87 106 267078 14470 64217078
Catatonia 14.02 9.87 7 267177 7613 64223935
Tenosynovitis 14.02 9.87 17 267167 11816 64219732
Muscle haemorrhage 14.00 9.87 54 267130 5699 64225849
Localised oedema 13.98 9.87 63 267121 7128 64224420
Ovarian cyst 13.95 9.87 15 267169 11003 64220545
Uveitic glaucoma 13.95 9.87 4 267180 7 64231541
Muscle necrosis 13.93 9.87 21 267163 1202 64230346
Abdominal wall wound 13.90 9.87 7 267177 83 64231465
Myelodysplastic syndrome 13.88 9.87 175 267009 27404 64204144
Coagulation test abnormal 13.88 9.87 20 267164 1099 64230449
Endocarditis 13.85 9.87 76 267108 9302 64222246
Vessel puncture site haemorrhage 13.85 9.87 9 267175 178 64231370
Pathogen resistance 13.85 9.87 19 267165 12524 64219024
Drug tolerance 13.84 9.87 4 267180 6081 64225467
Mucosal erosion 13.82 9.87 27 267157 1907 64229641
Dysuria 13.80 9.87 248 266936 41809 64189739
Cardiac autonomic neuropathy 13.75 9.87 6 267178 50 64231498
Disseminated intravascular coagulation 13.71 9.87 199 266985 32149 64199399
Thrombin time prolonged 13.69 9.87 11 267173 306 64231242
Visual impairment 13.67 9.87 220 266964 73857 64157691
Oroantral fistula 13.65 9.87 12 267172 379 64231169
Hepatic failure 13.65 9.87 313 266871 55081 64176467
Amenorrhoea 13.64 9.87 5 267179 6534 64225014
Malignant transformation 13.58 9.87 20 267164 1121 64230427
Hyperhidrosis 13.49 9.87 404 266780 124516 64107032
Medication error 13.47 9.87 286 266898 49680 64181868
Oesophageal mucosal blister 13.47 9.87 3 267181 0 64231548
Serum ferritin increased 13.44 9.87 70 267114 8398 64223150
Device use error 13.41 9.87 5 267179 6466 64225082
Acute pulmonary oedema 13.40 9.87 95 267089 12714 64218834
Bone erosion 13.38 9.87 17 267167 11578 64219970
Microcytic anaemia 13.38 9.87 46 267138 4592 64226956
Tricuspid valve incompetence 13.33 9.87 118 267066 16885 64214663
Cerebral haemorrhage 13.32 9.87 291 266893 50799 64180749
Uveitis 13.29 9.87 20 267164 12688 64218860
B-cell unclassifiable lymphoma high grade 13.29 9.87 4 267180 9 64231539
Sternal fracture 13.27 9.87 29 267155 2218 64229330
Periarthritis calcarea 13.26 9.87 6 267178 55 64231493
Eye injury 13.25 9.87 24 267160 1600 64229948
Hot flush 13.20 9.87 125 267059 46110 64185438
Injection site discolouration 13.14 9.87 6 267178 6869 64224679
Gastritis haemorrhagic 13.13 9.87 29 267155 2233 64229315
Pylorus dilatation 13.13 9.87 5 267179 28 64231520
Acute graft versus host disease 13.10 9.87 11 267173 9073 64222475
Vasculitis necrotising 13.06 9.87 19 267165 1053 64230495
Nodular regenerative hyperplasia 12.97 9.87 17 267167 853 64230695
Prostatomegaly 12.89 9.87 34 267150 2933 64228615
Preternatural anus 12.88 9.87 7 267177 98 64231450
Cytomegalovirus nephritis 12.87 9.87 8 267176 146 64231402
Cytogenetic analysis abnormal 12.85 9.87 18 267166 963 64230585
Complication associated with device 12.82 9.87 27 267157 15053 64216495
Ventricular internal diameter abnormal 12.82 9.87 8 267176 147 64231401
Orthostatic hypotension 12.76 9.87 268 266916 46470 64185078
Activated partial thromboplastin time shortened 12.75 9.87 16 267168 769 64230779
Ichthyosis acquired 12.72 9.87 4 267180 11 64231537
Grip strength decreased 12.70 9.87 18 267166 11706 64219842
Haemorrhage intracranial 12.64 9.87 153 267031 23731 64207817
Retinitis viral 12.64 9.87 7 267177 102 64231446
Ischaemic cardiomyopathy 12.62 9.87 59 267125 6779 64224769
Parakeratosis 12.61 9.87 11 267173 344 64231204
Adult failure to thrive 12.59 9.87 8 267176 152 64231396
Portal vein flow decreased 12.58 9.87 5 267179 32 64231516
Staphylococcal sepsis 12.53 9.87 94 267090 12805 64218743
Diverticulum oesophageal 12.50 9.87 8 267176 154 64231394
Oesophagobronchial fistula 12.45 9.87 9 267175 213 64231335
Pulmonary haemorrhage 12.44 9.87 95 267089 13014 64218534
Viral infection 12.44 9.87 93 267091 36047 64195501
Disorientation 12.40 9.87 311 266873 55517 64176031
Bradyarrhythmia 12.39 9.87 39 267145 3719 64227829
Bladder tamponade 12.38 9.87 13 267171 514 64231034
Subclavian artery occlusion 12.36 9.87 8 267176 157 64231391
Erysipelas 12.36 9.87 72 267112 9009 64222539
Constipation 12.36 9.87 1107 266077 228230 64003318
Paraneoplastic syndrome 12.33 9.87 17 267167 896 64230652
Amnesia 12.33 9.87 134 267050 48135 64183413
Hypoaesthesia oral 12.33 9.87 18 267166 11562 64219986
Antipsychotic drug level increased 12.33 9.87 3 267181 5112 64226436
Acute lymphocytic leukaemia 12.30 9.87 43 267141 4328 64227220
Frequent bowel movements 12.28 9.87 37 267147 18268 64213280
Ventricular arrhythmia 12.26 9.87 62 267122 7353 64224195
Hysterectomy 12.22 9.87 3 267181 5082 64226466
Orthopnoea 12.16 9.87 72 267112 9062 64222486
Parathyroid hyperplasia 12.15 9.87 8 267176 162 64231386
Cerebellar stroke 12.14 9.87 12 267172 441 64231107
Testicular swelling 12.12 9.87 17 267167 911 64230637
Dermatitis 12.07 9.87 121 267063 17908 64213640
Streptococcal sepsis 12.05 9.87 29 267155 2363 64229185
Gastric ulcer haemorrhage 12.03 9.87 66 267118 8077 64223471
Oesophageal perforation 12.03 9.87 18 267166 1023 64230525
Drug use disorder 12.02 9.87 5 267179 6049 64225499
Myopathy 12.01 9.87 119 267065 17561 64213987
Peripheral arterial occlusive disease 11.97 9.87 59 267125 6928 64224620
Weight decreased 11.93 9.87 1020 266164 284719 63946829
Diabetes mellitus inadequate control 11.91 9.87 138 267046 21183 64210365
Brain oedema 11.88 9.87 49 267135 22026 64209522
Renal cyst 11.88 9.87 91 267093 12479 64219069
Helicobacter test positive 11.86 9.87 18 267166 1036 64230512
Ankylosing spondylitis 11.84 9.87 10 267174 8224 64223324
Pneumonia fungal 11.84 9.87 70 267114 8807 64222741
Erythema 11.83 9.87 914 266270 186156 64045392
Red blood cell count decreased 11.80 9.87 273 266911 48113 64183435
Haemorrhoidal haemorrhage 11.80 9.87 51 267133 5668 64225880
Chronic myeloid leukaemia transformation 11.76 9.87 9 267175 233 64231315
Hip fracture 11.75 9.87 65 267119 27034 64204514
Gallbladder disorder 11.73 9.87 34 267150 16996 64214552
Mucormycosis 11.73 9.87 8 267176 7333 64224215
Oxygen consumption decreased 11.72 9.87 11 267173 379 64231169
Femur fracture 11.67 9.87 88 267096 34047 64197501
Rash pruritic 11.66 9.87 316 266868 57088 64174460
Affect lability 11.65 9.87 12 267172 8978 64222570
Carcinoma in situ of skin 11.65 9.87 8 267176 174 64231374
Forced expiratory volume decreased 11.63 9.87 7 267177 6860 64224688
Jaundice 11.61 9.87 273 266911 48239 64183309
Lower gastrointestinal haemorrhage 11.59 9.87 98 267086 13841 64217707
Pelvic pain 11.57 9.87 17 267167 10893 64220655
Herpes zoster 11.54 9.87 245 266939 78942 64152606
Angina pectoris 11.50 9.87 256 266928 44825 64186723
Middle insomnia 11.49 9.87 92 267092 12785 64218763
Injection site induration 11.49 9.87 12 267172 8920 64222628
Pancreatic carcinoma 11.48 9.87 78 267106 10295 64221253
Adverse reaction 11.47 9.87 9 267175 7678 64223870
Disseminated aspergillosis 11.47 9.87 14 267170 654 64230894
Xerosis 11.45 9.87 17 267167 960 64230588
Stenosis 11.38 9.87 24 267160 1791 64229757
Anticoagulation drug level above therapeutic 11.35 9.87 33 267151 3012 64228536
Subcutaneous haematoma 11.35 9.87 29 267155 2454 64229094
Scleral haemorrhage 11.35 9.87 7 267177 126 64231422
Lymphoid tissue hypoplasia 11.33 9.87 12 267172 479 64231069
Electrocardiogram abnormal 11.32 9.87 95 267089 13386 64218162
Skin swelling 11.31 9.87 31 267153 2735 64228813
Leukostasis syndrome 11.30 9.87 6 267178 80 64231468
Schizophrenia 11.27 9.87 18 267166 11150 64220398
Therapeutic drug monitoring analysis incorrectly performed 11.26 9.87 8 267176 184 64231364
Neovascularisation 11.25 9.87 18 267166 1085 64230463
Heat stroke 11.24 9.87 21 267163 1434 64230114
Lower respiratory tract infection 11.23 9.87 302 266882 94312 64137236
Soft tissue injury 11.23 9.87 22 267162 1557 64229991
Osteonecrosis of jaw 11.23 9.87 108 267076 39717 64191831
Chest discomfort 11.21 9.87 381 266803 115725 64115823
Breast cancer metastatic 11.21 9.87 8 267176 7161 64224387
Tinnitus 11.20 9.87 89 267095 34044 64197504
Neutropenic infection 11.19 9.87 25 267159 1940 64229608
Crystal arthropathy 11.19 9.87 8 267176 186 64231362
Potentiating drug interaction 11.18 9.87 63 267121 7789 64223759
Duodenal stenosis 11.13 9.87 14 267170 674 64230874
Mastication disorder 11.09 9.87 28 267156 2351 64229197
Sleep inertia 11.04 9.87 4 267180 19 64231529
Acquired epidermolysis bullosa 11.04 9.87 6 267178 84 64231464
Eosinopenia 11.03 9.87 5 267179 46 64231502
Joint range of motion decreased 11 9.87 42 267142 19301 64212247
Drug screen positive 10.95 9.87 5 267179 5724 64225824
Thrombotic microangiopathy 10.94 9.87 34 267150 16621 64214927
Metastases to lymph nodes 10.89 9.87 12 267172 8705 64222843
Adrenal cyst 10.86 9.87 6 267178 87 64231461
Rash erythematous 10.83 9.87 271 266913 48362 64183186
Hyperglycaemia 10.83 9.87 330 266854 60638 64170910
Endocarditis candida 10.80 9.87 6 267178 88 64231460
Mucosal haemorrhage 10.80 9.87 27 267157 2254 64229294
Pulmonary arterial hypertension 10.73 9.87 156 267028 25211 64206337
Suspected suicide 10.72 9.87 12 267172 8642 64222906
Hypoxia 10.70 9.87 457 266727 87692 64143856
Myocardial ischaemia 10.64 9.87 145 267039 23106 64208442
Amaurosis 10.60 9.87 17 267167 1027 64230521
Ventricular fibrillation 10.59 9.87 148 267036 23712 64207836
Blood pressure ambulatory increased 10.59 9.87 5 267179 51 64231497
Duodenal ulcer haemorrhage 10.54 9.87 53 267131 6272 64225276
Palpitations 10.53 9.87 341 266843 104147 64127401
Bronchospasm 10.53 9.87 50 267134 21632 64209916
Secretion discharge 10.53 9.87 21 267163 11943 64219605
Thymus hypoplasia 10.52 9.87 12 267172 521 64231027
Multiple-drug resistance 10.50 9.87 7 267177 6495 64225053
Articular calcification 10.45 9.87 6 267178 94 64231454
Light chain disease 10.45 9.87 8 267176 207 64231341
Hepatic calcification 10.43 9.87 10 267174 354 64231194
Hypomagnesaemia 10.42 9.87 215 266969 37161 64194387
Sexual dysfunction 10.41 9.87 7 267177 6464 64225084
Anal haemorrhage 10.41 9.87 34 267150 3306 64228242
Ankle fracture 10.40 9.87 29 267155 14681 64216867
Product storage error 10.38 9.87 25 267159 13293 64218255
Alanine aminotransferase abnormal 10.36 9.87 8 267176 6880 64224668
Respiratory fatigue 10.35 9.87 8 267176 210 64231338
Dental caries 10.35 9.87 18 267166 10782 64220766
Blast cells present 10.32 9.87 15 267169 831 64230717
Sudden cardiac death 10.32 9.87 42 267142 4545 64227003
Ear discomfort 10.28 9.87 9 267175 7271 64224277
Genital haemorrhage 10.27 9.87 5 267179 5517 64226031
Acute graft versus host disease in skin 10.26 9.87 8 267176 6847 64224701
Drug therapeutic incompatibility 10.24 9.87 7 267177 151 64231397
Enterococcal infection 10.24 9.87 95 267089 13771 64217777
Interstitial granulomatous dermatitis 10.23 9.87 8 267176 214 64231334
Nasal vestibulitis 10.20 9.87 3 267181 6 64231542
Pseudohyperkalaemia 10.20 9.87 3 267181 6 64231542
Genital erosion 10.20 9.87 10 267174 364 64231184
Systemic inflammatory response syndrome 10.18 9.87 75 267109 10160 64221388
Acinetobacter sepsis 10.18 9.87 5 267179 56 64231492
JC virus CSF test positive 10.16 9.87 7 267177 153 64231395
Subarachnoid haemorrhage 10.15 9.87 119 267065 18319 64213229
Human herpesvirus 6 infection reactivation 10.14 9.87 9 267175 288 64231260
Squamous cell carcinoma of skin 10.14 9.87 84 267100 11792 64219756
Exostosis 10.13 9.87 20 267164 11418 64220130
Implant site inflammation 10.13 9.87 8 267176 217 64231331
Stress 10.12 9.87 183 267001 60351 64171197
Testicular cancer metastatic 10.10 9.87 5 267179 57 64231491
Sinus disorder 10.08 9.87 36 267148 16872 64214676
Inspiratory capacity decreased 10.08 9.87 6 267178 101 64231447
Stomatitis 10.05 9.87 362 266822 109243 64122305
Dyshidrotic eczema 10.01 9.87 12 267172 550 64230998
Large intestine polyp 9.99 9.87 78 267106 10759 64220789
Bladder hypertrophy 9.97 9.87 12 267172 552 64230996
Graft versus host disease 9.94 9.87 27 267157 13786 64217762
Haemorrhagic stroke 9.94 9.87 73 267111 9878 64221670
Restlessness 9.94 9.87 111 267073 39674 64191874
Chronic lymphocytic leukaemia recurrent 9.94 9.87 12 267172 554 64230994
Blood creatine increased 9.91 9.87 63 267121 8129 64223419
Aortic valve disease 9.91 9.87 21 267163 1572 64229976
Malaise 9.90 9.87 1465 265719 394782 63836766
Granulomatous liver disease 9.90 9.87 18 267166 1204 64230344
Coombs positive haemolytic anaemia 9.89 9.87 15 267169 863 64230685
Fungating wound 9.88 9.87 4 267180 27 64231521
B-cell small lymphocytic lymphoma 9.87 9.87 6 267178 105 64231443

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC M04AA01 MUSCULO-SKELETAL SYSTEM
ANTIGOUT PREPARATIONS
ANTIGOUT PREPARATIONS
Preparations inhibiting uric acid production
ATC M04AA51 MUSCULO-SKELETAL SYSTEM
ANTIGOUT PREPARATIONS
ANTIGOUT PREPARATIONS
Preparations inhibiting uric acid production
FDA MoA N0000000206 Xanthine Oxidase Inhibitors
MeSH PA D000963 Antimetabolites
MeSH PA D000975 Antioxidants
MeSH PA D018501 Antirheumatic Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D016166 Free Radical Scavengers
MeSH PA D006074 Gout Suppressants
MeSH PA D009676 Noxae
FDA EPC N0000175698 Xanthine Oxidase Inhibitor
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35634 xanthine oxidase inhibitors
CHEBI has role CHEBI:35845 gout suppressants
CHEBI has role CHEBI:48578 free radical scavengers

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

DiseaseRelationSNOMED_IDDOID
Hyperuricemia indication 35885006 DOID:1920
Articular gout indication 48440001 DOID:13189
Gout indication 90560007 DOID:13189
Uric acid renal calculus indication 274401005
Calcium renal calculus indication 427649000
Uric Acid Nephropathy Gout indication
Chemotherapy-Induced Hyperuricemia indication
Recurrent Calcium Renal Calculi indication
Adjunctive treatment for bipolar disorder off-label use 13746004 DOID:3312
Deficiency of adenine phosphoribosyltransferase off-label use 124274002 DOID:0060350
Deficiency of ribose-phosphate pyrophosphokinase off-label use 124343001
Neonatal Phosphoribosylpyrophosphate Synthetase Superactivity off-label use
Dehydration contraindication 34095006
Chronic heart failure contraindication 48447003
Hypersensitivity angiitis contraindication 60555002
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409




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 8.52 acidic
pKa2 9.43 acidic
pKa3 1.45 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
200MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 10183012 Nov. 26, 2028 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
200MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 8283369 Nov. 26, 2028 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
300MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 10183012 Nov. 26, 2028 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
300MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 8283369 Nov. 26, 2028 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
200MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 8546437 April 29, 2029 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
300MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 8546437 April 29, 2029 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
200MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 8084483 Aug. 17, 2029 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
300MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 8084483 Aug. 17, 2029 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
200MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 8357713 Dec. 22, 2029 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
300MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 8357713 Dec. 22, 2029 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
200MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 9216179 Aug. 1, 2031 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
300MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 9216179 Aug. 1, 2031 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
200MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 9956205 Dec. 28, 2031 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
300MG;200MG DUZALLO IRONWOOD PHARMS INC N209203 Aug. 18, 2017 DISCN TABLET ORAL 9956205 Dec. 28, 2031 TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Xanthine dehydrogenase/oxidase Enzyme INHIBITOR Ki 5.15 CHEMBL CHEMBL
Hypoxanthine-guanine phosphoribosyltransferase Enzyme WOMBAT-PK
Xanthine dehydrogenase/oxidase Enzyme Ki 6 CHEMBL
Xanthine dehydrogenase/oxidase Enzyme IC50 6.12 CHEMBL
Shiga toxin subunit A Ribosomal protein IC50 4.62 CHEMBL

External reference:

IDSource
4017895 VUID
N0000146247 NUI
D00224 KEGG_DRUG
17795-21-0 SECONDARY_CAS_RN
203600 RXNORM
C0002144 UMLSCUI
CHEBI:40279 CHEBI
CHEMBL1467 ChEMBL_ID
135401907 PUBCHEM_CID
DB00437 DRUGBANK_ID
CHEMBL1200477 ChEMBL_ID
D000493 MESH_DESCRIPTOR_UI
1731 INN_ID
6795 IUPHAR_LIGAND_ID
63CZ7GJN5I UNII
1590 MMSL
1816 MMSL
4150 MMSL
8255 MMSL
8256 MMSL
d00023 MMSL
001084 NDDF
005000 NDDF
4017895 VANDF
25246002 SNOMEDCT_US
387135004 SNOMEDCT_US
425496004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Allopurinol sodium HUMAN PRESCRIPTION DRUG LABEL 1 0143-9533 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 32 sections
Allopurinol sodium HUMAN PRESCRIPTION DRUG LABEL 1 0143-9533 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 32 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0378-0137 TABLET 100 mg ORAL ANDA 20 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0378-0181 TABLET 300 mg ORAL ANDA 20 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0591-5543 TABLET 100 mg ORAL NDA 20 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0591-5544 TABLET 300 mg ORAL NDA 20 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0603-2115 TABLET 100 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0603-2116 TABLET 300 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0615-8321 TABLET 100 mg ORAL NDA 20 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0615-8385 TABLET 100 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6571 TABLET 100 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6571 TABLET 100 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6572 TABLET 300 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6572 TABLET 300 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0904-7041 TABLET 100 mg ORAL ANDA 16 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 10544-545 TABLET 100 mg ORAL ANDA 17 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 10544-547 TABLET 300 mg ORAL ANDA 17 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 10544-911 TABLET 300 mg ORAL ANDA 19 sections
Allopurinol Human Prescription Drug Label 1 16714-041 TABLET 100 mg ORAL ANDA 21 sections
Allopurinol Human Prescription Drug Label 1 16714-042 TABLET 300 mg ORAL ANDA 21 sections
Allopurinol Human Prescription Drug Label 1 16714-576 TABLET 100 mg ORAL ANDA 19 sections
Allopurinol Human Prescription Drug Label 1 16714-577 TABLET 300 mg ORAL ANDA 19 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 16729-134 TABLET 100 mg ORAL ANDA 20 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 16729-135 TABLET 300 mg ORAL ANDA 20 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 21695-246 TABLET 300 mg ORAL ANDA 21 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 21695-836 TABLET 100 mg ORAL ANDA 21 sections
Allopurinol Human Prescription Drug Label 1 23155-693 TABLET 100 mg ORAL ANDA 19 sections
Allopurinol Human Prescription Drug Label 1 23155-694 TABLET 300 mg ORAL ANDA 19 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 29300-349 TABLET 100 mg ORAL ANDA 15 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 29300-350 TABLET 300 mg ORAL ANDA 15 sections