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febuxostat 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| xanthine oxydase and xanthine dehydrogenase inhibitor | 1137 | 144060-53-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A thiazole derivative and inhibitor of XANTHINE OXIDASE that is used for the treatment of HYPERURICEMIA in patients with chronic GOUT.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 80 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.01 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 3 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 3.61 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 84 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,ACVRL1,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,ERBB2,FLT3,GRK2,GSK3B,IKBKB,ITK,JAK1,JAK2,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MTOR,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKDC,SIK2,STK33,SYK,TEK,TGFBR1,ULK1 | 45 | |||
| kinase-selectivity-class | BRAF,CAMK2D,CDK9,DYRK1B,GRK2,MAPK7,PDK4,PIK3CA,PIK3CG,PRKDC,STK33 | 11 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 7.621 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| rat-kpuu-brain | Rat brain Kpuu | 0.039 | % | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 26, 2015 | EMA | ||
| Feb. 13, 2009 | FDA | TAKEDA PHARMS USA | |
| Jan. 21, 2011 | PMDA | Teijin Pharma Limited |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Enthesopathy | 324.34 | 16.11 | 111 | 21558 | 9293 | 90597485 |
| Renal impairment | 295.86 | 16.11 | 226 | 21443 | 105195 | 90501583 |
| Tongue disorder | 286.31 | 16.11 | 105 | 21564 | 10755 | 90596023 |
| Cardiac failure | 279.63 | 16.11 | 222 | 21447 | 109274 | 90497504 |
| Tenosynovitis | 276.99 | 16.11 | 111 | 21558 | 14456 | 90592322 |
| Blood parathyroid hormone decreased | 267.13 | 16.11 | 103 | 21566 | 12113 | 90594665 |
| Panniculitis | 257.12 | 16.11 | 105 | 21564 | 14353 | 90592425 |
| Red blood cell sedimentation rate | 246.19 | 16.11 | 76 | 21593 | 4582 | 90602196 |
| Skin necrosis | 237.82 | 16.11 | 104 | 21565 | 16837 | 90589941 |
| Granuloma skin | 236.91 | 16.11 | 91 | 21578 | 10589 | 90596189 |
| Drug eruption | 236.65 | 16.11 | 131 | 21538 | 35276 | 90571502 |
| Tendonitis | 217.73 | 16.11 | 105 | 21564 | 21267 | 90585511 |
| Rheumatoid nodule | 217.39 | 16.11 | 103 | 21566 | 20063 | 90586715 |
| Hypercalcaemia | 213.37 | 16.11 | 121 | 21548 | 34119 | 90572659 |
| Acute kidney injury | 205.47 | 16.11 | 313 | 21356 | 320074 | 90286704 |
| Ulcer | 172.64 | 16.11 | 104 | 21565 | 32778 | 90574000 |
| Aspartate aminotransferase increased | 172.11 | 16.11 | 164 | 21505 | 102773 | 90504005 |
| Basal cell carcinoma | 168.60 | 16.11 | 103 | 21566 | 33286 | 90573492 |
| Anaemia | 155.94 | 16.11 | 292 | 21377 | 352510 | 90254268 |
| Skin ulcer | 150.62 | 16.11 | 112 | 21557 | 49963 | 90556815 |
| Alanine aminotransferase increased | 147.64 | 16.11 | 161 | 21508 | 118177 | 90488601 |
| Alanine aminotransferase abnormal | 137.60 | 16.11 | 51 | 21618 | 5375 | 90601403 |
| Hyperkalaemia | 126.99 | 16.11 | 113 | 21556 | 64851 | 90541927 |
| Blood creatinine increased | 126.55 | 16.11 | 138 | 21531 | 101248 | 90505530 |
| Fear of injection | 112.14 | 16.11 | 50 | 21619 | 8465 | 90598313 |
| Platelet count decreased | 111.33 | 16.11 | 150 | 21519 | 136819 | 90469959 |
| Hepatic function abnormal | 107.74 | 16.11 | 89 | 21580 | 46199 | 90560579 |
| Rash pruritic | 102.74 | 16.11 | 112 | 21557 | 82102 | 90524676 |
| Neutrophil count decreased | 97.41 | 16.11 | 102 | 21567 | 71430 | 90535348 |
| Maternal exposure during pregnancy | 73.18 | 16.11 | 3 | 21666 | 360060 | 90246718 |
| Red blood cell sedimentation rate increased | 72.54 | 16.11 | 94 | 21575 | 82501 | 90524277 |
| Tumour lysis syndrome | 71.02 | 16.11 | 40 | 21629 | 11112 | 90595666 |
| Granuloma | 70.98 | 16.11 | 33 | 21636 | 6152 | 90600626 |
| Drug tolerance decreased | 69.02 | 16.11 | 59 | 21610 | 32071 | 90574707 |
| Systemic lupus erythematosus | 67.43 | 16.11 | 5 | 21664 | 361891 | 90244887 |
| Loss of personal independence in daily activities | 66.71 | 16.11 | 118 | 21551 | 135987 | 90470791 |
| Glossodynia | 64.33 | 16.11 | 3 | 21666 | 321776 | 90285002 |
| C-reactive protein abnormal | 61.83 | 16.11 | 110 | 21559 | 127319 | 90479459 |
| Cardiac failure acute | 58.15 | 16.11 | 36 | 21633 | 11893 | 90594885 |
| Erythema | 56.03 | 16.11 | 150 | 21519 | 229096 | 90377682 |
| Cardiac failure chronic | 55.25 | 16.11 | 27 | 21642 | 5619 | 90601159 |
| Joint injury | 54.44 | 16.11 | 52 | 21617 | 32612 | 90574166 |
| Rheumatoid lung | 53.73 | 16.11 | 24 | 21645 | 4079 | 90602699 |
| Wound | 51.60 | 16.11 | 6 | 21663 | 302974 | 90303804 |
| Discomfort | 50.49 | 16.11 | 4 | 21665 | 274331 | 90332447 |
| Drug ineffective | 49.68 | 16.11 | 168 | 21501 | 1384130 | 89222648 |
| Nephrogenic anaemia | 47.58 | 16.11 | 19 | 21650 | 2447 | 90604331 |
| Blood uric acid increased | 47.35 | 16.11 | 27 | 21642 | 7677 | 90599101 |
| Chronic kidney disease | 47.01 | 16.11 | 59 | 21610 | 50132 | 90556646 |
| Musculoskeletal disorder | 46.80 | 16.11 | 40 | 21629 | 21729 | 90585049 |
| C-reactive protein increased | 46.66 | 16.11 | 121 | 21548 | 181268 | 90425510 |
| Sinusitis | 45.19 | 16.11 | 13 | 21656 | 343075 | 90263703 |
| Lower respiratory tract infection | 45.18 | 16.11 | 4 | 21665 | 250655 | 90356123 |
| Swelling | 44.98 | 16.11 | 22 | 21647 | 419036 | 90187742 |
| Gout | 44.70 | 16.11 | 35 | 21634 | 16824 | 90589954 |
| Tubulointerstitial nephritis | 43.48 | 16.11 | 41 | 21628 | 25302 | 90581476 |
| Inflammation | 42.75 | 16.11 | 116 | 21553 | 178476 | 90428302 |
| Impaired healing | 41.50 | 16.11 | 4 | 21665 | 234195 | 90372583 |
| Duodenal ulcer perforation | 41.36 | 16.11 | 3 | 21666 | 221285 | 90385493 |
| Pericarditis | 39.96 | 16.11 | 8 | 21661 | 270143 | 90336635 |
| Cerebral infarction | 39.95 | 16.11 | 40 | 21629 | 26556 | 90580222 |
| Renal failure | 39.62 | 16.11 | 93 | 21576 | 130914 | 90475864 |
| Drug tolerance | 38.68 | 16.11 | 33 | 21636 | 17883 | 90588895 |
| Blood pressure systolic increased | 38.64 | 16.11 | 58 | 21611 | 58287 | 90548491 |
| Osteomyelitis | 36.63 | 16.11 | 39 | 21630 | 27807 | 90578971 |
| Cardiac failure congestive | 36.55 | 16.11 | 76 | 21593 | 98618 | 90508160 |
| White blood cell count decreased | 36.50 | 16.11 | 105 | 21564 | 167004 | 90439774 |
| Fibromyalgia | 35.32 | 16.11 | 4 | 21665 | 206265 | 90400513 |
| Pneumonia aspiration | 35 | 16.11 | 46 | 21623 | 40894 | 90565884 |
| Right ventricular failure | 34.74 | 16.11 | 32 | 21637 | 19173 | 90587605 |
| Cytokine release syndrome | 34.73 | 16.11 | 38 | 21631 | 27935 | 90578843 |
| Type 2 diabetes mellitus | 34.65 | 16.11 | 4 | 21665 | 203240 | 90403538 |
| Migraine | 34.41 | 16.11 | 3 | 21666 | 190389 | 90416389 |
| Paraesthesia | 33.86 | 16.11 | 9 | 21660 | 250317 | 90356461 |
| Anaemia macrocytic | 33.52 | 16.11 | 18 | 21651 | 4554 | 90602224 |
| Injury | 33.36 | 16.11 | 4 | 21665 | 197345 | 90409433 |
| Pulmonary arterial hypertension | 33.25 | 16.11 | 36 | 21633 | 26151 | 90580627 |
| Ill-defined disorder | 33.18 | 16.11 | 3 | 21666 | 184888 | 90421890 |
| Fatigue | 33.05 | 16.11 | 153 | 21516 | 1153870 | 89452908 |
| Melaena | 32.74 | 16.11 | 41 | 21628 | 34756 | 90572022 |
| Hyperuricaemia | 32.05 | 16.11 | 20 | 21649 | 6699 | 90600079 |
| Decreased appetite | 31.51 | 16.11 | 175 | 21494 | 376365 | 90230413 |
| Sleep disorder | 31.15 | 16.11 | 5 | 21664 | 198025 | 90408753 |
| Gastric disorder | 30.87 | 16.11 | 39 | 21630 | 33345 | 90573433 |
| Hepatic enzyme increased | 30.38 | 16.11 | 25 | 21644 | 360711 | 90246067 |
| Blood pressure decreased | 28.11 | 16.11 | 58 | 21611 | 74837 | 90531941 |
| Blister | 27.93 | 16.11 | 13 | 21656 | 254985 | 90351793 |
| Hypocalcaemia | 27.88 | 16.11 | 42 | 21627 | 42326 | 90564452 |
| Folate deficiency | 27.61 | 16.11 | 14 | 21655 | 3151 | 90603627 |
| Blood cholesterol increased | 27.16 | 16.11 | 8 | 21661 | 208004 | 90398774 |
| Wheezing | 26.29 | 16.11 | 12 | 21657 | 238068 | 90368710 |
| Disseminated intravascular coagulation | 26.29 | 16.11 | 29 | 21640 | 21509 | 90585269 |
| Dry mouth | 26.09 | 16.11 | 6 | 21663 | 184053 | 90422725 |
| Blood urea increased | 25.73 | 16.11 | 34 | 21635 | 30379 | 90576399 |
| Intentional product use issue | 25.44 | 16.11 | 10 | 21659 | 216882 | 90389896 |
| Atrial fibrillation | 25.44 | 16.11 | 80 | 21589 | 133531 | 90473247 |
| Depression | 25.10 | 16.11 | 21 | 21648 | 300580 | 90306198 |
| Interstitial lung disease | 25.03 | 16.11 | 56 | 21613 | 76349 | 90530429 |
| Coronavirus test positive | 24.87 | 16.11 | 9 | 21660 | 886 | 90605892 |
| Hypokalaemia | 24.50 | 16.11 | 78 | 21591 | 131038 | 90475740 |
| Renal disorder | 24.16 | 16.11 | 37 | 21632 | 37822 | 90568956 |
| Toxicity to various agents | 24.16 | 16.11 | 20 | 21649 | 287826 | 90318952 |
| Hypoalbuminaemia | 24.04 | 16.11 | 24 | 21645 | 15873 | 90590905 |
| Upper respiratory tract inflammation | 23.84 | 16.11 | 12 | 21657 | 2660 | 90604118 |
| Hypoaesthesia | 23.80 | 16.11 | 24 | 21645 | 314186 | 90292592 |
| Anaemia vitamin B12 deficiency | 23.43 | 16.11 | 8 | 21661 | 664 | 90606114 |
| Altered state of consciousness | 23.28 | 16.11 | 33 | 21636 | 31499 | 90575279 |
| Rhabdomyolysis | 23.25 | 16.11 | 43 | 21626 | 51213 | 90555565 |
| Gastrointestinal haemorrhage | 22.97 | 16.11 | 60 | 21609 | 90188 | 90516590 |
| Glomerular filtration rate decreased | 22.77 | 16.11 | 24 | 21645 | 16908 | 90589870 |
| Gastrointestinal disorder | 22.60 | 16.11 | 17 | 21652 | 256670 | 90350108 |
| Joint range of motion decreased | 22.31 | 16.11 | 3 | 21666 | 135640 | 90471138 |
| Lymphocyte count decreased | 22.01 | 16.11 | 34 | 21635 | 35016 | 90571762 |
| Anti-neutrophil cytoplasmic antibody positive vasculitis | 21.91 | 16.11 | 13 | 21656 | 3980 | 90602798 |
| Dyspepsia | 21.86 | 16.11 | 10 | 21659 | 198150 | 90408628 |
| Bile duct stone | 21.57 | 16.11 | 13 | 21656 | 4094 | 90602684 |
| Enanthema | 21.47 | 16.11 | 7 | 21662 | 503 | 90606275 |
| Pain | 21.44 | 16.11 | 145 | 21524 | 996196 | 89610582 |
| Therapeutic response decreased | 21.17 | 16.11 | 58 | 21611 | 89671 | 90517107 |
| Haemorrhage subcutaneous | 21.13 | 16.11 | 12 | 21657 | 3384 | 90603394 |
| Haemorrhoidal haemorrhage | 20.85 | 16.11 | 14 | 21655 | 5309 | 90601469 |
| Confusional state | 20.67 | 16.11 | 38 | 21631 | 386167 | 90220611 |
| Blood lactate dehydrogenase increased | 20.42 | 16.11 | 28 | 21641 | 25904 | 90580874 |
| Transfusion | 20.40 | 16.11 | 23 | 21646 | 17465 | 90589313 |
| Gait inability | 20.31 | 16.11 | 5 | 21664 | 146451 | 90460327 |
| Renal tubular necrosis | 20.23 | 16.11 | 21 | 21648 | 14534 | 90592244 |
| Dehydration | 20.16 | 16.11 | 96 | 21573 | 194351 | 90412427 |
| Urinary retention | 20.14 | 16.11 | 34 | 21635 | 37710 | 90569068 |
| Myoglobin blood increased | 20.07 | 16.11 | 9 | 21660 | 1543 | 90605235 |
| Haematochezia | 19.98 | 16.11 | 49 | 21620 | 70864 | 90535914 |
| Osteoarthritis | 19.90 | 16.11 | 11 | 21658 | 195719 | 90411059 |
| Systemic infection | 19.77 | 16.11 | 13 | 21656 | 4762 | 90602016 |
| Brain natriuretic peptide increased | 19.32 | 16.11 | 14 | 21655 | 5991 | 90600787 |
| Hyperferritinaemia | 19.25 | 16.11 | 6 | 21663 | 373 | 90606405 |
| Alopecia | 19.08 | 16.11 | 58 | 21611 | 495013 | 90111765 |
| Rash | 18.99 | 16.11 | 281 | 21388 | 795819 | 89810959 |
| Mesenteric vein thrombosis | 18.91 | 16.11 | 8 | 21661 | 1193 | 90605585 |
| Aplasia pure red cell | 18.77 | 16.11 | 13 | 21656 | 5181 | 90601597 |
| Shunt occlusion | 18.61 | 16.11 | 7 | 21662 | 768 | 90606010 |
| Bradycardia | 18.60 | 16.11 | 53 | 21616 | 83794 | 90522984 |
| Haematoma muscle | 18.56 | 16.11 | 9 | 21660 | 1841 | 90604937 |
| Concomitant disease aggravated | 18.55 | 16.11 | 18 | 21651 | 11500 | 90595278 |
| Product dose omission issue | 18.13 | 16.11 | 26 | 21643 | 291661 | 90315117 |
| Anxiety | 17.92 | 16.11 | 29 | 21640 | 309743 | 90297035 |
| Head injury | 17.85 | 16.11 | 29 | 21640 | 31159 | 90575619 |
| Iron deficiency anaemia | 17.81 | 16.11 | 25 | 21644 | 23637 | 90583141 |
| Nasal mucosal erosion | 17.81 | 16.11 | 4 | 21665 | 68 | 90606710 |
| Gastric ulcer | 17.76 | 16.11 | 27 | 21642 | 27421 | 90579357 |
| Nasopharyngitis | 17.68 | 16.11 | 45 | 21624 | 407059 | 90199719 |
| Psoriatic arthropathy | 17.68 | 16.11 | 104 | 21565 | 228231 | 90378547 |
| Pneumonia fungal | 17.36 | 16.11 | 14 | 21655 | 7017 | 90599761 |
| Injection site pain | 17.32 | 16.11 | 10 | 21659 | 173689 | 90433089 |
| Hepatic mass | 17.17 | 16.11 | 9 | 21660 | 2168 | 90604610 |
| Oedema peripheral | 17.17 | 16.11 | 113 | 21556 | 257802 | 90348976 |
| Chondrocalcinosis pyrophosphate | 16.50 | 16.11 | 7 | 21662 | 1051 | 90605727 |
| Memory impairment | 16.18 | 16.11 | 14 | 21655 | 197230 | 90409548 |
| Fixed eruption | 16.11 | 16.11 | 8 | 21661 | 1722 | 90605056 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Renal impairment | 284.42 | 13.06 | 409 | 36325 | 109819 | 42474782 |
| Cardiac failure | 199.65 | 13.06 | 342 | 36392 | 106514 | 42478087 |
| Tenosynovitis | 171.87 | 13.06 | 83 | 36651 | 4612 | 42579989 |
| Enthesopathy | 166.68 | 13.06 | 82 | 36652 | 4746 | 42579855 |
| Interstitial lung disease | 165.09 | 13.06 | 265 | 36469 | 78197 | 42506404 |
| Hepatic function abnormal | 160.92 | 13.06 | 210 | 36524 | 51357 | 42533244 |
| Tongue disorder | 132.88 | 13.06 | 73 | 36661 | 5310 | 42579291 |
| Acute kidney injury | 132.08 | 13.06 | 645 | 36089 | 366692 | 42217909 |
| Hyperkalaemia | 130.22 | 13.06 | 242 | 36492 | 80216 | 42504385 |
| Cerebral infarction | 119.82 | 13.06 | 141 | 36593 | 31028 | 42553573 |
| C-reactive protein abnormal | 107.85 | 13.06 | 78 | 36656 | 9183 | 42575418 |
| Platelet count decreased | 96.18 | 13.06 | 300 | 36434 | 138281 | 42446320 |
| Alanine aminotransferase abnormal | 95.13 | 13.06 | 57 | 36677 | 4887 | 42579714 |
| Tendonitis | 83.84 | 13.06 | 69 | 36665 | 9825 | 42574776 |
| Synovitis | 81.74 | 13.06 | 83 | 36651 | 15484 | 42569117 |
| Cardiac failure chronic | 81.45 | 13.06 | 67 | 36667 | 9534 | 42575067 |
| Tumour lysis syndrome | 81.19 | 13.06 | 98 | 36636 | 22133 | 42562468 |
| Drug abuse | 77.19 | 13.06 | 3 | 36731 | 104768 | 42479833 |
| Aspartate aminotransferase increased | 70.97 | 13.06 | 185 | 36549 | 76978 | 42507623 |
| Anaemia | 70.86 | 13.06 | 448 | 36286 | 279830 | 42304771 |
| Neutrophil count decreased | 69.93 | 13.06 | 163 | 36571 | 63252 | 42521349 |
| Blood creatinine increased | 67.12 | 13.06 | 228 | 36506 | 109775 | 42474826 |
| Drug ineffective | 67.09 | 13.06 | 298 | 36436 | 629899 | 41954702 |
| Respiratory tract haemorrhage | 64.24 | 13.06 | 29 | 36705 | 1380 | 42583221 |
| Gout | 63.40 | 13.06 | 98 | 36636 | 27957 | 42556644 |
| Drug eruption | 59.87 | 13.06 | 86 | 36648 | 22989 | 42561612 |
| Toxicity to various agents | 58.29 | 13.06 | 67 | 36667 | 229069 | 42355532 |
| Alanine aminotransferase increased | 55.46 | 13.06 | 185 | 36549 | 88221 | 42496380 |
| Red blood cell sedimentation rate | 54.93 | 13.06 | 24 | 36710 | 1056 | 42583545 |
| Granuloma skin | 52.99 | 13.06 | 24 | 36710 | 1151 | 42583450 |
| Cardiac failure acute | 52.91 | 13.06 | 62 | 36672 | 13571 | 42571030 |
| Gouty tophus | 52.85 | 13.06 | 15 | 36719 | 176 | 42584425 |
| Contraindicated product administered | 52.57 | 13.06 | 85 | 36649 | 25187 | 42559414 |
| Chronic kidney disease | 51.59 | 13.06 | 121 | 36613 | 47120 | 42537481 |
| Death | 51.11 | 13.06 | 221 | 36513 | 470964 | 42113637 |
| Blood parathyroid hormone decreased | 51.09 | 13.06 | 26 | 36708 | 1617 | 42582984 |
| Hyperuricaemia | 45.42 | 13.06 | 48 | 36686 | 9376 | 42575225 |
| Haemorrhage subcutaneous | 44.51 | 13.06 | 28 | 36706 | 2618 | 42581983 |
| Pemphigoid | 44.25 | 13.06 | 52 | 36682 | 11415 | 42573186 |
| Panniculitis | 44.19 | 13.06 | 26 | 36708 | 2155 | 42582446 |
| Fatigue | 43.24 | 13.06 | 211 | 36523 | 435430 | 42149171 |
| Hypocalcaemia | 40.54 | 13.06 | 84 | 36650 | 30089 | 42554512 |
| Concomitant disease aggravated | 39.94 | 13.06 | 38 | 36696 | 6548 | 42578053 |
| C-reactive protein increased | 39.84 | 13.06 | 133 | 36601 | 63427 | 42521174 |
| Cerebral haemorrhage | 39.52 | 13.06 | 97 | 36637 | 38869 | 42545732 |
| Off label use | 39.28 | 13.06 | 357 | 36377 | 637978 | 41946623 |
| Liver disorder | 38.43 | 13.06 | 97 | 36637 | 39547 | 42545054 |
| Rash | 38.04 | 13.06 | 385 | 36349 | 276569 | 42308032 |
| Psoriatic arthropathy | 36.51 | 13.06 | 72 | 36662 | 24895 | 42559706 |
| Pneumonia bacterial | 35.70 | 13.06 | 55 | 36679 | 15637 | 42568964 |
| Rubber sensitivity | 34.29 | 13.06 | 13 | 36721 | 395 | 42584206 |
| Lactic acidosis | 34.15 | 13.06 | 101 | 36633 | 45160 | 42539441 |
| Transformation to acute myeloid leukaemia | 32.95 | 13.06 | 17 | 36717 | 1088 | 42583513 |
| Hypokalaemia | 32.34 | 13.06 | 135 | 36599 | 71586 | 42513015 |
| Fulminant type 1 diabetes mellitus | 32.17 | 13.06 | 18 | 36716 | 1356 | 42583245 |
| Rheumatoid nodule | 32.10 | 13.06 | 24 | 36710 | 2971 | 42581630 |
| Congenital diaphragmatic anomaly | 31.16 | 13.06 | 7 | 36727 | 28 | 42584573 |
| Intentional overdose | 30.75 | 13.06 | 4 | 36730 | 51452 | 42533149 |
| Renal failure | 29.79 | 13.06 | 219 | 36515 | 143507 | 42441094 |
| Anxiety | 29.75 | 13.06 | 35 | 36699 | 118525 | 42466076 |
| Depression | 28.89 | 13.06 | 32 | 36702 | 111331 | 42473270 |
| Nephrogenic anaemia | 28.34 | 13.06 | 21 | 36713 | 2565 | 42582036 |
| Decreased appetite | 28.18 | 13.06 | 272 | 36462 | 192865 | 42391736 |
| Osteoma | 28.18 | 13.06 | 8 | 36726 | 94 | 42584507 |
| Corneal abscess | 27.80 | 13.06 | 6 | 36728 | 19 | 42584582 |
| Polycystic liver disease | 27.80 | 13.06 | 8 | 36726 | 99 | 42584502 |
| Orthostatic intolerance | 27.53 | 13.06 | 14 | 36720 | 869 | 42583732 |
| Stress | 27.50 | 13.06 | 3 | 36731 | 44209 | 42540392 |
| Glomerular filtration rate decreased | 27.43 | 13.06 | 50 | 36684 | 16301 | 42568300 |
| Product dose omission issue | 26.97 | 13.06 | 58 | 36676 | 154307 | 42430294 |
| Hyperhidrosis | 26.96 | 13.06 | 23 | 36711 | 90489 | 42494112 |
| Stevens-Johnson syndrome | 26.63 | 13.06 | 59 | 36675 | 22119 | 42562482 |
| Splenic necrosis | 26.57 | 13.06 | 8 | 36726 | 117 | 42584484 |
| Disseminated intravascular coagulation | 26.51 | 13.06 | 63 | 36671 | 24731 | 42559870 |
| Hyperkinetic heart syndrome | 26.38 | 13.06 | 8 | 36726 | 120 | 42584481 |
| Hypercalcaemia | 26.31 | 13.06 | 52 | 36682 | 18006 | 42566595 |
| Suicidal ideation | 25.94 | 13.06 | 5 | 36729 | 48156 | 42536445 |
| Gouty arthritis | 25.84 | 13.06 | 15 | 36719 | 1212 | 42583389 |
| Splenic cyst | 25.56 | 13.06 | 8 | 36726 | 134 | 42584467 |
| Cytomegalovirus nephritis | 25.51 | 13.06 | 8 | 36726 | 135 | 42584466 |
| Blood lactic acid | 25.43 | 13.06 | 10 | 36724 | 336 | 42584265 |
| Shock haemorrhagic | 25.16 | 13.06 | 48 | 36686 | 16194 | 42568407 |
| Haemoglobin urine present | 25.13 | 13.06 | 8 | 36726 | 142 | 42584459 |
| Skin necrosis | 24.97 | 13.06 | 29 | 36705 | 6285 | 42578316 |
| Activated partial thromboplastin time abnormal | 24.77 | 13.06 | 8 | 36726 | 149 | 42584452 |
| Altered state of consciousness | 24.70 | 13.06 | 68 | 36666 | 29191 | 42555410 |
| Adrenal insufficiency | 24.62 | 13.06 | 52 | 36682 | 18872 | 42565729 |
| Oedema peripheral | 24.12 | 13.06 | 200 | 36534 | 135876 | 42448725 |
| Product use in unapproved indication | 24.12 | 13.06 | 80 | 36654 | 184376 | 42400225 |
| Seizure | 23.92 | 13.06 | 42 | 36692 | 120519 | 42464082 |
| Asthenia | 23.91 | 13.06 | 143 | 36591 | 280650 | 42303951 |
| Hepatic enzyme increased | 23.70 | 13.06 | 90 | 36644 | 45694 | 42538907 |
| Diabetic nephropathy | 23.41 | 13.06 | 18 | 36716 | 2323 | 42582278 |
| Aggression | 22.93 | 13.06 | 5 | 36729 | 44158 | 42540443 |
| Drug ineffective for unapproved indication | 22.45 | 13.06 | 6 | 36728 | 46157 | 42538444 |
| Blood uric acid decreased | 22.39 | 13.06 | 10 | 36724 | 464 | 42584137 |
| Cerebral ventricular rupture | 22.24 | 13.06 | 8 | 36726 | 209 | 42584392 |
| Agitation | 22.19 | 13.06 | 14 | 36720 | 64300 | 42520301 |
| Cerebellar infarction | 22.15 | 13.06 | 17 | 36717 | 2188 | 42582413 |
| Drug-induced liver injury | 22.14 | 13.06 | 78 | 36656 | 38195 | 42546406 |
| General physical health deterioration | 22.04 | 13.06 | 213 | 36521 | 151033 | 42433568 |
| Thalamus haemorrhage | 21.78 | 13.06 | 13 | 36721 | 1106 | 42583495 |
| Procedural failure | 21.58 | 13.06 | 6 | 36728 | 65 | 42584536 |
| Erythema | 21.52 | 13.06 | 164 | 36570 | 108629 | 42475972 |
| Heat illness | 21.33 | 13.06 | 9 | 36725 | 363 | 42584238 |
| Arrhythmia | 20.66 | 13.06 | 79 | 36655 | 40238 | 42544363 |
| Suicide attempt | 20.59 | 13.06 | 7 | 36727 | 46093 | 42538508 |
| Brain natriuretic peptide increased | 20.21 | 13.06 | 27 | 36707 | 6743 | 42577858 |
| Urinary sediment present | 20.17 | 13.06 | 8 | 36726 | 275 | 42584326 |
| Erythema multiforme | 19.99 | 13.06 | 33 | 36701 | 9944 | 42574657 |
| Hypothyroidism | 19.97 | 13.06 | 67 | 36667 | 32017 | 42552584 |
| Gastric cancer | 19.79 | 13.06 | 27 | 36707 | 6876 | 42577725 |
| Dyspnoea paroxysmal nocturnal | 19.67 | 13.06 | 14 | 36720 | 1606 | 42582995 |
| Underdose | 19.63 | 13.06 | 44 | 36690 | 16622 | 42567979 |
| Mental status changes | 19.51 | 13.06 | 6 | 36728 | 42109 | 42542492 |
| Blood uric acid increased | 19.39 | 13.06 | 42 | 36692 | 15505 | 42569096 |
| Thrombotic cerebral infarction | 19.33 | 13.06 | 9 | 36725 | 460 | 42584141 |
| Lordosis | 18.50 | 13.06 | 8 | 36726 | 343 | 42584258 |
| Splenic lesion | 18.40 | 13.06 | 8 | 36726 | 348 | 42584253 |
| Post infection glomerulonephritis | 18.37 | 13.06 | 6 | 36728 | 116 | 42584485 |
| Disease progression | 18.30 | 13.06 | 63 | 36671 | 143593 | 42441008 |
| Melaena | 18.30 | 13.06 | 74 | 36660 | 38672 | 42545929 |
| Blood urea increased | 18.26 | 13.06 | 66 | 36668 | 32727 | 42551874 |
| Toxic skin eruption | 18.18 | 13.06 | 38 | 36696 | 13692 | 42570909 |
| Acute myeloid leukaemia | 18.07 | 13.06 | 51 | 36683 | 22205 | 42562396 |
| Upper respiratory tract inflammation | 17.71 | 13.06 | 14 | 36720 | 1882 | 42582719 |
| Nephrotic syndrome | 17.69 | 13.06 | 29 | 36705 | 8689 | 42575912 |
| Familial mediterranean fever | 17.59 | 13.06 | 5 | 36729 | 59 | 42584542 |
| Product prescribing error | 17.57 | 13.06 | 56 | 36678 | 26056 | 42558545 |
| Enterocolitis | 17.47 | 13.06 | 31 | 36703 | 9898 | 42574703 |
| Conjunctival ulcer | 17.44 | 13.06 | 5 | 36729 | 61 | 42584540 |
| White blood cell count decreased | 17.33 | 13.06 | 158 | 36576 | 110238 | 42474363 |
| Pleural effusion | 17.31 | 13.06 | 143 | 36591 | 97023 | 42487578 |
| Blood creatine phosphokinase increased | 17.30 | 13.06 | 85 | 36649 | 48253 | 42536348 |
| Somnolence | 17.23 | 13.06 | 63 | 36671 | 141042 | 42443559 |
| Infective spondylitis | 17.21 | 13.06 | 7 | 36727 | 257 | 42584344 |
| Pain | 17.18 | 13.06 | 132 | 36602 | 244716 | 42339885 |
| Intentional product use issue | 17.17 | 13.06 | 22 | 36712 | 71811 | 42512790 |
| Asthma | 17.17 | 13.06 | 17 | 36717 | 62297 | 42522304 |
| Haematochezia | 16.97 | 13.06 | 97 | 36637 | 58339 | 42526262 |
| Putamen haemorrhage | 16.74 | 13.06 | 7 | 36727 | 276 | 42584325 |
| Colon cancer | 16.74 | 13.06 | 30 | 36704 | 9651 | 42574950 |
| Hypopituitarism | 16.73 | 13.06 | 16 | 36718 | 2775 | 42581826 |
| Red blood cell abnormality | 16.64 | 13.06 | 8 | 36726 | 440 | 42584161 |
| Weight decreased | 16.59 | 13.06 | 108 | 36626 | 207840 | 42376761 |
| Low cardiac output syndrome | 16.50 | 13.06 | 9 | 36725 | 645 | 42583956 |
| Metastases to soft tissue | 16.45 | 13.06 | 8 | 36726 | 451 | 42584150 |
| Myelodysplastic syndrome | 16.43 | 13.06 | 50 | 36684 | 22695 | 42561906 |
| Tonsil cancer | 16.37 | 13.06 | 11 | 36723 | 1150 | 42583451 |
| Lymphocyte count decreased | 16.36 | 13.06 | 57 | 36677 | 27752 | 42556849 |
| Skin erosion | 16.25 | 13.06 | 16 | 36718 | 2875 | 42581726 |
| Dyslipidaemia | 16.05 | 13.06 | 29 | 36705 | 9389 | 42575212 |
| Small intestinal perforation | 16.02 | 13.06 | 16 | 36718 | 2925 | 42581676 |
| Loss of personal independence in daily activities | 16.01 | 13.06 | 85 | 36649 | 49731 | 42534870 |
| Cholangitis | 15.76 | 13.06 | 31 | 36703 | 10696 | 42573905 |
| International normalised ratio abnormal | 15.73 | 13.06 | 17 | 36717 | 3406 | 42581195 |
| Lower gastrointestinal haemorrhage | 15.59 | 13.06 | 31 | 36703 | 10777 | 42573824 |
| Oedema | 15.55 | 13.06 | 87 | 36647 | 51914 | 42532687 |
| Tachycardia | 15.25 | 13.06 | 41 | 36693 | 101046 | 42483555 |
| Orthopnoea | 15.25 | 13.06 | 21 | 36713 | 5396 | 42579205 |
| Lethargy | 15.11 | 13.06 | 11 | 36723 | 46879 | 42537722 |
| Rhabdomyolysis | 15.08 | 13.06 | 117 | 36617 | 77902 | 42506699 |
| Drug monitoring procedure incorrectly performed | 15.05 | 13.06 | 7 | 36727 | 357 | 42584244 |
| Cerebrovascular accident | 14.97 | 13.06 | 39 | 36695 | 97121 | 42487480 |
| Traumatic intracranial haematoma | 14.86 | 13.06 | 4 | 36730 | 38 | 42584563 |
| Physical deconditioning | 14.82 | 13.06 | 14 | 36720 | 2391 | 42582210 |
| Cardiac failure congestive | 14.72 | 13.06 | 125 | 36609 | 85477 | 42499124 |
| Prerenal failure | 14.68 | 13.06 | 14 | 36720 | 2419 | 42582182 |
| Hospitalisation | 14.64 | 13.06 | 26 | 36708 | 74304 | 42510297 |
| Sleep disorder | 14.59 | 13.06 | 12 | 36722 | 48083 | 42536518 |
| Prothrombin time ratio decreased | 14.57 | 13.06 | 8 | 36726 | 581 | 42584020 |
| Cardiac arrest | 14.56 | 13.06 | 47 | 36687 | 109273 | 42475328 |
| Musculoskeletal stiffness | 14.53 | 13.06 | 17 | 36717 | 57748 | 42526853 |
| Immune-mediated hepatic disorder | 14.29 | 13.06 | 14 | 36720 | 2500 | 42582101 |
| Thirst | 14.21 | 13.06 | 27 | 36707 | 9081 | 42575520 |
| Drug resistance | 13.97 | 13.06 | 6 | 36728 | 34242 | 42550359 |
| Puncture site infection | 13.94 | 13.06 | 4 | 36730 | 49 | 42584552 |
| Hypovolaemic shock | 13.92 | 13.06 | 26 | 36708 | 8633 | 42575968 |
| Periodontitis | 13.87 | 13.06 | 13 | 36721 | 2198 | 42582403 |
| Marasmus | 13.85 | 13.06 | 9 | 36725 | 890 | 42583711 |
| Haematocrit abnormal | 13.78 | 13.06 | 9 | 36725 | 897 | 42583704 |
| Pseudohyponatraemia | 13.78 | 13.06 | 5 | 36729 | 134 | 42584467 |
| Azotaemia | 13.75 | 13.06 | 21 | 36713 | 5923 | 42578678 |
| Intentional product misuse | 13.74 | 13.06 | 20 | 36714 | 61880 | 42522721 |
| Dehydration | 13.57 | 13.06 | 184 | 36550 | 141583 | 42443018 |
| Confusional state | 13.38 | 13.06 | 87 | 36647 | 167510 | 42417091 |
| Sputum discoloured | 13.36 | 13.06 | 28 | 36706 | 10104 | 42574497 |
| Hepatitis acute | 13.26 | 13.06 | 26 | 36708 | 8949 | 42575652 |
| Adverse drug reaction | 13.12 | 13.06 | 8 | 36726 | 37426 | 42547175 |
| Brain contusion | 13.09 | 13.06 | 9 | 36725 | 977 | 42583624 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Renal impairment | 615.78 | 12.39 | 605 | 54781 | 187840 | 110346073 |
| Cardiac failure | 472.16 | 12.39 | 524 | 54862 | 187102 | 110346811 |
| Enthesopathy | 408.00 | 12.39 | 173 | 55213 | 12305 | 110521608 |
| Acute kidney injury | 393.31 | 12.39 | 934 | 54452 | 634496 | 109899417 |
| Tenosynovitis | 366.92 | 12.39 | 174 | 55212 | 16109 | 110517804 |
| Tongue disorder | 341.31 | 12.39 | 159 | 55227 | 14139 | 110519774 |
| Hepatic function abnormal | 306.81 | 12.39 | 295 | 55091 | 89000 | 110444913 |
| Hyperkalaemia | 288.85 | 12.39 | 348 | 55038 | 135448 | 110398465 |
| Platelet count decreased | 265.21 | 12.39 | 440 | 54946 | 230003 | 110303910 |
| Tendonitis | 251.62 | 12.39 | 159 | 55227 | 25924 | 110507989 |
| Anaemia | 244.64 | 12.39 | 713 | 54673 | 546373 | 109987540 |
| Alanine aminotransferase abnormal | 232.75 | 12.39 | 107 | 55279 | 9227 | 110524686 |
| Interstitial lung disease | 228.58 | 12.39 | 314 | 55072 | 139020 | 110394893 |
| Drug eruption | 222.57 | 12.39 | 197 | 55189 | 53462 | 110480451 |
| Blood parathyroid hormone decreased | 221.10 | 12.39 | 115 | 55271 | 12974 | 110520939 |
| Red blood cell sedimentation rate | 220.70 | 12.39 | 87 | 55299 | 5127 | 110528786 |
| Aspartate aminotransferase increased | 215.05 | 12.39 | 328 | 55058 | 159608 | 110374305 |
| Panniculitis | 207.70 | 12.39 | 117 | 55269 | 15465 | 110518448 |
| Granuloma skin | 195.95 | 12.39 | 101 | 55285 | 11182 | 110522731 |
| Blood creatinine increased | 194.15 | 12.39 | 337 | 55049 | 182552 | 110351361 |
| Cerebral infarction | 188.92 | 12.39 | 177 | 55209 | 51661 | 110482252 |
| Neutrophil count decreased | 187.07 | 12.39 | 265 | 55121 | 120676 | 110413237 |
| Alanine aminotransferase increased | 176.29 | 12.39 | 324 | 55062 | 183449 | 110350464 |
| Skin necrosis | 175.32 | 12.39 | 118 | 55268 | 21394 | 110512519 |
| Tumour lysis syndrome | 173.40 | 12.39 | 135 | 55251 | 30666 | 110503247 |
| Rheumatoid nodule | 169.42 | 12.39 | 113 | 55273 | 20183 | 110513730 |
| Hypercalcaemia | 165.60 | 12.39 | 157 | 55229 | 46500 | 110487413 |
| Cardiac failure chronic | 137.73 | 12.39 | 86 | 55300 | 13725 | 110520188 |
| Cardiac failure acute | 115.28 | 12.39 | 96 | 55290 | 23982 | 110509931 |
| Maternal exposure during pregnancy | 113.54 | 12.39 | 3 | 55383 | 254880 | 110279033 |
| Chronic kidney disease | 111.81 | 12.39 | 163 | 55223 | 76128 | 110457785 |
| Ulcer | 109.21 | 12.39 | 121 | 55265 | 42995 | 110490918 |
| Drug ineffective | 107.80 | 12.39 | 396 | 54990 | 1520144 | 109013769 |
| Skin ulcer | 103.63 | 12.39 | 143 | 55243 | 63502 | 110470411 |
| Basal cell carcinoma | 99.40 | 12.39 | 118 | 55268 | 45152 | 110488761 |
| Systemic lupus erythematosus | 94.66 | 12.39 | 9 | 55377 | 254329 | 110279584 |
| Glossodynia | 93.99 | 12.39 | 4 | 55382 | 222000 | 110311913 |
| Gout | 93.27 | 12.39 | 103 | 55283 | 36463 | 110497450 |
| Fear of injection | 92.68 | 12.39 | 57 | 55329 | 8854 | 110525059 |
| Renal failure | 87.53 | 12.39 | 281 | 55105 | 226293 | 110307620 |
| Pemphigus | 87.22 | 12.39 | 5 | 55381 | 214565 | 110319348 |
| Hyperuricaemia | 86.83 | 12.39 | 66 | 55320 | 14465 | 110519448 |
| Fatigue | 83.19 | 12.39 | 321 | 55065 | 1215637 | 109318276 |
| Sinusitis | 77.41 | 12.39 | 26 | 55360 | 296662 | 110237251 |
| Hypocalcaemia | 76.64 | 12.39 | 126 | 55260 | 65240 | 110468673 |
| Cerebral haemorrhage | 75.85 | 12.39 | 125 | 55261 | 64843 | 110469070 |
| Toxicity to various agents | 75.03 | 12.39 | 78 | 55308 | 480477 | 110053436 |
| Fibromyalgia | 72.60 | 12.39 | 3 | 55383 | 170906 | 110363007 |
| Nephrogenic anaemia | 71.01 | 12.39 | 38 | 55348 | 4539 | 110529374 |
| Duodenal ulcer perforation | 69.67 | 12.39 | 5 | 55381 | 177695 | 110356218 |
| Respiratory tract haemorrhage | 69.42 | 12.39 | 29 | 55357 | 1985 | 110531928 |
| Pemphigoid | 67.42 | 12.39 | 65 | 55321 | 19642 | 110514271 |
| Pericarditis | 66.99 | 12.39 | 14 | 55372 | 219100 | 110314813 |
| Haemorrhage subcutaneous | 66.87 | 12.39 | 39 | 55347 | 5500 | 110528413 |
| Migraine | 66.80 | 12.39 | 5 | 55381 | 171647 | 110362266 |
| Helicobacter infection | 66.19 | 12.39 | 7 | 55379 | 181870 | 110352043 |
| Pain | 65.91 | 12.39 | 251 | 55135 | 954704 | 109579209 |
| Wound | 65.75 | 12.39 | 18 | 55368 | 234419 | 110299494 |
| Swelling | 65.64 | 12.39 | 48 | 55338 | 350993 | 110182920 |
| Depression | 65.27 | 12.39 | 39 | 55347 | 317296 | 110216617 |
| White blood cell count decreased | 64.99 | 12.39 | 257 | 55129 | 229133 | 110304780 |
| Rash pruritic | 64.45 | 12.39 | 148 | 55238 | 97921 | 110435992 |
| Lower respiratory tract infection | 63.94 | 12.39 | 21 | 55365 | 243085 | 110290828 |
| Impaired healing | 63.47 | 12.39 | 11 | 55375 | 196706 | 110337207 |
| Irritable bowel syndrome | 63.30 | 12.39 | 5 | 55381 | 164210 | 110369703 |
| Disseminated intravascular coagulation | 63.09 | 12.39 | 90 | 55296 | 41196 | 110492717 |
| Discomfort | 63.06 | 12.39 | 15 | 55371 | 214692 | 110319221 |
| Drug abuse | 61.65 | 12.39 | 8 | 55378 | 177403 | 110356510 |
| Decreased appetite | 60.07 | 12.39 | 426 | 54960 | 475420 | 110058493 |
| Ill-defined disorder | 59.83 | 12.39 | 5 | 55381 | 156848 | 110377065 |
| Injury | 59.24 | 12.39 | 9 | 55377 | 177256 | 110356657 |
| Cardiac failure congestive | 58.94 | 12.39 | 188 | 55198 | 150812 | 110383101 |
| Sleep disorder | 58.10 | 12.39 | 14 | 55372 | 198630 | 110335283 |
| Muscle injury | 58.09 | 12.39 | 3 | 55383 | 140804 | 110393109 |
| C-reactive protein abnormal | 57.65 | 12.39 | 169 | 55217 | 129526 | 110404387 |
| Dry mouth | 56.73 | 12.39 | 15 | 55371 | 199933 | 110333980 |
| Lactic acidosis | 56.56 | 12.39 | 136 | 55250 | 92675 | 110441238 |
| Concomitant disease aggravated | 56.03 | 12.39 | 54 | 55332 | 16310 | 110517603 |
| C-reactive protein increased | 55.29 | 12.39 | 236 | 55150 | 217683 | 110316230 |
| Pneumonia bacterial | 55.26 | 12.39 | 67 | 55319 | 26194 | 110507719 |
| Folliculitis | 54.92 | 12.39 | 9 | 55377 | 167644 | 110366269 |
| Granuloma | 54.28 | 12.39 | 42 | 55344 | 9448 | 110524465 |
| Anxiety | 53.84 | 12.39 | 56 | 55330 | 345022 | 110188891 |
| Rheumatoid lung | 53.81 | 12.39 | 31 | 55355 | 4273 | 110529640 |
| Rheumatoid factor positive | 53.70 | 12.39 | 3 | 55383 | 131637 | 110402276 |
| Melaena | 53.41 | 12.39 | 111 | 55275 | 68646 | 110465267 |
| Loss of personal independence in daily activities | 52.50 | 12.39 | 180 | 55206 | 149840 | 110384073 |
| Hypokalaemia | 51.33 | 12.39 | 204 | 55182 | 182244 | 110351669 |
| Type 2 diabetes mellitus | 50.84 | 12.39 | 13 | 55373 | 177219 | 110356694 |
| Gastrointestinal disorder | 50.78 | 12.39 | 29 | 55357 | 241923 | 110291990 |
| Joint swelling | 50.77 | 12.39 | 90 | 55296 | 442755 | 110091158 |
| Rhabdomyolysis | 50.77 | 12.39 | 154 | 55232 | 120247 | 110413666 |
| Altered state of consciousness | 50.71 | 12.39 | 98 | 55288 | 57528 | 110476385 |
| Blood urea increased | 50.25 | 12.39 | 95 | 55291 | 54862 | 110479051 |
| Intentional product use issue | 50.22 | 12.39 | 31 | 55355 | 247875 | 110286038 |
| Erythema | 49.84 | 12.39 | 282 | 55104 | 291165 | 110242748 |
| Cytokine release syndrome | 49.43 | 12.39 | 109 | 55277 | 70197 | 110463716 |
| Transformation to acute myeloid leukaemia | 49.39 | 12.39 | 21 | 55365 | 1502 | 110532411 |
| Intentional overdose | 48.47 | 12.39 | 5 | 55381 | 132496 | 110401417 |
| Atrial fibrillation | 47.35 | 12.39 | 234 | 55152 | 229408 | 110304505 |
| Asthma | 47.07 | 12.39 | 34 | 55352 | 250257 | 110283656 |
| Pleural effusion | 47.05 | 12.39 | 195 | 55191 | 177514 | 110356399 |
| Glomerular filtration rate decreased | 47.03 | 12.39 | 65 | 55321 | 28891 | 110505022 |
| Blood creatine phosphokinase increased | 46.60 | 12.39 | 109 | 55277 | 72968 | 110460945 |
| Bursitis | 44.80 | 12.39 | 6 | 55380 | 129912 | 110404001 |
| Haematochezia | 44.32 | 12.39 | 143 | 55243 | 115381 | 110418532 |
| Paraesthesia | 42.98 | 12.39 | 45 | 55341 | 276476 | 110257437 |
| Dehydration | 42.97 | 12.39 | 263 | 55123 | 279248 | 110254665 |
| Blood pressure decreased | 42.83 | 12.39 | 141 | 55245 | 114950 | 110418963 |
| Alopecia | 42.83 | 12.39 | 73 | 55313 | 364680 | 110169233 |
| Blood cholesterol increased | 41.95 | 12.39 | 20 | 55366 | 184765 | 110349148 |
| Pneumonia aspiration | 41.14 | 12.39 | 111 | 55275 | 81122 | 110452791 |
| Joint range of motion decreased | 41.13 | 12.39 | 6 | 55380 | 121826 | 110412087 |
| Blood lactate dehydrogenase increased | 40.98 | 12.39 | 77 | 55309 | 44257 | 110489656 |
| Upper respiratory tract inflammation | 40.53 | 12.39 | 26 | 55360 | 4345 | 110529568 |
| Lymphocyte count decreased | 40.52 | 12.39 | 89 | 55297 | 57154 | 110476759 |
| Hypoaesthesia | 39.60 | 12.39 | 60 | 55326 | 314163 | 110219750 |
| Stevens-Johnson syndrome | 39.13 | 12.39 | 78 | 55308 | 46823 | 110487090 |
| Gait inability | 39.12 | 12.39 | 10 | 55376 | 136366 | 110397547 |
| Oedema peripheral | 38.99 | 12.39 | 290 | 55096 | 328370 | 110205543 |
| Right ventricular failure | 38.80 | 12.39 | 56 | 55330 | 25898 | 110508015 |
| Acute myeloid leukaemia | 38.78 | 12.39 | 69 | 55317 | 38041 | 110495872 |
| Sleep disorder due to general medical condition, insomnia type | 38.60 | 12.39 | 4 | 55382 | 105639 | 110428274 |
| Wheezing | 38.04 | 12.39 | 43 | 55343 | 255187 | 110278726 |
| Diabetic nephropathy | 37.92 | 12.39 | 23 | 55363 | 3485 | 110530428 |
| Blister | 37.64 | 12.39 | 35 | 55351 | 227341 | 110306572 |
| Asthenia | 37.28 | 12.39 | 198 | 55188 | 688801 | 109845112 |
| Musculoskeletal disorder | 37.00 | 12.39 | 51 | 55335 | 22613 | 110511300 |
| Osteoarthritis | 36.76 | 12.39 | 23 | 55363 | 182600 | 110351313 |
| Erythema multiforme | 36.75 | 12.39 | 49 | 55337 | 21048 | 110512865 |
| Product use in unapproved indication | 36.64 | 12.39 | 109 | 55277 | 447268 | 110086645 |
| Brain natriuretic peptide increased | 36.52 | 12.39 | 36 | 55350 | 11173 | 110522740 |
| Confusional state | 36.39 | 12.39 | 117 | 55269 | 468563 | 110065350 |
| Nasopharyngitis | 36.09 | 12.39 | 91 | 55295 | 394270 | 110139643 |
| Off label use | 35.43 | 12.39 | 534 | 54852 | 1499651 | 109034262 |
| Renal disorder | 35.10 | 12.39 | 77 | 55309 | 49402 | 110484511 |
| Fulminant type 1 diabetes mellitus | 34.93 | 12.39 | 19 | 55367 | 2344 | 110531569 |
| Memory impairment | 34.18 | 12.39 | 29 | 55357 | 196915 | 110336998 |
| Arrhythmia | 34.16 | 12.39 | 94 | 55292 | 69481 | 110464432 |
| Stress | 33.74 | 12.39 | 6 | 55380 | 105342 | 110428571 |
| Injection site pain | 33.66 | 12.39 | 24 | 55362 | 177898 | 110356015 |
| Nephrotic syndrome | 33.62 | 12.39 | 38 | 55348 | 13793 | 110520120 |
| Aplasia pure red cell | 33.53 | 12.39 | 32 | 55354 | 9546 | 110524367 |
| Obesity | 33.11 | 12.39 | 8 | 55378 | 113343 | 110420570 |
| Colon cancer | 33.06 | 12.39 | 41 | 55345 | 16402 | 110517511 |
| Blood uric acid increased | 32.99 | 12.39 | 47 | 55339 | 21482 | 110512431 |
| Drug ineffective for unapproved indication | 32.62 | 12.39 | 6 | 55380 | 102832 | 110431081 |
| Thalamus haemorrhage | 32.43 | 12.39 | 17 | 55369 | 1947 | 110531966 |
| Drug tolerance decreased | 32.15 | 12.39 | 53 | 55333 | 27487 | 110506426 |
| Product dose omission issue | 32.03 | 12.39 | 71 | 55315 | 321711 | 110212202 |
| Hyperhidrosis | 31.99 | 12.39 | 28 | 55358 | 187270 | 110346643 |
| Pulmonary arterial hypertension | 31.91 | 12.39 | 58 | 55328 | 32510 | 110501403 |
| Adverse drug reaction | 31.73 | 12.39 | 7 | 55379 | 105552 | 110428361 |
| Cholangitis | 31.67 | 12.39 | 40 | 55346 | 16295 | 110517618 |
| Joint injury | 31.56 | 12.39 | 65 | 55321 | 39929 | 110493984 |
| Hypoalbuminaemia | 31.49 | 12.39 | 54 | 55332 | 28920 | 110504993 |
| Enterocolitis | 31.47 | 12.39 | 43 | 55343 | 18906 | 110515007 |
| Tubulointerstitial nephritis | 31.42 | 12.39 | 78 | 55308 | 54206 | 110479707 |
| Osteoma | 31.39 | 12.39 | 8 | 55378 | 109 | 110533804 |
| Febrile neutropenia | 31.27 | 12.39 | 268 | 55118 | 316499 | 110217414 |
| Pneumonia | 31.24 | 12.39 | 614 | 54772 | 876100 | 109657813 |
| Shock haemorrhagic | 31.23 | 12.39 | 52 | 55334 | 27195 | 110506718 |
| Peripheral venous disease | 31.22 | 12.39 | 3 | 55383 | 84114 | 110449799 |
| Drug tolerance | 31.19 | 12.39 | 40 | 55346 | 16545 | 110517368 |
| Gouty tophus | 31.06 | 12.39 | 11 | 55375 | 480 | 110533433 |
| Orthostatic intolerance | 31.05 | 12.39 | 17 | 55369 | 2124 | 110531789 |
| Hepatocellular carcinoma | 30.84 | 12.39 | 31 | 55355 | 9849 | 110524064 |
| Physical deconditioning | 30.25 | 12.39 | 20 | 55366 | 3517 | 110530396 |
| Dyspepsia | 29.75 | 12.39 | 31 | 55355 | 190934 | 110342979 |
| Hyperkinetic heart syndrome | 29.53 | 12.39 | 8 | 55378 | 140 | 110533773 |
| Osteomyelitis | 29.49 | 12.39 | 60 | 55326 | 36540 | 110497373 |
| Pyrexia | 29.33 | 12.39 | 621 | 54765 | 897644 | 109636269 |
| Suicidal ideation | 28.71 | 12.39 | 6 | 55380 | 93931 | 110439982 |
| Azotaemia | 28.51 | 12.39 | 30 | 55356 | 10055 | 110523858 |
| Cytomegalovirus nephritis | 28.38 | 12.39 | 8 | 55378 | 163 | 110533750 |
| Night sweats | 28.19 | 12.39 | 16 | 55370 | 133967 | 110399946 |
| Polycystic liver disease | 27.89 | 12.39 | 8 | 55378 | 174 | 110533739 |
| Wound infection | 27.81 | 12.39 | 7 | 55379 | 96458 | 110437455 |
| Cerebral ventricular rupture | 27.62 | 12.39 | 10 | 55376 | 465 | 110533448 |
| Blood lactic acid | 27.56 | 12.39 | 10 | 55376 | 468 | 110533445 |
| Splenic necrosis | 27.34 | 12.39 | 8 | 55378 | 187 | 110533726 |
| Suicide attempt | 27.05 | 12.39 | 9 | 55377 | 103385 | 110430528 |
| Embolic stroke | 26.50 | 12.39 | 27 | 55359 | 8716 | 110525197 |
| Gastric cancer | 26.34 | 12.39 | 30 | 55356 | 10978 | 110522935 |
| Arthropathy | 25.79 | 12.39 | 67 | 55319 | 287455 | 110246458 |
| Vomiting | 25.06 | 12.39 | 314 | 55072 | 910361 | 109623552 |
| Injection site reaction | 24.66 | 12.39 | 7 | 55379 | 89063 | 110444850 |
| Sedation | 24.55 | 12.39 | 3 | 55383 | 69680 | 110464233 |
| Corneal abscess | 24.40 | 12.39 | 6 | 55380 | 70 | 110533843 |
| Plasma cell myeloma | 24.21 | 12.39 | 78 | 55308 | 62858 | 110471055 |
| Splenic cyst | 24.08 | 12.39 | 8 | 55378 | 287 | 110533626 |
| Product prescribing error | 23.87 | 12.39 | 68 | 55318 | 51263 | 110482650 |
| Gouty arthritis | 23.59 | 12.39 | 13 | 55373 | 1646 | 110532267 |
| Weight increased | 23.56 | 12.39 | 119 | 55267 | 419525 | 110114388 |
| Red blood cell sedimentation rate increased | 23.18 | 12.39 | 89 | 55297 | 78213 | 110455700 |
| Shunt occlusion | 23.03 | 12.39 | 13 | 55373 | 1724 | 110532189 |
| Musculoskeletal pain | 23.00 | 12.39 | 35 | 55351 | 182988 | 110350925 |
| Infective spondylitis | 22.85 | 12.39 | 9 | 55377 | 529 | 110533384 |
| Cerebellar infarction | 22.80 | 12.39 | 18 | 55368 | 4169 | 110529744 |
| Putamen haemorrhage | 22.74 | 12.39 | 9 | 55377 | 536 | 110533377 |
| Thrombotic cerebral infarction | 22.65 | 12.39 | 10 | 55376 | 784 | 110533129 |
| Psoriasis | 22.63 | 12.39 | 22 | 55364 | 139971 | 110393942 |
| Influenza like illness | 22.60 | 12.39 | 8 | 55378 | 88404 | 110445509 |
| Pain in extremity | 22.58 | 12.39 | 147 | 55239 | 486971 | 110046942 |
| Pancreatitis acute | 22.56 | 12.39 | 74 | 55312 | 60200 | 110473713 |
| Adrenal insufficiency | 22.55 | 12.39 | 59 | 55327 | 42331 | 110491582 |
| Low cardiac output syndrome | 22.43 | 12.39 | 11 | 55375 | 1095 | 110532818 |
| Activated partial thromboplastin time abnormal | 22.14 | 12.39 | 8 | 55378 | 370 | 110533543 |
| Sudden death | 22.09 | 12.39 | 42 | 55344 | 24353 | 110509560 |
| Blood uric acid decreased | 22.06 | 12.39 | 12 | 55374 | 1481 | 110532432 |
| Incorrect route of product administration | 21.98 | 12.39 | 3 | 55383 | 64058 | 110469855 |
| Liver disorder | 21.94 | 12.39 | 134 | 55252 | 142109 | 110391804 |
| Gait disturbance | 21.89 | 12.39 | 69 | 55317 | 278139 | 110255774 |
| Enteritis infectious | 21.81 | 12.39 | 17 | 55369 | 3865 | 110530048 |
| Prerenal failure | 21.80 | 12.39 | 18 | 55368 | 4441 | 110529472 |
| Product quality issue | 21.54 | 12.39 | 6 | 55380 | 77293 | 110456620 |
| Gastric disorder | 21.53 | 12.39 | 50 | 55336 | 33307 | 110500606 |
| Ear infection | 21.38 | 12.39 | 3 | 55383 | 62729 | 110471184 |
| Pulmonary alveolar haemorrhage | 21.17 | 12.39 | 37 | 55349 | 20113 | 110513800 |
| Lung disorder | 21.14 | 12.39 | 36 | 55350 | 180011 | 110353902 |
| Gastrooesophageal reflux disease | 21.12 | 12.39 | 36 | 55350 | 179940 | 110353973 |
| Dyspnoea paroxysmal nocturnal | 21.04 | 12.39 | 14 | 55372 | 2488 | 110531425 |
| Drug titration error | 20.96 | 12.39 | 12 | 55374 | 1635 | 110532278 |
| Gamma-glutamyltransferase increased | 20.94 | 12.39 | 73 | 55313 | 61236 | 110472677 |
| Rash | 20.77 | 12.39 | 548 | 54838 | 820416 | 109713497 |
| Subdural haematoma | 20.70 | 12.39 | 52 | 55334 | 36402 | 110497511 |
| Coronavirus test positive | 20.69 | 12.39 | 11 | 55375 | 1296 | 110532617 |
| Arthralgia | 20.62 | 12.39 | 271 | 55115 | 779361 | 109754552 |
| Urinary retention | 20.46 | 12.39 | 79 | 55307 | 69604 | 110464309 |
| Thirst | 20.43 | 12.39 | 38 | 55348 | 21669 | 110512244 |
| Lordosis | 20.39 | 12.39 | 8 | 55378 | 465 | 110533448 |
| Neck pain | 20.31 | 12.39 | 19 | 55367 | 123111 | 110410802 |
| Seizure | 20.25 | 12.39 | 51 | 55335 | 221134 | 110312779 |
| Aortic dissection | 20.22 | 12.39 | 18 | 55368 | 4915 | 110528998 |
| Post infection glomerulonephritis | 20.05 | 12.39 | 6 | 55380 | 152 | 110533761 |
| Small intestinal perforation | 20.02 | 12.39 | 17 | 55369 | 4359 | 110529554 |
| Procedural failure | 19.94 | 12.39 | 6 | 55380 | 155 | 110533758 |
| Cytomegalovirus enterocolitis | 19.76 | 12.39 | 13 | 55373 | 2268 | 110531645 |
| Hypovolaemic shock | 19.69 | 12.39 | 30 | 55356 | 14553 | 110519360 |
| Spinal compression fracture | 19.62 | 12.39 | 34 | 55352 | 18358 | 110515555 |
| Drug monitoring procedure incorrectly performed | 19.59 | 12.39 | 9 | 55377 | 774 | 110533139 |
| Epistaxis | 19.59 | 12.39 | 122 | 55264 | 130250 | 110403663 |
| Gastrointestinal haemorrhage | 19.57 | 12.39 | 146 | 55240 | 165372 | 110368541 |
| Heat illness | 19.50 | 12.39 | 9 | 55377 | 783 | 110533130 |
| Lower gastrointestinal haemorrhage | 19.49 | 12.39 | 34 | 55352 | 18452 | 110515461 |
| Hepatotoxicity | 19.47 | 12.39 | 4 | 55382 | 63396 | 110470517 |
| Anaemia macrocytic | 19.36 | 12.39 | 21 | 55365 | 7282 | 110526631 |
| Haemoglobin decreased | 19.31 | 12.39 | 200 | 55186 | 248527 | 110285386 |
| Chest pain | 19.31 | 12.39 | 110 | 55276 | 376265 | 110157648 |
| Pneumocystis jirovecii pneumonia | 19.28 | 12.39 | 56 | 55330 | 42679 | 110491234 |
| Nail disorder | 19.21 | 12.39 | 3 | 55383 | 57932 | 110475981 |
| Abdominal discomfort | 19.20 | 12.39 | 117 | 55269 | 393741 | 110140172 |
| Intentional product misuse | 19.14 | 12.39 | 23 | 55363 | 132881 | 110401032 |
| Hepatitis acute | 19.12 | 12.39 | 34 | 55352 | 18732 | 110515181 |
| Rubber sensitivity | 19.07 | 12.39 | 13 | 55373 | 2405 | 110531508 |
| Conjunctival ulcer | 18.82 | 12.39 | 5 | 55381 | 81 | 110533832 |
| Myelodysplastic syndrome | 18.75 | 12.39 | 51 | 55335 | 37433 | 110496480 |
| Constipation | 18.74 | 12.39 | 267 | 55119 | 357519 | 110176394 |
| Blood pressure fluctuation | 18.74 | 12.39 | 7 | 55379 | 74817 | 110459096 |
| Tachycardia | 18.69 | 12.39 | 55 | 55331 | 226590 | 110307323 |
| General physical health deterioration | 18.68 | 12.39 | 308 | 55078 | 424987 | 110108926 |
| Myelosuppression | 18.62 | 12.39 | 95 | 55291 | 94245 | 110439668 |
| Toxic skin eruption | 18.59 | 12.39 | 42 | 55344 | 27473 | 110506440 |
| Concomitant disease progression | 18.55 | 12.39 | 15 | 55371 | 3595 | 110530318 |
| Illness | 18.48 | 12.39 | 9 | 55377 | 82162 | 110451751 |
| Bile duct stone | 18.30 | 12.39 | 19 | 55367 | 6270 | 110527643 |
| Orthopnoea | 18.29 | 12.39 | 25 | 55361 | 10996 | 110522917 |
| Splenic lesion | 18.12 | 12.39 | 8 | 55378 | 627 | 110533286 |
| Marasmus | 18.05 | 12.39 | 11 | 55375 | 1680 | 110532233 |
| Tonsil cancer | 17.93 | 12.39 | 10 | 55376 | 1296 | 110532617 |
| Hypercreatininaemia | 17.91 | 12.39 | 10 | 55376 | 1299 | 110532614 |
| Folate deficiency | 17.81 | 12.39 | 16 | 55370 | 4422 | 110529491 |
| Hypothyroidism | 17.74 | 12.39 | 78 | 55308 | 72821 | 110461092 |
| Cerebellar haemorrhage | 17.68 | 12.39 | 14 | 55372 | 3257 | 110530656 |
| Mental status changes | 17.64 | 12.39 | 8 | 55378 | 76114 | 110457799 |
| Prostatic specific antigen abnormal | 17.61 | 12.39 | 8 | 55378 | 671 | 110533242 |
| Systemic infection | 17.40 | 12.39 | 23 | 55363 | 9796 | 110524117 |
| Frequent bowel movements | 17.35 | 12.39 | 7 | 55379 | 71383 | 110462530 |
| Dyspnoea exertional | 17.31 | 12.39 | 100 | 55286 | 103960 | 110429953 |
| Cardiac amyloidosis | 17.20 | 12.39 | 13 | 55373 | 2824 | 110531089 |
| Metastases to soft tissue | 17.17 | 12.39 | 8 | 55378 | 711 | 110533202 |
| Renal ischaemia | 17.17 | 12.39 | 12 | 55374 | 2311 | 110531602 |
| Peritonitis | 16.95 | 12.39 | 45 | 55341 | 32562 | 110501351 |
| Haematoma muscle | 16.92 | 12.39 | 15 | 55371 | 4075 | 110529838 |
| Agitation | 16.89 | 12.39 | 19 | 55367 | 113032 | 110420881 |
| Iron deficiency anaemia | 16.86 | 12.39 | 44 | 55342 | 31515 | 110502398 |
| Sciatica | 16.78 | 12.39 | 13 | 55373 | 92386 | 110441527 |
| Cardiac dysfunction | 16.68 | 12.39 | 18 | 55368 | 6205 | 110527708 |
| Sleep disorder due to a general medical condition | 16.61 | 12.39 | 3 | 55383 | 52109 | 110481804 |
| Traumatic intracranial haematoma | 16.48 | 12.39 | 4 | 55382 | 44 | 110533869 |
| Enanthema | 16.44 | 12.39 | 9 | 55377 | 1125 | 110532788 |
| Dyslipidaemia | 16.36 | 12.39 | 29 | 55357 | 15936 | 110517977 |
| Haemoptysis | 16.35 | 12.39 | 75 | 55311 | 71279 | 110462634 |
| Henoch-Schonlein purpura | 16.31 | 12.39 | 14 | 55372 | 3643 | 110530270 |
| Weight decreased | 16.20 | 12.39 | 153 | 55233 | 467904 | 110066009 |
| Hip arthroplasty | 16.18 | 12.39 | 4 | 55382 | 55809 | 110478104 |
| Road traffic accident | 16.10 | 12.39 | 18 | 55368 | 107380 | 110426533 |
| Hypopituitarism | 16.00 | 12.39 | 15 | 55371 | 4375 | 110529538 |
| Drug-induced liver injury | 15.99 | 12.39 | 109 | 55277 | 119958 | 110413955 |
| Haematuria | 15.98 | 12.39 | 83 | 55303 | 82922 | 110450991 |
| Cerebral artery embolism | 15.82 | 12.39 | 11 | 55375 | 2101 | 110531812 |
| Anaemia vitamin B12 deficiency | 15.77 | 12.39 | 9 | 55377 | 1218 | 110532695 |
| Accidental exposure to product | 15.68 | 12.39 | 3 | 55383 | 50005 | 110483908 |
| Immobilisation syndrome | 15.67 | 12.39 | 8 | 55378 | 868 | 110533045 |
| Erectile dysfunction | 15.64 | 12.39 | 31 | 55355 | 18525 | 110515388 |
| Hyperglycaemia | 15.63 | 12.39 | 84 | 55302 | 85006 | 110448907 |
| Periodontitis | 15.63 | 12.39 | 16 | 55370 | 5192 | 110528721 |
| Red blood cell abnormality | 15.56 | 12.39 | 8 | 55378 | 880 | 110533033 |
| Subarachnoid haemorrhage | 15.45 | 12.39 | 41 | 55345 | 29661 | 110504252 |
| Head injury | 15.37 | 12.39 | 52 | 55334 | 42965 | 110490948 |
| Abdominal pain upper | 15.34 | 12.39 | 107 | 55279 | 349004 | 110184909 |
| Inflammation | 15.29 | 12.39 | 156 | 55230 | 193082 | 110340831 |
| Diarrhoea | 15.29 | 12.39 | 707 | 54679 | 1138798 | 109395115 |
| Throat irritation | 15.21 | 12.39 | 4 | 55382 | 53548 | 110480365 |
| Atrioventricular block | 15.21 | 12.39 | 29 | 55357 | 16848 | 110517065 |
| Haemoglobin urine present | 15.20 | 12.39 | 8 | 55378 | 924 | 110532989 |
| Injection site erythema | 14.99 | 12.39 | 15 | 55371 | 94161 | 110439752 |
| Diverticulum intestinal haemorrhagic | 14.97 | 12.39 | 15 | 55371 | 4748 | 110529165 |
| Pulmonary hypertension | 14.92 | 12.39 | 61 | 55325 | 55159 | 110478754 |
| Nasal mucosal erosion | 14.87 | 12.39 | 4 | 55382 | 68 | 110533845 |
| Puncture site infection | 14.87 | 12.39 | 4 | 55382 | 68 | 110533845 |
| Cellulitis | 14.81 | 12.39 | 111 | 55275 | 125905 | 110408008 |
| Psoriatic arthropathy | 14.70 | 12.39 | 157 | 55229 | 196604 | 110337309 |
| Retinal artery occlusion | 14.50 | 12.39 | 14 | 55372 | 4235 | 110529678 |
| Pseudohyponatraemia | 14.46 | 12.39 | 5 | 55381 | 203 | 110533710 |
| Full blood count abnormal | 14.45 | 12.39 | 5 | 55381 | 56047 | 110477866 |
| Stomatitis | 14.39 | 12.39 | 78 | 55308 | 270164 | 110263749 |
| Fibrin D dimer increased | 14.36 | 12.39 | 21 | 55365 | 9824 | 110524089 |
| Subcutaneous haematoma | 14.31 | 12.39 | 12 | 55374 | 3024 | 110530889 |
| Beta 2 microglobulin increased | 14.30 | 12.39 | 7 | 55379 | 694 | 110533219 |
| Hepatic enzyme increased | 14.27 | 12.39 | 98 | 55288 | 320794 | 110213119 |
| Hypozincaemia | 14.26 | 12.39 | 4 | 55382 | 80 | 110533833 |
| Joint stiffness | 14.18 | 12.39 | 8 | 55378 | 67235 | 110466678 |
| Haemorrhagic cerebral infarction | 14.13 | 12.39 | 9 | 55377 | 1486 | 110532427 |
| Psychotic disorder | 14.10 | 12.39 | 4 | 55382 | 50933 | 110482980 |
| Skin erosion | 14.09 | 12.39 | 16 | 55370 | 5838 | 110528075 |
| Ureterolithiasis | 14.09 | 12.39 | 14 | 55372 | 4388 | 110529525 |
| Mesenteric vein thrombosis | 14.03 | 12.39 | 10 | 55376 | 1985 | 110531928 |
| Bradycardia | 14.00 | 12.39 | 129 | 55257 | 155388 | 110378525 |
| Immune-mediated hepatic disorder | 13.96 | 12.39 | 14 | 55372 | 4436 | 110529477 |
| Feeling hot | 13.95 | 12.39 | 15 | 55371 | 91091 | 110442822 |
| Exostosis | 13.91 | 12.39 | 3 | 55383 | 45953 | 110487960 |
| Cognitive disorder | 13.86 | 12.39 | 14 | 55372 | 87497 | 110446416 |
| Chronic lymphocytic leukaemia | 13.83 | 12.39 | 16 | 55370 | 5952 | 110527961 |
| Labelled drug-drug interaction medication error | 13.80 | 12.39 | 39 | 55347 | 29263 | 110504650 |
| Bacterial prostatitis | 13.77 | 12.39 | 4 | 55382 | 91 | 110533822 |
| Renal cyst haemorrhage | 13.76 | 12.39 | 7 | 55379 | 754 | 110533159 |
| Tendon rupture | 13.70 | 12.39 | 25 | 55361 | 14053 | 110519860 |
| Syphilis | 13.64 | 12.39 | 7 | 55379 | 767 | 110533146 |
| Hypertriglyceridaemia | 13.63 | 12.39 | 27 | 55359 | 16127 | 110517786 |
| Gastrointestinal polyp haemorrhage | 13.55 | 12.39 | 7 | 55379 | 778 | 110533135 |
| Injection site swelling | 13.55 | 12.39 | 7 | 55379 | 61783 | 110472130 |
| Hypomagnesaemia | 13.50 | 12.39 | 63 | 55323 | 60307 | 110473606 |
| Hypermagnesaemia | 13.45 | 12.39 | 9 | 55377 | 1614 | 110532299 |
| Brain contusion | 13.43 | 12.39 | 9 | 55377 | 1619 | 110532294 |
| Amnesia | 13.39 | 12.39 | 20 | 55366 | 105388 | 110428525 |
| Anti-neutrophil cytoplasmic antibody positive vasculitis | 13.36 | 12.39 | 15 | 55371 | 5402 | 110528511 |
| Muscle spasms | 13.36 | 12.39 | 83 | 55303 | 278074 | 110255839 |
| Knee arthroplasty | 13.31 | 12.39 | 8 | 55378 | 64940 | 110468973 |
| Dizziness | 13.31 | 12.39 | 258 | 55128 | 697935 | 109835978 |
| Cytomegalovirus test positive | 13.28 | 12.39 | 17 | 55369 | 7019 | 110526894 |
| Cerebral artery thrombosis | 13.23 | 12.39 | 9 | 55377 | 1659 | 110532254 |
| Angina pectoris | 13.19 | 12.39 | 64 | 55322 | 62231 | 110471682 |
| Acute coronary syndrome | 13.15 | 12.39 | 33 | 55353 | 23079 | 110510834 |
| Haemolytic anaemia | 13.11 | 12.39 | 31 | 55355 | 20889 | 110513024 |
| Muscular weakness | 13.07 | 12.39 | 72 | 55314 | 248396 | 110285517 |
| Obstructive pancreatitis | 13.06 | 12.39 | 8 | 55378 | 1233 | 110532680 |
| Urine output decreased | 13.05 | 12.39 | 30 | 55356 | 19846 | 110514067 |
| Renal cyst infection | 13.05 | 12.39 | 5 | 55381 | 273 | 110533640 |
| Drug resistance | 12.95 | 12.39 | 6 | 55380 | 56368 | 110477545 |
| Haematocrit abnormal | 12.92 | 12.39 | 9 | 55377 | 1724 | 110532189 |
| Prothrombin time abnormal | 12.82 | 12.39 | 8 | 55378 | 1274 | 110532639 |
| Ascites | 12.80 | 12.39 | 85 | 55301 | 92723 | 110441190 |
| Colitis ulcerative | 12.69 | 12.39 | 12 | 55374 | 77351 | 110456562 |
| Lethargy | 12.63 | 12.39 | 17 | 55369 | 93559 | 110440354 |
| Gastric ulcer haemorrhage | 12.56 | 12.39 | 20 | 55366 | 10074 | 110523839 |
| Underdose | 12.54 | 12.39 | 64 | 55322 | 63490 | 110470423 |
| Bladder transitional cell carcinoma stage 0 | 12.51 | 12.39 | 4 | 55382 | 127 | 110533786 |
| Dermatophytosis of nail | 12.50 | 12.39 | 5 | 55381 | 306 | 110533607 |
| COVID-19 pneumonia | 12.49 | 12.39 | 44 | 55342 | 37099 | 110496814 |
| Pulmonary congestion | 12.48 | 12.39 | 39 | 55347 | 30927 | 110502986 |
| Troponin increased | 12.47 | 12.39 | 38 | 55348 | 29728 | 110504185 |
| Peripheral arterial occlusive disease | 12.40 | 12.39 | 19 | 55367 | 9261 | 110524652 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | M04AA03 | MUSCULO-SKELETAL SYSTEM ANTIGOUT PREPARATIONS ANTIGOUT PREPARATIONS Preparations inhibiting uric acid production |
| FDA MoA | N0000000206 | Xanthine Oxidase Inhibitors |
| MeSH PA | D006074 | Gout Suppressants |
| MeSH PA | D018501 | Antirheumatic Agents |
| FDA EPC | N0000175698 | Xanthine Oxidase Inhibitor |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:35634 | EC 1.17.3.2 (xanthine oxidase) inhibitor |
| CHEBI has role | CHEBI:35674 | antihypertensive agent |
| CHEBI has role | CHEBI:35845 | gout suppressant |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
Related Drugs by ATC class:
M04AA Preparations inhibiting uric acid production 2 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hyperuricemia | indication | 35885006 | DOID:1920 |
| Gout | indication | 90560007 | DOID:13189 |
| Gout Prevention | indication | ||
| Myocardial infarction | contraindication | 22298006 | DOID:5844 |
| Liver function tests abnormal | contraindication | 166603001 | |
| Cerebrovascular accident | contraindication | 230690007 | |
| Thromboembolic disorder | contraindication | 371039008 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 3.3 | acidic |
| pKa2 | 0.46 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 40MG | ULORIC | TAKEDA PHARMS USA | N021856 | Feb. 13, 2009 | RX | TABLET | ORAL | 8372872 | Sept. 8, 2031 | USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF THEOPHYLLINE |
| 40MG | ULORIC | TAKEDA PHARMS USA | N021856 | Feb. 13, 2009 | RX | TABLET | ORAL | 9107912 | Sept. 8, 2031 | USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF THEOPHYLLINE |
| 80MG | ULORIC | TAKEDA PHARMS USA | N021856 | Feb. 13, 2009 | RX | TABLET | ORAL | 8372872 | Sept. 8, 2031 | USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF THEOPHYLLINE |
| 80MG | ULORIC | TAKEDA PHARMS USA | N021856 | Feb. 13, 2009 | RX | TABLET | ORAL | 9107912 | Sept. 8, 2031 | USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF THEOPHYLLINE |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Xanthine dehydrogenase/oxidase | Enzyme | INHIBITOR | Ki | 9.22 | WOMBAT-PK | CHEMBL | |||
| ATP-binding cassette sub-family G member 2 | Transporter | IC50 | 7.57 | CHEMBL | |||||
| Flavin reductase (NADPH) | Enzyme | Kd | 5.79 | CHEMBL | |||||
| Histone deacetylase 6 | Enzyme | IC50 | 7.26 | CHEMBL | |||||
| Potassium voltage-gated channel subfamily H member 2 | Ion channel | EC50 | 7.44 | WOMBAT-PK | |||||
| RISC-loading complex subunit TARBP2 | Cytosolic other | EC50 | 7.04 | CHEMBL | |||||
| Xanthine dehydrogenase/oxidase | Enzyme | IC50 | 8.52 | CHEMBL | |||||
| Xanthine dehydrogenase/oxidase | Enzyme | IC50 | 8.40 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4025245 | VUID |
| N0000179385 | NUI |
| D01206 | KEGG_DRUG |
| 4025245 | VANDF |
| C0249529 | UMLSCUI |
| CHEBI:31596 | CHEBI |
| TEI | PDB_CHEM_ID |
| CHEMBL1164729 | ChEMBL_ID |
| DB04854 | DRUGBANK_ID |
| D000069465 | MESH_DESCRIPTOR_UI |
| 134018 | PUBCHEM_CID |
| 6817 | IUPHAR_LIGAND_ID |
| 8140 | INN_ID |
| 101V0R1N2E | UNII |
| 73689 | RXNORM |
| 161190 | MMSL |
| 232999 | MMSL |
| 26212 | MMSL |
| d07397 | MMSL |
| 012966 | NDDF |
| 441610003 | SNOMEDCT_US |
| 441743008 | SNOMEDCT_US |
| 101V0R1N2E | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Febuxostat | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0413 | TABLET | 40 mg | ORAL | ANDA | 27 sections |
| Febuxostat | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0414 | TABLET | 80 mg | ORAL | ANDA | 27 sections |
| FEBUXOSTAT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0527-2244 | TABLET | 40 mg | ORAL | ANDA | 31 sections |
| FEBUXOSTAT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0527-2248 | TABLET | 80 mg | ORAL | ANDA | 31 sections |
| Febuxostat | Human Prescription Drug Label | 1 | 0904-7395 | TABLET, FILM COATED | 40 mg | ORAL | ANDA | 26 sections |
| Febuxostat | Human Prescription Drug Label | 1 | 0904-7396 | TABLET, FILM COATED | 80 mg | ORAL | ANDA | 26 sections |
| Febuxostat | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7484 | TABLET, FILM COATED | 40 mg | ORAL | ANDA | 26 sections |
| Febuxostat | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7484 | TABLET, FILM COATED | 40 mg | ORAL | ANDA | 26 sections |
| Febuxostat | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7485 | TABLET, FILM COATED | 80 mg | ORAL | ANDA | 26 sections |
| Febuxostat | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7485 | TABLET, FILM COATED | 80 mg | ORAL | ANDA | 26 sections |
| Febuxostat | Human Prescription Drug Label | 1 | 14445-156 | TABLET, FILM COATED | 40 mg | ORAL | ANDA | 27 sections |
| Febuxostat | Human Prescription Drug Label | 1 | 14445-157 | TABLET, FILM COATED | 80 mg | ORAL | ANDA | 27 sections |
| Febuxostat | Human Prescription Drug Label | 1 | 16714-059 | TABLET, FILM COATED | 40 mg | ORAL | ANDA | 30 sections |
| Febuxostat | Human Prescription Drug Label | 1 | 16714-060 | TABLET, FILM COATED | 80 mg | ORAL | ANDA | 30 sections |
| ULORIC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-516 | TABLET | 80 mg | ORAL | NDA | 29 sections |
| Febuxostat | HUMAN PRESCRIPTION DRUG LABEL | 1 | 27808-206 | TABLET | 40 mg | ORAL | ANDA | 31 sections |
| Febuxostat | HUMAN PRESCRIPTION DRUG LABEL | 1 | 27808-207 | TABLET | 80 mg | ORAL | ANDA | 31 sections |
| Febuxostat | Human Prescription Drug Label | 1 | 33342-274 | FILM | 40 mg | ORAL | ANDA | 27 sections |
| Febuxostat | Human Prescription Drug Label | 1 | 33342-275 | FILM | 80 mg | ORAL | ANDA | 27 sections |
| ULORIC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43353-305 | TABLET | 40 mg | ORAL | NDA | 29 sections |
| FEBUXOSTAT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43547-295 | TABLET | 40 mg | ORAL | ANDA | 28 sections |
| FEBUXOSTAT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43547-296 | TABLET | 80 mg | ORAL | ANDA | 28 sections |
| Febuxostat | Human Prescription Drug Label | 1 | 46708-190 | TABLET, COATED | 40 mg | ORAL | ANDA | 29 sections |
| Febuxostat | Human Prescription Drug Label | 1 | 46708-191 | TABLET, COATED | 80 mg | ORAL | ANDA | 29 sections |
| Febuxostat | Human Prescription Drug Label | 1 | 47335-721 | TABLET, FILM COATED | 40 mg | ORAL | ANDA | 30 sections |
| Febuxostat | Human Prescription Drug Label | 1 | 47335-722 | TABLET, FILM COATED | 80 mg | ORAL | ANDA | 30 sections |
| Febuxostat | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-293 | TABLET | 40 mg | ORAL | ANDA | 27 sections |
| Febuxostat | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-294 | TABLET | 80 mg | ORAL | ANDA | 27 sections |
| Febuxostat | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55111-796 | TABLET | 40 mg | ORAL | ANDA | 29 sections |
| Febuxostat | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55111-797 | TABLET | 80 mg | ORAL | ANDA | 29 sections |