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

Stem definitionDrug idCAS RN
xanthine oxydase and xanthine dehydrogenase inhibitor 1137 144060-53-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • februxostat
  • febuxostat
  • feburic
  • uloric
  • adenuric
A thiazole derivative and inhibitor of XANTHINE OXIDASE that is used for the treatment of HYPERURICEMIA in patients with chronic GOUT.
  • Molecular weight: 316.38
  • Formula: C16H16N2O3S
  • CLOGP: 4.25
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 83.21
  • ALOGS: -4.24
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
80 mg O

ADMET properties:

PropertyValueReference
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

Approvals:

DateAgencyCompanyOrphan
Feb. 26, 2015 EMA
Feb. 13, 2009 FDA TAKEDA PHARMS USA

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
Enthesopathy 310.62 18.01 111 17711 7952 56266293
Blood parathyroid hormone decreased 273.34 18.01 102 17720 8262 56265983
Tongue disorder 269.26 18.01 106 17716 9930 56264315
Tenosynovitis 267.03 18.01 112 17710 12349 56261896
Panniculitis 260.71 18.01 103 17719 9739 56264506
Granuloma skin 241.46 18.01 89 17733 6962 56267283
Skin necrosis 241.31 18.01 104 17718 12257 56261988
Red blood cell sedimentation rate 235.10 18.01 77 17745 4231 56270014
Rheumatoid nodule 219.87 18.01 103 17719 14754 56259491
Drug eruption 211.15 18.01 120 17702 25643 56248602
Tendonitis 206.38 18.01 105 17717 17992 56256253
Hypercalcaemia 204.60 18.01 117 17705 25294 56248951
Ulcer 179.59 18.01 103 17719 22382 56251863
Renal impairment 172.61 18.01 167 17655 80546 56193699
Basal cell carcinoma 163.52 18.01 101 17721 25120 56249125
Cardiac failure 148.24 18.01 155 17667 81938 56192307
Skin ulcer 146.39 18.01 111 17711 38497 56235748
Aspartate aminotransferase increased 145.66 18.01 154 17668 82448 56191797
Alanine aminotransferase abnormal 142.33 18.01 53 17769 4262 56269983
C-reactive protein abnormal 137.72 18.01 105 17717 36704 56237541
Acute kidney injury 127.63 18.01 253 17569 240510 56033735
Alanine aminotransferase increased 121.60 18.01 149 17673 93513 56180732
Fear of injection 121.19 18.01 53 17769 6462 56267783
Rash pruritic 116.47 18.01 111 17711 52483 56221762
Red blood cell sedimentation rate increased 110.33 18.01 92 17730 36531 56237714
Blood creatinine increased 99.92 18.01 125 17697 80066 56194179
Inflammation 94.69 18.01 113 17709 68958 56205287
Gout 92.28 18.01 54 17768 12167 56262078
Hyperkalaemia 89.89 18.01 95 17727 50770 56223475
Drug tolerance decreased 87.64 18.01 54 17768 13357 56260888
Anaemia 84.06 18.01 229 17593 267282 56006963
Loss of personal independence in daily activities 81.54 18.01 114 17708 81255 56192990
C-reactive protein increased 78.48 18.01 110 17712 78574 56195671
Psoriatic arthropathy 76.11 18.01 105 17717 73903 56200342
Granuloma 68.89 18.01 34 17788 5453 56268792
Platelet count decreased 66.36 18.01 120 17702 106263 56167982
Hepatic function abnormal 65.45 18.01 67 17755 34491 56239754
Drug tolerance 63.17 18.01 33 17789 5961 56268284
Erythema 63.03 18.01 147 17675 155792 56118453
Hyperuricaemia 59.45 18.01 30 17792 5043 56269202
Drug ineffective 56.96 18.01 130 17692 918859 55355386
Joint injury 56.48 18.01 54 17768 25600 56248645
Rheumatoid lung 53.42 18.01 24 17798 3116 56271129
Neutrophil count decreased 48.68 18.01 69 17753 49753 56224492
Blood uric acid increased 43.69 18.01 23 17799 4219 56270026
Systemic lupus erythematosus 42.46 18.01 4 17818 180074 56094171
Blood pressure systolic increased 40.55 18.01 57 17765 40779 56233466
Cardiac failure acute 36.93 18.01 27 17795 8846 56265399
Musculoskeletal disorder 36.02 18.01 37 17785 19110 56255135
Tumour lysis syndrome 35.00 18.01 25 17797 7898 56266347
Decreased appetite 34.41 18.01 149 17673 219082 56055163
Sinusitis 34.30 18.01 10 17812 197571 56076674
Cardiac failure chronic 33.44 18.01 19 17803 4048 56270197
Therapy non-responder 32.99 18.01 65 17757 61290 56212955
Anaemia macrocytic 32.46 18.01 17 17805 3086 56271159
Fatigue 32.03 18.01 135 17687 788417 55485828
Toxicity to various agents 29.86 18.01 17 17805 224547 56049698
Anxiety 29.68 18.01 12 17810 193160 56081085
Chronic kidney disease 29.51 18.01 50 17772 42006 56232239
Swelling 29.32 18.01 20 17802 239751 56034494
Wound 28.12 18.01 5 17817 138799 56135446
Osteomyelitis 27.22 18.01 36 17786 24310 56249935
Rash 26.52 18.01 255 17567 492792 55781453
Depression 26.38 18.01 12 17810 180105 56094140
Right ventricular failure 26.12 18.01 29 17793 16350 56257895
Gastric disorder 25.34 18.01 41 17781 33169 56241076
Pneumonia aspiration 24.71 18.01 40 17782 32371 56241874
Coronavirus test positive 24.62 18.01 9 17813 686 56273559
Therapeutic response decreased 23.79 18.01 52 17770 52706 56221539
Cerebral infarction 23.21 18.01 32 17790 22473 56251772
Anaemia vitamin B12 deficiency 21.96 18.01 7 17815 352 56273893
Paraesthesia 21.93 18.01 7 17815 130507 56143738
Synovitis 21.83 18.01 105 17717 161200 56113045
Upper respiratory tract inflammation 21.52 18.01 12 17810 2465 56271780
Product dose omission issue 21.36 18.01 20 17802 204733 56069512
Anti-neutrophil cytoplasmic antibody positive vasculitis 21.05 18.01 12 17810 2571 56271674
Haemorrhoidal haemorrhage 20.99 18.01 14 17808 3962 56270283
Systemic infection 20.94 18.01 13 17809 3256 56270989
Melaena 20.33 18.01 34 17788 28256 56245989
Altered state of consciousness 19.75 18.01 30 17792 22991 56251254
Renal failure 19.58 18.01 78 17744 110422 56163823
Renal function test abnormal 19.50 18.01 12 17810 2959 56271286
Intentional product use issue 19.33 18.01 4 17818 99729 56174516
General physical health deterioration 19.06 18.01 105 17717 169905 56104340
Concomitant disease aggravated 19.04 18.01 18 17804 8408 56265837
Peripheral swelling 18.82 18.01 133 17689 234593 56039652
Myoglobin blood increased 18.77 18.01 9 17813 1355 56272890
Mixed liver injury 18.71 18.01 13 17809 3931 56270314
Mesenteric vein thrombosis 18.18 18.01 8 17814 989 56273256
Hyperferritinaemia 18.04 18.01 5 17817 154 56274091
Pericarditis 18.02 18.01 6 17816 108917 56165328

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
Gout 234.87 13.74 164 27592 18010 31651578
Renal impairment 178.99 13.74 292 27464 86057 31583531
Tenosynovitis 173.07 13.74 81 27675 4129 31665459
Enthesopathy 168.60 13.74 80 27676 4207 31665381
Cardiac failure 143.21 13.74 264 27492 85689 31583899
Tongue disorder 136.64 13.74 73 27683 4944 31664644
Hepatic function abnormal 122.16 13.74 165 27591 41057 31628531
C-reactive protein abnormal 114.31 13.74 76 27680 7693 31661895
Interstitial lung disease 106.49 13.74 192 27564 61211 31608377
Alanine aminotransferase abnormal 100.44 13.74 55 27701 3912 31665676
Hyperuricaemia 93.42 13.74 66 27690 7372 31662216
Synovitis 93.39 13.74 81 27675 12202 31657386
Acute kidney injury 92.32 13.74 485 27271 279229 31390359
Tendonitis 89.53 13.74 68 27688 8490 31661098
Hyperkalaemia 89.20 13.74 183 27573 64168 31605420
Cerebral infarction 80.01 13.74 106 27650 25871 31643717
Tumour lysis syndrome 74.29 13.74 79 27677 15306 31654282
Aspartate aminotransferase increased 64.07 13.74 158 27598 62561 31607027
Red blood cell sedimentation rate 52.27 13.74 23 27733 1013 31668575
Alanine aminotransferase increased 51.47 13.74 163 27593 74493 31595095
Platelet count decreased 51.35 13.74 212 27544 110223 31559365
Granuloma skin 50.34 13.74 23 27733 1108 31668480
Drug eruption 49.62 13.74 70 27686 18117 31651471
Psoriatic arthropathy 49.10 13.74 73 27683 19810 31649778
Blood uric acid increased 48.39 13.74 42 27714 6328 31663260
Cardiac failure chronic 47.28 13.74 44 27712 7259 31662329
Blood parathyroid hormone decreased 46.92 13.74 23 27733 1299 31668289
Respiratory tract haemorrhage 46.85 13.74 22 27734 1129 31668459
Panniculitis 45.74 13.74 25 27731 1771 31667817
Cardiac failure acute 45.22 13.74 49 27707 9692 31659896
Contraindicated product administered 45.15 13.74 70 27686 19702 31649886
Pemphigoid 44.47 13.74 45 27711 8226 31661362
Neutrophil count decreased 44.35 13.74 114 27642 46280 31623308
Anaemia 43.69 13.74 328 27428 213194 31456394
Hypocalcaemia 43.62 13.74 73 27683 21905 31647683
Loss of personal independence in daily activities 42.19 13.74 83 27673 28205 31641383
Haemorrhage subcutaneous 41.14 13.74 25 27731 2163 31667425
Blood creatinine increased 39.82 13.74 169 27587 88909 31580679
Gouty tophus 38.91 13.74 11 27745 125 31669463
General physical health deterioration 38.79 13.74 199 27557 113236 31556352
Toxicity to various agents 38.73 13.74 62 27694 181425 31488163
Death 36.07 13.74 178 27578 360391 31309197
Lactic acidosis 35.31 13.74 83 27673 31854 31637734
Rash 33.85 13.74 296 27460 201190 31468398
Erythema 33.22 13.74 149 27607 80256 31589332
Concomitant disease aggravated 32.91 13.74 31 27725 5193 31664395
Cerebral haemorrhage 32.78 13.74 82 27674 32730 31636858
Rheumatoid nodule 31.84 13.74 23 27733 2658 31666930
Congenital diaphragmatic anomaly 31.05 13.74 7 27749 28 31669560
Orthostatic intolerance 29.53 13.74 14 27742 734 31668854
Hypercalcaemia 28.44 13.74 47 27709 13953 31655635
Renal failure 28.36 13.74 195 27561 123135 31546453
Hepatic enzyme increased 28.09 13.74 82 27674 35826 31633762
Corneal abscess 27.70 13.74 6 27750 19 31669569
Hyperkinetic heart syndrome 26.90 13.74 8 27748 110 31669478
Transformation to acute myeloid leukaemia 26.75 13.74 13 27743 720 31668868
Fulminant type 1 diabetes mellitus 26.65 13.74 13 27743 726 31668862
Fatigue 26.23 13.74 179 27577 335027 31334561
Intentional overdose 25.79 13.74 3 27753 41386 31628202
Hypokalaemia 25.77 13.74 104 27652 53470 31616118
Asthenia 25.37 13.74 106 27650 224649 31444939
Blood lactic acid 25.27 13.74 10 27746 336 31669252
Shock haemorrhagic 24.60 13.74 37 27719 10140 31659448
Renal ischaemia 24.07 13.74 11 27745 530 31669058
Cerebral ventricular rupture 23.40 13.74 8 27748 176 31669412
Liver disorder 23.39 13.74 68 27688 29639 31639949
C-reactive protein increased 23.04 13.74 94 27662 48556 31621032
Treatment failure 22.74 13.74 83 27673 40709 31628879
Anxiety 22.47 13.74 28 27728 91005 31578583
Depression 22.34 13.74 28 27728 90787 31578801
Skin necrosis 22.29 13.74 26 27730 5572 31664016
Cytomegalovirus nephritis 22.11 13.74 7 27749 120 31669468
Pneumonia bacterial 21.50 13.74 35 27721 10261 31659327
Pulmonary alveolar haemorrhage 21.42 13.74 28 27728 6738 31662850
Post infection glomerulonephritis 21.40 13.74 6 27750 66 31669522
Procedural failure 21.32 13.74 6 27750 67 31669521
Chronic kidney disease 20.94 13.74 77 27679 37898 31631690
Rubber sensitivity 20.65 13.74 7 27749 150 31669438
Thalamus haemorrhage 20.63 13.74 12 27744 958 31668630
Product prescribing error 20.58 13.74 50 27706 19592 31649996
Arrhythmia 19.89 13.74 69 27687 33008 31636580
Decreased appetite 19.73 13.74 213 27543 153004 31516584
Hyperhidrosis 19.67 13.74 18 27738 67375 31602213
Drug ineffective 19.66 13.74 237 27519 395336 31274252
Suicidal ideation 19.59 13.74 4 27752 36402 31633186
Blood uric acid decreased 18.72 13.74 8 27748 328 31669260
Seizure 18.62 13.74 37 27719 99731 31569857
Nephrogenic anaemia 18.31 13.74 15 27741 2088 31667500
Aggression 18.29 13.74 5 27751 37286 31632302
Haematochezia 18.23 13.74 77 27679 40387 31629201
Product dose omission issue 18.17 13.74 41 27715 105545 31564043
Conjunctival ulcer 17.67 13.74 5 27751 57 31669531
Gastric cancer 17.58 13.74 24 27732 6021 31663567
Altered state of consciousness 17.36 13.74 49 27707 21002 31648586
Hypothyroidism 17.03 13.74 44 27712 17903 31651685
Ulcer 16.90 13.74 27 27729 7794 31661794
Off label use 16.88 13.74 209 27547 347065 31322523
Multiple drug therapy 16.88 13.74 8 27748 419 31669169
Pseudohyponatraemia 16.80 13.74 5 27751 69 31669519
Diabetic nephropathy 16.73 13.74 14 27742 2007 31667581
Suicide attempt 16.47 13.74 6 27750 37242 31632346
Agitation 16.37 13.74 14 27742 54155 31615433
Dyspnoea paroxysmal nocturnal 16.28 13.74 12 27744 1431 31668157
Thirst 15.75 13.74 24 27732 6652 31662936
Drug hypersensitivity 15.62 13.74 113 27643 72486 31597102
Mental status changes 15.56 13.74 6 27750 35962 31633626
Respiratory distress 15.54 13.74 5 27751 33548 31636040
Thrombotic cerebral infarction 15.32 13.74 7 27749 337 31669251
Adrenal insufficiency 15.20 13.74 34 27722 12625 31656963
Disseminated intravascular coagulation 15.20 13.74 46 27710 20491 31649097
Tonsil cancer 14.94 13.74 10 27746 1023 31668565
Hypovolaemic shock 14.92 13.74 23 27733 6439 31663149
Stevens-Johnson syndrome 14.88 13.74 41 27715 17331 31652257
Hypoparathyroidism 14.81 13.74 8 27748 553 31669035
Low cardiac output syndrome 14.73 13.74 8 27748 559 31669029
Blood urea increased 14.49 13.74 57 27699 28955 31640633
Cerebrovascular accident 14.38 13.74 30 27726 79454 31590134
Cardiac arrest 14.19 13.74 36 27720 89026 31580562
Subarachnoid haemorrhage 13.95 13.74 29 27727 10242 31659346
Drug-induced liver injury 13.94 13.74 50 27706 24313 31645275
Melaena 13.83 13.74 61 27695 32593 31636995

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
Enthesopathy 402.15 14.06 174 42923 10695 70874652
Tenosynovitis 366.34 14.06 176 42921 13800 70871547
Renal impairment 346.86 14.06 432 42665 143505 70741842
Tongue disorder 335.90 14.06 163 42934 13064 70872283
Cardiac failure 282.41 14.06 390 42707 143151 70742196
Tendonitis 252.47 14.06 161 42936 21961 70863386
Blood parathyroid hormone decreased 237.56 14.06 114 42983 8910 70876437
Alanine aminotransferase abnormal 231.13 14.06 108 42989 7951 70877396
Panniculitis 228.04 14.06 117 42980 10559 70874788
Acute kidney injury 226.56 14.06 717 42380 473907 70411440
Gout 224.92 14.06 152 42945 22854 70862493
Red blood cell sedimentation rate 219.68 14.06 90 43007 4820 70880527
Granuloma skin 214.30 14.06 101 42996 7581 70877766
Hepatic function abnormal 206.60 14.06 230 42867 67766 70817581
Drug eruption 198.95 14.06 176 42921 39320 70846027
Hyperkalaemia 186.48 14.06 274 42823 106317 70779030
Rheumatoid nodule 185.31 14.06 115 42982 14952 70870395
Skin necrosis 184.47 14.06 118 42979 16173 70869174
C-reactive protein abnormal 180.66 14.06 165 42932 38414 70846933
Aspartate aminotransferase increased 175.67 14.06 293 42804 126685 70758662
Hypercalcaemia 168.75 14.06 151 42946 34234 70851113
Hyperuricaemia 153.65 14.06 91 43006 10875 70874472
Alanine aminotransferase increased 141.84 14.06 291 42806 147189 70738158
Ulcer 138.19 14.06 119 42978 25635 70859712
Interstitial lung disease 134.75 14.06 234 42863 104451 70780896
Platelet count decreased 134.45 14.06 319 42778 177903 70707444
Tumour lysis syndrome 125.51 14.06 104 42993 21256 70864091
Anaemia 123.99 14.06 529 42568 402894 70482453
Blood creatinine increased 121.13 14.06 268 42829 142733 70742614
Cerebral infarction 112.95 14.06 135 42962 42874 70842473
Psoriatic arthropathy 109.60 14.06 164 42933 64607 70820740
Fear of injection 108.47 14.06 61 43036 6611 70878736
Basal cell carcinoma 107.51 14.06 117 42980 33581 70851766
Skin ulcer 100.84 14.06 135 42962 48010 70837337
Neutrophil count decreased 97.52 14.06 179 42918 83377 70801970
Loss of personal independence in daily activities 92.98 14.06 177 42920 84733 70800614
Cardiac failure acute 84.20 14.06 76 43021 17411 70867936
Rash pruritic 81.26 14.06 141 42956 62850 70822497
Toxicity to various agents 78.58 14.06 70 43027 382102 70503245
Drug ineffective 75.57 14.06 305 42792 939447 69945900
Cardiac failure chronic 75.36 14.06 57 43040 10212 70875135
C-reactive protein increased 74.94 14.06 190 42907 110327 70775020
Erythema 69.27 14.06 272 42825 199291 70686056
Drug abuse 64.72 14.06 7 43090 147249 70738098
Drug tolerance decreased 64.36 14.06 51 43046 9782 70875565
Inflammation 63.82 14.06 145 42952 78520 70806827
Pemphigoid 59.88 14.06 57 43040 13965 70871382
Fatigue 58.60 14.06 280 42817 824039 70061308
General physical health deterioration 57.87 14.06 290 42807 235741 70649606
Hypocalcaemia 57.31 14.06 100 42997 44759 70840588
Rheumatoid lung 57.25 14.06 32 43065 3427 70881920
Granuloma 57.10 14.06 43 43054 7652 70877695
Decreased appetite 55.76 14.06 346 42751 304434 70580913
Sinusitis 55.30 14.06 17 43080 169178 70716169
Red blood cell sedimentation rate increased 54.46 14.06 90 43007 38552 70846795
Drug tolerance 54.00 14.06 41 43056 7387 70877960
Renal failure 53.37 14.06 242 42855 188828 70696519
Blood uric acid increased 52.69 14.06 44 43053 9085 70876262
Anxiety 52.03 14.06 35 43062 220295 70665052
Haemorrhage subcutaneous 51.88 14.06 33 43064 4476 70880871
Cerebral haemorrhage 50.19 14.06 105 42992 53759 70831588
Depression 47.80 14.06 31 43066 198943 70686404
Concomitant disease aggravated 47.52 14.06 47 43050 12067 70873280
Chronic kidney disease 46.72 14.06 110 42987 60947 70824400
Respiratory tract haemorrhage 46.43 14.06 22 43075 1670 70883677
Intentional overdose 45.03 14.06 4 43093 98431 70786916
Joint injury 43.84 14.06 67 43030 26865 70858482
Pain 41.50 14.06 219 42878 628597 70256750
Transformation to acute myeloid leukaemia 41.10 14.06 17 43080 932 70884415
Glossodynia 40.99 14.06 3 43094 86484 70798863
Swelling 40.57 14.06 33 43064 188506 70696841
Synovitis 39.16 14.06 169 42928 129059 70756288
Lactic acidosis 38.17 14.06 106 42991 64918 70820429
Systemic lupus erythematosus 37.58 14.06 8 43089 101894 70783453
Lower respiratory tract infection 37 14.06 11 43086 111902 70773445
Haematochezia 36.08 14.06 112 42985 72969 70812378
Altered state of consciousness 34.95 14.06 76 43021 39946 70845401
Liver disorder 34.80 14.06 99 42998 61469 70823878
Asthenia 34.46 14.06 152 42945 457514 70427833
Disseminated intravascular coagulation 34.26 14.06 68 43029 33530 70851817
Melaena 34.20 14.06 93 43004 56262 70829085
Discomfort 33.72 14.06 11 43086 105425 70779922
Blood urea increased 33.27 14.06 81 43016 45828 70839519
Nephrogenic anaemia 33.20 14.06 23 43074 3595 70881752
Hyperhidrosis 32.28 14.06 20 43077 131566 70753781
Gastrointestinal disorder 31.99 14.06 12 43085 105415 70779932
Musculoskeletal disorder 31.54 14.06 49 43048 19922 70865425
Orthostatic intolerance 31.03 14.06 17 43080 1750 70883597
Migraine 30.33 14.06 4 43093 72234 70813113
Hyperkinetic heart syndrome 29.15 14.06 8 43089 120 70885227
Product dose omission issue 29.00 14.06 55 43042 217413 70667934
Injection site pain 28.68 14.06 18 43079 117601 70767746
Therapy non-responder 28.41 14.06 107 42990 76808 70808539
Aplasia pure red cell 27.80 14.06 28 43069 7346 70878001
Fulminant type 1 diabetes mellitus 27.59 14.06 14 43083 1233 70884114
Cardiac failure congestive 27.41 14.06 158 42939 135299 70750048
Cerebral ventricular rupture 26.69 14.06 10 43087 421 70884926
Suicidal ideation 26.63 14.06 5 43092 69591 70815756
Pneumonia bacterial 26.52 14.06 41 43056 16600 70868747
Right ventricular failure 26.32 14.06 48 43049 22226 70863121
Pulmonary alveolar haemorrhage 26.31 14.06 32 43065 10337 70875010
Thalamus haemorrhage 26.06 14.06 15 43082 1699 70883648
Blood lactic acid 25.99 14.06 10 43087 453 70884894
Suicide attempt 25.94 14.06 8 43089 79502 70805845
Stress 25.76 14.06 5 43092 67961 70817386
Rash 25.62 14.06 444 42653 510118 70375229
Blood pressure fluctuation 25.43 14.06 3 43094 59009 70826338
Intentional product use issue 24.64 14.06 22 43075 120120 70765227
Hypokalaemia 24.60 14.06 150 42947 131038 70754309
Rhabdomyolysis 24.37 14.06 119 42978 95641 70789706
Corneal abscess 24.37 14.06 6 43091 57 70885290
Injury 24.31 14.06 5 43092 65240 70820107
Oedema peripheral 24.19 14.06 228 42869 227863 70657484
Drug titration error 24.15 14.06 12 43085 1011 70884336
Arrhythmia 24.06 14.06 82 43015 56061 70829286
Shock haemorrhagic 23.95 14.06 41 43056 18065 70867282
White blood cell count decreased 23.83 14.06 181 42916 169960 70715387
Osteomyelitis 23.60 14.06 55 43042 30263 70855084
Renal disorder 23.34 14.06 63 43034 37946 70847401
Renal ischaemia 23.29 14.06 12 43085 1091 70884256
Pneumonia aspiration 23.29 14.06 87 43010 62202 70823145
Cytomegalovirus nephritis 23.21 14.06 7 43090 149 70885198
Atrial fibrillation 23.02 14.06 191 42906 184157 70701190
Confusional state 22.89 14.06 92 43005 284306 70601041
Wound 22.87 14.06 16 43081 98716 70786631
Seizure 22.86 14.06 46 43051 177916 70707431
Gait disturbance 22.81 14.06 49 43048 185057 70700290
Upper respiratory tract inflammation 22.75 14.06 19 43078 3923 70881424
Post infection glomerulonephritis 22.65 14.06 6 43091 78 70885269
Procedural failure 22.44 14.06 6 43091 81 70885266
Influenza like illness 22.37 14.06 6 43091 65325 70820022
Blood lactate dehydrogenase increased 22.35 14.06 59 43038 35068 70850279
Contraindicated product administered 22.21 14.06 149 42948 134463 70750884
Blood pressure decreased 22.07 14.06 112 42985 91403 70793944
Pericarditis 22.01 14.06 12 43085 84693 70800654
Diabetic nephropathy 21.70 14.06 16 43081 2757 70882590
Gastric cancer 21.70 14.06 27 43070 8928 70876419
Impaired healing 21.68 14.06 9 43088 74365 70810982
Psoriasis 21.45 14.06 17 43080 98416 70786931
Gouty tophus 21.39 14.06 8 43089 335 70885012
Colon cancer 21.07 14.06 34 43063 14272 70871075
Duodenal ulcer perforation 21.05 14.06 3 43094 51109 70834238
Systemic infection 21.02 14.06 23 43074 6634 70878713
Paraesthesia 21.02 14.06 35 43062 145502 70739845
Nephrotic syndrome 21.00 14.06 29 43068 10611 70874736
Enterocolitis 20.55 14.06 32 43065 13034 70872313
Agitation 20.50 14.06 16 43081 93359 70791988
Thirst 20.48 14.06 34 43063 14615 70870732
Product prescribing error 20.44 14.06 61 43036 38891 70846456
Hypercreatininaemia 20.27 14.06 10 43087 829 70884518
Blood creatine phosphokinase increased 20.01 14.06 82 43015 61181 70824166
Heart rate increased 19.96 14.06 21 43076 106127 70779220
Erythema multiforme 19.95 14.06 36 43061 16528 70868819
Low cardiac output syndrome 19.80 14.06 10 43087 872 70884475
Tachycardia 19.50 14.06 42 43055 158504 70726843
Helicobacter infection 19.27 14.06 5 43092 55651 70829696
Cardiac arrest 19.12 14.06 43 43054 159791 70725556
Vomiting 19.10 14.06 250 42847 592861 70292486
Hypoaesthesia 18.68 14.06 41 43056 153698 70731649
Pain in extremity 18.51 14.06 120 42977 327962 70557385
Anaemia macrocytic 18.39 14.06 19 43078 5136 70880211
Folate deficiency 18.31 14.06 15 43082 3015 70882332
Injection site reaction 18.20 14.06 4 43093 49848 70835499
Azotaemia 18.18 14.06 23 43074 7730 70877617
Conjunctival ulcer 18.09 14.06 5 43092 77 70885270
Coronavirus test positive 17.94 14.06 10 43087 1065 70884282
Dehydration 17.84 14.06 213 42884 225929 70659418
Mental status changes 17.82 14.06 8 43089 63093 70822254
Hypovolaemic shock 17.69 14.06 27 43070 10810 70874537
Stevens-Johnson syndrome 17.68 14.06 55 43042 35852 70849495
Asthma 17.49 14.06 29 43068 120764 70764583
Drug-induced liver injury 17.46 14.06 74 43023 56039 70829308
Subdural haematoma 17.42 14.06 48 43049 29250 70856097
Sudden death 17.26 14.06 39 43058 21025 70864322
Brain natriuretic peptide increased 17.23 14.06 23 43074 8148 70877199
Nasopharyngitis 17.17 14.06 73 43024 222133 70663214
Aortic dissection 17.12 14.06 16 43081 3831 70881516
Prerenal failure 16.86 14.06 15 43082 3371 70881976
Injection site erythema 16.65 14.06 12 43085 72912 70812435
Sleep disorder 16.61 14.06 11 43086 69861 70815486
Tubulointerstitial nephritis 16.60 14.06 51 43046 33025 70852322
Therapeutic response decreased 16.60 14.06 75 43022 58378 70826969
Off label use 16.38 14.06 336 42761 742724 70142623
Anaemia vitamin B12 deficiency 16.28 14.06 8 43089 658 70884689
Dyspnoea paroxysmal nocturnal 16.21 14.06 12 43085 2081 70883266
Troponin increased 16.19 14.06 33 43064 16581 70868766
Embolic stroke 16.12 14.06 21 43076 7268 70878079
Death 16.04 14.06 216 42881 509845 70375502
Renal function test abnormal 16.01 14.06 16 43081 4158 70881189
Subarachnoid haemorrhage 15.86 14.06 36 43061 19468 70865879
Enteritis infectious 15.73 14.06 14 43083 3148 70882199
Obstructive pancreatitis 15.71 14.06 8 43089 710 70884637
Joint swelling 15.64 14.06 90 43007 253121 70632226
Pseudohyponatraemia 15.56 14.06 5 43092 132 70885215
Dry mouth 15.56 14.06 12 43085 70445 70814902
Dysphagia 15.51 14.06 28 43069 112806 70772541
Infective spondylitis 15.47 14.06 7 43090 478 70884869
Gastric disorder 15.46 14.06 50 43047 33272 70852075
Glomerular filtration rate decreased 15.44 14.06 37 43060 20719 70864628
Mesenteric vein thrombosis 15.24 14.06 10 43087 1429 70883918
Tonsil cancer 15.22 14.06 9 43088 1072 70884275
Pleural effusion 15.18 14.06 135 42962 132729 70752618
Thrombotic cerebral infarction 15.16 14.06 7 43090 501 70884846
Alopecia 14.85 14.06 66 43031 198424 70686923
Eosinophilia 14.81 14.06 56 43041 40263 70845084
Adverse drug reaction 14.69 14.06 7 43090 53337 70832010
Intentional product misuse 14.68 14.06 16 43081 79579 70805768
Urinary retention 14.62 14.06 67 43030 52453 70832894
Cough 14.55 14.06 127 42970 325250 70560097
Blood pressure systolic increased 14.45 14.06 71 43026 57188 70828159
Bacterial prostatitis 14.39 14.06 4 43093 63 70885284
Blood uric acid decreased 14.35 14.06 9 43088 1191 70884156
Henoch-Schonlein purpura 14.34 14.06 12 43085 2483 70882864
Product use in unapproved indication 14.34 14.06 71 43026 207407 70677940
Shock symptom 14.22 14.06 5 43092 175 70885172
Hypoalbuminaemia 14.13 14.06 34 43063 19088 70866259

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC M04AA03 MUSCULO-SKELETAL SYSTEM
ANTIGOUT PREPARATIONS
ANTIGOUT PREPARATIONS
Preparations inhibiting uric acid production
FDA MoA N0000000206 Xanthine Oxidase Inhibitors
MeSH PA D018501 Antirheumatic Agents
MeSH PA D006074 Gout Suppressants
FDA EPC N0000175698 Xanthine Oxidase Inhibitor
CHEBI has role CHEBI:35634 xanthine oxidase inhibitors

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

DiseaseRelationSNOMED_IDDOID
Hyperuricemia indication 35885006 DOID:1920
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 levelDissociation constantType (acidic/basic)
pKa1 3.3 acidic
pKa2 0.46 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Xanthine dehydrogenase/oxidase Enzyme INHIBITOR Ki 9.22 WOMBAT-PK CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel EC50 7.44 WOMBAT-PK
Xanthine dehydrogenase/oxidase Enzyme IC50 8.52 CHEMBL
Xanthine dehydrogenase/oxidase Enzyme IC50 8.40 CHEMBL

External reference:

IDSource
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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Febuxostat HUMAN PRESCRIPTION DRUG LABEL 1 0054-0413 TABLET 40 mg ORAL ANDA 29 sections
Febuxostat HUMAN PRESCRIPTION DRUG LABEL 1 0054-0414 TABLET 80 mg ORAL ANDA 29 sections
Febuxostat HUMAN PRESCRIPTION DRUG LABEL 1 0378-3925 TABLET, FILM COATED 40 mg ORAL ANDA 29 sections
Febuxostat HUMAN PRESCRIPTION DRUG LABEL 1 0378-3926 TABLET, FILM COATED 80 mg ORAL ANDA 29 sections
FEBUXOSTAT HUMAN PRESCRIPTION DRUG LABEL 1 0527-2244 TABLET 40 mg ORAL ANDA 32 sections
FEBUXOSTAT HUMAN PRESCRIPTION DRUG LABEL 1 0527-2244 TABLET 40 mg ORAL ANDA 32 sections
FEBUXOSTAT HUMAN PRESCRIPTION DRUG LABEL 1 0527-2248 TABLET 80 mg ORAL ANDA 32 sections
FEBUXOSTAT HUMAN PRESCRIPTION DRUG LABEL 1 0527-2248 TABLET 80 mg ORAL ANDA 32 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 31 sections
Febuxostat Human Prescription Drug Label 1 16714-060 TABLET, FILM COATED 80 mg ORAL ANDA 31 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 32 sections
Febuxostat HUMAN PRESCRIPTION DRUG LABEL 1 27808-206 TABLET 40 mg ORAL ANDA 32 sections
Febuxostat HUMAN PRESCRIPTION DRUG LABEL 1 27808-207 TABLET 80 mg ORAL ANDA 32 sections
Febuxostat HUMAN PRESCRIPTION DRUG LABEL 1 27808-207 TABLET 80 mg ORAL ANDA 32 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 29 sections
FEBUXOSTAT HUMAN PRESCRIPTION DRUG LABEL 1 43547-296 TABLET 80 mg ORAL ANDA 29 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 31 sections
Febuxostat Human Prescription Drug Label 1 47335-722 TABLET, FILM COATED 80 mg ORAL ANDA 31 sections
Febuxostat HUMAN PRESCRIPTION DRUG LABEL 1 51407-293 TABLET 40 mg ORAL ANDA 29 sections
Febuxostat HUMAN PRESCRIPTION DRUG LABEL 1 51407-294 TABLET 80 mg ORAL ANDA 29 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
ULORIC HUMAN PRESCRIPTION DRUG LABEL 1 55154-5158 TABLET 40 mg ORAL NDA 32 sections
ULORIC HUMAN PRESCRIPTION DRUG LABEL 1 55154-5159 TABLET 80 mg ORAL NDA 32 sections