allopurinol Indications/Contra | FAERs | Orange Book | BioActivity |

Stem definitionDrug idCAS RN
124 315-30-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

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

Drug dosage:

DoseUnitRoute
0.40 g O
0.40 g P

Approvals:

DateAgencyCompanyOrphan
Aug. 19, 1966 FDA PROMETHEUS LABS

FDA Adverse Event Reporting System

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug reaction with eosinophilia and systemic symptoms 7974.39 43.18 1515 6576 10198 4620703
Toxic epidermal necrolysis 1876.19 43.18 414 7677 5778 4625123
Acute kidney injury 1821.73 43.18 688 7403 69743 4561158
Stevens-Johnson syndrome 1812.29 43.18 428 7663 8211 4622690
Rash 1137.70 43.18 561 7530 107827 4523074
Eosinophilia 1088.65 43.18 273 7818 6720 4624181
Pyrexia 1001.01 43.18 513 7578 106631 4524270
Rash maculo-papular 968.03 43.18 259 7832 8270 4622631
Pruritus 699.63 43.18 356 7735 72216 4558685
Renal failure 661.13 43.18 288 7803 41081 4589820
Hyperkalaemia 585.37 43.18 203 7888 15634 4615267
Toxic skin eruption 553.34 43.18 145 7946 4235 4626666
Drug interaction 525.18 43.18 283 7808 64225 4566676
Erythema 511.35 43.18 242 7849 41698 4589203
Pancytopenia 499.72 43.18 204 7887 24649 4606252
Skin exfoliation 470.43 43.18 157 7934 10730 4620171
Thrombocytopenia 467.16 43.18 237 7854 47436 4583465
Anaemia 418.16 43.18 253 7838 71307 4559594
Diarrhoea 383.71 43.18 320 7771 149865 4481036
Renal impairment 383.05 43.18 170 7921 25168 4605733
Dermatitis exfoliative 366.78 43.18 97 7994 2929 4627972
Hepatitis 365.57 43.18 134 7957 12071 4618830
Tubulointerstitial nephritis 357.33 43.18 111 7980 6008 4624893
Hepatocellular injury 353.35 43.18 117 7974 7783 4623118
Erythema multiforme 321.48 43.18 94 7997 4129 4626772
Gout 313.87 43.18 93 7998 4280 4626621
Drug eruption 304.10 43.18 100 7991 6503 4624398
Face oedema 302.81 43.18 100 7991 6590 4624311
Purpura 300.11 43.18 87 8004 3705 4627196
Interstitial lung disease 270.84 43.18 123 7968 19162 4611739
Rash erythematous 269.42 43.18 103 7988 10406 4620495
Sepsis 269.15 43.18 159 7932 42680 4588221
Hypotension 262.29 43.18 185 7906 67215 4563686
Oedema peripheral 261.62 43.18 155 7936 41817 4589084
Agranulocytosis 256.71 43.18 91 8000 7426 4623475
Multiple organ dysfunction syndrome 255.10 43.18 117 7974 18639 4612262
Conjunctivitis 248.82 43.18 78 8013 4342 4626559
Blood creatinine increased 246.23 43.18 128 7963 26772 4604129
Eczema 242.08 43.18 82 8009 5839 4625062
International normalised ratio increased 234.23 43.18 107 7984 16881 4614020
Blister 232.62 43.18 95 7996 11414 4619487
Human herpesvirus 6 infection 229.66 43.18 53 8038 893 4630008
Completed suicide 229.15 43.18 143 7948 42302 4588599
Alanine aminotransferase increased 228.58 43.18 124 7967 28249 4602652
Cardiac failure 221.88 43.18 120 7971 27168 4603733
Angioedema 218.78 43.18 107 7984 19658 4611243
Drug hypersensitivity 214.68 43.18 165 7926 68235 4562666
Rhabdomyolysis 213.84 43.18 105 7986 19453 4611448
Leukopenia 209.14 43.18 107 7984 21629 4609272
Pemphigoid 209.03 43.18 59 8032 2277 4628624
Cholestasis 207.88 43.18 79 8012 7841 4623060
Lactic acidosis 205.71 43.18 88 8003 11868 4619033
Dilatation intrahepatic duct acquired 203.35 43.18 35 8056 107 4630794
Liver injury 191.87 43.18 66 8025 4919 4625982
Hepatotoxicity 190.14 43.18 75 8016 8224 4622677
Rash pruritic 189.09 43.18 84 8007 12399 4618502
Chronic kidney disease 181.95 43.18 78 8013 10567 4620334
Bone marrow failure 181.10 43.18 82 8009 12656 4618245
Hyperuricaemia 178.21 43.18 49 8042 1714 4629187
Dyspnoea 177.28 43.18 203 7888 138782 4492119
Metabolic acidosis 176.59 43.18 80 8011 12360 4618541
Dermatitis exfoliative generalised 173.49 43.18 41 8050 769 4630132
Liver disorder 169.54 43.18 79 8012 13019 4617882
Drug-induced liver injury 167.03 43.18 69 8022 8522 4622379
Neutropenia 164.27 43.18 122 7969 47828 4583073
Urticaria 161.48 43.18 112 7979 39461 4591440
Melaena 153.97 43.18 68 8023 9890 4621011
Lymphadenopathy 151.19 43.18 68 8023 10324 4620577
Septic shock 151.02 43.18 79 8012 16687 4614214
Oedema 151.02 43.18 82 8009 18669 4612232
Pneumonia 147.78 43.18 160 7931 102655 4528246
General physical health deterioration 147.71 43.18 94 7997 28684 4602217
Hypersensitivity 145.72 43.18 104 7987 38317 4592584
Aspartate aminotransferase increased 144.52 43.18 88 8003 24850 4606051
Rash morbilliform 143.67 43.18 37 8054 1001 4629900
Gastrointestinal haemorrhage 142.62 43.18 94 7997 30441 4600460
Confusional state 142.56 43.18 113 7978 48721 4582180
Bradycardia 142.07 43.18 84 8007 22485 4608416
Tumour lysis syndrome 139.82 43.18 47 8044 3262 4627639
Lip erosion 139.70 43.18 29 8062 289 4630612
Blood urea increased 139.31 43.18 61 8030 8689 4622212
Hepatic function abnormal 138.57 43.18 71 8020 14365 4616536
Malaise 137.80 43.18 145 7946 90012 4540889
Dermatitis bullous 137.06 43.18 45 8046 2902 4627999
Shock 134.99 43.18 60 8031 8856 4622045
Hypersensitivity vasculitis 129.05 43.18 42 8049 2634 4628267
Actinic keratosis 127.85 43.18 34 8057 1045 4629856
Jaundice 127.44 43.18 64 8027 12410 4618491
Toxicity to various agents 126.64 43.18 125 7966 71915 4558986
Dermatitis 121.84 43.18 46 8045 4475 4626426
Dehydration 121.55 43.18 97 7994 42193 4588708
Condition aggravated 121.38 43.18 111 7980 58060 4572841
Leukocytosis 120.81 43.18 53 8038 7581 4623320
Respiratory failure 119.35 43.18 84 8007 30242 4600659
Skin lesion 118.24 43.18 52 8039 7481 4623420
Acute generalised exanthematous pustulosis 116.11 43.18 40 8051 2990 4627911
Atrial fibrillation 112.59 43.18 82 8009 31133 4599768
Lichenoid keratosis 112.40 43.18 29 8062 790 4630111
Vomiting 112.25 43.18 150 7941 119549 4511352
Transaminases increased 112.18 43.18 54 8037 9552 4621349
Blood lactic acid 111.74 43.18 18 8073 31 4630870
Hepatic failure 107.21 43.18 58 8033 13091 4617810
Haemoglobin decreased 105.26 43.18 85 8006 37572 4593329
Hepatitis acute 105.03 43.18 37 8054 2955 4627946
Allergic reaction to excipient 103.80 43.18 19 8072 90 4630811
Pancreatitis acute 102.18 43.18 49 8042 8594 4622307
Skin reaction 100.85 43.18 38 8053 3675 4627226
Rash papular 99.74 43.18 40 8051 4571 4626330
Rash macular 97.88 43.18 42 8049 5690 4625211
Stomatitis 97.06 43.18 59 8032 16580 4614321
Asthenia 94.86 43.18 117 7974 86046 4544855
Acute motor-sensory axonal neuropathy 93.31 43.18 17 8074 78 4630823
Haematoma 92.90 43.18 48 8043 9868 4621033
Swelling face 92.72 43.18 55 8036 14785 4616116
Shock haemorrhagic 91.30 43.18 33 8058 2839 4628062
Photosensitivity reaction 89.35 43.18 37 8054 4589 4626312
Hyponatraemia 89.23 43.18 65 8026 24665 4606236
Aplasia pure red cell 88.68 43.18 29 8062 1845 4629056
Blood alkaline phosphatase increased 87.80 43.18 50 8041 12457 4618444
Cardiac arrest 87.14 43.18 73 8018 33934 4596967
Cytomegalovirus infection 85.69 43.18 41 8050 7152 4623749
Decreased appetite 84.73 43.18 90 8001 56307 4574594
C-reactive protein increased 84.02 43.18 49 8042 12763 4618138
Pleural effusion 83.23 43.18 62 8029 24336 4606565
Acute lymphocytic leukaemia recurrent 83.22 43.18 22 8069 660 4630241
Rash pustular 83.07 43.18 31 8060 2918 4627983
Splenomegaly 82.97 43.18 34 8057 4106 4626795
Blood uric acid increased 81.15 43.18 27 8064 1813 4629088
White blood cell count increased 81.08 43.18 51 8040 15216 4615685
Labelled drug-drug interaction medication error 80.72 43.18 31 8060 3157 4627744
Conjunctival hyperaemia 78.18 43.18 24 8067 1242 4629659
Platelet count decreased 77.25 43.18 69 8022 34933 4595968
Haematocrit decreased 77.07 43.18 41 8050 8941 4621960
Aplastic anaemia 77.03 43.18 26 8065 1825 4629076
Hyperglycaemia 76.09 43.18 44 8047 11278 4619623
Pulmonary fibrosis 76.04 43.18 35 8056 5595 4625306
Precancerous skin lesion 76.02 43.18 18 8073 340 4630561
Mucosal inflammation 76.01 43.18 44 8047 11299 4619602
Oral mucosa erosion 74.77 43.18 19 8072 486 4630415
Haemodialysis 74.30 43.18 33 8058 4854 4626047
Blood creatine phosphokinase increased 74.12 43.18 48 8043 15051 4615850
Haemophagocytic lymphohistiocytosis 73.89 43.18 29 8062 3130 4627771
Hyperpyrexia 73.58 43.18 23 8068 1264 4629637
Mouth ulceration 73.08 43.18 35 8056 6115 4624786
Liver function test abnormal 72.84 43.18 47 8044 14645 4616256
Mucosal erosion 72.70 43.18 18 8073 413 4630488
Vasculitis 71.81 43.18 31 8060 4260 4626641
Medication error 71.19 43.18 46 8045 14370 4616531
Fixed eruption 70.59 43.18 18 8073 467 4630434
Mixed liver injury 69.50 43.18 19 8072 649 4630252
Dyspnoea exertional 69.24 43.18 40 8051 10232 4620669
Nodular regenerative hyperplasia 67.99 43.18 16 8075 294 4630607
Premature baby 67.38 43.18 39 8052 10012 4620889
Venoocclusive liver disease 66.22 43.18 24 8067 2079 4628822
Blood lactate dehydrogenase increased 66.06 43.18 35 8056 7568 4623333
Staphylococcal infection 65.15 43.18 39 8052 10649 4620252
Anticoagulation drug level above therapeutic 65.02 43.18 17 8074 488 4630413
Petechiae 64.47 43.18 28 8063 3903 4626998
Hepatic enzyme increased 64.22 43.18 47 8044 17944 4612957
Product use in unapproved indication 64.19 43.18 54 8037 25219 4605682
Tricuspid valve incompetence 63.85 43.18 26 8065 3088 4627813
Cheilitis 62.36 43.18 21 8070 1463 4629438
Klebsiella infection 62.21 43.18 22 8069 1775 4629126
Cerebral haemorrhage 61.75 43.18 41 8050 13400 4617501
Blood bilirubin increased 61.55 43.18 40 8051 12612 4618289
Hyperthermia 61.47 43.18 26 8065 3398 4627503
Renal tubular necrosis 60.66 43.18 27 8064 3991 4626910
Abdominal pain 60.39 43.18 78 8013 59946 4570955
Blood glucose increased 60.00 43.18 51 8040 24153 4606748
Pulmonary sarcoidosis 59.86 43.18 15 8076 362 4630539
Overdose 59.24 43.18 66 8025 43493 4587408
Fatigue 58.53 43.18 125 7966 145441 4485460
Xerosis 57.99 43.18 14 8077 288 4630613
Extravasation blood 57.48 43.18 11 8080 69 4630832
Hepatitis cholestatic 57.44 43.18 23 8068 2615 4628286
Oral disorder 57.44 43.18 22 8069 2223 4628678
Epidermolysis 57.41 43.18 13 8078 200 4630701
Cough 57.11 43.18 73 8018 55514 4575387
Abnormal loss of weight 56.47 43.18 19 8072 1320 4629581
Wheezing 56.01 43.18 36 8055 11138 4619763
Myalgia 55.96 43.18 63 8028 41985 4588916
Haematuria 55.83 43.18 38 8053 12932 4617969
Disseminated intravascular coagulation 55.47 43.18 31 8060 7442 4623459
Enanthema 55.03 43.18 13 8078 243 4630658
Acute hepatic failure 54.73 43.18 28 8063 5634 4625267
Blood potassium increased 54.54 43.18 27 8064 5068 4625833
Tachycardia 54.50 43.18 54 8037 31091 4599810
Odynophagia 54.21 43.18 20 8071 1822 4629079
Lip haemorrhage 54.20 43.18 13 8078 260 4630641
Hypovolaemia 53.87 43.18 22 8069 2631 4628270
Granulomatous liver disease 53.55 43.18 13 8078 274 4630627
Lip swelling 52.87 43.18 31 8060 8148 4622753
Lung disorder 52.67 43.18 36 8055 12335 4618566
Epistaxis 52.01 43.18 43 8048 19600 4611301
Hepatic necrosis 51.92 43.18 20 8071 2052 4628849
Dysphagia 51.74 43.18 48 8043 25483 4605418
Foetal exposure during pregnancy 51.73 43.18 46 8045 23123 4607778
Nausea 51.39 43.18 134 7957 177199 4453702
Parakeratosis 50.73 43.18 11 8080 137 4630764
Febrile neutropenia 50.50 43.18 48 8043 26264 4604637
Serum ferritin increased 50.49 43.18 19 8072 1829 4629072
Myositis 50.08 43.18 22 8069 3151 4627750
Tachypnoea 49.54 43.18 25 8066 4886 4626015
Hypokalaemia 49.52 43.18 41 8050 18719 4612182
Ejection fraction decreased 49.28 43.18 26 8065 5570 4625331
Venoocclusive disease 49.27 43.18 16 8075 995 4629906
Blood bicarbonate decreased 49.25 43.18 16 8075 996 4629905
Linear IgA disease 49.08 43.18 15 8076 764 4630137
Gouty tophus 49.08 43.18 10 8081 90 4630811
Patent ductus arteriosus 48.62 43.18 18 8073 1656 4629245
Acidosis 48.58 43.18 22 8069 3384 4627517
Hyperbilirubinaemia 48.36 43.18 24 8067 4527 4626374
Anaemia macrocytic 48.00 43.18 15 8076 823 4630078
Epstein-Barr virus infection 47.82 43.18 20 8071 2541 4628360
Lymphocyte morphology abnormal 47.75 43.18 12 8079 293 4630608
Base excess decreased 46.93 43.18 10 8081 114 4630787
Copper deficiency 46.83 43.18 8 8083 23 4630878
Anti-erythropoietin antibody negative 46.33 43.18 8 8083 25 4630876
Acute respiratory failure 46.10 43.18 26 8065 6350 4624551
Hypoglycaemia 46.04 43.18 39 8052 18370 4612531
Rectal haemorrhage 45.86 43.18 33 8058 12263 4618638
Left ventricular enlargement 45.81 43.18 9 8082 66 4630835
Off label use 45.24 43.18 105 7986 129008 4501893
Skin cancer 45.13 43.18 21 8070 3438 4627463
Cellulitis 45.07 43.18 37 8054 16695 4614206
Oral candidiasis 44.91 43.18 21 8070 3476 4627425
Vasculitis necrotising 44.83 43.18 12 8079 378 4630523
Neutropenic sepsis 44.59 43.18 21 8070 3532 4627369
Weight decreased 44.49 43.18 64 8027 54400 4576501
Skin oedema 44.47 43.18 12 8079 390 4630511
Cardiac murmur 44.42 43.18 20 8071 3035 4627866
Cholecystitis 44.33 43.18 22 8069 4149 4626752
Central nervous system vasculitis 44.32 43.18 12 8079 395 4630506
Haemolytic anaemia 44.30 43.18 22 8069 4156 4626745
Eyelid oedema 44.19 43.18 22 8069 4177 4626724
Gamma-glutamyltransferase increased 43.81 43.18 31 8060 11223 4619678
Oral herpes 43.79 43.18 20 8071 3138 4627763
Mucosal disorder 43.58 43.18 14 8077 841 4630060
Cholestatic liver injury 43.55 43.18 13 8078 611 4630290
Interstitial granulomatous dermatitis 43.22 43.18 9 8082 91 4630810
Hypereosinophilic syndrome 43.22 43.18 10 8081 170 4630731

Pharmacologic Action:

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

Drug Use (View source of the data)

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

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.52 acidic
pKa2 9.43 acidic
pKa3 1.45 Basic

Orange Book patent data (new drug applications)

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

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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

External reference:

IDSource
D000493 MESH_DESCRIPTOR_UI
4017895 VUID
N0000146247 NUI
C0002144 UMLSCUI
D00224 KEGG_DRUG
428673RC2Z UNII
17795-21-0 SECONDARY_CAS_RN
1731 INN_ID
25246002 SNOMEDCT_US
1816 MMSL
519 RXNORM
387135004 SNOMEDCT_US
4150 MMSL
d00023 MMSL
4017895 VANDF
001084 NDDF
8256 MMSL
135401907 PUBCHEM_CID
CHEBI:40279 CHEBI
CHEMBL1467 ChEMBL_ID
DB00437 DRUGBANK_ID
CHEMBL1200477 ChEMBL_ID
6795 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Allopurinol sodium HUMAN PRESCRIPTION DRUG LABEL 1 0143-9533 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0378-0137 TABLET 100 mg ORAL ANDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0378-0181 TABLET 300 mg ORAL ANDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0591-5543 TABLET 100 mg ORAL NDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0591-5544 TABLET 300 mg ORAL NDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0603-2115 TABLET 100 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0603-2116 TABLET 300 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0615-1592 TABLET 100 mg ORAL ANDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0615-1593 TABLET 300 mg ORAL ANDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0615-8321 TABLET 100 mg ORAL NDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6571 TABLET 100 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 0904-6572 TABLET 300 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 10544-545 TABLET 100 mg ORAL ANDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 10544-547 TABLET 300 mg ORAL ANDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 10544-911 TABLET 300 mg ORAL ANDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 16714-041 TABLET 100 mg ORAL ANDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 16714-042 TABLET 300 mg ORAL ANDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 16729-134 TABLET 100 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 16729-135 TABLET 300 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 21695-246 TABLET 300 mg ORAL ANDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 21695-836 TABLET 100 mg ORAL ANDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 29300-349 TABLET 100 mg ORAL ANDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 29300-350 TABLET 300 mg ORAL ANDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 33261-597 TABLET 300 mg ORAL NDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 33261-810 TABLET 100 mg ORAL NDA 11 sections
ALLOPURINOL HUMAN PRESCRIPTION DRUG LABEL 1 42549-500 TABLET 100 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 43063-079 TABLET 100 mg ORAL ANDA 12 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 43063-774 TABLET 300 mg ORAL NDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 43063-793 TABLET 100 mg ORAL NDA 11 sections
Allopurinol HUMAN PRESCRIPTION DRUG LABEL 1 43063-934 TABLET 300 mg ORAL ANDA 12 sections