{
 "query": "allopurinol",
 "ingredient": "allopurinol",
 "slug": "allopurinol",
 "rxcui": "519",
 "brands": [
  "Aloprim",
  "Zyloprim"
 ],
 "names": [
  "allopurinol",
  "allopurinol sodium"
 ],
 "classes": [
  {
   "id": "M04AA",
   "name": "Preparations inhibiting uric acid production"
  }
 ],
 "alternatives": [
  "febuxostat",
  "tisopurine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 130,
   "INTRAVENOUS": 4
  },
  "boxed_warning": "BOXED WARNING",
  "indications_and_usage": "Allopurinol tablets are indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) Limitations of Use Allopurinol tablets are not recommended for the treatment of asymptomatic hyperuricemia. Allopurinol tablets are a xanthine oxidase inhibitor indicated for the management of: Adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) ( 1 ) Adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receivin...",
  "contraindications": "Allopurinol tablets are contraindicated in patients with a history of hypersensitivity reaction to allopurinol or to any of the ingredients of allopurinol tablets. Known hypersensitivity to allopurinol or to any of the ingredients of allopurinol tablets.",
  "warnings_and_cautions": "Skin Rash and Hypersensitivity: Allopurinol has been associated with serious and sometimes fatal dermatological reactions. Discontinue allopurinol tablets at the first appearance of skin rash or other signs of hypersensitivity reaction. ( 5.1 ) Gout Flares: May occur during initiation of treatment. Concurrent prophylactic treatment with colchicine or anti-inflammatory agents is recommended. ( 5.2 ) Nephrotoxicity: Allopurinol may affect kidney function. Patients with decreased kidney function require lower doses of allopurinol tablets. ( 5.3 ) Hepatoxicity: Cases of reversible hepatotoxicity have occurred. If signs and symptoms of hepatotoxicity develop, evaluate liver function. ( 5.4 ) Myelosuppression: Bone marrow suppression has been reported with allopurinol. ( 5.5 ) Potential Effect on Driving and Use of Machinery: Drowsiness, somnolence and dizziness have been reported in patients taking allopurinol tablets. ( 5.6 ) 5.1 Skin Rash and Hypersensitivity Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in patients taki...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Skin Rash and Hypersensitivity [see Warnings and Precautions ( 5.1 )] Nephrotoxicity [see Warnings and Precautions ( 5.3 )] Hepatoxicity [see Warnings and Precautions ( 5.4 )] Myelosuppression [see Warnings and Precautions ( 5.5 )] Potential Effect on Driving and Use of Machinery [see Warnings and Precautions ( 5.6 )] The following adverse reactions associated with the use of allopurinol tablets were identified in literature, unpublished clinical trials or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most frequent adverse reaction to allopurinol tablets is skin rash. Most Common Adverse Reactions (\u2265 1%) Gastrointestinal : Diarrhea, nausea, alkaline phosphatase increase, AST/ALT increase. Metabolic and Nutritional : Acute attacks of gout. Skin and Appendages : Rash, maculopapular rash. Less Common Adverse Reactions (< 1%) Body As a Whole : Ecchymosis, fever, headache, malaise. Cardiovascular : Necro...",
  "drug_abuse_and_dependence": "DEPENDENCE",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Administration Advise patients to take allopurinol tablets after meals to minimize gastric irritation. If a single dose of allopurinol tablets is occasionally forgotten, there is no need to double the dose at the next scheduled time. Skin Rash and Hypersensitivity Inform patients that allopurinol tablets may increase the risk of serious and sometimes fatal dermatologic reactions. Instruct patients to discontinue allopurinol tablets and to seek medical attention immediately, at the first sign of a skin rash, blisters, fever, painful urination, blood in the urine, irritation of the eyes, swelling of the lips or mouth, or other signs and symptoms of hypersensitivity reactions [see Warnings and Precautions ( 5.1 )]. Gout Flares During Treatment With Allopurinol Tablets Inform patients that gout flares may occur during initiation of treatment with allopurinol tablets, even when their serum uric acid is normal. Concurrent use of additional medications such as colchicine or other anti-inflammatory agents can prevent gout flares. Advise patients to continue treatment with both, allopurinol tablets and the prophylactic therapy as prescribed, even if gout flares occur. Reassure them that it ...",
  "spl_medguide": "",
  "clinical_studies": "STUDIES",
  "brand_name": "Allopurinol",
  "manufacturer": "Bryant Ranch Prepack",
  "application_number": "ANDA075798",
  "pharm_class_epc": [
   "Xanthine Oxidase Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240708",
  "set_id": "005048dd-844f-468c-bf56-1a09727e3477",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 136853,
  "serious": 112933,
  "death": 18791,
  "hospitalization": 67308,
  "primary_suspect": 136283,
  "top_reactions": [
   [
    "Diarrhoea",
    7749
   ],
   [
    "Fatigue",
    7529
   ],
   [
    "Acute Kidney Injury",
    7523
   ],
   [
    "Off Label Use",
    6988
   ],
   [
    "Dyspnoea",
    6882
   ],
   [
    "Death",
    6605
   ],
   [
    "Nausea",
    6283
   ],
   [
    "Pyrexia",
    5183
   ],
   [
    "Pneumonia",
    5103
   ],
   [
    "Asthenia",
    4818
   ],
   [
    "Anaemia",
    4736
   ],
   [
    "Drug Ineffective",
    4629
   ],
   [
    "Dizziness",
    4367
   ],
   [
    "Fall",
    4127
   ],
   [
    "Renal Failure",
    3791
   ]
  ],
  "by_year": {
   "2019": 14833,
   "2020": 14415,
   "2021": 12131,
   "2022": 10938,
   "2023": 9442,
   "2024": 9152,
   "2025": 9226,
   "2026": 4327
  },
  "by_year_primary": {
   "2019": 14822,
   "2020": 14383,
   "2021": 12087,
   "2022": 10792,
   "2023": 9351,
   "2024": 9059,
   "2025": 9141,
   "2026": 4272
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20240607",
   "reason": "Presence of foreign substance.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230112",
   "reason": "Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220126",
   "reason": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
   "firm": "CARDINAL HEALTHCARE",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200505",
   "reason": "Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.",
   "firm": "Mylan Institutional LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20150720",
   "reason": "Failed Tablet/Capsule Specifications; report of oversized and discolored tablets",
   "firm": "Qualitest Pharmaceuticals",
   "status": "Terminated"
  }
 ],
 "recall_total": 5,
 "drugsfda": {
  "applications": 35,
  "nda": 7,
  "anda": 24,
  "first_approval": "19660819",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 23,
  "labeling_recent": 10,
  "sponsors": [
   "ABBOTT",
   "ACCORD HLTHCARE",
   "AIPING PHARM INC",
   "AUROBINDO PHARMA LTD",
   "CASPER PHARMA LLC",
   "CHARTWELL",
   "DR REDDYS",
   "GLAND"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/19/1966"
 },
 "trials": {
  "total": 227,
  "completed": 153,
  "terminated": 26,
  "with_results": 72,
  "industry": 80,
  "phase3": 51,
  "results_share": 0.47058823529411764,
  "terminated_share": 0.1145374449339207
 },
 "pubmed": {
  "rct": 281,
  "meta": 68,
  "recent_rct": 38,
  "cochrane": [
   {
    "pmid": "25314636",
    "title": "Allopurinol for chronic gout",
    "year": "2014"
   },
   {
    "pmid": "22786499",
    "title": "Allopurinol for preventing mortality and morbidity in newborn infants with hypoxic-ischaemic encephalopathy",
    "year": "2012"
   },
   {
    "pmid": "18425971",
    "title": "Allopurinol for preventing mortality and morbidity in newborn infants with suspected hypoxic-ischaemic encephalopathy",
    "year": "2008"
   },
   {
    "pmid": "12519549",
    "title": "Allopurinol for chronic prostatitis",
    "year": "2002"
   },
   {
    "pmid": "10796738",
    "title": "Allopurinol for chronic prostatitis",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "allopurinol",
   "Aloprim",
   "Zyloprim"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 9710041,
  "beneficiaries": 2355824,
  "spend": 96258249.59,
  "by_brand": [
   {
    "brand": "Allopurinol",
    "claims": 9710041,
    "per_claim": 9.9132691191,
    "is_generic": true
   }
  ],
  "per_claim": 9.913269119049033
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "allopurinol",
  "matched": "allopurinol",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 22472,
  "fills": 9710041,
  "per_million": 2314.3053669907263,
  "ratio": 0.8358061982969003,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 65,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,314 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x the median drug on this site",
    "Death appears in 1.5x the FAERS average share of reports (within the margin this measure deserves)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 72,
   "letter": "C",
   "why": [
    "281 randomized trials and 68 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "5 independent Cochrane review(s) exist",
    "Only 47% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 86,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 4 Class II, 0 Class III across 24 generic makers (-6)",
    "10 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 90,
   "letter": "A",
   "why": [
    "Generic versions approved (24 applications)",
    "2 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 78,
 "grade": "B",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are diarrhoea, fatigue, acute kidney injury. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over febuxostat, tisopurine? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}