{
 "query": "azathioprine",
 "ingredient": "azathioprine",
 "slug": "azathioprine",
 "rxcui": "1256",
 "brands": [
  "Imuran",
  "Azasan"
 ],
 "names": [
  "azathioprine",
  "azathioprine sodium"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 18,
   "INTRAVENOUS": 1
  },
  "boxed_warning": "WARNING - MALIGNANCY Chronic immunosuppression with IMURAN, a purine antimetabolite increases risk of malignancy in humans. Reports of malignancy include post-transplant lymphoma and hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease. Physicians using this drug should be very familiar with this risk as well as with the mutagenic potential to both men and women and with possible hematologic toxicities. Physicians should inform patients of the risk of malignancy with IMURAN. See WARNINGS.",
  "indications_and_usage": "INDICATIONS AND USAGE: IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation: IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of IMURAN on these variables has not been tested in controlled trials. Rheumatoid Arthritis: IMURAN is indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with IMURAN. The combined use of IMURAN with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of IMURAN with these agents cannot be recommended.",
  "contraindications": "CONTRAINDICATIONS: IMURAN should not be given to patients who have shown hypersensitivity to the drug. IMURAN should not be used for treating rheumatoid arthritis in pregnant women. Patients with rheumatoid arthritis previously treated with alkylating agents (cyclophosphamide, chlorambucil, melphalan, or others) may have a prohibitive risk of malignancy if treated with IMURAN.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS: Malignancy Patients receiving immunosuppressants, including IMURAN, are at increased risk of developing lymphoma and other malignancies, particularly of the skin. Physicians should inform patients of the risk of malignancy with IMURAN. As usual for patients with increased risk for skin cancer, exposure to sunlight and ultraviolet light should be limited by wearing protective clothing and using a sunscreen with a high protection factor. Post-transplant Renal transplant patients are known to have an increased risk of malignancy, predominantly skin cancer and reticulum cell or lymphomatous tumors. The risk of post-transplant lymphomas may be increased in patients who receive aggressive treatment with immunosuppressive drugs, including IMURAN. Therefore, immunosuppressive drug therapy should be maintained at the lowest effective levels. Rheumatoid Arthritis Information is available on the risk of malignancy with the use of IMURAN in rheumatoid arthritis (see ADVERSE REACTIONS ). It has not been possible to define the precise risk of malignancy due to IMURAN. The data suggest the risk may be elevated in patients with rheumatoid arthritis, though lower than for renal transplant...",
  "adverse_reactions": "ADVERSE REACTIONS: The principal and potentially serious toxic effects of IMURAN are hematologic and gastrointestinal. The risks of secondary infection and malignancy are also significant (see WARNINGS ). The frequency and severity of adverse reactions depend on the dose and duration of IMURAN as well as on the patient's underlying disease or concomitant therapies. The incidence of hematologic toxicities and neoplasia encountered in groups of renal homograft recipients is significantly higher than that in studies employing IMURAN for rheumatoid arthritis. The relative incidences in clinical studies are summarized below: * Data on the rate and risk of neoplasia among persons with rheumatoid arthritis treated with azathioprine are limited. The incidence of lymphoproliferative disease in patients with RA appears to be significantly higher than that in the general population. In one completed study, the rate of lymphoproliferative disease in RA patients receiving higher than recommended doses of azathioprine (5 mg/kg per day) was 1.8 cases per 1000 patient-years of follow-up, compared with 0.8 cases per 1000 patient-years of follow-up in those not receiving azathioprine. However, the p...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients: Patients being started on IMURAN should be informed of the necessity of periodic blood counts while they are receiving the drug and should be encouraged to report any unusual bleeding or bruising to their physician. They should be informed of the danger of infection while receiving IMURAN and asked to report signs and symptoms of infection to their physician. Careful dosage instructions should be given to the patient, especially when IMURAN is being administered in the presence of impaired renal function or concomitantly with allopurinol (see Drug Interactions subsection and DOSAGE AND ADMINISTRATION ). Patients should be advised of the potential risks of the use of IMURAN during pregnancy and during the nursing period. The increased risk of malignancy following therapy with IMURAN should be explained to the patient.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "IMURAN",
  "manufacturer": "Sebela Pharmaceuticals Inc.",
  "application_number": "NDA016324",
  "pharm_class_epc": [
   "Purine Antimetabolite [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251108",
  "set_id": "606101a0-6244-7eff-e053-2a91aa0acadd",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 73769,
  "serious": 65593,
  "death": 7413,
  "hospitalization": 25234,
  "primary_suspect": 73594,
  "top_reactions": [
   [
    "Off Label Use",
    14111
   ],
   [
    "Drug Ineffective",
    13088
   ],
   [
    "Condition Aggravated",
    6865
   ],
   [
    "Arthralgia",
    5716
   ],
   [
    "Diarrhoea",
    4962
   ],
   [
    "Fatigue",
    4942
   ],
   [
    "Nausea",
    4796
   ],
   [
    "Headache",
    4226
   ],
   [
    "Drug Intolerance",
    4176
   ],
   [
    "Crohn^S Disease",
    4054
   ],
   [
    "Pain",
    4025
   ],
   [
    "Rheumatoid Arthritis",
    3839
   ],
   [
    "Pneumonia",
    3729
   ],
   [
    "Malaise",
    3672
   ],
   [
    "Intentional Product Use Issue",
    3657
   ]
  ],
  "by_year": {
   "2019": 7156,
   "2020": 8355,
   "2021": 6640,
   "2022": 6708,
   "2023": 6183,
   "2024": 7015,
   "2025": 6582,
   "2026": 2625
  },
  "by_year_primary": {
   "2019": 7152,
   "2020": 8349,
   "2021": 6623,
   "2022": 6665,
   "2023": 6144,
   "2024": 6985,
   "2025": 6556,
   "2026": 2618
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 9,
  "nda": 2,
  "anda": 6,
  "first_approval": "19680320",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 18,
  "labeling_recent": 2,
  "sponsors": [
   "AAIPHARMA LLC",
   "ALKEM LABS LTD",
   "AMNEAL",
   "CASPER PHARMA LLC",
   "HIKMA",
   "LEGACY",
   "QUAD PHARMS",
   "RISING"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/20/1968"
 },
 "trials": {
  "total": 320,
  "completed": 140,
  "terminated": 48,
  "with_results": 57,
  "industry": 98,
  "phase3": 86,
  "results_share": 0.40714285714285714,
  "terminated_share": 0.15
 },
 "pubmed": {
  "rct": 350,
  "meta": 67,
  "recent_rct": 21,
  "cochrane": [
   {
    "pmid": "40013523",
    "title": "Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis",
    "year": "2025"
   },
   {
    "pmid": "39651635",
    "title": "Azathioprine for people with multiple sclerosis",
    "year": "2024"
   },
   {
    "pmid": "31425621",
    "title": "Azathioprine and 6-mercaptopurine for maintenance of surgically-induced remission in Crohn's disease",
    "year": "2019"
   },
   {
    "pmid": "27783843",
    "title": "Azathioprine or 6-mercaptopurine for induction of remission in Crohn's disease",
    "year": "2016"
   },
   {
    "pmid": "27192092",
    "title": "Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis",
    "year": "2016"
   },
   {
    "pmid": "26633102",
    "title": "Mycophenolic acid versus azathioprine as primary immunosuppression for kidney transplant recipients",
    "year": "2015"
   },
   {
    "pmid": "26517527",
    "title": "Azathioprine or 6-mercaptopurine for maintenance of remission in Crohn's disease",
    "year": "2015"
   },
   {
    "pmid": "25081347",
    "title": "Azathioprine and 6-mercaptopurine for maintenance of surgically-induced remission in Crohn's disease",
    "year": "2014"
   },
   {
    "pmid": "23633304",
    "title": "Azathioprine or 6-mercaptopurine for induction of remission in Crohn's disease",
    "year": "2013"
   },
   {
    "pmid": "22972046",
    "title": "Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis",
    "year": "2012"
   },
   {
    "pmid": "20556747",
    "title": "Azathioprine or 6-mercaptopurine for induction of remission in Crohn's disease",
    "year": "2010"
   },
   {
    "pmid": "19821270",
    "title": "Azathioprine or 6-mercaptopurine for induction of remission in Crohn's disease",
    "year": "2009"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "azathioprine",
   "Imuran",
   "Azasan"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 397668,
  "beneficiaries": 92567,
  "spend": 20295287.029999997,
  "by_brand": [
   {
    "brand": "Azathioprine",
    "claims": 397033,
    "per_claim": 49.6403202,
    "is_generic": true
   },
   {
    "brand": "Imuran",
    "claims": 453,
    "per_claim": 1017.9133333,
    "is_generic": false
   },
   {
    "brand": "Azathioprine Sodium",
    "claims": 99,
    "per_claim": 615.14545455,
    "is_generic": true
   },
   {
    "brand": "Azasan",
    "claims": 83,
    "per_claim": 776.23662651,
    "is_generic": false
   }
  ],
  "per_claim": 51.03575603267046
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "azathioprine",
  "matched": "azathioprine",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 16159,
  "fills": 397668,
  "per_million": 40634.39854350866,
  "ratio": 14.675021996294392,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 50,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "40,634 FDA reports naming it as the suspect drug per million Medicare fills, 14.7x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (1.1x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 73,
   "letter": "C",
   "why": [
    "350 randomized trials and 67 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "12 independent Cochrane review(s) exist",
    "Only 41% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 96,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "2 label changes approved since 2021 (-4)"
   ],
   "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": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (6 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 72,
 "grade": "C",
 "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 condition aggravated, arthralgia. 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?",
  "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.)"
 ]
}