Substance / Medication

Azathioprine

Overview

Active Ingredient
azathioprine
RxNorm CUI
1256

Indications

Azathioprine tablets are 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: Azathioprine tablets are 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-do

Labeler: PD-Rx Pharmaceuticals, Inc.Updated: 2026-02-16T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

risk of malignancy WARNINGS Chronic immunosuppression with azathioprine, a purine antimetabolite increasesin 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

Contraindications

When this intervention should not be used

Azathioprine tablets should not be given to patients who have shown hypersensitivity to the drug. Azathioprine tablets should not be used for treating rheumatoid arthritis in pregnant women. Patients with rheumatoid arthritis previously treated with alkylating agents (cyclophosphamide, chlorambucil,

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

Clinical Trials

84 trials linked to this intervention

84
Total Trials
30
Recruiting
15
With Results

Research Evidence

Published studies and systematic reviews

Sort:
Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis.
Hasskamp Johannes, Meinhardt Christian, Patton Petrease H et al. · Cochrane Database Syst Rev · 2025
PMID: 40013523Meta-AnalysisFull text (PMC)
Comparative Efficacy of Mycophenolate Mofetil vs. Azathioprine in Autoimmune Hepatitis: A Systematic Review and Meta-Analysis.
Ibrahim Momen Mohamed, Sawaf Bisher, Hassan Noheir Ashraf Ibrahem Fathy et al. · Digestion · 2025
PMID: 40875669Meta-AnalysisFull text (PMC)
Mycophenolate mofetil versus azathioprine as a first-line treatment for autoimmune hepatitis: a comparative systematic review and meta-analysis.
Ali Amani M, Abdelrahim Mohamed E, AbdelMagid Aya M · BMC Gastroenterol · 2025
PMID: 40846917Meta-AnalysisFull text (PMC)
Azathioprine and risk of non-melanoma skin cancers in organ transplant recipients: a systematic review and update meta-analysis.
Kreuz Michele, Cardoso Jorge Cavalcanti Orestes, Sobreira Luis Eduardo Rodrigues et al. · Clin Transl Oncol · 2025
PMID: 39825996Meta-Analysis
Mycophenolate and azathioprine efficacy in interstitial lung disease: a systematic review and meta-analysis.
Lombardi Francesco, Stewart Iain, Fabbri Laura et al. · BMJ Open Respir Res · 2024
PMID: 38413120Meta-AnalysisFull text (PMC)
Azathioprine for people with multiple sclerosis.
Ridley Ben, Nonino Francesco, Baldin Elisa et al. · Cochrane Database Syst Rev · 2024
PMID: 39651635Meta-AnalysisFull text (PMC)
DNA methylation of the TPMT gene and azathioprine pharmacokinetics in children with very early onset inflammatory bowel disease.
Selvestrel Davide, Stocco Gabriele, Aloi Marina et al. · Biomed Pharmacother · 2023
PMID: 36462311Meta-Analysis
Subclinical atherosclerosis in Behcet's disease and its inverse relation to azathioprine use: an updated meta-analysis.
Merashli Mira, Bucci Tommaso, Arcaro Alessia et al. · Clin Exp Med · 2023
PMID: 37169964Meta-Analysis
The clinical efficacy of azathioprine as maintenance treatment for autoimmune pancreatitis: a systematic review and meta-analysis.
Masaki Yoshiharu, Nakase Hiroshi, Tsuji Yoshihisa et al. · J Gastroenterol · 2021
PMID: 34426870Meta-AnalysisFull text (PMC)

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Health Goals

Goals connected through associated conditions

Quick Facts

Type
Substance / Medication
Fully Specified Name
Azathioprine (substance)
SNOMED CT
372574004
UMLS CUI
C0004482
RxNorm CUI
1256
Labeler
PD-Rx Pharmaceuticals, Inc.

Clinical Data

This intervention maps to 17 entities in the Ltrl knowledge graph.

5
Conditions
7
Biomarkers
3
Specialists
0
Symptoms
84
Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Ltrl clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.