AZATHIOPRINE SODIUM
AZATHIOPRINE SODIUM is indicated for the treatment of Rheumatoid Arthritis.
Details
- Status
- Prescription
- First Approved
- 1995-03-31
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
AZATHIOPRINE SODIUM Approval History
What AZATHIOPRINE SODIUM Treats
1 indicationsAZATHIOPRINE SODIUM is approved for 1 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
AZATHIOPRINE SODIUM Boxed Warning
WARNING - MALIGNANCY Chronic immunosuppression with azathioprine, 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 malignanc...
WARNING - MALIGNANCY Chronic immunosuppression with azathioprine, 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 azathioprine. See WARNINGS .
AZATHIOPRINE SODIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in AZATHIOPRINE SODIUM's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AZATHIOPRINE SODIUM treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AZATHIOPRINE SODIUM
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AZATHIOPRINE SODIUM FDA Label Details
Indications & Usage
AZATHIOPRINE SODIUM is indicated for the treatment of Rheumatoid Arthritis.
WARNING - MALIGNANCY Chronic immunosuppression with azathioprine, 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 s...
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IMURAN
Full clinical data, patents, trials, and competitive landscape for azathioprine sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.