What the FDA labels say about taking them together
Azathioprine and methotrexate
Methotrexate's FDA label (Rasuvo) of December 15, 2025 names azathioprine in its drug interactions section; the azathioprine label PlainMeds reads does not name methotrexate. The methotrexate label: “Therefore, patients receiving concomitant therapy with Rasuvo and other potential hepatotoxins should be closely monitored for possible increased risk of hepatotoxicity.”
Check it at the source: the azathioprine FDA label on DailyMed (effective November 8, 2025, Sebela Pharmaceuticals Inc.); the methotrexate FDA label on DailyMed (effective May 27, 2026, Accord Healthcare Inc.).
What does the azathioprine label say about methotrexate?
Azathioprine's label (effective November 8, 2025) does not name methotrexate in these sections. A label lists what its studies and reports found; it is not a complete list.
Source: FDA drug label (IMURAN), NDA016324 (Legacy), as published by Sebela Pharmaceuticals Inc., effective November 8, 2025 (SPL set 606101a0-6244-7eff-e053-2a91aa0acadd), via openFDA; the full label on DailyMed
What does the methotrexate label say about azathioprine?
Rasuvo label (Medexus Pharma Inc., December 15, 2025), drug interactionsTherefore, patients receiving concomitant therapy with Rasuvo and other potential hepatotoxins (e.g., azathioprine, retinoids, and sulfasalazine) should be closely monitored for possible increased risk of hepatotoxicity.
Otrexup label (Antares Pharma, Inc., January 31, 2025), drug interactionsTherefore, patients receiving concomitant therapy with Otrexup and other potential hepatotoxins (e.g., azathioprine, retinoids, and sulfasalazine) should be closely monitored for possible increased risk of hepatotoxicity.
Source: FDA drug label (Rasuvo, NDA205776), Medexus Pharma Inc., effective December 15, 2025 (SPL set d0075461-0e7e-4967-9c9b-d6440e912c0e), via openFDA
Source: FDA drug label (Otrexup, NDA204824), Antares Pharma, Inc., effective January 31, 2025 (SPL set 9ab8ce16-f7de-41d4-a4c8-1c742621b6d5), via openFDA
Source: FDA drug label (Methotrexate), Accord Healthcare Inc., effective May 27, 2026 (SPL set 874c7f43-a3be-4236-89cc-24c44e3c5813), via openFDA; the full label on DailyMed
These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.
Both medicines on the record
| Azathioprine | Methotrexate | |
|---|---|---|
| Labeled for | Organ transplant rejection, Rheumatoid arthritis | Rheumatoid arthritis, Psoriasis, Leukemia, lymphoma and myeloma, Breast cancer |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | $0.124 per tablet 50 mg tablet | $0.158 per tablet 2.5 mg tablet |
| Shortage now | No current entry | In shortage |
Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)
What next?
- Check more medicines together
- up to five at once