Skip to main content

What the FDA labels say about taking them together

Azathioprine and chlorambucil

Azathioprine's FDA label of November 8, 2025 names chlorambucil in its contraindications section; the chlorambucil label PlainMeds reads does not name azathioprine. The azathioprine label: “Patients with rheumatoid arthritis previously treated with alkylating agents may have a prohibitive risk of malignancy if treated with IMURAN.”

Check it at the source: the azathioprine FDA label on DailyMed (effective November 8, 2025, Sebela Pharmaceuticals Inc.); the chlorambucil FDA label on DailyMed (effective January 8, 2025, Waylis Therapeutics LLC).

What does the azathioprine label say about chlorambucil?

Azathioprine label, contraindications

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.

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 chlorambucil label say about azathioprine?

Chlorambucil's label (effective January 8, 2025) does not name azathioprine in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (LEUKERAN), Waylis Therapeutics LLC, effective January 8, 2025 (SPL set 58a3c995-5ad6-465d-8437-5970c9088213), 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

17Azathioprine generic labelers
0Chlorambucil generic labelers
AzathioprineChlorambucil
Labeled forOrgan transplant rejection, Rheumatoid arthritisLeukemia, lymphoma and myeloma
Boxed warningYesYes
Pharmacy cost (NADAC)$0.124 per tablet 50 mg tabletn/a
Shortage nowNo current entryNo current entry

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?