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What the FDA labels say about taking them together

Azathioprine and sirolimus

Sirolimus's FDA label of January 28, 2026 names azathioprine in its warnings and precautions section; the azathioprine label PlainMeds reads does not name sirolimus. The sirolimus label: “Increased serum cholesterol and triglycerides requiring treatment occurred more frequently in patients treated with sirolimus compared with azathioprine or placebo controls in Studies 1 and 2 [ see Adverse Reactions ].”

Check it at the source: the azathioprine FDA label on DailyMed (effective November 8, 2025, Sebela Pharmaceuticals Inc.); the sirolimus FDA label on DailyMed (effective January 28, 2026, Glenmark Pharmaceuticals Inc., USA).

What does the azathioprine label say about sirolimus?

Azathioprine's label (effective November 8, 2025) does not name sirolimus 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 sirolimus label say about azathioprine?

Sirolimus label, warnings and precautions

Increased serum cholesterol and triglycerides requiring treatment occurred more frequently in patients treated with sirolimus compared with azathioprine or placebo controls in Studies 1 and 2 [ see Adverse Reactions ( 6.1 ) ].

Source: FDA drug label (sirolimus), Glenmark Pharmaceuticals Inc., USA, effective January 28, 2026 (SPL set 57fb4d90-3ccb-4a69-af1e-53be83f7a504), 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
17Sirolimus generic labelers
AzathioprineSirolimus
Labeled forOrgan transplant rejection, Rheumatoid arthritisOrgan transplant rejection
Boxed warningYesYes
Pharmacy cost (NADAC)$0.124 per tablet 50 mg tablet$0.723 per tablet 1 mg tablet
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?