What the FDA labels say about taking them together
Sirolimus and tacrolimus
Sirolimus's FDA label of January 28, 2026 names tacrolimus in its boxed warning section, and tacrolimus's label names sirolimus too. The tacrolimus label: “Observe patients receiving tacrolimus injection for signs and symptoms of anaphylaxis. Not recommended for use with sirolimus:”
Check it at the source: the sirolimus FDA label on DailyMed (effective January 28, 2026, Glenmark Pharmaceuticals Inc., USA); the tacrolimus FDA label on DailyMed (effective July 17, 2026, Stellon Biotech Inc.).
What does the sirolimus label say about tacrolimus?
Sirolimus label, boxed warningIn this and another study in de novo liver transplant patients, the use of sirolimus in combination with cyclosporine or tacrolimus was associated with an increase in HAT; most cases of HAT occurred within 30 days post-transplantation and most led to graft loss or death [ see Warnings and Precautions ( 5.2 ) ].
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
What does the tacrolimus label say about sirolimus?
Tacrolimus label, warnings and precautionsObserve patients receiving tacrolimus injection for signs and symptoms of anaphylaxis. ( 5.9 ) Not recommended for use with sirolimus:
Prograf label (Astellas Pharma US, Inc., August 25, 2023), warnings and precautionsNot recommended for use with sirolimus: Not recommended in liver and heart transplant due to increased risk of serious adverse reactions.
Source: FDA drug label (Prograf, NDA050708), Astellas Pharma US, Inc., effective August 25, 2023 (SPL set 7f667de1-9dfa-4bd6-8ba0-15ee2d78873b), via openFDA
Source: FDA drug label (Tacrolimus), Stellon Biotech Inc., effective July 17, 2026 (SPL set 6b89e8a4-9f11-42e3-8e79-fe617e7c461f), 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
| Sirolimus | Tacrolimus | |
|---|---|---|
| Labeled for | Organ transplant rejection | Organ transplant rejection, Eczema (atopic dermatitis) |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | $0.723 per tablet 1 mg tablet | $0.970 per gram 0.1% ointment |
| Shortage now | No current entry | No 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?
- Check more medicines together
- up to five at once