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What the FDA labels say about taking them together

Cyclosporine and sirolimus

Cyclosporine's FDA label of August 10, 2026 names sirolimus in its drug interactions section, and sirolimus's label names cyclosporine too. The sirolimus label: “Use with Cyclosporine Cyclosporine, a substrate and inhibitor of CYP3A4 and P-gp, was demonstrated to increase sirolimus concentrations when co-administered with sirolimus.”

Check it at the source: the cyclosporine FDA label on DailyMed (effective August 10, 2026, Novartis Pharmaceuticals Corporation); the sirolimus FDA label on DailyMed (effective January 28, 2026, Glenmark Pharmaceuticals Inc., USA).

What does the cyclosporine label say about sirolimus?

Cyclosporine label, drug interactions

Cyclosporine may reduce the clearance of digoxin, colchicine, prednisolone, HMG-CoA reductase inhibitors (statins), aliskiren, bosentan, dabigatran, repaglinide, NSAIDs, sirolimus, etoposide, and other drugs.

Source: FDA drug label (Sandimmune, NDA050573), Novartis Pharmaceuticals Corporation, effective July 10, 2026 (SPL set 5e5926a7-1de0-4b54-a5c0-286b6200ff82), via openFDA

Source: FDA drug label (Neoral), Novartis Pharmaceuticals Corporation, effective August 10, 2026 (SPL set 94461af3-11f1-4670-95d4-2965b9538ae3), via openFDA; the full label on DailyMed

What does the sirolimus label say about cyclosporine?

Sirolimus label, boxed warning

In 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 ) ].

Sirolimus label, drug interactions

Use with Cyclosporine Cyclosporine, a substrate and inhibitor of CYP3A4 and P-gp, was demonstrated to increase sirolimus concentrations when co-administered with sirolimus.

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

14Cyclosporine generic labelers
17Sirolimus generic labelers
CyclosporineSirolimus
Labeled forOrgan transplant rejection, Rheumatoid arthritisOrgan transplant rejection
Boxed warningYesYes
Pharmacy cost (NADAC)$1.04 per unit 0.05% eye emulsion$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?