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What the FDA labels say about taking them together

Ketoconazole and sirolimus

Sirolimus's FDA label of January 28, 2026 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name sirolimus. The sirolimus label: “Inducers and Strong Inhibitors of CYP3A4 and P-gp Avoid concomitant use of sirolimus with strong inducers and strong inhibitors of CYP3A4 and P-gp.”

Check it at the source: the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC); the sirolimus FDA label on DailyMed (effective January 28, 2026, Glenmark Pharmaceuticals Inc., USA).

What does the ketoconazole label say about sirolimus?

Ketoconazole's label (effective January 28, 2026) 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 (ketoconazole), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set cad7c647-34a9-4e4e-83b3-8d78e58f588f), via openFDA; the full label on DailyMed

What does the sirolimus label say about ketoconazole?

Sirolimus label, drug interactions

Inducers and Strong Inhibitors of CYP3A4 and P-gp Avoid concomitant use of sirolimus with strong inducers (e.g., rifampin, rifabutin) and strong inhibitors (e.g., ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, clarithromycin) of CYP3A4 and P-gp.

Sirolimus label, warnings and precautions

Inhibitors and Inducers of CYP3A4 and/or P-gp Avoid concomitant use of sirolimus with strong inhibitors of CYP3A4 and/or P-gp (such as ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, or clarithromycin) or strong inducers of CYP3A4 and/or P-gp (such as rifampin or rifabutin) [ see Drug Interactions ( 7.2 ) ].

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

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

30Ketoconazole generic labelers
17Sirolimus generic labelers
KetoconazoleSirolimus
Labeled forFungal infectionsOrgan transplant rejection
Boxed warningNoYes
Pharmacy cost (NADAC)$0.249 per gram 2% cream$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?