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What the FDA labels say about taking them together

Itraconazole and sirolimus

Itraconazole's FDA label of July 13, 2026 names sirolimus in its drug interactions section, and sirolimus's label names itraconazole too. The itraconazole label: “Everolimus Sirolimus Temsirolimus (IV) Not recommended during and 2 weeks after SPORANOX ® treatment.”

Check it at the source: the itraconazole FDA label on DailyMed (effective July 13, 2026, Janssen Pharmaceuticals, Inc.); the sirolimus FDA label on DailyMed (effective January 28, 2026, Glenmark Pharmaceuticals Inc., USA).

What does the itraconazole label say about sirolimus?

Itraconazole label, drug interactions

Everolimus Sirolimus Temsirolimus (IV) Not recommended during and 2 weeks after SPORANOX ® treatment.

Source: FDA drug label (Tolsura, NDA208901), Mayne Pharma Commercial LLC, effective April 23, 2025 (SPL set 306352d1-9d5a-49ad-b72d-893b99546861), via openFDA

Source: FDA drug label (SPORANOX), Janssen Pharmaceuticals, Inc., effective July 13, 2026 (SPL set a4d555fa-787c-40fb-bb7d-b0d4f7318fd0), via openFDA; the full label on DailyMed

What does the sirolimus label say about itraconazole?

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

11Itraconazole generic labelers
17Sirolimus generic labelers
ItraconazoleSirolimus
Labeled forFungal infectionsOrgan transplant rejection
Boxed warningYesYes
Pharmacy cost (NADAC)$0.910 per capsule 100 mg capsule$0.723 per tablet 1 mg tablet
Shortage nowA presentation being discontinuedNo current entry

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

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