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What the FDA labels say about taking them together

Ketoconazole and temsirolimus

Temsirolimus's FDA label of December 26, 2025 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name temsirolimus. The temsirolimus label: “Agents Inhibiting CYP3A Metabolism Co-administration of TORISEL with ketoconazole, a potent CYP3A4 inhibitor, had no significant effect on temsirolimus C max or AUC; …”

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 temsirolimus FDA label on DailyMed (effective December 26, 2025, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.).

What does the ketoconazole label say about temsirolimus?

Ketoconazole's label (effective January 28, 2026) does not name temsirolimus 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 temsirolimus label say about ketoconazole?

Temsirolimus label, drug interactions

Agents Inhibiting CYP3A Metabolism Co-administration of TORISEL with ketoconazole, a potent CYP3A4 inhibitor, had no significant effect on temsirolimus C max or AUC; however, sirolimus AUC increased 3.1-fold, and C max increased 2.2-fold compared to TORISEL alone.

Temsirolimus label, warnings and precautions

Agents Inhibiting CYP3A Metabolism: Strong CYP3A4 inhibitors such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin may increase blood concentrations of the active metabolite sirolimus.

Source: FDA drug label (Torisel), NDA022088 (Pf Prism Cv), as published by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective December 26, 2025 (SPL set 95b7dc92-2180-42f1-8699-3c28f609e674), 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
4Temsirolimus generic labelers
KetoconazoleTemsirolimus
Labeled forFungal infectionsn/a
Boxed warningNoNo
Pharmacy cost (NADAC)$0.249 per gram 2% creamn/a
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?