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What the FDA labels say about taking them together

Ketoconazole and ospemifene

Ospemifene's FDA label of February 14, 2025 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name ospemifene. The ospemifene label: “Ketoconazole Ketoconazole, a strong CYP3A4 inhibitor, increases the systemic exposure of ospemifene by 1.4-fold.”

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 ospemifene FDA label on DailyMed (effective February 14, 2025, Duchesnay USA, Inc.).

What does the ketoconazole label say about ospemifene?

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

Ospemifene label, drug interactions

Ketoconazole Ketoconazole, a strong CYP3A4 inhibitor, increases the systemic exposure of ospemifene by 1.4-fold.

Source: FDA drug label (Osphena), Duchesnay USA, Inc., effective February 14, 2025 (SPL set 9accbcc9-78ee-4f84-9b7e-704f2ab1c413), 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
0Ospemifene generic labelers
KetoconazoleOspemifene
Labeled forFungal infectionsMenopause symptoms
Boxed warningNoYes
Pharmacy cost (NADAC)$0.249 per gram 2% cream$8.17 per tablet 60 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)

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