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What the FDA labels say about taking them together

Estazolam and ketoconazole

Estazolam's FDA label of November 11, 2022 names ketoconazole in its contraindications section; the ketoconazole label PlainMeds reads does not name estazolam. The estazolam label: “CONTRAINDICATIONS Estazolam is contraindicated with ketoconazole and itraconazole, since these medications significantly impair oxidative metabolism mediated by CYP3A.”

Check it at the source: the estazolam FDA label on DailyMed (effective November 11, 2022, Novitium Pharma LLC); the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC).

What does the estazolam label say about ketoconazole?

Estazolam label, contraindications

CONTRAINDICATIONS Estazolam is contraindicated with ketoconazole and itraconazole, since these medications significantly impair oxidative metabolism mediated by CYP3A (see WARNINGS and PRECAUTIONS, Drug Interactions ).

Estazolam label, drug interactions

Consequently, estazolam should be avoided in patients receiving ketoconazole and itraconazole, which are very potent inhibitors of CYP3A (see CONTRAINDICATIONS ).

Source: FDA drug label (Estazolam), Novitium Pharma LLC, effective November 11, 2022 (SPL set e1c77eb1-9cba-4e89-a03f-9fb797add4f0), via openFDA; the full label on DailyMed

What does the ketoconazole label say about estazolam?

Ketoconazole's label (effective January 28, 2026) does not name estazolam 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

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

3Estazolam generic labelers
30Ketoconazole generic labelers
EstazolamKetoconazole
Labeled forInsomniaFungal infections
Boxed warningYesNo
Pharmacy cost (NADAC)$0.839 per tablet 2 mg tablet$0.249 per gram 2% cream
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?