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What the FDA labels say about taking them together

Estazolam and itraconazole

Estazolam's FDA label of November 11, 2022 names itraconazole in its contraindications section; the itraconazole labels PlainMeds reads (2) do 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 itraconazole FDA label on DailyMed (effective July 13, 2026, Janssen Pharmaceuticals, Inc.).

What does the estazolam label say about itraconazole?

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 itraconazole label say about estazolam?

Itraconazole's label (effective July 13, 2026) and its 1 other brand-application label do 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 (SPORANOX), Janssen Pharmaceuticals, Inc., effective July 13, 2026 (SPL set a4d555fa-787c-40fb-bb7d-b0d4f7318fd0), 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
11Itraconazole generic labelers
EstazolamItraconazole
Labeled forInsomniaFungal infections
Boxed warningYesYes
Pharmacy cost (NADAC)$0.839 per tablet 2 mg tablet$0.910 per capsule 100 mg capsule
Shortage nowNo current entryA presentation being discontinued

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

What next?