Ketoconazole and Mitapivat interaction

Ketoconazole and Mitapivat: both prescribing labels flag this combination with the strongest language, such as a contraindication, a boxed warning, or an instruction to avoid it.

Major

Do not combine without a prescriber's guidance. The label language below is the strongest FDA uses.

What the FDA labels say

From the Ketoconazole label · effective 2026-07-07

Major

Therefore, administration of potent enzyme inducers of CYP3A4 with ketoconazole tablets is not recommended.

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Moderate

Coadministration of ketoconazole tablets with potent enzyme inducers of CYP3A4 may decrease the bioavailability of ketoconazole to such an extent that efficacy may be reduced.

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From the Mitapivat (AQVESME) label · effective 2026-08-27

Major

Strong CYP3A Inhibitors and Inducers: Avoid concomitant use.

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Major

Moderate CYP3A Inhibitors: Avoid concomitant use.

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Major

Prevention or Management Avoid co-administration of strong CYP3A inhibitors with AQVESME [see Dosage and Administration (2.4) ] .

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Major

Prevention or Management Avoid co-administration of moderate CYP3A inhibitors with AQVESME [see Dosage and Administration (2.4) ] .

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Moderate

Effect of Other Drugs on AQVESME Strong CYP3A Inhibitors Clinical Impact Co-administration of AQVESME with strong CYP3A inhibitors increased mitapivat plasma concentrations [see Clinical Pharmacology (12.3) ] .

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Not medical advice. Interaction Checker quotes FDA label text and NIH fact sheets. Whether an interaction matters for you depends on doses, timing, kidney and liver function, and other conditions. Confirm with a pharmacist or prescriber.