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Drug interactions

Ketoconazole + Roflumilast

Severity: Moderate

Ketoconazole and Roflumilast: moderate interaction.

Last updated

For healthcare professionals — reference only. This page is a brief summary, not medical advice and not a substitute for official labeling or clinical judgement. Always verify before prescribing or dispensing.

Summary

Ketoconazole strongly inhibits CYP3A4 and increases roflumilast and active metabolite exposure. Higher exposure may increase adverse effects such as diarrhea, weight loss, nausea and psychiatric symptoms.

What this interaction means in plain words

Ketoconazole and Roflumilast can affect each other. The combination is often manageable, but it may need a change of dose, a change of timing, or extra checks while both are taken.

Ketoconazole belongs to Anti Fungals; Roflumilast belongs to Respiratory.

Evidence level: High

Why it happens

Ketoconazole inhibits CYP3A4-mediated metabolism of roflumilast.

What to do

Monitor for roflumilast adverse effects, weight and mood during combined use; discontinue roflumilast if intolerable effects occur.

What to ask your pharmacist

  • Should I take them at different times of day?
  • Does the dose of either medicine need to change?
  • Is there anything I should avoid, such as alcohol or certain foods, while on both?

Bring a full list of your medicines, including over-the-counter products, supplements and herbal remedies, to every pharmacy visit.

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Frequently asked questions

Can I take Ketoconazole with Roflumilast?

MediHelp rates the interaction as moderate. Ketoconazole and Roflumilast can affect each other. The combination is often manageable, but it may need a change of dose, a change of timing, or extra checks while both are taken. Ketoconazole strongly inhibits CYP3A4 and increases roflumilast and active metabolite exposure. Higher exposure may increase adverse effects such as diarrhea, weight loss, nausea and psychiatric symptoms.

How serious is the interaction between Ketoconazole and Roflumilast?

MediHelp rates it moderate, on a four-level scale (minor, moderate, major, contraindicated) based on published labels and references. What to do, in brief: Monitor for roflumilast adverse effects, weight and mood during combined use; discontinue roflumilast if intolerable effects occur.

What other medicines interact with Roflumilast?

MediHelp also lists interactions of Roflumilast with, for example, Apalutamide, Carbamazepine, Efavirenz. The full list is on the Roflumilast page.

Full monographs, dosing and an interaction checker in the MediHelp app

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