Does Dabigatran Interact With Ketoconazole?

In patients with moderate renal impairment (CrCl 30 to 50 mL/min), reduce the dosage of dabigatran etexilate to 75 mg twice daily when administered concomitantly with the P-gp inhibitors dronedarone or systemic ketoconazole.

Severity: Minor

Severity basis: drug interactions section. Combining Dabigatran (Direct thrombin inhibitor) and Ketoconazole (Azole antifungal (strong CYP3A4 inhibitor)) is classified as a minor interaction.

What to Do

This is generally a minor interaction, but review it with your pharmacist to be sure it is safe for you.

From the FDA Label

In patients with moderate renal impairment (CrCl 30 to 50 mL/min), reduce the dosage of dabigatran etexilate to 75 mg twice daily when administered concomitantly with the P-gp inhibitors dronedarone or systemic ketoconazole.

Source: FDA structured product labeling (set_id 13649035-a498-4e31-a7ea-8b18cedceca7).

Dabigatran

Direct thrombin inhibitor

Brands: Pradaxa

View Dabigatran safety profile

Ketoconazole

Azole antifungal (strong CYP3A4 inhibitor)

Brands: Nizoral

View Ketoconazole safety profile

Check these against your full medication list in our free Interaction Checker

This information is educational — not medical advice.

This page is provided for general educational purposes and summarizes publicly available data from sources such as the U.S. Food & Drug Administration. It is not a substitute for the judgment of a licensed clinician and should not be used to start, stop, or change any medication. It may be incomplete or out of date, and individual circumstances vary. Always talk with your prescriber or pharmacist about your specific medications and health conditions. If you think you may have a medical emergency, call 911.

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