Dronedarone and Ketoconazole Interaction
Drug interaction information between Dronedarone and Ketoconazole.
Dronedarone and Ketoconazole have a documented major interaction in FDA labeling.
FDA drug labeling documents a major-severity interaction between Dronedarone and Ketoconazole. Major interactions are generally avoided, moderate ones may need monitoring or a dose adjustment, and minor ones are usually low-risk. This page shows the documented mechanism and guidance. Label-documented interactions are not a complete safety review, so always confirm your own medications with a pharmacist or doctor. Educational information, not medical advice.
How They Interact
Ketoconazole stops the liver enzyme that breaks down dronedarone from working. This causes dronedarone to build up to much higher levels in your body.
What To Do
Do not use these medications at the same time. This combination is contraindicated by the manufacturer.
FDA Label Information
7.2 Effects of Other Drugs on Dronedarone Ketoconazole and Other Potent CYP3A Inhibitors Concomitant use of ketoconazole as well as other potent CYP3A inhibitors such as itraconazole, voriconazole, ritonavir, clarithromycin, and nefazodone is contraindicated because exposure to dronedarone is significantly increased [see Contraindications (4) , Clinical Pharmacology (12.3) ] .
Dronedarone Also Interacts With
- Clarithromycin major
- Voriconazole major
- Darunavir major
- Ezetimibe major
- Ezetimibe/Simvastatin major
Ketoconazole Also Interacts With
- Alfuzosin major
- Ranolazine major
- Saxagliptin major
- Sildenafil major
- Theophylline major
Frequently Asked Questions
Can I take Dronedarone and Ketoconazole together?
This is a major interaction. Do not use these medications at the same time. This combination is contraindicated by the manufacturer.
How serious is the interaction between Dronedarone and Ketoconazole?
This interaction is classified as "major" severity by the FDA. Major interactions may be life-threatening or cause serious side effects.
Why do Dronedarone and Ketoconazole interact?
Ketoconazole stops the liver enzyme that breaks down dronedarone from working. This causes dronedarone to build up to much higher levels in your body.
Understanding the Dronedarone and Ketoconazole Interaction
FDA-approved prescribing information for these two drugs flags their combination as a major-severity interaction. Dronedarone belongs to the Class III Antiarrhythmic class and Ketoconazole belongs to the Azole Antifungal class - two categories that can collide when co-prescribed. The mechanism described in FDA labeling is: Ketoconazole stops the liver enzyme that breaks down dronedarone from working. Severity tiers matter: major flags generally advise avoidance, moderate flags often require monitoring or dose adjustment, and minor flags may only call for awareness.
Context around a specific patient determines real-world impact. Dronedarone has 22 total documented interactions on file in this dataset, and Ketoconazole has 113. Each additional medication compounds the interaction surface, which is why pharmacists run full-profile checks rather than evaluating one pair at a time. FDA-derived guidance for this pair is: Do not use these medications at the same time. Timing of doses, renal and hepatic function, age, and other concurrent prescriptions all shape whether a labeled interaction matters clinically.
An interaction flag is not a verdict. A large share of labeled interactions are managed routinely in clinical practice, the fix may be as simple as spacing doses or adding a monitoring test. Others require the prescriber to choose a different medication entirely. This page surfaces FDA-sourced labeling and openFDA data for educational purposes only; it is not medical advice and cannot account for your full clinical picture. Never start, stop, or adjust either Dronedarone or Ketoconazole based on a web page, speak with your prescriber or pharmacist before making any change.
Sources: FDA Drug Labels (SPL) via openFDA (2026). This is for informational purposes only and is not medical advice. Always consult your healthcare provider about drug interactions.
Read our methodology - how this data is sourced, computed, and verified.