Ketoconazole and Dronedarone Interaction
Drug interaction information between Ketoconazole and Dronedarone.
Ketoconazole and Dronedarone have a documented major interaction in FDA labeling.
FDA drug labeling documents a major-severity interaction between Ketoconazole and Dronedarone. This page displays the available source-record category and label text. The category is not an individual risk estimate or medication-combination direction.
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.
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) ] .
Ketoconazole Also Interacts With
- Alfuzosin major
- Ranolazine major
- Saxagliptin major
- Sildenafil major
- Theophylline major
Dronedarone Also Interacts With
- Clarithromycin major
- Voriconazole major
- Darunavir major
- Ezetimibe major
- Ezetimibe/Simvastatin major
Frequently Asked Questions
What SPL severity band is on file for Ketoconazole + Dronedarone?
Compiled FDA labeling labels this pair major. That is a source-record field, not an individual medication-combination decision.
Which drug in this pair has the larger labeled-interaction portfolio?
Ketoconazole has 113 labeled pairs on file vs Dronedarone's 22. In the major band specifically: Ketoconazole has 6 (also Alfuzosin, Ranolazine, Saxagliptin, Sildenafil); Dronedarone has 9 (also Clarithromycin, Voriconazole, Darunavir, Ezetimibe).
What mechanism field is on file for Ketoconazole and Dronedarone?
Ketoconazole stops the liver enzyme that breaks down dronedarone from working. This causes dronedarone to build up to much higher levels in your body.
Dronedarone carries more major-labeled pairs than Ketoconazole
SPL source-record counts only. This page's band is major · classes on file: Ketoconazole (Azole Antifungal); Dronedarone (Class III Antiarrhythmic).
Dronedarone has 9 major-labeled pairs vs Ketoconazole's 6.
6 major · 22 moderate · 85 minor · 113 total
- Other major peers for Ketoconazole
- Alfuzosin
- Ranolazine
- Saxagliptin
- Sildenafil
9 major · 5 moderate · 8 minor · 22 total
- Other major peers for Dronedarone
- Clarithromycin
- Voriconazole
- Darunavir
- Ezetimibe
Sources: FDA Drug Labels (SPL) via openFDA (2026). This is for informational purposes only and is not medical advice. This registry does not provide individual medication-combination directions.
Read our methodology - how this data is sourced, computed, and verified.