What the FDA labels say about taking them together
Dronedarone and ketoconazole
Dronedarone's FDA label of May 29, 2025 names ketoconazole in its contraindications section; the ketoconazole label PlainMeds reads does not name dronedarone. The dronedarone label: “… syndrome Bradycardia <50 bpm Concomitant use of strong CYP3A inhibitors, such as ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, and ritonavir Concomitant use of …”
Check it at the source: the dronedarone FDA label on DailyMed (effective May 29, 2025, Sanofi-Aventis U.S. LLC); the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC).
What does the dronedarone label say about ketoconazole?
Dronedarone label, contraindicationsCONTRAINDICATIONS MULTAQ is contraindicated in patients with: Permanent atrial fibrillation (patients in whom normal sinus rhythm will not or cannot be restored) [see Boxed Warning, Warnings and Precautions (5.2) ] Symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV symptoms [see Boxed Warning, Warnings and Precautions (5.1) ] Second or third-degree atrioventricular (AV) block, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker) Bradycardia <50 bpm Concomitant use of strong CYP3A inhibitors, such as ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, and ritonavir …
Dronedarone label, drug interactionsDrugs 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) ].
Source: FDA drug label (Multaq), Sanofi-Aventis U.S. LLC, effective May 29, 2025 (SPL set 7fa41601-7fb5-4155-8e50-2ae903f0d2d6), via openFDA; the full label on DailyMed
What does the ketoconazole label say about dronedarone?
Ketoconazole's label (effective January 28, 2026) does not name dronedarone in these sections. A label lists what its studies and reports found; it is not a complete list.
Source: FDA drug label (ketoconazole), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set cad7c647-34a9-4e4e-83b3-8d78e58f588f), via openFDA; the full label on DailyMed
These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.
Both medicines on the record
| Dronedarone | Ketoconazole | |
|---|---|---|
| Labeled for | n/a | Fungal infections |
| Boxed warning | Yes | No |
| Pharmacy cost (NADAC) | $13.19 per tablet 400 mg tablet | $0.249 per gram 2% cream |
| Shortage now | No current entry | No current entry |
Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)
What next?
- Check more medicines together
- up to five at once