What the FDA labels say about taking them together
Amiodarone and dronedarone
Dronedarone's FDA label of May 29, 2025 names amiodarone in its contraindications section; the amiodarone labels PlainMeds reads (2) do not name dronedarone. The dronedarone label: “… III antiarrhythmics Liver or lung toxicity related to the previous use of amiodarone QTc interval >500 ms or PR interval >280 ms Severe hepatic impairment Hypersensitivity to the active substance or to any of the …”
Check it at the source: the amiodarone FDA label on DailyMed (effective December 9, 2025, Chartwell RX, LLC); the dronedarone FDA label on DailyMed (effective May 29, 2025, Sanofi-Aventis U.S. LLC).
What does the amiodarone label say about dronedarone?
Amiodarone's label (effective December 9, 2025) and its 1 other brand-application label do 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 (Amiodarone Hydrochloride), Chartwell RX, LLC, effective December 9, 2025 (SPL set 5520f11d-968d-4f4f-bf57-d14369c0d746), via openFDA; the full label on DailyMed
What does the dronedarone label say about amiodarone?
Dronedarone label, contraindications… might increase the risk of torsade de pointes, such as phenothiazine antipsychotics, tricyclic antidepressants, certain oral macrolide antibiotics, and Class I and III antiarrhythmics Liver or lung toxicity related to the previous use of amiodarone QTc interval >500 ms or PR interval >280 ms Severe hepatic impairment Hypersensitivity to the active substance or to any of the excipients Permanent AF (patients in whom normal sinus rhythm will not or cannot be restored) ( Boxed Warning, 4 ) Recently decompensated heart failure requiring hospitalization or Class IV heart failure ( Boxed Warning, 4 ) Second or third-degree atrioventricular (AV) block or sick sinus syndrome (except when used in …
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
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
| Amiodarone | Dronedarone | |
|---|---|---|
| Labeled for | n/a | n/a |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | $0.122 per tablet 200 mg tablet | $13.19 per tablet 400 mg tablet |
| 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