What the label lists and what reports show
Dronedarone side effects
Dronedarone's FDA label: “Most common adverse reactions (≥2%) are diarrhea, nausea, abdominal pain, vomiting, dyspepsia, bradycardia, skin issues (rashes, pruritus, eczema, dermatitis, dermatitis allergic), and asthenia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact …” FAERS holds 10,142 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (848 reports).
- No generic listed
- Boxed warning
Check it at the source: the dronedarone FDA label on DailyMed (effective May 29, 2025, Sanofi-Aventis U.S. LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of MULTAQ?MULTAQ may cause serious side effects, including: See " What is the most important information I should know about MULTAQ? " Inflammation of the lungs, including scarring and thickening. Call your healthcare provider if you develop shortness of breath or a dry cough during treatment with MULTAQ. Low potassium and magnesium levels in your blood. This can happen if you take certain water pills (diuretics) during treatment with MULTAQ. Your healthcare provider may check you for this problem before and during treatment. Tell your healthcare provider if you develop any of the following symptoms of low potassium or low magnesium during treatment with MULTAQ: nausea or vomiting weakness or sleepiness muscle weakness, spasms, or tremors loss of appetite constipation heart palpitations tingling or numbness Changes in the electrical activity in your heart called QT interval prolongation. […]
Source: FDA drug label, 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 label list?
From the label: adverse reactionsMost common adverse reactions (≥2%) are diarrhea, nausea, abdominal pain, vomiting, dyspepsia, bradycardia, skin issues (rashes, pruritus, eczema, dermatitis, dermatitis allergic), and asthenia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 1: Adverse Drug Reactions that Occurred in at Least 1% of Patients and were More Frequent than Placebo
| Reaction | Placebo (N=2875) | Dronedarone 400 mg twice daily (N=3282) |
|---|---|---|
| Diarrhea | 6% | 9% |
| Nausea | 3% | 5% |
| Abdominal pain | 3% | 4% |
| Vomiting | 1% | 2% |
| Dyspeptic signs and symptoms | 1% | 2% |
| Asthenic conditions | 5% | 7% |
| Bradycardia | 1% | 3% |
| Including rashes (generalized, macular, maculo-papular, erythematous), pruritus, eczema,… | 3% | 5% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following safety concerns are described elsewhere in the label: New or worsening heart failure [see Warnings and Precautions (5.4) ] Liver Injury [see Warnings and Precautions (5.5) ] Pulmonary toxicity [see Warnings and Precautions (5.6) ] Hypokalemia and hypomagnesemia with potassium-depleting diuretics [see Warnings and Precautions (5.7) ] QT prolongation [see Warnings and Precautions (5.8) ] Most common adverse reactions (≥2%) are diarrhea, nausea, abdominal pain, vomiting, dyspepsia, bradycardia, skin issues (rashes, pruritus, eczema, dermatitis, dermatitis allergic), and asthenia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The safety evaluation of dronedarone 400 mg twice daily in patients with AF or AFL is based on 5 placebo-controlled studies, ATHENA, EURIDIS, ADONIS, ERATO and DAFNE. In these studies, a total of 6285 patients were randomized and treated, 3282 patients with MULTAQ 400 mg twice daily, and 2875 with placebo. The mean exposure across studies was 12 months. In ATHENA, the maximum follow-up was 30 months. In clinical trials, premature discontinuation because of adverse reactions occurred in 11.8% of the dronedarone-treated patients and in 7.7% of the placebo-treated group. …
Source: FDA drug label, Sanofi-Aventis U.S. LLC, effective May 29, 2025 (SPL set 7fa41601-7fb5-4155-8e50-2ae903f0d2d6), via openFDA; the full label on DailyMed
What do FAERS reports show?
10,142 reports list dronedarone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 668 are coded as a death and 3,359 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Dronedarone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions