dronedarone Side Effects
Also known as: Multaq
Analysis of 9,899 adverse event reports submitted to the FDA from 2009 to 2025.
Total Reports
9,899
Death-Related
658
6.6% of reports
Hospitalizations
3,327
33.6% of reports
Top Indication
Atrial Fibrillation
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 658 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 195 |
| GASTROINTESTINAL HAEMORRHAGE | 60 |
| DYSPNOEA | 49 |
| ATRIAL FIBRILLATION | 38 |
| PNEUMONIA | 37 |
| RENAL FAILURE | 37 |
| CARDIAC ARREST | 31 |
| OFF LABEL USE | 31 |
| DRUG INTERACTION | 28 |
| HYPOTENSION | 28 |
| VENTRICULAR FIBRILLATION | 27 |
| ACUTE KIDNEY INJURY | 25 |
| DIARRHOEA | 25 |
| RESPIRATORY FAILURE | 25 |
| CARDIAC FAILURE CONGESTIVE | 24 |
| SEPSIS | 24 |
| NAUSEA | 22 |
| FATIGUE | 20 |
| HEPATIC FAILURE | 19 |
| RECTAL HAEMORRHAGE | 19 |
Reactions in Hospitalization Reports
Top reactions in 3,327 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| ATRIAL FIBRILLATION | 445 |
| GASTROINTESTINAL HAEMORRHAGE | 396 |
| DYSPNOEA | 349 |
| DRUG INTERACTION | 221 |
| ANAEMIA | 155 |
| NAUSEA | 147 |
| PNEUMONIA | 147 |
| DIARRHOEA | 145 |
| ASTHENIA | 138 |
| FATIGUE | 135 |
| DIZZINESS | 133 |
| CARDIAC FAILURE CONGESTIVE | 113 |
| FALL | 100 |
| RENAL FAILURE ACUTE | 96 |
| CARDIAC FAILURE | 93 |
| HYPOTENSION | 93 |
| RECTAL HAEMORRHAGE | 90 |
| BLOOD CREATININE INCREASED | 84 |
| HAEMORRHAGIC ANAEMIA | 81 |
| HAEMORRHAGE | 80 |
Nearby — Related Medications
What the FAERS Data Reveals About dronedarone Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 9,899 voluntary reports linked to dronedarone and its brand equivalents (Multaq), spanning 2009 through 2025. Of those, 658 (6.6%) listed death as an outcome and 3,327 (33.6%) involved hospitalization. The most common indication reported alongside adverse events was Atrial Fibrillation.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 53% were female and 46% male; age distribution skews toward 75+, with 3,019 reports in that bracket. The single most reported reaction is atrial fibrillation with 1,420 submissions, followed by dyspnoea and fatigue.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.