amiodarone Side Effects
Also known as: Cordarone, Pacerone
Analysis of 10,687 adverse event reports submitted to the FDA from 2000 to 2025.
Total Reports
10,687
Death-Related
1,847
17.3% of reports
Hospitalizations
5,301
49.6% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 1,847 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 393 |
| OFF LABEL USE | 306 |
| DYSPNOEA | 298 |
| ASTHENIA | 262 |
| SEPSIS | 245 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 244 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 233 |
| RESPIRATORY FAILURE | 228 |
| NAUSEA | 225 |
| CARDIOGENIC SHOCK | 213 |
| PNEUMONIA | 209 |
| VOMITING | 209 |
| HYPONATRAEMIA | 208 |
| PRODUCT USE IN UNAPPROVED INDICATION | 205 |
| ABDOMINAL PAIN | 202 |
| VENTRICULAR FIBRILLATION | 201 |
| ASCITES | 198 |
| ABDOMINAL DISTENSION | 196 |
| CONDITION AGGRAVATED | 196 |
| FATIGUE | 196 |
Reactions in Hospitalization Reports
Top reactions in 5,301 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 624 |
| ASTHENIA | 474 |
| ATRIAL FIBRILLATION | 440 |
| OFF LABEL USE | 428 |
| PNEUMONIA | 414 |
| FATIGUE | 386 |
| HYPOTENSION | 339 |
| PRODUCT USE IN UNAPPROVED INDICATION | 324 |
| NAUSEA | 318 |
| ANAEMIA | 299 |
| DRUG INEFFECTIVE | 296 |
| VOMITING | 285 |
| CARDIAC FAILURE CONGESTIVE | 279 |
| COUGH | 267 |
| DRUG INTERACTION | 266 |
| FALL | 249 |
| CONDITION AGGRAVATED | 235 |
| ACUTE KIDNEY INJURY | 233 |
| RESPIRATORY FAILURE | 228 |
| HYPERTHYROIDISM | 226 |
Nearby — Related Medications
What the FAERS Data Reveals About amiodarone Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 10,687 voluntary reports linked to amiodarone and its brand equivalents (Cordarone, Pacerone), spanning 2000 through 2025. Of those, 1,847 (17.3%) listed death as an outcome and 5,301 (49.6%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 39% were female and 61% male; age distribution skews toward 75+, with 3,370 reports in that bracket. The single most reported reaction is dyspnoea with 1,158 submissions, followed by asthenia 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.