propafenone Side Effects
Also known as: Rythmol
Analysis of 4,113 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
4,113
Death-Related
483
11.7% of reports
Hospitalizations
1,763
42.9% 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 483 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 114 |
| DEATH | 87 |
| TOXICITY TO VARIOUS AGENTS | 61 |
| DRUG INTERACTION | 46 |
| CARDIAC ARREST | 40 |
| ACUTE KIDNEY INJURY | 32 |
| SUBARACHNOID HAEMORRHAGE | 29 |
| ELECTROCARDIOGRAM QRS COMPLEX PROLONGED | 27 |
| LOSS OF CONSCIOUSNESS | 26 |
| HYPOTENSION | 25 |
| NAUSEA | 24 |
| GASTROINTESTINAL HAEMORRHAGE | 23 |
| RESPIRATORY FAILURE | 21 |
| SEIZURE | 20 |
| ASTHENIA | 19 |
| OFF LABEL USE | 19 |
| COMA | 18 |
| DIARRHOEA | 18 |
| CARDIO-RESPIRATORY ARREST | 17 |
| ATRIAL FIBRILLATION | 16 |
Reactions in Hospitalization Reports
Top reactions in 1,763 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| ATRIAL FIBRILLATION | 194 |
| DRUG INTERACTION | 158 |
| TOXICITY TO VARIOUS AGENTS | 151 |
| DYSPNOEA | 124 |
| DRUG INEFFECTIVE | 116 |
| NAUSEA | 109 |
| BRADYCARDIA | 108 |
| DIZZINESS | 107 |
| ASTHENIA | 105 |
| HYPOTENSION | 102 |
| ACUTE KIDNEY INJURY | 87 |
| FATIGUE | 84 |
| ELECTROCARDIOGRAM QRS COMPLEX PROLONGED | 82 |
| OFF LABEL USE | 82 |
| GASTROINTESTINAL HAEMORRHAGE | 78 |
| PNEUMONIA | 69 |
| VOMITING | 69 |
| CARDIAC ARREST | 67 |
| SYNCOPE | 67 |
| FALL | 64 |
Nearby — Related Medications
What the FAERS Data Reveals About propafenone Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 4,113 voluntary reports linked to propafenone and its brand equivalents (Rythmol), spanning 2004 through 2025. Of those, 483 (11.7%) listed death as an outcome and 1,763 (42.9%) 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, 58% were female and 41% male; age distribution skews toward 75+, with 1,019 reports in that bracket. The single most reported reaction is atrial fibrillation with 347 submissions, followed by drug ineffective and drug interaction.
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.