MID-VOLUME · HOSP-HEAVY
dronedarone Side Effects
dronedarone (also sold as Multaq) sits MID-VOLUME #320 of 524 by FAERS report count. Lead signal: HOSP-HEAVY - 33.6% mention hospitalization (3,327 reports). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 9,899
- FAERS reports
FDA Adverse Event Reporting System extract for dronedarone. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
dronedarone: 33.6% mention hospitalization (3,327 reports). Death stamp DEATH-HEAVY; volume band MID-VOLUME #320 of 524 by FAERS report count.
Mid-book FAERS page for dronedarone (Multaq) (9,899 reports). Signature HOSP-HEAVY. Dominant age band on file: 75+. Educational reference only.
Counts from the openFDA FAERS extract (2009–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ATRIAL FIBRILLATION leads 1,420 of 9,899 reports
Who reports · age peak 75+ (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 75+ (3,019 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (658 reports, 6.6%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 195 |
| GASTROINTESTINAL HAEMORRHAGE | 60 |
| DYSPNOEA | 49 |
| ATRIAL FIBRILLATION | 38 |
| PNEUMONIA | 37 |
| RENAL FAILURE | 37 |
| CARDIAC ARREST | 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
Hospitalization is HEAVY (3,327, 33.6% of the book). Top reactions in those rows:
| 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 |
How to read dronedarone FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 9,899 voluntary reports linked to dronedarone (Multaq), 2009-2025. Death is listed on 658 (6.6%). Hospitalization appears on 3,327 (33.6%). Top co-reported indication: Atrial Fibrillation.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 33.6% mention hospitalization (3,327 reports).
Read with dronedarone
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 9,877 FAERS cases (Δ 22 lighter vs dronedarone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 9,944 FAERS cases (Δ 45 heavier vs dronedarone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 10,014 FAERS cases (Δ 115 heavier vs dronedarone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 9,782 FAERS cases (Δ 117 lighter vs dronedarone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 55.5 pp vs dronedarone's DEATH-HEAVY): CASELOAD · HOSP-MID.
dronedarone stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.