MID-VOLUME · HOSP-HEAVY
sotalol Side Effects
sotalol (also sold as Betapace) sits MID-VOLUME #262 of 524 by FAERS report count. Lead signal: HOSP-HEAVY - 42.5% mention hospitalization (6,822 reports). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 16,062
- FAERS reports
FDA Adverse Event Reporting System extract for sotalol. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
sotalol: 42.5% mention hospitalization (6,822 reports). Death stamp DEATH-HEAVY; volume band MID-VOLUME #262 of 524 by FAERS report count.
Mid-book FAERS page for sotalol (Betapace) (16,062 reports). Signature HOSP-HEAVY. Dominant age band on file: 75+. Educational reference only.
Counts from the openFDA FAERS extract (2002–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ATRIAL FIBRILLATION leads 1,179 of 16,062 reports
Who reports · age peak 75+ (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 75+ (4,755 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (1,665 reports, 10.4%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 496 |
| COMPLETED SUICIDE | 128 |
| CARDIAC ARREST | 111 |
| ATRIAL FIBRILLATION | 102 |
| DYSPNOEA | 91 |
| HYPOTENSION | 90 |
| TOXICITY TO VARIOUS AGENTS | 86 |
| PNEUMONIA | 79 |
| FALL | 70 |
| GASTROINTESTINAL HAEMORRHAGE | 69 |
| RENAL FAILURE | 68 |
| ANAEMIA | 66 |
| ACUTE KIDNEY INJURY | 64 |
| ASTHENIA | 64 |
| FATIGUE | 60 |
| RESPIRATORY FAILURE | 58 |
| CARDIAC FAILURE CONGESTIVE | 56 |
| CARDIO-RESPIRATORY ARREST | 54 |
| NAUSEA | 53 |
| DIARRHOEA | 51 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (6,822, 42.5% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| ATRIAL FIBRILLATION | 715 |
| DYSPNOEA | 468 |
| HYPOTENSION | 394 |
| FALL | 370 |
| GASTROINTESTINAL HAEMORRHAGE | 364 |
| ASTHENIA | 340 |
| FATIGUE | 317 |
| DRUG INTERACTION | 294 |
| DIARRHOEA | 292 |
| DIZZINESS | 292 |
| NAUSEA | 289 |
| PNEUMONIA | 283 |
| BRADYCARDIA | 257 |
| ANAEMIA | 254 |
| ACUTE KIDNEY INJURY | 243 |
| VOMITING | 235 |
| ELECTROCARDIOGRAM QT PROLONGED | 216 |
| CARDIAC FAILURE CONGESTIVE | 213 |
How to read sotalol FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 16,062 voluntary reports linked to sotalol (Betapace), 2002-2025. Death is listed on 1,665 (10.4%). Hospitalization appears on 6,822 (42.5%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 42.5% mention hospitalization (6,822 reports).
Read with sotalol
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 16,005 FAERS cases (Δ 57 lighter vs sotalol); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 16,231 FAERS cases (Δ 169 heavier vs sotalol); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 16,238 FAERS cases (Δ 176 heavier vs sotalol); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 16,243 FAERS cases (Δ 181 heavier vs sotalol); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 51.7 pp vs sotalol's DEATH-HEAVY): CASELOAD · HOSP-MID.
sotalol stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.