MID-VOLUME · HOSP-HEAVY
labetalol Side Effects
labetalol (also sold as Trandate) sits MID-VOLUME #293 of 524 by FAERS report count. Lead signal: HOSP-HEAVY - 38.0% mention hospitalization (4,839 reports). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 12,726
- FAERS reports
FDA Adverse Event Reporting System extract for labetalol. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
labetalol: 38.0% mention hospitalization (4,839 reports). Death stamp DEATH-HEAVY; volume band MID-VOLUME #293 of 524 by FAERS report count.
Mid-book FAERS page for labetalol (Trandate) (12,726 reports). Signature HOSP-HEAVY. Dominant age band on file: 18-44. Educational reference only.
Counts from the openFDA FAERS extract (2004–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
FOETAL EXPOSURE DURING PREGNANCY leads 931 of 12,726 reports
Who reports · age peak 18-44 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 18-44 (2,615 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (1,314 reports, 10.3%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 371 |
| COMPLETED SUICIDE | 165 |
| FOETAL EXPOSURE DURING PREGNANCY | 118 |
| RENAL FAILURE | 110 |
| CARDIAC ARREST | 103 |
| ACUTE KIDNEY INJURY | 96 |
| CHRONIC KIDNEY DISEASE | 92 |
| END STAGE RENAL DISEASE | 72 |
| TOXICITY TO VARIOUS AGENTS | 53 |
| HYPOTENSION | 52 |
| PNEUMONIA | 50 |
| RESPIRATORY FAILURE | 50 |
| ALANINE AMINOTRANSFERASE INCREASED | 42 |
| CEREBROVASCULAR ACCIDENT | 42 |
| DYSPNOEA | 42 |
| ASPARTATE AMINOTRANSFERASE INCREASED | 41 |
| HYDROPS FOETALIS | 41 |
| PAIN | 40 |
| CLEFT LIP AND PALATE | 39 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (4,839, 38.0% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| HYPERTENSION | 440 |
| ACUTE KIDNEY INJURY | 346 |
| MATERNAL EXPOSURE DURING PREGNANCY | 316 |
| RENAL FAILURE | 275 |
| DYSPNOEA | 251 |
| FOETAL EXPOSURE DURING PREGNANCY | 236 |
| HYPOTENSION | 230 |
| CHRONIC KIDNEY DISEASE | 224 |
| PNEUMONIA | 222 |
| EXPOSURE DURING PREGNANCY | 204 |
| NAUSEA | 203 |
| FATIGUE | 192 |
| PREMATURE BABY | 174 |
| VOMITING | 174 |
| FALL | 173 |
| HEADACHE | 173 |
| PAIN | 169 |
| ASTHENIA | 167 |
How to read labetalol FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 12,726 voluntary reports linked to labetalol (Trandate), 2004-2025. Death is listed on 1,314 (10.3%). Hospitalization appears on 4,839 (38.0%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 38.0% mention hospitalization (4,839 reports).
Read with labetalol
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 12,758 FAERS cases (Δ 32 heavier vs labetalol); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 12,687 FAERS cases (Δ 39 lighter vs labetalol); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 12,687 FAERS cases (Δ 39 lighter vs labetalol); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 12,794 FAERS cases (Δ 68 heavier vs labetalol); DEATH-HEAVY · HOSP-HEAVY · MALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 51.8 pp vs labetalol's DEATH-HEAVY): CASELOAD · HOSP-MID.
labetalol stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.