labetalol Side Effects
Also known as: Trandate
Analysis of 12,726 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
12,726
Death-Related
1,314
10.3% of reports
Hospitalizations
4,839
38.0% 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 1,314 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| 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 |
| OFF LABEL USE | 76 |
| 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
Top reactions in 4,839 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| HYPERTENSION | 440 |
| DRUG INEFFECTIVE | 410 |
| ACUTE KIDNEY INJURY | 346 |
| MATERNAL EXPOSURE DURING PREGNANCY | 316 |
| RENAL FAILURE | 275 |
| OFF LABEL USE | 274 |
| 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 |
Nearby — Related Medications
What the FAERS Data Reveals About labetalol Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 12,726 voluntary reports linked to labetalol and its brand equivalents (Trandate), spanning 2004 through 2025. Of those, 1,314 (10.3%) listed death as an outcome and 4,839 (38.0%) 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, 64% were female and 36% male; age distribution skews toward 18-44, with 2,615 reports in that bracket. The single most reported reaction is drug ineffective with 988 submissions, followed by foetal exposure during pregnancy and maternal exposure during pregnancy.
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.