acebutolol Side Effects
Also known as: Sectral
Analysis of 1,220 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
1,220
Death-Related
44
3.6% of reports
Hospitalizations
921
75.5% 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 44 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DRUG INTERACTION | 6 |
| HAEMATEMESIS | 6 |
| AGRANULOCYTOSIS | 5 |
| CEREBRAL HAEMATOMA | 5 |
| OFF LABEL USE | 5 |
| CONDITION AGGRAVATED | 4 |
| ACUTE KIDNEY INJURY | 3 |
| FALL | 3 |
| INTENTIONAL PRODUCT USE ISSUE | 3 |
| LEUKAEMIA | 3 |
| LEUKOPENIA | 3 |
| ASTHENIA | 2 |
| BLOOD CREATININE INCREASED | 2 |
| DEATH | 2 |
| DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS | 2 |
| DYSPNOEA | 2 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 2 |
| HEAD INJURY | 2 |
| HEMIPLEGIA | 2 |
| THERAPEUTIC RESPONSE SHORTENED | 2 |
Reactions in Hospitalization Reports
Top reactions in 921 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| COGNITIVE DISORDER | 613 |
| FALL | 601 |
| ORTHOSTATIC HYPOTENSION | 566 |
| BALANCE DISORDER | 558 |
| CONSTIPATION | 554 |
| HYPOTENSION | 550 |
| SEDATION | 531 |
| MOBILITY DECREASED | 501 |
| DEPRESSED LEVEL OF CONSCIOUSNESS | 493 |
| SEDATION COMPLICATION | 486 |
| PAIN | 479 |
| BLOOD CALCIUM DECREASED | 478 |
| CREATININE RENAL CLEARANCE DECREASED | 478 |
| TOXICITY TO VARIOUS AGENTS | 465 |
| DYSPNOEA | 94 |
| MULTIPLE DRUG THERAPY | 93 |
| DRUG INTERACTION | 82 |
| OFF LABEL USE | 80 |
| PRODUCT USE IN UNAPPROVED INDICATION | 62 |
| RENAL FUNCTION TEST ABNORMAL | 60 |
Nearby — Related Medications
What the FAERS Data Reveals About acebutolol Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 1,220 voluntary reports linked to acebutolol and its brand equivalents (Sectral), spanning 2004 through 2025. Of those, 44 (3.6%) listed death as an outcome and 921 (75.5%) 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, 81% were female and 19% male; age distribution skews toward 75+, with 726 reports in that bracket. The single most reported reaction is cognitive disorder with 620 submissions, followed by fall and orthostatic hypotension.
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.