What the label lists and what reports show
Acebutolol side effects
Acebutolol's FDA label lists its adverse reactions in its own words. FAERS holds 1,258 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is cognitive disorder (635 reports).
- Generic listed
Check it at the source: the acebutolol FDA label on DailyMed (effective December 11, 2024, Amneal Pharmaceuticals of New York LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsAcebutolol is well tolerated in properly selected patients. Most adverse reactions have been mild, not required discontinuation of therapy, and tended to decrease as duration of treatment increases. The following table shows the frequency of treatment-related side effects derived from controlled clinical trials in patients with hypertension, angina pectoris, and arrhythmia. These patients received acebutolol, propranolol, or hydrochlorothiazide as monotherapy, or placebo. TOTAL VOLUNTEERED AND ELICITED (U.S. STUDIES) Body System/ Adverse Reaction Acebutolol (N=1002) % Propranolol (N=424) % Hydrochlorthiazide (n=178) % Placebo (N=314) % Cardiovascular Chest Pain 2 4 4 1 Edema 2 2 4 1 Central Nervous System Depression 2 1 3 1 Dizziness 6 7 12 2 Fatigue 11 17 10 4 Headache 6 9 13 4 Insomnia 3 6 5 1 Abnormal dreams 2 3 0 1 Dermatologic Rash 2 2 4 1 Gastrointestinal Constipation 4 2 7 0 …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Body System | 400 mg/day (N=132) | 800 mg/day (N=63) | 1200 mg/day (N=71) |
|---|---|---|---|
| Cardiovascular | 5% | 2% | 1% |
| Gastrointestinal | 3% | 3% | 1% |
| Musculoskeletal | 2% | 3% | 4% |
| Central Nervous system | 9% | 13% | 17% |
| Respiratory | 1% | 5% | 6% |
| Skin | 1% | 2% | 1% |
| Special Senses | 2% | 2% | 6% |
| Genitourinary | 2% | 3% | 1% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Amneal Pharmaceuticals of New York LLC, effective December 11, 2024 (SPL set fe2cd5c0-ee16-4bcb-ad92-3755881dbe79), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,258 reports list acebutolol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 49 are coded as a death and 949 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Acebutolol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions