Drug · FAERS side-effect profile with label screen
Acebutolol side effects: what 1,258 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Acebutolol Hydrochloride (Acebutolol Hydrochloride)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
1,258 reports · 97% serious · 49 with death outcome · 80% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Hypertension Acebutolol Hydrochloride Capsules USP are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Ventricular Arrhythmias Acebut.
FDA label, Indications and Usage
What it is
DESCRIPTION Acebutolol hydrochloride USP is a selective, hydrophilic beta-adrenoreceptor blocking agent with mild intrinsic sympathomimetic activity for use in treating patients with hypertension and ventricular arrhythmias. It is marketed in capsule form for oral administration.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 38 strongest signals
Labeled adverse reaction 3Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 7Lab value / disease marker 4Not in label — unassessed 21
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 10 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Blood calcium decreased | 491 | 758.7 706.3–815.1ROR 1,243.8 · χ² 354,638 / p <1e-300 | 705.2 EB05 654.4 · IC025 +8.6 3/3 methods agree | Lab value / disease marker | serious PRR 540.9 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 579 | 572.2 538.0–608.7ROR 1,059.3 · χ² 318,767 / p <1e-300 | 543.0 EB05 506.9 · IC025 +8.4 3/3 methods agree | Not in label — unassessed | serious PRR 375.1 | no trial data cached |
| Sedation | 544 | 355.3 333.1–379.0ROR 625.2 · χ² 188,015 / p <1e-300 | 343.6 EB05 320.0 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | serious PRR 285.8 | no trial data cached |
| Cognitive disorder | 635 | 230.7 218.2–243.9ROR 464.8 · χ² 143,309 / p <1e-300 | 226.0 EB05 211.6 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious PRR 190.1 | no trial data cached |
| Depressed level of consciousness | 507 | 216.9 202.6–232.1ROR 362.6 · χ² 107,519 / p <1e-300 | 212.4 EB05 197.3 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 131.1 | no trial data cached |
| Mobility decreased | 522 | 122.4 114.6–130.7ROR 208.5 · χ² 62,473 / p <1e-300 | 121.0 EB05 112.5 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 106.8 | no trial data cached |
| Balance disorder | 574 | 111.2 104.7–118.2ROR 203.8 · χ² 62,441 / p <1e-300 | 110.1 EB05 102.8 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 106.1 | no trial data cached |
| Diabetes mellitus inadequate control | 54 | 51.0 39.3–66.2ROR 53.2 · χ² 2,590 / p <1e-300 | 50.0 EB05 39.8 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 35.6 | no trial data cached |
| Toxicity to various agents | 480 | 47.8 44.6–51.3ROR 76.7 · χ² 22,064 / p <1e-300 | 47.6 EB05 44.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 29.2 | no trial data cached |
| Hypotension (low blood pressure) | 569 | 47.5 44.7–50.5ROR 85.9 · χ² 26,022 / p <1e-300 | 47.3 EB05 44.1 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 33.0 | no trial data cached |
| Incorrect route of product administration | 47 | 46.7 35.3–61.9ROR 48.5 · χ² 2,054 / p <1e-300 | 45.8 EB05 35.8 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 55.5 | no trial data cached |
| Constipation | 571 | 44.1 41.5–46.9ROR 79.9 · χ² 24,192 / p <1e-300 | 43.9 EB05 41.0 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 47.1 | no trial data cached |
| Bladder disorder | 26 | 43.7 29.8–63.9ROR 44.6 · χ² 1,039 / p 3e-228 | 42.3 EB05 30.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial data cached |
| Fall | 622 | 31.2 29.5–33.0ROR 60.8 · χ² 18,437 / p <1e-300 | 31.2 EB05 29.2 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 | no trial data cached |
| Body temperature decreased | 13 | 21.8 12.7–37.5ROR 22.1 · χ² 238 / p 5e-54 | 21.0 EB05 12.8 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 14.5 | no trial data cached |
| Dementia | 33 | 19.8 14.1–27.7ROR 20.3 · χ² 570 / p 3e-126 | 19.5 EB05 14.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 | no trial data cached |
| Arthritis | 84 | 17.8 14.5–21.9ROR 19.0 · χ² 1,318 / p 8e-289 | 17.7 EB05 14.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 | no trial data cached |
| Chronic kidney disease | 78 | 17.0 13.7–21.1ROR 18.0 · χ² 1,160 / p 2e-254 | 16.9 EB05 13.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Obstructive airways disorder | 11 | 16.4 9.1–29.6ROR 16.6 · χ² 144 / p 1e-33 | 15.1 EB05 8.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Eosinophilia | 17 | 16.2 10.1–26.0ROR 16.4 · χ² 228 / p 8e-52 | 15.6 EB05 9.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 | no trial data cached |
| Drug intolerance | 93 | 16.1 13.3–19.6ROR 17.3 · χ² 1,309 / p 7e-287 | 16.0 EB05 13.5 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 15.3 | no trial data cached |
| Migraine | 79 | 13.9 11.2–17.2ROR 14.8 · χ² 936 / p 9e-206 | 13.8 EB05 11.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 | no trial data cached |
| Asthma | 91 | 13.5 11.1–16.5ROR 14.5 · χ² 1,049 / p 2e-230 | 13.4 EB05 11.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Pain | 496 | 13.4 12.6–14.4ROR 21.5 · χ² 5,870 / p <1e-300 | 13.4 EB05 12.5 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 | no trial data cached |
| Cardiomyopathy | 11 | 12.4 6.9–22.3ROR 12.5 · χ² 104 / p 9e-25 | 10.6 EB05 5.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Depressed mood | 38 | 12.0 8.8–16.5ROR 12.4 · χ² 374 / p 1e-83 | 11.6 EB05 8.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Medication error | 38 | 11.4 8.3–15.6ROR 11.7 · χ² 352 / p 1e-78 | 11.0 EB05 8.2 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 11.0 | no trial data cached |
| Drug abuse | 57 | 11.4 8.8–14.6ROR 11.9 · χ² 530 / p 1e-117 | 11.1 EB05 8.8 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 · 95% clinician | no trial data cached |
| Hypertension (high blood pressure) | 143 | 11.2 9.6–13.1ROR 12.6 · χ² 1,338 / p 4e-293 | 11.1 EB05 9.7 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.4 | no trial data cached |
| Treatment noncompliance | 34 | 10.4 7.5–14.5ROR 10.7 · χ² 281 / p 2e-63 | 9.9 EB05 7.2 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.4 | no trial data cached |
| Amnesia (memory loss) | 40 | 10.2 7.5–13.9ROR 10.5 · χ² 324 / p 1e-72 | 9.7 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Psoriasis | 80 | 10.2 8.3–12.6ROR 10.8 · χ² 659 / p 1e-145 | 10.0 EB05 8.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 | no trial data cached |
| Drug interaction | 97 | 10.2 8.4–12.3ROR 11.0 · χ² 801 / p 2e-176 | 10.0 EB05 8.4 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 | no trial data cached |
| Contusion | 55 | 9.5 7.4–12.4ROR 9.9 · χ² 414 / p 3e-92 | 9.2 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Blood pressure systolic increased | 11 | 9.4 5.2–16.9ROR 9.4 · χ² 74 / p 4e-18 | 7.5 EB05 4.2 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 6.1 | no trial data cached |
| Blood creatine phosphokinase increased | 12 | 6.8 3.9–12.0ROR 6.9 · χ² 54 / p 9e-14 | 5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 4.5 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 10 | 6.5 3.5–12.1ROR 6.6 · χ² 41 / p 6e-11 | 5.2 EB05 3.0 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 | no trial data cached |
| Overdose | 62 | 4.8 3.7–6.1ROR 5.0 · χ² 183 / p 6e-42 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 · 95% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Cognitive disorder | 635 | 230.7 218.2–243.9ROR 464.8 · χ² 143,309 / p <1e-300 | 226.0 EB05 211.6 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious PRR 190.1 | no trial data cached |
| Fall | 622 | 31.2 29.5–33.0ROR 60.8 · χ² 18,437 / p <1e-300 | 31.2 EB05 29.2 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 579 | 572.2 538.0–608.7ROR 1,059.3 · χ² 318,767 / p <1e-300 | 543.0 EB05 506.9 · IC025 +8.4 3/3 methods agree | Not in label — unassessed | serious PRR 375.1 | no trial data cached |
| Balance disorder | 574 | 111.2 104.7–118.2ROR 203.8 · χ² 62,441 / p <1e-300 | 110.1 EB05 102.8 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 106.1 | no trial data cached |
| Constipation | 571 | 44.1 41.5–46.9ROR 79.9 · χ² 24,192 / p <1e-300 | 43.9 EB05 41.0 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 47.1 | no trial data cached |
| Hypotension (low blood pressure) | 569 | 47.5 44.7–50.5ROR 85.9 · χ² 26,022 / p <1e-300 | 47.3 EB05 44.1 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 33.0 | no trial data cached |
| Sedation | 544 | 355.3 333.1–379.0ROR 625.2 · χ² 188,015 / p <1e-300 | 343.6 EB05 320.0 · IC025 +7.9 3/3 methods agree | Not in label — unassessed | serious PRR 285.8 | no trial data cached |
| Mobility decreased | 522 | 122.4 114.6–130.7ROR 208.5 · χ² 62,473 / p <1e-300 | 121.0 EB05 112.5 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 106.8 | no trial data cached |
| Depressed level of consciousness | 507 | 216.9 202.6–232.1ROR 362.6 · χ² 107,519 / p <1e-300 | 212.4 EB05 197.3 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 131.1 | no trial data cached |
| Pain | 496 | 13.4 12.6–14.4ROR 21.5 · χ² 5,870 / p <1e-300 | 13.4 EB05 12.5 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 | no trial data cached |
| Blood calcium decreased | 491 | 758.7 706.3–815.1ROR 1,243.8 · χ² 354,638 / p <1e-300 | 705.2 EB05 654.4 · IC025 +8.6 3/3 methods agree | Lab value / disease marker | serious PRR 540.9 | no trial data cached |
| Toxicity to various agents | 480 | 47.8 44.6–51.3ROR 76.7 · χ² 22,064 / p <1e-300 | 47.6 EB05 44.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 29.2 | no trial data cached |
| Hypertension (high blood pressure) | 143 | 11.2 9.6–13.1ROR 12.6 · χ² 1,338 / p 4e-293 | 11.1 EB05 9.7 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.4 | no trial data cached |
| Drug interaction | 97 | 10.2 8.4–12.3ROR 11.0 · χ² 801 / p 2e-176 | 10.0 EB05 8.4 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 | no trial data cached |
| Drug intolerance | 93 | 16.1 13.3–19.6ROR 17.3 · χ² 1,309 / p 7e-287 | 16.0 EB05 13.5 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 15.3 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Orthostatic hypotension — n=579, PRR 572.2
- Sedation — n=544, PRR 355.3
- Cognitive disorder — n=635, PRR 230.7
- Depressed level of consciousness — n=507, PRR 216.9
- Mobility decreased — n=522, PRR 122.4
- Balance disorder — n=574, PRR 111.2
- Toxicity to various agents — n=480, PRR 47.8
- Bladder disorder — n=26, PRR 43.7
- Fall — n=622, PRR 31.2
- Dementia — n=33, PRR 19.8
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Acebutolol?
In FDA FAERS, the most frequently co-reported reaction terms for Acebutolol are cognitive disorder, fall, orthostatic hypotension, balance disorder, constipation, hypotension. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Acebutolol have an FDA boxed warning?
No. The FDA label retrieved for Acebutolol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Acebutolol causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 48bded12-09c7-47f2-b162-ec970a77f2d8, effective 20251107; matched on
openfda.generic_name.exact:"ACEBUTOLOL HYDROCHLORIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 48 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.