Betaxolol side effects: what 817 FDA adverse event reports show

Betaxolol · 38 reaction terms · 381 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

817 reports · 84% serious · 104 with death outcome · 60% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Betaxolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics.

FDA label, Indications and Usage

What it is

DESCRIPTION Betaxolol is a β 1 -selective (cardioselective) adrenergic receptor blocking agent available as 10-mg and 20-mg tablets for oral administration. Betaxolol is chemically described as 2-propanol,1-[4-[2-(cyclopropylmethoxy)ethyl]phenoxy]-3-[(1-methylethyl)amino]-,hydrochloride,(±).

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 15 strongest signals

Labeled adverse reaction 1Labeled (related wording) 2Reporting / coding artifact 1Not in label — unassessed 11

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.
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.
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. 23 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Status epilepticus	15	34.1 20.6–56.3ROR 34.7 · χ² 449 / p 6e-100	32.8 EB05 21.1 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 23.2	no trial data cached
Skin laceration	12	28.6 16.3–50.1ROR 29.0 · χ² 292 / p 8e-66	27.4 EB05 16.6 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 28.2	no trial data cached
Sopor	14	26.9 16.0–45.3ROR 27.4 · χ² 324 / p 9e-73	26.0 EB05 16.4 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 18.3	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	20	20.1 13.1–31.0ROR 20.6 · χ² 345 / p 3e-77	19.7 EB05 13.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.7	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	16	18.5 11.4–30.0ROR 18.8 · χ² 247 / p 5e-56	17.9 EB05 11.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.7	no trial data cached
Cardiogenic shock	10	18.0 9.7–33.4ROR 18.2 · χ² 144 / p 2e-33	16.7 EB05 8.6 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.2	no trial data cached
Orthostatic hypotension (dizziness on standing)	12	17.7 10.1–31.0ROR 17.9 · χ² 173 / p 1e-39	16.7 EB05 9.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 13.7	no trial data cached
Ischaemic stroke	11	15.8 8.8–28.5ROR 16.0 · χ² 138 / p 3e-32	14.5 EB05 7.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.8	no trial data cached
Fungal infection	19	14.7 9.4–22.9ROR 15.0 · χ² 229 / p 5e-52	14.0 EB05 9.0 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.3	no trial data cached
Glaucoma	10	13.3 7.2–24.7ROR 13.5 · χ² 102 / p 3e-24	11.4 EB05 5.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 9.8	no trial data cached
Cardiac disorder	48	13.1 10.0–17.3ROR 13.9 · χ² 528 / p 3e-117	12.9 EB05 10.0 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.3 · ♀ 2% (drug 60%) · 92% clinician	no trial data cached
Depressed level of consciousness	17	11.1 6.9–17.7ROR 11.3 · χ² 146 / p 6e-34	9.9 EB05 6.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.7	no trial data cached
Limb injury	11	10.4 5.8–18.8ROR 10.6 · χ² 85 / p 2e-20	8.5 EB05 4.7 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.8	no trial data cached
Drug abuse	16	4.9 3.0–8.0ROR 5.0 · χ² 46 / p 5e-12	4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 3.4	no trial data cached
Drug withdrawal syndrome	10	2.9 1.6–5.4ROR 2.9 · χ² 11 / p 6e-4	2.6 EB05 1.6 · IC025 +0.3	Labeled (related wording) related wording	serious PRR 2.5	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
Cardiac disorder	48	13.1 10.0–17.3ROR 13.9 · χ² 528 / p 3e-117	12.9 EB05 10.0 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.3 · ♀ 2% (drug 60%) · 92% clinician	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	20	20.1 13.1–31.0ROR 20.6 · χ² 345 / p 3e-77	19.7 EB05 13.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.7	no trial data cached
Fungal infection	19	14.7 9.4–22.9ROR 15.0 · χ² 229 / p 5e-52	14.0 EB05 9.0 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.3	no trial data cached
Depressed level of consciousness	17	11.1 6.9–17.7ROR 11.3 · χ² 146 / p 6e-34	9.9 EB05 6.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.7	no trial data cached
Drug abuse	16	4.9 3.0–8.0ROR 5.0 · χ² 46 / p 5e-12	4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 3.4	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	16	18.5 11.4–30.0ROR 18.8 · χ² 247 / p 5e-56	17.9 EB05 11.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.7	no trial data cached
Status epilepticus	15	34.1 20.6–56.3ROR 34.7 · χ² 449 / p 6e-100	32.8 EB05 21.1 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 23.2	no trial data cached
Sopor	14	26.9 16.0–45.3ROR 27.4 · χ² 324 / p 9e-73	26.0 EB05 16.4 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 18.3	no trial data cached
Orthostatic hypotension (dizziness on standing)	12	17.7 10.1–31.0ROR 17.9 · χ² 173 / p 1e-39	16.7 EB05 9.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 13.7	no trial data cached
Skin laceration	12	28.6 16.3–50.1ROR 29.0 · χ² 292 / p 8e-66	27.4 EB05 16.6 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 28.2	no trial data cached
Drug dependence	11	1.7 1.0–3.1ROR 1.7 · χ² 3 / p 0.048	1.7 EB05 1.0 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 1.2	no trial data cached
Limb injury	11	10.4 5.8–18.8ROR 10.6 · χ² 85 / p 2e-20	8.5 EB05 4.7 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.8	no trial data cached
Ischaemic stroke	11	15.8 8.8–28.5ROR 16.0 · χ² 138 / p 3e-32	14.5 EB05 7.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.8	no trial data cached
Drug withdrawal syndrome	10	2.9 1.6–5.4ROR 2.9 · χ² 11 / p 6e-4	2.6 EB05 1.6 · IC025 +0.3	Labeled (related wording) related wording	serious PRR 2.5	no trial data cached
Glaucoma	10	13.3 7.2–24.7ROR 13.5 · χ² 102 / p 3e-24	11.4 EB05 5.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 9.8	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.

Drug reaction with eosinophilia and systemic symptoms — n=20, PRR 20.1

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 Betaxolol?

In FDA FAERS, the most frequently co-reported reaction terms for Betaxolol are cardiac disorder, drug reaction with eosinophilia and systemic symptoms, fungal infection, depressed level of consciousness, stevens-johnson syndrome, status epilepticus. 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 Betaxolol have an FDA boxed warning?

No. The FDA label retrieved for Betaxolol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Betaxolol 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 e198244d-fda3-4015-8c01-390f3f88e238, effective 20191031; matched on openfda.generic_name.exact:"BETAXOLOL")
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, field patient.drug.openfda.generic_name.exact, 38 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.