Betaxolol side effects: what 514 FDA adverse event reports show

Betaxolol Hydrochloride · 37 reaction terms · 622 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

514 reports · 77% serious · 44 with death outcome · 70% 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 29 strongest signals

Labeled adverse reaction 3Labeled (related wording) 4Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 20

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.
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. 8 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
Sputum discoloured	18	77.8 49.4–122.6ROR 80.6 · χ² 1,287 / p 3e-282	72.0 EB05 48.2 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 75.8	no trial data cached
Poor venous access	16	63.3 39.1–102.6ROR 65.3 · χ² 919 / p 3e-202	59.0 EB05 38.5 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=16	no trial data cached
Pulmonary congestion	18	55.5 35.3–87.5ROR 57.5 · χ² 910 / p 4e-200	52.6 EB05 35.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 48.1	no trial data cached
Status epilepticus	15	54.1 32.9–89.2ROR 55.7 · χ² 730 / p 5e-161	50.8 EB05 32.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 40.4	no trial data cached
Glaucoma	24	50.9 34.4–75.2ROR 53.3 · χ² 1,124 / p 1e-246	49.0 EB05 34.6 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 40.8 · ♀ 100% (drug 70%)	no trial data cached
Skin laceration	13	49.2 28.7–84.1ROR 50.4 · χ² 566 / p 2e-125	46.0 EB05 28.6 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 53.0	no trial data cached
Limb injury	30	45.2 32.0–64.0ROR 48.0 · χ² 1,254 / p 6e-275	44.0 EB05 32.3 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 46.1 · ♀ 100% (drug 70%) · 97% clinician	no trial data cached
Intraocular pressure increased (raised eye pressure)	14	44.5 26.6–74.7ROR 45.7 · χ² 553 / p 2e-122	42.1 EB05 26.7 · IC025 +3.3 3/3 methods agree	Lab value / disease marker	serious PRR 14.0	no trial data cached
Wound	30	44.1 31.1–62.4ROR 46.7 · χ² 1,220 / p 1e-267	42.9 EB05 31.5 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 39.1 · ♀ 100% (drug 70%) · 97% clinician	no trial data cached
Ulcer	16	41.0 25.3–66.4ROR 42.3 · χ² 585 / p 2e-129	39.2 EB05 25.6 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 38.5	no trial data cached
Sopor	13	39.7 23.2–67.9ROR 40.7 · χ² 452 / p 1e-100	37.7 EB05 23.4 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 29.6	no trial data cached
Choking	18	37.8 24.0–59.6ROR 39.2 · χ² 609 / p 8e-135	36.5 EB05 24.4 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 33.2	no trial data cached
Middle insomnia	17	37.3 23.4–59.6ROR 38.6 · χ² 565 / p 3e-125	35.9 EB05 23.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 57.0	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	20	36.6 23.8–56.3ROR 38.1 · χ² 658 / p 2e-145	35.5 EB05 24.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 27.5 · 100% clinician	no trial data cached
Transient ischaemic attack (mini-stroke)	29	34.9 24.5–49.8ROR 37.0 · χ² 923 / p 5e-203	34.2 EB05 25.0 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 26.5 · ♀ 100% (drug 70%) · 97% clinician	no trial data cached
Product availability issue	15	27.3 16.6–45.0ROR 28.1 · χ² 355 / p 2e-79	26.5 EB05 17.0 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 36.6	no trial data cached
Fibromyalgia	16	26.9 16.6–43.6ROR 27.7 · χ² 374 / p 2e-83	26.1 EB05 17.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 26.4	no trial data cached
Coronary artery disease	20	26.8 17.4–41.1ROR 27.8 · χ² 471 / p 1e-104	26.1 EB05 17.8 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 20.3	no trial data cached
Acute myocardial infarction	19	26.2 16.8–40.7ROR 27.2 · χ² 436 / p 4e-97	25.6 EB05 17.3 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 19.5	no trial data cached
Eye irritation	35	25.6 18.6–35.3ROR 27.4 · χ² 805 / p 2e-177	25.3 EB05 19.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 62.6	no trial data cached
Urinary retention	20	24.5 16.0–37.7ROR 25.5 · χ² 429 / p 2e-95	24.0 EB05 16.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 20.5 · 95% clinician	no trial data cached
Fungal infection	17	20.8 13.1–33.3ROR 21.5 · χ² 302 / p 7e-68	20.3 EB05 13.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 28.4	no trial data cached
Heart rate decreased	18	20.8 13.2–32.8ROR 21.5 · χ² 320 / p 6e-72	20.3 EB05 13.4 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 19.3	no trial data cached
Panic attack	18	20.1 12.8–31.7ROR 20.8 · χ² 309 / p 2e-69	19.7 EB05 13.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 21.7	no trial data cached
Blindness	20	20.0 13.0–30.8ROR 20.8 · χ² 344 / p 5e-77	19.6 EB05 13.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 15.3	no trial data cached
Coma	22	18.8 12.5–28.3ROR 19.6 · χ² 355 / p 2e-79	18.5 EB05 12.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 14.1 · 100% clinician	no trial data cached
Cardiac failure congestive	30	15.1 10.7–21.4ROR 16.0 · χ² 382 / p 2e-85	14.8 EB05 10.7 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.3 · ♀ 100% (drug 70%) · 93% clinician	no trial data cached
Throat irritation	16	14.6 9.0–23.7ROR 15.0 · χ² 190 / p 2e-43	13.8 EB05 8.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 25.2	no trial data cached
Haemorrhage	32	12.5 8.9–17.5ROR 13.3 · χ² 328 / p 1e-73	12.0 EB05 8.7 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.4 · ♀ 93% (drug 70%) · 97% 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
Eye irritation	35	25.6 18.6–35.3ROR 27.4 · χ² 805 / p 2e-177	25.3 EB05 19.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 62.6	no trial data cached
Haemorrhage	32	12.5 8.9–17.5ROR 13.3 · χ² 328 / p 1e-73	12.0 EB05 8.7 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.4 · ♀ 93% (drug 70%) · 97% clinician	no trial data cached
Cardiac failure congestive	30	15.1 10.7–21.4ROR 16.0 · χ² 382 / p 2e-85	14.8 EB05 10.7 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.3 · ♀ 100% (drug 70%) · 93% clinician	no trial data cached
Wound	30	44.1 31.1–62.4ROR 46.7 · χ² 1,220 / p 1e-267	42.9 EB05 31.5 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 39.1 · ♀ 100% (drug 70%) · 97% clinician	no trial data cached
Limb injury	30	45.2 32.0–64.0ROR 48.0 · χ² 1,254 / p 6e-275	44.0 EB05 32.3 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 46.1 · ♀ 100% (drug 70%) · 97% clinician	no trial data cached
Transient ischaemic attack (mini-stroke)	29	34.9 24.5–49.8ROR 37.0 · χ² 923 / p 5e-203	34.2 EB05 25.0 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 26.5 · ♀ 100% (drug 70%) · 97% clinician	no trial data cached
Glaucoma	24	50.9 34.4–75.2ROR 53.3 · χ² 1,124 / p 1e-246	49.0 EB05 34.6 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 40.8 · ♀ 100% (drug 70%)	no trial data cached
Coma	22	18.8 12.5–28.3ROR 19.6 · χ² 355 / p 2e-79	18.5 EB05 12.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 14.1 · 100% clinician	no trial data cached
Blindness	20	20.0 13.0–30.8ROR 20.8 · χ² 344 / p 5e-77	19.6 EB05 13.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 15.3	no trial data cached
Urinary retention	20	24.5 16.0–37.7ROR 25.5 · χ² 429 / p 2e-95	24.0 EB05 16.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 20.5 · 95% clinician	no trial data cached
Coronary artery disease	20	26.8 17.4–41.1ROR 27.8 · χ² 471 / p 1e-104	26.1 EB05 17.8 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 20.3	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	20	36.6 23.8–56.3ROR 38.1 · χ² 658 / p 2e-145	35.5 EB05 24.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 27.5 · 100% clinician	no trial data cached
Acute myocardial infarction	19	26.2 16.8–40.7ROR 27.2 · χ² 436 / p 4e-97	25.6 EB05 17.3 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 19.5	no trial data cached
Panic attack	18	20.1 12.8–31.7ROR 20.8 · χ² 309 / p 2e-69	19.7 EB05 13.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 21.7	no trial data cached
Heart rate decreased	18	20.8 13.2–32.8ROR 21.5 · χ² 320 / p 6e-72	20.3 EB05 13.4 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 19.3	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.

Glaucoma — n=24, PRR 50.9
Limb injury — n=30, PRR 45.2
Wound — n=30, PRR 44.1
Stevens-johnson syndrome — n=20, PRR 36.6
Eye irritation — n=35, PRR 25.6
Urinary retention — n=20, PRR 24.5
Blindness — n=20, PRR 20.0
Coma — n=22, PRR 18.8

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 Betaxolol?

In FDA FAERS, the most frequently co-reported reaction terms for Betaxolol are eye irritation, haemorrhage, cardiac failure congestive, wound, limb injury, transient ischaemic attack. 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, 37 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.