Drug · FAERS side-effect profile with label screen

Brimonidine and Timolol side effects: what 379 FDA adverse event reports show

Brimonidine Tartrate And Timolol Maleate · 15 reaction terms · 177 drug–reaction co-reports · data 2026-09-14

Drug class

Alpha adrenergic agonist

FDA label, Indications wording of the closest related product

Label matched

Brimonidine (Brimonidine)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

379 reports · 62% serious · 13 with death outcome · 59% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Brimonidine topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older. Brimonidine topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. ( 1 )

FDA label, Indications and Usage

What it is

Brimonidine Topical Gel, 0.33% contains brimonidine tartrate, an alpha adrenergic agonist.

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 14 strongest signals

Labeled (related wording) 2Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 9

What the badges mean

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. 1 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
Intraocular pressure increased (raised eye pressure)	14	60.2 36.0–100.7ROR 62.5 · χ² 757 / p 6e-167	55.8 EB05 35.3 · IC025 +3.4 3/3 methods agree	Lab value / disease marker	serious PRR 53.3	no trial data cached
Ocular discomfort	10	50.9 27.6–93.8ROR 52.2 · χ² 440 / p 6e-98	46.6 EB05 27.0 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached
Eye inflammation	6	35.1 15.9–77.7ROR 35.7 · χ² 166 / p 3e-38	31.4 EB05 14.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Uveitis	8	32.7 16.5–64.9ROR 33.4 · χ² 215 / p 5e-49	30.4 EB05 16.2 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 32.4	no trial data cached
Ocular hyperaemia	25	29.5 20.2–43.2ROR 31.6 · χ² 662 / p 2e-146	28.9 EB05 20.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 25.9 · 71% consumer	no trial data cached
Eye pain	28	28.0 19.6–40.0ROR 30.1 · χ² 703 / p 3e-155	27.5 EB05 20.0 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 32.2	no trial data cached
Eye irritation	27	26.7 18.6–38.5ROR 28.7 · χ² 645 / p 2e-142	26.3 EB05 19.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 46.0	no trial data cached
Glaucoma	9	25.8 13.5–49.2ROR 26.4 · χ² 190 / p 1e-43	24.3 EB05 13.2 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 25.9	no trial data cached
Product packaging quantity issue	5	25.3 10.6–60.4ROR 25.6 · χ² 94 / p 2e-22	21.2 EB05 7.0 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Conjunctivitis	8	24.0 12.1–47.7ROR 24.5 · χ² 154 / p 1e-35	22.3 EB05 11.2 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 10.4	no trial data cached
Eye pruritus	11	18.4 10.3–33.0ROR 18.9 · χ² 164 / p 6e-38	17.3 EB05 9.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.6	no trial data cached
Middle insomnia	6	17.8 8.0–39.4ROR 18.1 · χ² 79 / p 3e-19	14.5 EB05 5.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 36.1	no trial data cached
Product substitution issue	11	10.5 5.9–18.9ROR 10.8 · χ² 86 / p 9e-21	8.6 EB05 4.7 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 15.2	no trial data cached
Extra dose administered	6	8.3 3.8–18.4ROR 8.4 · χ² 32 / p 9e-9	5.6 EB05 2.7 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	–	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 pain	28	28.0 19.6–40.0ROR 30.1 · χ² 703 / p 3e-155	27.5 EB05 20.0 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 32.2	no trial data cached
Eye irritation	27	26.7 18.6–38.5ROR 28.7 · χ² 645 / p 2e-142	26.3 EB05 19.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 46.0	no trial data cached
Ocular hyperaemia	25	29.5 20.2–43.2ROR 31.6 · χ² 662 / p 2e-146	28.9 EB05 20.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 25.9 · 71% consumer	no trial data cached
Intraocular pressure increased (raised eye pressure)	14	60.2 36.0–100.7ROR 62.5 · χ² 757 / p 6e-167	55.8 EB05 35.3 · IC025 +3.4 3/3 methods agree	Lab value / disease marker	serious PRR 53.3	no trial data cached
Product substitution issue	11	10.5 5.9–18.9ROR 10.8 · χ² 86 / p 9e-21	8.6 EB05 4.7 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 15.2	no trial data cached
Eye pruritus	11	18.4 10.3–33.0ROR 18.9 · χ² 164 / p 6e-38	17.3 EB05 9.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.6	no trial data cached
Ocular discomfort	10	50.9 27.6–93.8ROR 52.2 · χ² 440 / p 6e-98	46.6 EB05 27.0 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached
Glaucoma	9	25.8 13.5–49.2ROR 26.4 · χ² 190 / p 1e-43	24.3 EB05 13.2 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 25.9	no trial data cached
Conjunctivitis	8	24.0 12.1–47.7ROR 24.5 · χ² 154 / p 1e-35	22.3 EB05 11.2 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 10.4	no trial data cached
Uveitis	8	32.7 16.5–64.9ROR 33.4 · χ² 215 / p 5e-49	30.4 EB05 16.2 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 32.4	no trial data cached
Extra dose administered	6	8.3 3.8–18.4ROR 8.4 · χ² 32 / p 9e-9	5.6 EB05 2.7 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Middle insomnia	6	17.8 8.0–39.4ROR 18.1 · χ² 79 / p 3e-19	14.5 EB05 5.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 36.1	no trial data cached
Eye inflammation	6	35.1 15.9–77.7ROR 35.7 · χ² 166 / p 3e-38	31.4 EB05 14.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Product packaging quantity issue	5	25.3 10.6–60.4ROR 25.6 · χ² 94 / p 2e-22	21.2 EB05 7.0 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Wrong technique in device usage process	3	3.6 1.2–11.2ROR 3.6 · χ² 3 / p 0.033	2.6 EB05 1.1 · IC025 -0.7 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	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.

Ocular hyperaemia — n=25, PRR 29.5
Eye irritation — n=27, PRR 26.7

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 Brimonidine and Timolol?

In FDA FAERS, the most frequently co-reported reaction terms for Brimonidine and Timolol are eye pain, eye irritation, ocular hyperaemia, intraocular pressure increased, eye pruritus, ocular discomfort. 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 Brimonidine and Timolol have an FDA boxed warning?

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

Do FAERS signals prove that Brimonidine and Timolol 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 c899b329-cc5e-4443-8e94-451314de47c9, effective 20240731; matched on openfda.generic_name.exact:"BRIMONIDINE")
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, 15 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.