Drug · FAERS side-effect profile with label screen
Brimonidine and Timolol side effects: what 6,591 FDA adverse event reports show
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
6,591 reports · 41% serious · 315 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 40 strongest signals
Labeled adverse reaction 1Labeled (related wording) 5Reporting / coding artifact 6Lab value / disease marker 2Not in label — unassessed 26
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. 232 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 |
|---|---|---|---|---|---|---|
| Intraocular pressure increased (raised eye pressure) | 293 | 74.2 66.3–83.1ROR 77.6 · χ² 20,622 / p <1e-300 | 72.2 EB05 65.5 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious PRR 79.3 · 73% consumer | no trial data cached |
| Ocular hyperaemia | 541 | 37.2 34.3–40.4ROR 40.5 · χ² 18,863 / p <1e-300 | 36.8 EB05 34.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 22.6 · 79% consumer | no trial data cached |
| Eye irritation | 524 | 30.2 27.8–32.8ROR 32.7 · χ² 14,643 / p <1e-300 | 29.9 EB05 27.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 · 80% consumer | no trial data cached |
| Glaucoma | 164 | 27.3 23.4–31.8ROR 28.0 · χ² 4,095 / p <1e-300 | 27.0 EB05 23.7 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 34.4 · 72% consumer | no trial data cached |
| Eye pain | 470 | 27.3 25.0–29.8ROR 29.3 · χ² 11,803 / p <1e-300 | 27.0 EB05 25.0 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.2 · 78% consumer | no trial data cached |
| Eye discharge | 85 | 26.7 21.6–33.0ROR 27.0 · χ² 2,058 / p <1e-300 | 26.3 EB05 21.9 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=11 · 74% consumer | no trial data cached |
| Eye pruritus | 254 | 24.7 21.9–27.9ROR 25.6 · χ² 5,711 / p <1e-300 | 24.5 EB05 22.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 · 83% consumer | no trial data cached |
| Ocular discomfort | 65 | 19.1 15.0–24.4ROR 19.3 · χ² 1,093 / p 5e-240 | 18.9 EB05 15.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=18 · 75% consumer | no trial data cached |
| Lacrimation increased | 176 | 18.8 16.3–21.8ROR 19.3 · χ² 2,941 / p <1e-300 | 18.7 EB05 16.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · 75% consumer | no trial data cached |
| Product packaging quantity issue | 58 | 17.0 13.1–22.0ROR 17.1 · χ² 852 / p 1e-187 | 16.8 EB05 13.4 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious n=7 · 81% consumer | no trial data cached |
| Eye inflammation | 49 | 16.6 12.5–22.0ROR 16.7 · χ² 699 / p 2e-154 | 16.4 EB05 12.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=30 · 71% consumer | no trial data cached |
| Blindness unilateral | 68 | 15.4 12.2–19.5ROR 15.6 · χ² 899 / p 9e-198 | 15.2 EB05 12.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 21.4 · 77% consumer | no trial data cached |
| Eye infection | 51 | 14.5 11.0–19.1ROR 14.6 · χ² 626 / p 2e-138 | 14.3 EB05 11.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=22 · 82% consumer | no trial data cached |
| Eyelid oedema | 51 | 13.9 10.6–18.3ROR 14.0 · χ² 596 / p 6e-132 | 13.7 EB05 10.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 80% consumer | no trial data cached |
| Eye swelling | 153 | 13.2 11.3–15.5ROR 13.5 · χ² 1,710 / p <1e-300 | 13.1 EB05 11.4 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.7 · 77% consumer | no trial data cached |
| Photophobia (light sensitivity) | 74 | 12.6 10.1–15.9ROR 12.8 · χ² 780 / p 7e-172 | 12.4 EB05 10.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · 82% consumer | no trial data cached |
| Uveitis | 45 | 10.6 7.9–14.2ROR 10.7 · χ² 382 / p 3e-85 | 10.2 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 | no trial data cached |
| Visual acuity reduced | 109 | 10.4 8.6–12.5ROR 10.5 · χ² 913 / p 8e-201 | 10.2 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Dry eye | 138 | 9.1 7.7–10.7ROR 9.3 · χ² 983 / p 3e-216 | 8.9 EB05 7.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · 79% consumer | no trial data cached |
| Cataract | 160 | 8.6 7.4–10.0ROR 8.8 · χ² 1,067 / p 3e-234 | 8.4 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Vitreous floaters | 25 | 8.2 5.5–12.1ROR 8.2 · χ² 150 / p 8e-35 | 7.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Vision blurred (blurred vision) | 337 | 7.9 7.1–8.7ROR 8.2 · χ² 2,019 / p <1e-300 | 7.8 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 · 72% consumer | no trial data cached |
| Conjunctivitis | 45 | 7.8 5.8–10.4ROR 7.8 · χ² 260 / p 1e-58 | 7.3 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Eye disorder | 77 | 7.5 6.0–9.3ROR 7.6 · χ² 426 / p 7e-95 | 7.2 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · 75% consumer | no trial data cached |
| Retinal detachment | 21 | 7.3 4.7–11.2ROR 7.3 · χ² 107 / p 2e-25 | 6.4 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · ♀ 30% (drug 59%) | no trial data cached |
| Eye haemorrhage | 27 | 6.4 4.4–9.4ROR 6.5 · χ² 118 / p 7e-28 | 5.8 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · 70% consumer | no trial data cached |
| Eyelid ptosis | 19 | 5.9 3.8–9.3ROR 6.0 · χ² 73 / p 6e-18 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Blindness | 76 | 5.9 4.8–7.4ROR 6.0 · χ² 308 / p 4e-69 | 5.7 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 73% consumer | no trial data cached |
| Product use complaint | 28 | 5.8 4.0–8.3ROR 5.8 · χ² 105 / p 6e-25 | 5.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious n=8 · 85% consumer | no trial data cached |
| Macular degeneration | 21 | 5.6 3.7–8.6ROR 5.6 · χ² 75 / p 2e-18 | 5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Visual impairment | 211 | 5.5 4.8–6.2ROR 5.6 · χ² 768 / p 3e-169 | 5.4 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · 73% consumer | no trial data cached |
| Poor quality product administered | 17 | 5.3 3.3–8.5ROR 5.3 · χ² 55 / p 6e-14 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Accidental exposure to product | 157 | 5.0 4.3–5.8ROR 5.1 · χ² 500 / p 4e-111 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 · 87% consumer | no trial data cached |
| Dry mouth | 116 | 4.6 3.8–5.5ROR 4.6 · χ² 320 / p 9e-72 | 4.5 EB05 3.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 · ♀ 83% (drug 59%) · 82% consumer | no trial data cached |
| Product packaging issue | 13 | 4.5 2.6–7.7ROR 4.5 · χ² 31 / p 1e-8 | 3.9 EB05 2.5 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious n=3 | no trial data cached |
| Heart rate decreased | 49 | 4.4 3.3–5.8ROR 4.4 · χ² 126 / p 1e-29 | 4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 · 71% consumer | no trial data cached |
| Product storage error | 117 | 4.3 3.6–5.2ROR 4.4 · χ² 294 / p 3e-66 | 4.2 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 · 79% consumer | no trial data cached |
| Product dose omission | 85 | 4.1 3.3–5.0ROR 4.1 · χ² 195 / p 1e-44 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 73% consumer | no trial data cached |
| Prostatic specific antigen increased | 17 | 3.9 2.4–6.3ROR 3.9 · χ² 34 / p 3e-9 | 3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 4.8 | no trial data cached |
| Body height decreased | 13 | 3.8 2.2–6.6ROR 3.8 · χ² 24 / p 4e-7 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious n=9 | 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 |
|---|---|---|---|---|---|---|
| Ocular hyperaemia | 541 | 37.2 34.3–40.4ROR 40.5 · χ² 18,863 / p <1e-300 | 36.8 EB05 34.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 22.6 · 79% consumer | no trial data cached |
| Eye irritation | 524 | 30.2 27.8–32.8ROR 32.7 · χ² 14,643 / p <1e-300 | 29.9 EB05 27.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 · 80% consumer | no trial data cached |
| Eye pain | 470 | 27.3 25.0–29.8ROR 29.3 · χ² 11,803 / p <1e-300 | 27.0 EB05 25.0 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.2 · 78% consumer | no trial data cached |
| Fatigue (tiredness) | 383 | 1.6 1.4–1.7ROR 1.6 · χ² 81 / p 1e-19 | 1.6 EB05 1.4 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Vision blurred (blurred vision) | 337 | 7.9 7.1–8.7ROR 8.2 · χ² 2,019 / p <1e-300 | 7.8 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 · 72% consumer | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 293 | 74.2 66.3–83.1ROR 77.6 · χ² 20,622 / p <1e-300 | 72.2 EB05 65.5 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious PRR 79.3 · 73% consumer | no trial data cached |
| Dizziness | 268 | 1.7 1.5–1.9ROR 1.7 · χ² 81 / p 1e-19 | 1.7 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.6 · 74% consumer | no trial data cached |
| Eye pruritus | 254 | 24.7 21.9–27.9ROR 25.6 · χ² 5,711 / p <1e-300 | 24.5 EB05 22.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 · 83% consumer | no trial data cached |
| Visual impairment | 211 | 5.5 4.8–6.2ROR 5.6 · χ² 768 / p 3e-169 | 5.4 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · 73% consumer | no trial data cached |
| Fall | 197 | 1.9 1.6–2.2ROR 1.9 · χ² 82 / p 6e-20 | 1.9 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Lacrimation increased | 176 | 18.8 16.3–21.8ROR 19.3 · χ² 2,941 / p <1e-300 | 18.7 EB05 16.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · 75% consumer | no trial data cached |
| Glaucoma | 164 | 27.3 23.4–31.8ROR 28.0 · χ² 4,095 / p <1e-300 | 27.0 EB05 23.7 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 34.4 · 72% consumer | no trial data cached |
| Cataract | 160 | 8.6 7.4–10.0ROR 8.8 · χ² 1,067 / p 3e-234 | 8.4 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Accidental exposure to product | 157 | 5.0 4.3–5.8ROR 5.1 · χ² 500 / p 4e-111 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 · 87% consumer | no trial data cached |
| Hypersensitivity (allergic reaction) | 156 | 2.7 2.3–3.1ROR 2.7 · χ² 164 / p 9e-38 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.4 · 73% consumer | 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=541, PRR 37.2
- Eye irritation — n=524, PRR 30.2
- Eye pruritus — n=254, PRR 24.7
- Ocular discomfort — n=65, PRR 19.1
- Lacrimation increased — n=176, PRR 18.8
- Eye inflammation — n=49, PRR 16.6
- Blindness unilateral — n=68, PRR 15.4
- Eye infection — n=51, PRR 14.5
- Eyelid oedema — n=51, PRR 13.9
- Photophobia — n=74, PRR 12.6
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 ocular hyperaemia, eye irritation, eye pain, fatigue, vision blurred, intraocular pressure increased. 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, fieldpatient.drug.openfda.generic_name.exact, 272 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.