Drug · FAERS side-effect profile with label screen
Brimonidine Tartrate side effects: what 17,706 FDA adverse event reports show
Drug class
Alpha adrenergic agonist
FDA label, Indications wording
Who reports
17,706 reports · 43% serious · 753 with death outcome · 60% 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 (related wording) 1Likely indication confounding 2Reporting / coding artifact 3Lab value / disease marker 3Not in label — unassessed 31
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.
- 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. 1,071 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 |
|---|---|---|---|---|---|---|
| Conjunctival follicles | 11 | 642.0 307.7–1,339.8ROR 642.4 · χ² 4,138 / p <1e-300 | 241.3 EB05 143.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=8 | not reported in cached trials |
| Hypotony maculopathy | 12 | 483.0 246.5–946.4ROR 483.4 · χ² 3,749 / p <1e-300 | 221.7 EB05 135.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Ocular surface disease | 45 | 243.2 176.5–335.2ROR 243.8 · χ² 8,783 / p <1e-300 | 185.7 EB05 144.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=45 · 91% clinician | not reported in cached trials |
| Corneal neovascularisation | 20 | 110.6 70.0–175.0ROR 110.8 · χ² 1,886 / p <1e-300 | 92.5 EB05 63.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Intraocular pressure fluctuation | 16 | 109.2 65.4–182.3ROR 109.3 · χ² 1,471 / p <1e-300 | 89.6 EB05 58.5 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=8 | not reported in cached trials |
| Conjunctival scar | 12 | 104.5 57.9–188.7ROR 104.6 · χ² 1,036 / p 1e-227 | 83.7 EB05 51.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Corneal opacity | 105 | 99.1 81.2–120.9ROR 99.7 · χ² 9,308 / p <1e-300 | 90.0 EB05 76.4 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=100 · 95% clinician | not reported in cached trials |
| Hypotony of eye | 27 | 81.7 55.3–120.6ROR 81.8 · χ² 1,936 / p <1e-300 | 72.6 EB05 52.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 0% (drug 60%) · 100% clinician | not reported in cached trials |
| Open angle glaucoma | 38 | 78.1 56.3–108.4ROR 78.3 · χ² 2,639 / p <1e-300 | 70.8 EB05 53.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=36 | not reported in cached trials |
| Choroidal detachment | 34 | 77.4 54.7–109.4ROR 77.5 · χ² 2,333 / p <1e-300 | 69.9 EB05 52.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 0% (drug 60%) · 100% clinician | not reported in cached trials |
| Corneal infiltrates | 18 | 73.2 45.5–117.8ROR 73.3 · χ² 1,139 / p 5e-250 | 64.5 EB05 43.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Palpable purpura | 15 | 68.7 40.8–115.6ROR 68.7 · χ² 882 / p 4e-194 | 60.2 EB05 38.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Product dropper issue | 42 | 65.8 48.2–89.8ROR 66.0 · χ² 2,477 / p <1e-300 | 60.7 EB05 46.8 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious n=8 · 71% consumer | not reported in cached trials |
| Scleral hyperaemia | 35 | 63.4 45.2–89.1ROR 63.6 · χ² 1,981 / p <1e-300 | 58.4 EB05 43.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Corneal degeneration | 12 | 61.2 34.2–109.3ROR 61.2 · χ² 619 / p 7e-137 | 53.5 EB05 32.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Choroidal effusion | 39 | 60.7 44.0–83.7ROR 60.8 · χ² 2,120 / p <1e-300 | 56.2 EB05 42.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=38 · 100% clinician | not reported in cached trials |
| Intraocular pressure increased (raised eye pressure) | 616 | 59.6 55.1–64.6ROR 61.8 · χ² 33,758 / p <1e-300 | 56.7 EB05 53.0 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious PRR 65.2 | not reported in cached trials |
| Glaucoma surgery | 12 | 58.4 32.7–104.2ROR 58.4 · χ² 591 / p 8e-131 | 51.4 EB05 31.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Cornea verticillata | 13 | 52.5 30.1–91.5ROR 52.5 · χ² 580 / p 2e-128 | 47.1 EB05 29.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Intraocular pressure test abnormal | 28 | 48.8 33.4–71.2ROR 48.9 · χ² 1,213 / p 6e-266 | 45.5 EB05 33.0 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious n=15 | not reported in cached trials |
| Rosacea | 183 | 48.7 42.0–56.4ROR 49.2 · χ² 8,157 / p <1e-300 | 46.5 EB05 41.2 · IC025 +5.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=45 · 77% consumer | not reported in cached trials |
| Corneal oedema | 88 | 48.3 39.0–59.7ROR 48.5 · χ² 3,869 / p <1e-300 | 46.0 EB05 38.5 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=63 · 92% clinician | not reported in cached trials |
| Intraocular pressure decreased | 20 | 46.2 29.6–72.3ROR 46.3 · χ² 808 / p 4e-178 | 42.8 EB05 29.3 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=12 | not reported in cached trials |
| Iris adhesions | 19 | 46.2 29.2–73.1ROR 46.3 · χ² 765 / p 9e-169 | 42.7 EB05 28.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Treatment failure | 2,875 | 43.0 41.5–44.5ROR 51.1 · χ² 114,045 / p <1e-300 | 41.5 EB05 40.2 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 1.7 · 80% consumer | not reported in cached trials |
| Corneal transplant | 25 | 39.8 26.7–59.2ROR 39.8 · χ² 876 / p 7e-193 | 37.5 EB05 26.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Instillation site erythema | 17 | 39.1 24.1–63.3ROR 39.1 · χ² 574 / p 4e-127 | 36.4 EB05 24.1 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | – | not reported in cached trials |
| Meibomian gland dysfunction | 14 | 38.8 22.8–66.1ROR 38.8 · χ² 463 / p 5e-103 | 35.9 EB05 22.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Fibroadenoma of breast | 14 | 37.7 22.2–64.3ROR 37.8 · χ² 450 / p 3e-100 | 35.0 EB05 22.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Growth of eyelashes | 24 | 36.8 24.5–55.2ROR 36.8 · χ² 775 / p 6e-171 | 34.8 EB05 24.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=7 · 100% consumer | not reported in cached trials |
| Hyphaema | 15 | 34.8 20.8–58.2ROR 34.8 · χ² 446 / p 3e-99 | 32.6 EB05 20.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Punctate keratitis | 25 | 34.5 23.2–51.3ROR 34.5 · χ² 758 / p 4e-167 | 32.8 EB05 23.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 33% (drug 60%) · 100% clinician | not reported in cached trials |
| Reaction to preservatives | 22 | 32.8 21.4–50.0ROR 32.8 · χ² 628 / p 6e-139 | 31.1 EB05 21.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | 76% consumer | not reported in cached trials |
| Floppy iris syndrome | 10 | 32.7 17.4–61.3ROR 32.7 · χ² 269 / p 1e-60 | 30.1 EB05 17.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Glare | 13 | 31.1 17.9–53.9ROR 31.1 · χ² 340 / p 3e-76 | 29.1 EB05 18.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=8 | not reported in cached trials |
| Anterior chamber inflammation | 15 | 31.0 18.6–51.7ROR 31.0 · χ² 395 / p 3e-88 | 29.2 EB05 18.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Ocular hypertension | 47 | 29.8 22.3–39.7ROR 29.8 · χ² 1,246 / p 3e-273 | 28.7 EB05 22.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=44 | not reported in cached trials |
| Corneal scar | 12 | 29.3 16.5–52.0ROR 29.3 · χ² 293 / p 5e-66 | 27.5 EB05 16.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=8 | not reported in cached trials |
| Eye allergy | 37 | 29.2 21.1–40.4ROR 29.2 · χ² 955 / p 7e-210 | 28.1 EB05 21.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | 89% consumer | NCT01297920: 5/235 (2.1%) on Brimonidine |
| Ocular vascular disorder | 19 | 27.7 17.6–43.6ROR 27.7 · χ² 452 / p 1e-100 | 26.4 EB05 17.9 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Brimonidine as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).
- NCT01309204 — Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in (N=1184, PHASE3; 20 AE terms posted; arms: Brinz/Brim; Brinz+Brim)
- NCT01297920 — Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brin (N=1062, PHASE3; 32 AE terms posted; arms: Brinz/Brim; Brinzolamide; Brimonidine)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Treatment failure | 2,875 | 43.0 41.5–44.5ROR 51.1 · χ² 114,045 / p <1e-300 | 41.5 EB05 40.2 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 1.7 · 80% consumer | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,285 | 1.2 1.1–1.2ROR 1.2 · χ² 29 / p 5e-8 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.7 | not reported in cached trials |
| Erythema (skin redness) | 755 | 4.4 4.1–4.7ROR 4.5 · χ² 1,969 / p <1e-300 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.3 | not reported in cached trials |
| Eye irritation | 755 | 16.2 15.1–17.4ROR 16.9 · χ² 10,665 / p <1e-300 | 16.0 EB05 15.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 20.3 | NCT01297920: 9/235 (3.8%) on Brimonidine |
| Ocular hyperaemia | 747 | 19.2 17.9–20.6ROR 20.0 · χ² 12,707 / p <1e-300 | 18.9 EB05 17.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 19.1 | not reported in cached trials |
| Eye pain | 735 | 16.0 14.9–17.1ROR 16.6 · χ² 10,178 / p <1e-300 | 15.7 EB05 14.8 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.8 · 74% consumer | NCT01297920: 1/221 (0.5%) on Brimonidine (serious AE) |
| Off label use (used outside approved label) | 706 | 1.0 0.9–1.0ROR 1.0 · χ² 1 / p 0.159 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.2 | not reported in cached trials |
| Fatigue (tiredness) | 703 | 1.1 1.0–1.2ROR 1.1 · χ² 3 / p 0.032 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.4 | not reported in cached trials |
| Hypersensitivity (allergic reaction) | 696 | 4.5 4.1–4.8ROR 4.6 · χ² 1,873 / p <1e-300 | 4.4 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.7 · 73% consumer | not reported in cached trials |
| Vision blurred (blurred vision) | 619 | 5.4 5.0–5.8ROR 5.5 · χ² 2,210 / p <1e-300 | 5.3 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · 71% consumer | NCT01297920: 1/235 (0.4%) on Brimonidine |
| Intraocular pressure increased (raised eye pressure) | 616 | 59.6 55.1–64.6ROR 61.8 · χ² 33,758 / p <1e-300 | 56.7 EB05 53.0 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious PRR 65.2 | not reported in cached trials |
| Dizziness | 551 | 1.3 1.2–1.4ROR 1.3 · χ² 41 / p 7e-11 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.7 | not reported in cached trials |
| Headache | 542 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.288 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.3 | NCT01309204: 1/452 (0.2%) on Brimonidine (serious AE) |
| Condition aggravated | 491 | 1.9 1.8–2.1ROR 2.0 · χ² 221 / p 3e-50 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 1.8 | not reported in cached trials |
| Diarrhoea (diarrhea) | 469 | 0.9 0.8–0.9ROR 0.9 · χ² 10 / p 7e-4 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.2 | not reported in cached trials |
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 surface disease — n=45, PRR 243.2
- Corneal neovascularisation — n=20, PRR 110.6
- Corneal opacity — n=105, PRR 99.1
- Hypotony of eye — n=27, PRR 81.7
- Open angle glaucoma — n=38, PRR 78.1
- Choroidal detachment — n=34, PRR 77.4
- Scleral hyperaemia — n=35, PRR 63.4
- Choroidal effusion — n=39, PRR 60.7
- Corneal oedema — n=88, PRR 48.3
- Corneal transplant — n=25, PRR 39.8
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 Brimonidine?
In FDA FAERS, the most frequently co-reported reaction terms for Brimonidine are erythema, eye irritation, ocular hyperaemia, eye pain, fatigue, hypersensitivity. 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 have an FDA boxed warning?
No. The FDA label retrieved for Brimonidine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Brimonidine 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, 1,111 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 - ClinicalTrials.gov API v2 (query
BRIMONIDINE, results-bearing studies sorted by enrollment)
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.