Drug · FAERS side-effect profile with label screen
Brimonidine side effects: what 7,629 FDA adverse event reports show
Drug class
Alpha adrenergic agonist
FDA label, Indications wording
Who reports
7,629 reports · 39% serious · 283 with death outcome · 56% 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 2Labeled (related wording) 3Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 30
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. 190 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 |
|---|---|---|---|---|---|---|
| Treatment failure | 2,763 | 95.7 92.8–98.7ROR 149.5 · χ² 251,056 / p <1e-300 | 92.4 EB05 89.6 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 · 80% consumer | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 231 | 50.3 44.3–57.2ROR 51.9 · χ² 10,924 / p <1e-300 | 49.2 EB05 44.1 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious PRR 72.6 | no trial data cached |
| Glaucoma | 145 | 20.8 17.7–24.5ROR 21.2 · χ² 2,699 / p <1e-300 | 20.6 EB05 18.0 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 30.6 | no trial data cached |
| Eye inflammation | 44 | 12.9 9.6–17.3ROR 12.9 · χ² 468 / p 4e-104 | 12.5 EB05 9.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=35 | no trial data cached |
| Ocular hyperaemia | 186 | 11.0 9.5–12.7ROR 11.2 · χ² 1,674 / p <1e-300 | 10.9 EB05 9.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 | no trial data cached |
| Eye irritation | 190 | 9.4 8.2–10.8ROR 9.6 · χ² 1,416 / p <1e-300 | 9.3 EB05 8.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 | no trial data cached |
| Vitreous floaters | 31 | 8.8 6.2–12.5ROR 8.8 · χ² 205 / p 8e-47 | 8.1 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=29 | no trial data cached |
| Eye pain | 172 | 8.6 7.4–10.0ROR 8.8 · χ² 1,144 / p 5e-251 | 8.4 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.5 | no trial data cached |
| Uveitis | 42 | 8.6 6.3–11.6ROR 8.6 · χ² 273 / p 2e-61 | 8.0 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 | no trial data cached |
| Hypotonia | 31 | 8.5 6.0–12.1ROR 8.5 · χ² 198 / p 3e-45 | 7.8 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 · 100% clinician | no trial data cached |
| Blindness unilateral | 43 | 8.4 6.2–11.3ROR 8.5 · χ² 273 / p 1e-61 | 7.9 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · ♀ 81% (drug 56%) | no trial data cached |
| Hypothermia | 27 | 7.3 5.0–10.7ROR 7.4 · χ² 141 / p 8e-33 | 6.6 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · ♀ 88% (drug 56%) · 100% clinician | no trial data cached |
| Retinal detachment | 23 | 6.9 4.6–10.4ROR 6.9 · χ² 110 / p 6e-26 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · ♀ 33% (drug 56%) | no trial data cached |
| Product packaging quantity issue | 26 | 6.6 4.5–9.6ROR 6.6 · χ² 117 / p 2e-27 | 5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious n=6 · 77% consumer | no trial data cached |
| Hypersensitivity (allergic reaction) | 441 | 6.6 6.0–7.2ROR 6.9 · χ² 2,082 / p <1e-300 | 6.5 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.5 · 76% consumer | no trial data cached |
| Conjunctivitis | 39 | 5.8 4.3–8.0ROR 5.9 · χ² 152 / p 4e-35 | 5.5 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Ocular discomfort | 23 | 5.8 3.9–8.8ROR 5.8 · χ² 87 / p 5e-21 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Eye pruritus | 69 | 5.8 4.6–7.3ROR 5.8 · χ² 267 / p 3e-60 | 5.5 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · 70% consumer | no trial data cached |
| Eye discharge | 21 | 5.7 3.7–8.7ROR 5.7 · χ² 76 / p 2e-18 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious n=9 | no trial data cached |
| Visual acuity reduced | 64 | 5.3 4.1–6.7ROR 5.3 · χ² 216 / p 3e-49 | 5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Photophobia (light sensitivity) | 34 | 5.0 3.6–7.0ROR 5.0 · χ² 105 / p 6e-25 | 4.7 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| End stage renal disease | 31 | 4.6 3.3–6.6ROR 4.6 · χ² 85 / p 2e-20 | 4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Dry eye | 80 | 4.5 3.7–5.7ROR 4.6 · χ² 218 / p 1e-49 | 4.4 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Lacrimation increased | 49 | 4.5 3.4–6.0ROR 4.5 · χ² 130 / p 2e-30 | 4.3 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Vasculitis | 19 | 4.5 2.9–7.0ROR 4.5 · χ² 48 / p 2e-12 | 4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Nocturia (night-time urination) | 17 | 3.9 2.4–6.2ROR 3.9 · χ² 33 / p 4e-9 | 3.5 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Cataract | 78 | 3.6 2.9–4.5ROR 3.6 · χ² 145 / p 9e-34 | 3.5 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Eye disorder | 42 | 3.5 2.6–4.8ROR 3.5 · χ² 73 / p 5e-18 | 3.4 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Vision blurred (blurred vision) | 174 | 3.5 3.0–4.1ROR 3.6 · χ² 310 / p 9e-70 | 3.5 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Eye haemorrhage | 17 | 3.5 2.2–5.6ROR 3.5 · χ² 28 / p 7e-8 | 3.2 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Macular degeneration | 15 | 3.5 2.1–5.7ROR 3.5 · χ² 24 / p 5e-7 | 3.2 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Dizziness postural | 12 | 3.4 2.0–6.1ROR 3.4 · χ² 18 / p 9e-6 | 3.1 EB05 1.9 · IC025 +0.7 | Not in label — unassessed | serious n=9 | no trial data cached |
| Blindness | 50 | 3.4 2.6–4.5ROR 3.4 · χ² 81 / p 9e-20 | 3.3 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 72% consumer | no trial data cached |
| Eye infection | 12 | 2.9 1.7–5.2ROR 2.9 · χ² 13 / p 1e-4 | 2.7 EB05 1.7 · IC025 +0.5 | Not in label — unassessed | serious n=10 | no trial data cached |
| Chronic kidney disease | 82 | 2.9 2.4–3.6ROR 3.0 · χ² 103 / p 1e-24 | 2.9 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Product use complaint | 16 | 2.8 1.7–4.6ROR 2.8 · χ² 17 / p 2e-5 | 2.7 EB05 1.8 · IC025 +0.6 | Reporting / coding artifact | serious n=4 | no trial data cached |
| Visual impairment | 126 | 2.8 2.4–3.3ROR 2.8 · χ² 146 / p 5e-34 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Renal tubular necrosis | 10 | 2.8 1.5–5.2ROR 2.8 · χ² 10 / p 9e-4 | 2.6 EB05 1.5 · IC025 +0.3 | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Hemiparesis | 17 | 2.7 1.7–4.4ROR 2.7 · χ² 17 / p 2e-5 | 2.6 EB05 1.7 · IC025 +0.6 | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Blood pressure fluctuation | 24 | 2.7 1.8–4.1ROR 2.7 · χ² 25 / p 3e-7 | 2.6 EB05 1.9 · IC025 +0.7 | Lab value / disease marker | serious PRR 3.6 · ♀ 83% (drug 56%) | 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 |
|---|---|---|---|---|---|---|
| Treatment failure | 2,763 | 95.7 92.8–98.7ROR 149.5 · χ² 251,056 / p <1e-300 | 92.4 EB05 89.6 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 · 80% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 575 | 1.2 1.1–1.3ROR 1.2 · χ² 20 / p 3e-6 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 2.1 | no trial data cached |
| Hypersensitivity (allergic reaction) | 441 | 6.6 6.0–7.2ROR 6.9 · χ² 2,082 / p <1e-300 | 6.5 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.5 · 76% consumer | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 231 | 50.3 44.3–57.2ROR 51.9 · χ² 10,924 / p <1e-300 | 49.2 EB05 44.1 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious PRR 72.6 | no trial data cached |
| Eye irritation | 190 | 9.4 8.2–10.8ROR 9.6 · χ² 1,416 / p <1e-300 | 9.3 EB05 8.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 | no trial data cached |
| Ocular hyperaemia | 186 | 11.0 9.5–12.7ROR 11.2 · χ² 1,674 / p <1e-300 | 10.9 EB05 9.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 | no trial data cached |
| Vision blurred (blurred vision) | 174 | 3.5 3.0–4.1ROR 3.6 · χ² 310 / p 9e-70 | 3.5 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Eye pain | 172 | 8.6 7.4–10.0ROR 8.8 · χ² 1,144 / p 5e-251 | 8.4 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.5 | no trial data cached |
| Fall | 161 | 1.3 1.1–1.6ROR 1.3 · χ² 13 / p 1e-4 | 1.3 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Glaucoma | 145 | 20.8 17.7–24.5ROR 21.2 · χ² 2,699 / p <1e-300 | 20.6 EB05 18.0 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 30.6 | no trial data cached |
| Drug hypersensitivity | 139 | 2.0 1.7–2.3ROR 2.0 · χ² 66 / p 3e-16 | 2.0 EB05 1.7 · IC025 +0.7 | Labeled (related wording) related wording | serious PRR 1.8 | no trial data cached |
| Visual impairment | 126 | 2.8 2.4–3.3ROR 2.8 · χ² 146 / p 5e-34 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Product dose omission issue | 110 | 1.1 0.9–1.3ROR 1.1 · χ² 0 / p 0.280 | 1.1 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 2.7 · 72% consumer | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 91 | 1.6 1.3–2.0ROR 1.6 · χ² 22 / p 1e-6 | 1.6 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Chronic kidney disease | 82 | 2.9 2.4–3.6ROR 3.0 · χ² 103 / p 1e-24 | 2.9 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | 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.
- Eye inflammation — n=44, PRR 12.9
- Ocular hyperaemia — n=186, PRR 11.0
- Eye irritation — n=190, PRR 9.4
- Vitreous floaters — n=31, PRR 8.8
- Uveitis — n=42, PRR 8.6
- Hypotonia — n=31, PRR 8.5
- Blindness unilateral — n=43, PRR 8.4
- Hypothermia — n=27, PRR 7.3
- Retinal detachment — n=23, PRR 6.9
- Conjunctivitis — n=39, PRR 5.8
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 hypersensitivity, intraocular pressure increased, eye irritation, ocular hyperaemia, vision blurred, eye pain. 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, 230 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.