Drug · FAERS side-effect profile with label screen
Brinzolamide and Brimonidine side effects: what 4,138 FDA adverse event reports show
Drug class
Carbonic Anhydrase Inhibitor
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Brinzolamide (Brinzolamide)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
4,138 reports · 42% serious · 149 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Brinzolamide ophthalmic suspension 1% is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. Brinzolamide ophthalmic suspension is a carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. ( 1 )
FDA label, Indications and Usage
What it is
Brinzolamide ophthalmic suspension 1% contains a carbonic anhydrase inhibitor formulated for multidose topical ophthalmic use. Brinzolamide is described chemically as: (R)-(+)-4-Ethylamino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno [3,2-e]-1,2-thiazine-6-sulfonamide-1,1- dioxide.
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 5Labeled (related wording) 5Likely indication confounding 3Reporting / coding artifact 5Lab value / disease marker 2Not 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.
- 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. 71 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) | 185 | 74.0 64.2–85.3ROR 77.5 · χ² 13,071 / p <1e-300 | 72.4 EB05 64.1 · IC025 +5.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 92.0 | no trial data cached |
| Glaucoma | 155 | 41.1 35.2–48.0ROR 42.6 · χ² 5,976 / p <1e-300 | 40.6 EB05 35.5 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 59.3 · 70% consumer | no trial data cached |
| Ocular hyperaemia | 363 | 39.7 35.9–43.8ROR 43.4 · χ² 13,563 / p <1e-300 | 39.3 EB05 36.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 40.3 | no trial data cached |
| Ocular discomfort | 69 | 32.4 25.6–40.9ROR 32.9 · χ² 2,055 / p <1e-300 | 31.9 EB05 26.1 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=19 · 72% consumer | no trial data cached |
| Eye irritation | 350 | 32.0 28.9–35.4ROR 34.9 · χ² 10,439 / p <1e-300 | 31.7 EB05 29.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 37.0 · 71% consumer | no trial data cached |
| Treatment failure | 381 | 23.6 21.5–26.0ROR 25.9 · χ² 8,223 / p <1e-300 | 23.5 EB05 21.6 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 1.3 · 87% consumer | no trial data cached |
| Uveitis | 61 | 23.0 17.9–29.5ROR 23.3 · χ² 1,255 / p 3e-275 | 22.7 EB05 18.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 32.5 | no trial data cached |
| Eye pain | 231 | 21.3 18.8–24.1ROR 22.5 · χ² 4,435 / p <1e-300 | 21.2 EB05 19.0 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.6 · 72% consumer | no trial data cached |
| Eye pruritus | 126 | 19.4 16.4–23.1ROR 20.0 · χ² 2,179 / p <1e-300 | 19.3 EB05 16.6 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.3 | no trial data cached |
| Blindness unilateral | 52 | 18.8 14.3–24.6ROR 19.0 · χ² 854 / p 4e-188 | 18.6 EB05 14.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 26.2 · 85% consumer | no trial data cached |
| Eye discharge | 37 | 18.4 13.3–25.4ROR 18.6 · χ² 590 / p 1e-130 | 18.2 EB05 13.7 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Product packaging quantity issue | 39 | 18.2 13.3–24.8ROR 18.3 · χ² 613 / p 1e-135 | 17.9 EB05 13.6 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=7 | no trial data cached |
| Eye inflammation | 30 | 16.2 11.3–23.1ROR 16.3 · χ² 410 / p 2e-91 | 15.8 EB05 11.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Lacrimation increased | 88 | 15.0 12.2–18.4ROR 15.3 · χ² 1,131 / p 4e-248 | 14.8 EB05 12.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · 76% consumer | no trial data cached |
| Conjunctivitis | 43 | 11.9 8.8–16.0ROR 12.0 · χ² 417 / p 6e-93 | 11.5 EB05 8.7 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.4 | no trial data cached |
| Blindness | 92 | 11.5 9.4–14.0ROR 11.7 · χ² 868 / p 4e-191 | 11.3 EB05 9.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.9 · 73% consumer | no trial data cached |
| Eye infection | 25 | 11.3 7.6–16.7ROR 11.4 · χ² 224 / p 5e-51 | 10.6 EB05 7.2 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | no trial data cached |
| Eye swelling | 70 | 9.6 7.6–12.1ROR 9.8 · χ² 531 / p 8e-118 | 9.3 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Vision blurred (blurred vision) | 258 | 9.6 8.5–10.8ROR 10.2 · χ² 1,984 / p <1e-300 | 9.5 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 | no trial data cached |
| Eyelid oedema | 22 | 9.5 6.3–14.5ROR 9.6 · χ² 159 / p 7e-37 | 8.6 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 | no trial data cached |
| Eye haemorrhage | 25 | 9.5 6.4–14.0ROR 9.5 · χ² 181 / p 1e-41 | 8.6 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 · 72% consumer | no trial data cached |
| Therapy partial responder | 28 | 9.4 6.5–13.6ROR 9.5 · χ² 202 / p 3e-46 | 8.7 EB05 6.1 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Dry eye | 86 | 9.0 7.3–11.1ROR 9.2 · χ² 604 / p 1e-133 | 8.7 EB05 7.3 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.9 | no trial data cached |
| Photophobia (light sensitivity) | 33 | 9.0 6.4–12.6ROR 9.0 · χ² 225 / p 3e-51 | 8.3 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Visual impairment | 179 | 7.4 6.4–8.5ROR 7.7 · χ² 985 / p 2e-216 | 7.3 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 | no trial data cached |
| Eye disorder | 43 | 6.7 4.9–9.0ROR 6.7 · χ² 201 / p 7e-46 | 6.2 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 | no trial data cached |
| Cataract | 75 | 6.4 5.1–8.0ROR 6.5 · χ² 338 / p 1e-75 | 6.2 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Visual acuity reduced | 40 | 6.1 4.4–8.2ROR 6.1 · χ² 164 / p 8e-38 | 5.7 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Dry mouth | 95 | 5.9 4.9–7.3ROR 6.1 · χ² 387 / p 2e-86 | 5.8 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Product use complaint | 18 | 5.9 3.7–9.3ROR 5.9 · χ² 68 / p 7e-17 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious n=3 | no trial data cached |
| Vitreous floaters | 11 | 5.7 3.2–10.3ROR 5.7 · χ² 38 / p 3e-10 | 4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Macular degeneration | 13 | 5.5 3.2–9.5ROR 5.5 · χ² 44 / p 2e-11 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Hypersensitivity (allergic reaction) | 198 | 5.4 4.7–6.2ROR 5.6 · χ² 714 / p 1e-157 | 5.3 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 · 74% consumer | no trial data cached |
| Glomerular filtration rate decreased | 12 | 5.0 2.9–8.8ROR 5.0 · χ² 35 / p 2e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious PRR 8.4 | no trial data cached |
| Malignant melanoma | 12 | 4.5 2.6–8.0ROR 4.5 · χ² 30 / p 3e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Blood pressure decreased | 56 | 4.3 3.3–5.6ROR 4.3 · χ² 138 / p 4e-32 | 4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.3 | no trial data cached |
| Expired product administered | 28 | 4.3 3.0–6.2ROR 4.3 · χ² 67 / p 1e-16 | 4.0 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Blood pressure fluctuation | 20 | 4.2 2.7–6.5ROR 4.2 · χ² 46 / p 6e-12 | 3.9 EB05 2.7 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 7.2 | no trial data cached |
| Hypoacusis | 35 | 4.1 3.0–5.7ROR 4.2 · χ² 80 / p 2e-19 | 3.9 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Pancreatitis acute | 18 | 4.1 2.6–6.5ROR 4.1 · χ² 39 / p 2e-10 | 3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | 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 | 381 | 23.6 21.5–26.0ROR 25.9 · χ² 8,223 / p <1e-300 | 23.5 EB05 21.6 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 1.3 · 87% consumer | no trial data cached |
| Ocular hyperaemia | 363 | 39.7 35.9–43.8ROR 43.4 · χ² 13,563 / p <1e-300 | 39.3 EB05 36.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 40.3 | no trial data cached |
| Eye irritation | 350 | 32.0 28.9–35.4ROR 34.9 · χ² 10,439 / p <1e-300 | 31.7 EB05 29.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 37.0 · 71% consumer | no trial data cached |
| Vision blurred (blurred vision) | 258 | 9.6 8.5–10.8ROR 10.2 · χ² 1,984 / p <1e-300 | 9.5 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 | no trial data cached |
| Eye pain | 231 | 21.3 18.8–24.1ROR 22.5 · χ² 4,435 / p <1e-300 | 21.2 EB05 19.0 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.6 · 72% consumer | no trial data cached |
| Hypersensitivity (allergic reaction) | 198 | 5.4 4.7–6.2ROR 5.6 · χ² 714 / p 1e-157 | 5.3 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 · 74% consumer | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 185 | 74.0 64.2–85.3ROR 77.5 · χ² 13,071 / p <1e-300 | 72.4 EB05 64.1 · IC025 +5.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 92.0 | no trial data cached |
| Visual impairment | 179 | 7.4 6.4–8.5ROR 7.7 · χ² 985 / p 2e-216 | 7.3 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 | no trial data cached |
| Glaucoma | 155 | 41.1 35.2–48.0ROR 42.6 · χ² 5,976 / p <1e-300 | 40.6 EB05 35.5 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 59.3 · 70% consumer | no trial data cached |
| Eye pruritus | 126 | 19.4 16.4–23.1ROR 20.0 · χ² 2,179 / p <1e-300 | 19.3 EB05 16.6 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.3 | no trial data cached |
| Drug hypersensitivity | 117 | 3.1 2.6–3.6ROR 3.1 · χ² 161 / p 4e-37 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 · 78% consumer | no trial data cached |
| Dry mouth | 95 | 5.9 4.9–7.3ROR 6.1 · χ² 387 / p 2e-86 | 5.8 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Somnolence (drowsiness) | 93 | 2.3 1.9–2.9ROR 2.4 · χ² 71 / p 2e-17 | 2.3 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Blindness | 92 | 11.5 9.4–14.0ROR 11.7 · χ² 868 / p 4e-191 | 11.3 EB05 9.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.9 · 73% consumer | no trial data cached |
| Lacrimation increased | 88 | 15.0 12.2–18.4ROR 15.3 · χ² 1,131 / p 4e-248 | 14.8 EB05 12.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · 76% 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=363, PRR 39.7
- Eye irritation — n=350, PRR 32.0
- Uveitis — n=61, PRR 23.0
- Blindness unilateral — n=52, PRR 18.8
- Eye inflammation — n=30, PRR 16.2
- Lacrimation increased — n=88, PRR 15.0
- Blindness — n=92, PRR 11.5
- Eye swelling — n=70, PRR 9.6
- Eyelid oedema — n=22, PRR 9.5
- Eye haemorrhage — n=25, PRR 9.5
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 Brinzolamide and Brimonidine?
In FDA FAERS, the most frequently co-reported reaction terms for Brinzolamide and Brimonidine are ocular hyperaemia, eye irritation, vision blurred, eye pain, hypersensitivity, 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 Brinzolamide and Brimonidine have an FDA boxed warning?
No. The FDA label retrieved for Brinzolamide and Brimonidine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Brinzolamide and 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 ed6dbc25-47d7-42db-9787-5814d71f45ce, effective 20230630; matched on
openfda.generic_name.exact:"BRINZOLAMIDE") - 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, 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
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.