Drug · FAERS side-effect profile with label screen
Brinzolamide side effects: what 8,636 FDA adverse event reports show
Drug class
FDA label (Established Pharmacologic Class) · compare the class
Who reports
8,636 reports · 60% serious · 638 with death outcome · 61% 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 3Labeled (related wording) 5Likely indication confounding 5Reporting / coding artifact 3Lab value / disease marker 1Not in label — unassessed 23
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. 964 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 |
|---|---|---|---|---|---|---|
| Amaurosis fugax | 229 | 663.3 573.9–766.7ROR 681.3 · χ² 118,084 / p <1e-300 | 497.9 EB05 446.1 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious n=229 · 94% clinician | no trial data cached |
| Ureteric injury | 10 | 234.8 122.7–449.5ROR 235.1 · χ² 1,913 / p <1e-300 | 152.4 EB05 88.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Intraocular pressure fluctuation | 10 | 135.3 71.6–255.8ROR 135.5 · χ² 1,138 / p 9e-250 | 103.4 EB05 60.1 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=8 | no trial data cached |
| Intraocular pressure decreased | 24 | 114.7 76.2–172.7ROR 115.1 · χ² 2,475 / p <1e-300 | 101.0 EB05 71.4 · IC025 +4.4 3/3 methods agree | Likely indication confounding term in indications | serious n=15 · ♀ 39% (drug 61%) | no trial data cached |
| Urinary tract disorder | 199 | 112.4 97.7–129.4ROR 115.0 · χ² 20,884 / p <1e-300 | 106.3 EB05 94.5 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=199 · 95% clinician | no trial data cached |
| Intraocular pressure test abnormal | 24 | 85.3 56.8–128.1ROR 85.5 · χ² 1,850 / p <1e-300 | 77.5 EB05 54.8 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=20 | no trial data cached |
| Punctate keratitis | 29 | 82.5 57.0–119.4ROR 82.8 · χ² 2,179 / p <1e-300 | 75.9 EB05 55.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=28 | no trial data cached |
| Epidermal necrosis | 32 | 81.8 57.5–116.3ROR 82.1 · χ² 2,392 / p <1e-300 | 75.7 EB05 56.1 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=32 · ♀ 100% (drug 61%) · 94% clinician | no trial data cached |
| Haemorrhagic stroke | 253 | 80.8 71.4–91.4ROR 83.2 · χ² 19,207 / p <1e-300 | 77.7 EB05 70.0 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 75.0 · 92% clinician | no trial data cached |
| Dental restoration failure | 19 | 65.7 41.7–103.5ROR 65.8 · χ² 1,116 / p 6e-245 | 60.3 EB05 40.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 335 | 65.0 58.5–72.4ROR 67.6 · χ² 20,517 / p <1e-300 | 63.1 EB05 57.7 · IC025 +5.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 67.2 | no trial data cached |
| Ocular discomfort | 282 | 64.7 57.6–72.7ROR 66.9 · χ² 17,175 / p <1e-300 | 62.8 EB05 56.9 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=260 | no trial data cached |
| Corneal erosion | 12 | 56.1 31.7–99.5ROR 56.2 · χ² 582 / p 6e-129 | 50.7 EB05 30.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Growth of eyelashes | 18 | 56.1 35.2–89.5ROR 56.3 · χ² 899 / p 6e-198 | 52.0 EB05 34.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Product dropper issue | 18 | 56.1 35.2–89.4ROR 56.2 · χ² 898 / p 1e-197 | 52.0 EB05 34.8 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious n=4 | no trial data cached |
| Choroidal detachment | 12 | 53.7 30.3–95.2ROR 53.8 · χ² 557 / p 2e-123 | 48.8 EB05 29.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Corneal opacity | 29 | 52.9 36.6–76.4ROR 53.1 · χ² 1,395 / p <1e-300 | 50.2 EB05 36.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | no trial data cached |
| Corneal oedema | 40 | 44.1 32.2–60.2ROR 44.3 · χ² 1,611 / p <1e-300 | 42.5 EB05 32.5 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=38 | no trial data cached |
| Generalised oedema | 217 | 43.5 38.1–49.7ROR 44.6 · χ² 8,823 / p <1e-300 | 42.6 EB05 38.1 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 45.6 · 96% clinician | no trial data cached |
| Treatment failure | 1,429 | 43.0 41.0–45.1ROR 51.3 · χ² 57,798 / p <1e-300 | 42.3 EB05 40.4 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 0.4 · 79% consumer | no trial data cached |
| Corneal epithelium defect | 10 | 43.0 23.0–80.3ROR 43.1 · χ² 363 / p 3e-81 | 39.3 EB05 22.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Open angle glaucoma | 10 | 40.2 21.5–75.1ROR 40.2 · χ² 338 / p 8e-76 | 37.0 EB05 21.4 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications | serious n=9 | no trial data cached |
| Glaucoma | 282 | 36.1 32.1–40.5ROR 37.2 · χ² 9,444 / p <1e-300 | 35.5 EB05 32.1 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 35.0 | no trial data cached |
| Nasal discharge discolouration | 20 | 35.6 22.9–55.4ROR 35.7 · χ² 630 / p 3e-139 | 34.1 EB05 23.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=20 · 90% clinician | no trial data cached |
| Corneal disorder | 31 | 35.2 24.7–50.1ROR 35.3 · χ² 981 / p 1e-215 | 34.0 EB05 25.1 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=29 | no trial data cached |
| Optic nerve injury | 16 | 34.2 20.9–56.0ROR 34.3 · χ² 476 / p 8e-106 | 32.5 EB05 21.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Conjunctival hyperaemia | 49 | 33.8 25.5–44.8ROR 34.0 · χ² 1,507 / p <1e-300 | 33.0 EB05 25.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=41 | no trial data cached |
| Head discomfort | 237 | 33.1 29.2–37.6ROR 34.0 · χ² 7,254 / p <1e-300 | 32.6 EB05 29.3 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 55.3 · 91% clinician | no trial data cached |
| Eye allergy | 19 | 30.4 19.3–47.7ROR 30.4 · χ² 504 / p 6e-112 | 29.2 EB05 19.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Ocular hypertension | 21 | 26.9 17.5–41.3ROR 27.0 · χ² 493 / p 2e-109 | 26.1 EB05 18.0 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications | serious n=21 | no trial data cached |
| Photophobia (light sensitivity) | 203 | 26.7 23.3–30.6ROR 27.3 · χ² 4,942 / p <1e-300 | 26.3 EB05 23.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 38.3 | no trial data cached |
| Altered state of consciousness | 226 | 25.7 22.6–29.3ROR 26.4 · χ² 5,295 / p <1e-300 | 25.4 EB05 22.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 24.7 · 94% clinician | no trial data cached |
| Foreign body sensation in eyes | 65 | 25.5 20.0–32.6ROR 25.7 · χ² 1,493 / p <1e-300 | 25.1 EB05 20.4 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=28 | no trial data cached |
| Haematemesis (vomiting blood) | 250 | 24.1 21.3–27.3ROR 24.8 · χ² 5,466 / p <1e-300 | 23.8 EB05 21.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 23.5 · 94% clinician | no trial data cached |
| Blindness | 375 | 22.6 20.4–24.9ROR 23.5 · χ² 7,651 / p <1e-300 | 22.3 EB05 20.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 22.0 | no trial data cached |
| Eye pain | 488 | 21.6 19.8–23.6ROR 22.9 · χ² 9,526 / p <1e-300 | 21.4 EB05 19.9 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 35.7 | no trial data cached |
| Ulcerative keratitis | 24 | 21.5 14.4–32.2ROR 21.6 · χ² 446 / p 3e-99 | 21.0 EB05 14.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=23 | no trial data cached |
| Presyncope (near-fainting) | 207 | 20.9 18.3–24.0ROR 21.4 · χ² 3,882 / p <1e-300 | 20.7 EB05 18.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 25.5 · 95% clinician | no trial data cached |
| Diplopia (double vision) | 212 | 20.0 17.5–22.8ROR 20.5 · χ² 3,776 / p <1e-300 | 19.8 EB05 17.6 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.6 · 91% clinician | no trial data cached |
| Eyelid margin crusting | 23 | 20.0 13.3–30.1ROR 20.0 · χ² 392 / p 1e-87 | 19.5 EB05 13.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=8 | 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 | 1,429 | 43.0 41.0–45.1ROR 51.3 · χ² 57,798 / p <1e-300 | 42.3 EB05 40.4 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 0.4 · 79% consumer | no trial data cached |
| Dyspnoea (shortness of breath) | 586 | 2.5 2.3–2.7ROR 2.6 · χ² 549 / p 1e-121 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Drug ineffective (drug did not work) | 509 | 0.9 0.9–1.0ROR 0.9 · χ² 2 / p 0.073 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Dizziness | 497 | 2.4 2.2–2.6ROR 2.5 · χ² 425 / p 1e-94 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Eye pain | 488 | 21.6 19.8–23.6ROR 22.9 · χ² 9,526 / p <1e-300 | 21.4 EB05 19.9 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 35.7 | no trial data cached |
| Fatigue (tiredness) | 472 | 1.5 1.4–1.6ROR 1.5 · χ² 75 / p 3e-18 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Diarrhoea (diarrhea) | 466 | 1.8 1.6–1.9ROR 1.8 · χ² 157 / p 3e-36 | 1.8 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Fall | 449 | 3.3 3.0–3.6ROR 3.4 · χ² 721 / p 4e-159 | 3.3 EB05 3.0 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Headache | 443 | 1.7 1.6–1.9ROR 1.8 · χ² 136 / p 8e-32 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Vision blurred (blurred vision) | 424 | 7.6 6.9–8.3ROR 7.9 · χ² 2,414 / p <1e-300 | 7.5 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.8 | no trial data cached |
| Asthenia (weakness) | 414 | 2.7 2.4–2.9ROR 2.8 · χ² 440 / p 5e-98 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Malaise (feeling unwell) | 395 | 2.2 2.0–2.4ROR 2.2 · χ² 257 / p 3e-58 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Nausea | 386 | 1.2 1.1–1.3ROR 1.2 · χ² 12 / p 3e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Blindness | 375 | 22.6 20.4–24.9ROR 23.5 · χ² 7,651 / p <1e-300 | 22.3 EB05 20.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 22.0 | no trial data cached |
| Arthralgia (joint pain) | 371 | 2.2 2.0–2.4ROR 2.2 · χ² 239 / p 3e-54 | 2.2 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 3.5 | 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.
- Amaurosis fugax — n=229, PRR 663.3
- Urinary tract disorder — n=199, PRR 112.4
- Punctate keratitis — n=29, PRR 82.5
- Haemorrhagic stroke — n=253, PRR 80.8
- Corneal opacity — n=29, PRR 52.9
- Generalised oedema — n=217, PRR 43.5
- Nasal discharge discolouration — n=20, PRR 35.6
- Conjunctival hyperaemia — n=49, PRR 33.8
- Photophobia — n=203, PRR 26.7
- Altered state of consciousness — n=226, PRR 25.7
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 Brinzolamide?
In FDA FAERS, the most frequently co-reported reaction terms for Brinzolamide are dyspnoea, dizziness, eye pain, fatigue, diarrhoea, fall. 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 have an FDA boxed warning?
No. The FDA label retrieved for Brinzolamide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Brinzolamide 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, 1,004 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.