What the label lists and what reports show
Brimonidine and brinzolamide side effects
Brimonidine and brinzolamide's FDA label: “Most common adverse reactions occurring in approximately 3% to 5% of patients included blurred vision, eye irritation, dysgeusia (bad taste), dry mouth, eye allergy.” FAERS holds 4,140 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is ocular hyperaemia (363 reports).
- No generic listed
Check it at the source: the brimonidine and brinzolamide FDA label on DailyMed (effective March 11, 2025, Alcon Laboratories, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions occurring in approximately 3% to 5% of patients included blurred vision, eye irritation, dysgeusia (bad taste), dry mouth, eye allergy.
From the label: adverse reactions, continuedMost common adverse reactions occurring in approximately 3% to 5% of patients included blurred vision, eye irritation, dysgeusia (bad taste), dry mouth, eye allergy. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. SIMBRINZA In two clinical trials of three months duration 435 patients were treated with SIMBRINZA, and 915 were treated with the two individual components. The most frequently reported adverse reactions in patients treated with SIMBRINZA occurring in approximately 3% to 5% of patients in descending order of incidence were blurred vision, eye irritation, dysgeusia (bad taste), dry mouth, and eye allergy. Rates of adverse reactions reported with the individual components were comparable. Treatment discontinuation, mainly due to adverse reactions, was reported in 11% of SIMBRINZA patients. Other adverse reactions that have been reported with the individual components during clinical trials are listed below. …
Source: FDA drug label, Alcon Laboratories, Inc., effective March 11, 2025 (SPL set a49c157e-6310-0011-7b7f-e26fc1820d59), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,140 reports list brimonidine and brinzolamide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 149 are coded as a death and 433 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Brimonidine and brinzolamide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions