Brinzolamide/brimonidine tartrate

What Brinzolamide/brimonidine tartrate is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

SIMBRINZA (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is a fixed combination of a carbonic anhydrase inhibitor and an alpha 2 adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. …

— FDA label: Simbrinza, Alcon Laboratories, Inc., effective March 11, 2025. Read the full label on DailyMed →

Label quoted: the one for the most common form (suspension/ drops, ophthalmic), Simbrinza, Alcon Laboratories, Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Brinzolamide/brimonidine tartrate side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

Most common adverse reactions occurring in approximately 3% to 5% of patients included blurred vision, eye irritation, dysgeusia (bad taste), dry mouth, eye allergy.

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(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. Brinzolamide 1% In clinical studies of brinzolamide ophthalmic suspension 1%, the most frequently reported adverse reactions reported in 5% to 10% of patients were blurred vision and bitter, sour or unusual taste. Adverse reactions occurring in 1% to 5% of patients were blepharitis, dermatitis, dry eye, foreign body sensation, headache, hyperemia, ocular discharge, ocular discomfort, ocular keratitis, ocular pain, ocular pruritus and rhinitis. The following adverse reactions were reported at an incidence below 1%: allergic reactions, alopecia, chest pain, conjunctivitis, diarrhea, diplopia, dizziness, dry mouth, dyspnea, dyspepsia, eye fatigue, hypertonia, keratoconjunctivitis, keratopathy, kidney pain, lid margin crusting or sticky sensation, nausea, pharyngitis, tearing and urticaria. Brimonidine Tartrate 0.2% In clinical studies of brimonidine tartrate 0.2%, adverse reactions occurring in approximately 10% to 30% of the subjects, in descending order of incidence, included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus. Reactions occurring in approximately 3% to 9% of the subjects, in descending order included corneal staining/erosion, photophobia, eyelid erythema, ocular ache/pain, ocular dryness, tearing, upper respiratory symptoms, eyelid edema, conjunctival edema, dizziness, blepharitis, ocular irritation, gastrointestinal symptoms, asthenia, conjunctival blanching, abnormal vision and muscular pain.

— FDA label: Simbrinza, Alcon Laboratories, Inc., effective March 11, 2025. This is part of the section. Read the full label on DailyMed →

Brinzolamide/brimonidine tartrate drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Oral Carbonic Anhydrase Inhibitors (7.1) High-dose Salicylate Therapy (7.2) Central Nervous System Depressants (7.3) Antihypertensives/Cardiac Glycosides (7.4) Tricyclic Antidepressants (7.5) Monoamine Oxidase (MAO) Inhibitors (7.6) 7.1 Oral Carbonic Anhydrase Inhibitors There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and brinzolamide ophthalmic suspension 1%, a component of SIMBRINZA ophthalmic suspension.

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The concomitant administration of SIMBRINZA and oral carbonic anhydrase inhibitors is not recommended. 7.2 High-Dose Salicylate Therapy Carbonic anhydrase inhibitors may produce acid-base and electrolyte alterations. These alterations were not reported in the clinical trials with brinzolamide ophthalmic suspension 1%. However, in patients treated with oral carbonic anhydrase inhibitors, rare instances of acid-base alterations have occurred with high-dose salicylate therapy. Therefore, the potential for such drug interactions should be considered in patients receiving SIMBRINZA. 7.3 Central Nervous System Depressants Although specific drug interaction studies have not been conducted with SIMBRINZA, the possibility of an additive or potentiating effect with Central Nervous System (CNS) depressants (alcohol, opiates, barbiturates, sedatives, or anesthetics) should be considered. 7.4 Antihypertensives/Cardiac Glycosides Because brimonidine tartrate, a component of SIMBRINZA, may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with SIMBRINZA is advised. 7.5 Tricyclic Antidepressants Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with SIMBRINZA in humans can lead to resulting interference with the IOP lowering effect. Caution is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines. 7.6 Monoamine Oxidase Inhibitors Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine tartrate and potentially result in an increased systemic side-effect such as hypotension. Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.

— FDA label: Simbrinza, Alcon Laboratories, Inc., effective March 11, 2025. Read the full label on DailyMed →

Brinzolamide/brimonidine tartrate dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

The recommended dose is one drop of SIMBRINZA in the affected eye(s) three times daily. Shake well before use. SIMBRINZA ophthalmic suspension may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. Shake well before use. Instill one drop in the affected eye(s) three times daily.

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If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. (2)

— FDA label: Simbrinza, Alcon Laboratories, Inc., effective March 11, 2025. Read the full label on DailyMed →

Brinzolamide/brimonidine tartrate in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Developmental toxicity studies with brinzolamide in rabbits at oral doses of 1, 3, and 6 mg/kg/day (20, 60, and 120 times the recommended human ophthalmic dose) produced maternal toxicity at 6 mg/kg/day and a significant increase in the number of fetal variations, such as accessory skull bones, which was only slightly higher than the historic value at 1 and 6 mg/kg. In rats, statistically decreased body weights of fetuses from dams receiving oral doses of 18 mg/kg/day (180 times the recommended human ophthalmic dose) during gestation were proportional to the reduced maternal weight gain, with no statistically significant effects on organ or tissue development.

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Increases in unossified sternebrae, reduced ossification of the skull, and unossified hyoid that occurred at 6 and 18 mg/kg were not statistically significant. No treatment-related malformations were seen. Following oral administration of 14 C-brinzolamide to pregnant rats, radioactivity was found to cross the placenta and was present in the fetal tissues and blood. Developmental toxicity studies performed in rats with oral doses of 0.66 mg brimonidine base/kg revealed no evidence of harm to the fetus. Dosing at this level resulted in a plasma drug concentration approximately 100 times higher than that seen in humans at the recommended human ophthalmic dose. In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. There are no adequate and well-controlled studies in pregnant women. SIMBRINZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

— FDA label: Simbrinza, Alcon Laboratories, Inc., effective March 11, 2025. Read the full label on DailyMed →

When Brinzolamide/brimonidine tartrate should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Hypersensitivity to any component of this product. (4.1) Neonates and infants (under the age of two years). (4.2) 4.1 Hypersensitivity SIMBRINZA is contraindicated in patients who are hypersensitive to any component of this product. 4.2 Neonates and Infants (under the age of two years) SIMBRINZA is contraindicated in neonates and infants (under the age of two years) [see Use in Specific Populations (8.4)].

— FDA label: Simbrinza, Alcon Laboratories, Inc., effective March 11, 2025. Read the full label on DailyMed →

Brinzolamide/brimonidine tartrate overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

Although no human data are available, electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur following an oral overdose of brinzolamide. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Very limited information exists on accidental ingestion of brimonidine in adults; the only adverse event reported to date has been hypotension.

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Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving brimonidine as part of medical treatment of congenital glaucoma or by accidental oral ingestion. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

— FDA label: Simbrinza, Alcon Laboratories, Inc., effective March 11, 2025. Read the full label on DailyMed →

Forms and how it is given

Same medicine, other forms and combinations

Prescription medicine pages on this site that share an active ingredient with this one, from the FDA NDC Directory. A combination is a different medicine: ask your pharmacist before you switch.

Other medicines with one of these active ingredients

• Brimonidine tartrateAlphagan P, Mirvaso · 33 products
• Brimonidine tartrate and timolol maleateCombigan · 21 products
• BrinzolamideAzopt · 6 products
• Carbachol and brimonidine tartrateYuvezzi · 1 product

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Alcon Laboratories, Inc.1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

Next steps

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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Simbrinza, Alcon Laboratories, Inc., effective March 11, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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