Medicine guide

Brimonidine

1 mg/mL · Solution/ Drops

Prescription only
alpha-Adrenergic Agonist

Active substance: Brimonidine Tartrate
Made by: Sandoz Inc
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-10-07

What it is

alpha-Adrenergic Agonist

Used for

Brimonidine tartrate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Do not take it if

Neonates and infants (pediatric patients younger than 2 years old). ( 4.1 )

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

22other products contain Brimonidine Tartrate — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Brimonidine tartrate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Brimonidine tartrate ophthalmic solution is an alpha adrenergic agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
( 1 )

From the official label · 2025-10-07 · DailyMed

How it works

From this product’s own US prescribing label.

Brimonidine tartrate ophthalmic solution is a relatively selective alpha-2 adrenergic receptor agonist with a peak ocular hypotensive effect occurring at two hours post-dosing.
Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow.

Half-life2 h

Mostly cleared after≈ 10 hfive half-lives — our arithmetic

How the body breaks it down

In humans, brimonidine is extensively metabolized by the liver.

How it leaves the body

Approximately 87% of an orally-administered radioactive dose of brimonidine was eliminated within 120 hours, with 74% found in the urine.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-10-07

Do not take it if

Neonates and infants (pediatric patients younger than 2 years old). ( 4.1 )
Hypersensitivity Reactions. ( 4.2 ) 4.1 Neonates and Infants (Pediatric Patients Younger than 2 Years Old) Brimonidine tartrate ophthalmic solution is contraindicated in neonates and infants (pediatric patients younger than 2 years old) [see Use in Specific Populations ( 8.4 )]. 4.2 Hypersensitivity Reactions Brimonidine tartrate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

The recommended dosage is one drop of brimonidine tartrate ophthalmic solution in the affected eye(s) three times daily, approximately 8 hours apart.
Brimonidine tartrate ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure.
If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart.
One drop in the affected eye(s) three times daily, approximately 8 hours apart.
( 2 )

Quoted from the official label, section “Dosage & Administration”.

Other warnings

( 5.1 )
5.1 Potentiation of Vascular Insufficiency Brimonidine tartrate ophthalmic solution may potentiate syndromes associated with vascular insufficiency.
Brimonidine tartrate ophthalmic solution should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans.
5.2 Severe Cardiovascular Disease Although brimonidine tartrate ophthalmic solution had minimal effect on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease.
5.3 Contamination of Topical Ophthalmic Products After Use There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products.
These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.
Do not touch the tip of the dispensing container to the eye or surrounding structures.
Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions [see Patient Counseling Information ( 17 )].

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary There are no adequate and well-controlled studies with brimonidine tartrate ophthalmic solution in pregnant women.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent (see Data).
Because animal reproduction studies are not always predictive of human response, brimonidine tartrate ophthalmic solution should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Data Human Data Limited available data from postmarketing safety reports and published literature with topical use of brimonidine ophthalmic solution in pregnant women are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes including miscarriage, stillbirth, congenital anomaly, and events experienced by offspring while breastfeeding.
Animal Data Embryofetal studies were conducted in pregnant rabbits administered brimonidine tartrate by daily oral gavage on gestation days 6 to 18, to target the period of organogenesis.
Brimonidine caused miscarriage at 5 mg/kg/day (approximately 70- or 50-times the recommended human ophthalmic dose [RHOD] based on AUC, respectively for brimonidine tartrate 0.1% and 0.15%).
The no observed adverse effect level (NOAEL) for developmental toxicity in rabbits was 1 mg/kg/day (approximately 9- and 6-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.1% and 0.15%).
No treatment-related malformations were observed in rabbits.
Signs of maternal sedation and fatigue were observed at all dose levels; the lowest observed adverse effect level (LOAEL) for maternal toxicity was 5 mg/kg/day, based on the dose response for these signs.
Embryofetal studies were conducted in pregnant rats administered brimonidine tartrate by daily oral gavage on gestation days 6 to 15, to target the period of organogenesis.
The NOAEL for developmental toxicity was 2.5 mg/kg/day (approximately 1100- and 750-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.1% and 0.15%).
No treatment-related malformations were observed in rats.
The LOAEL for maternal toxicity was 2.5 mg/kg/day, based on signs of sedation and fatigue.
The maternal NOAEL was 1.0 mg/kg/day (250- and 180-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.1% and 0.15%).
After pregnant rats received a single oral dose of 14 C-brimonidine tartrate, brimonidine and metabolites crossed the placenta and were detectable in fetal blood and organs.
IN SPECIFIC POPULATIONS Use with caution in pediatric patients aged 2 years and older.
( 8.4 )
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with brimonidine tartrate ophthalmic solution in pregnant women.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent (see Data).
Because animal reproduction studies are not always predictive of human response, brimonidine tartrate ophthalmic solution should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Data Human Data Limited available data from postmarketing safety reports and published literature with topical use of brimonidine ophthalmic solution in pregnant women are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes including miscarriage, stillbirth, congenital anomaly, and events experienced by offspring while breastfeeding.
Animal Data Embryofetal studies were conducted in pregnant rabbits administered brimonidine tartrate by daily oral gavage on gestation days 6 to 18, to target the period of organogenesis.
Brimonidine caused miscarriage at 5 mg/kg/day (approximately 70- or 50-times the recommended human ophthalmic dose [RHOD] based on AUC, respectively for brimonidine tartrate 0.1% and 0.15%).
The no observed adverse effect level (NOAEL) for developmental toxicity in rabbits was 1 mg/kg/day (approximately 9- and 6-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.1% and 0.15%).
No treatment-related malformations were observed in rabbits.
Signs of maternal sedation and fatigue were observed at all dose levels; the lowest observed adverse effect level (LOAEL) for maternal toxicity was 5 mg/kg/day, based on the dose response for these signs.
Embryofetal studies were conducted in pregnant rats administered brimonidine tartrate by daily oral gavage on gestation days 6 to 15, to target the period of organogenesis.
The NOAEL for developmental toxicity was 2.5 mg/kg/day (approximately 1100- and 750-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.1% and 0.15%).
No treatment-related malformations were observed in rats.
The LOAEL for maternal toxicity was 2.5 mg/kg/day, based on signs of sedation and fatigue.
The maternal NOAEL was 1.0 mg/kg/day (250- and 180-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.1% and 0.15%).
After pregnant rats received a single oral dose of 14 C-brimonidine tartrate, brimonidine and metabolites crossed the placenta and were detectable in fetal blood and organs.
8.2 Lactation Risk Summary It is not known whether brimonidine tartrate is excreted in human milk.
In animal studies, brimonidine tartrate has been shown to cross the blood-brain barrier and is excreted into breast milk after oral administration to lactating rats (see Data) .
Because of the potential for serious adverse reactions, including central nervous system depression and apnea, from brimonidine tartrate ophthalmic solution in nursing infants, brimonidine tartrate ophthalmic solution is not recommended for use during lactation.
Data Animal Data After a single oral dose of 14 C-labeled brimonidine tartrate to lactating rats, brimonidine and metabolites were detected in milk.
After male and female rats received a single oral dose of 14 C-brimonidine tartrate, brimonidine crossed the blood-brain barrier.
Radiolabel was detected in the cerebellum, cerebrum, and spinal cord.
8.4 Pediatric Use Brimonidine tartrate ophthalmic solution is contraindicated in pediatric patients younger than 2 years old [see Contraindications ( 4.1 )] .
During postmarketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine.
In a well-controlled clinical study conducted in pediatric glaucoma patients aged 2 to 7 years old, the most commonly observed adverse reactions with brimonidine tartrate ophthalmic solution 0.2% dosed three times daily were somnolence (50% to 83% in pediatric patients aged 2 to 6 years old) and decreased alertness.
In pediatric patients aged 7 years and older (greater than 20 kg), somnolence appears to occur less frequently (25%).
Approximately 16% of pediatric patients on brimonidine tartrate ophthalmic solution 0.2% discontinued from the study due to somnolence.
8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Antihypertensives/cardiac glycosides may lower blood pressure. ( 7.1 )
Use with CNS depressants may result in an additive or potentiating effect. ( 7.2 )
Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine. ( 7.3 )
Monoamine oxidase inhibitors may result in increased hypotension. ( 7.4 ) 7.1 Antihypertensives/Cardiac Glycosides Because brimonidine tartrate ophthalmic solution may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with brimonidine tartrate ophthalmic solution is advised. 7.2 CNS Depressants Although specific drug interaction studies have not been conducted with brimonidine tartrate ophthalmic solution the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered. 7.3 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 brimonidine tartrate ophthalmic solution 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. 7.4 Monoamine Oxidase Inhibitors Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine 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.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Limited information exists on accidental ingestion of brimonidine in
adults; the only adverse reaction reported to date has been hypotension.
Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving brimonidine tartrate ophthalmic solution as part of medical treatment of congenital glaucoma or by accidental oral ingestion [see Use in Specific Populations ( 8.4 )].
Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

Quoted from the official label, section “Overdosage”.

Use in children

Brimonidine tartrate ophthalmic solution is contraindicated in pediatric patients younger than 2 years old [see Contraindications ( 4.1 )] .
During postmarketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine.
In a well-controlled clinical study conducted in pediatric glaucoma patients aged 2 to 7 years old, the most commonly observed adverse reactions with brimonidine tartrate ophthalmic solution 0.2% dosed three times daily were somnolence (50% to 83% in pediatric patients aged 2 to 6 years old) and decreased alertness.
In pediatric patients aged 7 years and older (greater than 20 kg), somnolence appears to occur less frequently (25%).
Approximately 16% of pediatric patients on brimonidine tartrate ophthalmic solution 0.2% discontinued from the study due to somnolence.

Quoted from the official label, section “Pediatric Use”.

Use in older people

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Quoted from the official label, section “Geriatric Use”.

Side effects

The following serious adverse reactions are described elsewhere in the labeling:
Potentiation of Vascular Insufficiency [see Warnings and Precautions ( 5.1 )]
Severe Cardiovascular Disease [see Warnings and Precautions ( 5.2 )]
Contamination of Topical Ophthalmic Products after Use [see Warnings and Precautions ( 5.3 )]
Neonates and Infants (Pediatric Patients Younger than 2 Years Old) [see Contraindications ( 4.1 )] Most common adverse reactions occurring in approximately 5% to 20% of patients receiving brimonidine ophthalmic solution (0.1% to 0.2%) included allergic conjunctivitis, burning sensation, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, hypertension, ocular allergic reaction, oral dryness, and visual disturbance. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 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 rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions occurring in approximately 10% to 20% of the subjects receiving brimonidine ophthalmic solution (0.1% to 0.2%) included:
allergic conjunctivitis, conjunctival hyperemia, and eye pruritus. Adverse reactions occurring in approximately 5% to 9% included:
burning sensation, conjunctival folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance. Adverse reactions occurring in approximately 1% to 4% of the subjects receiving brimonidine ophthalmic solution (0.1% to 0.2%) included:
abnormal taste, allergic reaction, asthenia, blepharitis, blepharoconjunctivitis, blurred vision, bronchitis, cataract, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, fatigue, flu syndrome, follicular conjunctivitis, foreign body sensation, gastrointestinal disorder, headache, hypercholesterolemia, hypotension, infection (primarily colds and respiratory infections), insomnia, keratitis, lid disorder, pharyngitis, photophobia, rash, rhinitis, sinus infection, sinusitis, somnolence, stinging, superficial punctate keratopathy, tearing, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters, and worsened visual acuity. The following reactions were reported in less than 1% of subjects:
corneal erosion, hordeolum, nasal dryness, and taste perversion. 6.2 Postmarketing Experience The following reactions have been identified during postapproval use of brimonidine tartrate ophthalmic solutions. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Bradycardia, depression, hypersensitivity, iritis, keratoconjunctivitis sicca, miosis, nausea, skin reactions (including erythema, eyelid pruritus, rash, and vasodilation), syncope, and tachycardia.
Apnea, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine tartrate ophthalmic solutions.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Handling the Container Instruct patients that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular infections.
Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions [see Warnings and Precautions ( 5.3 )] .
Always replace the cap after using.
If solution changes color or becomes cloudy, do not use.
Do not use the product after the expiration date marked on the bottle.
When to Seek Physician Advice Advise patients that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advice concerning the continued use of the present multidose container.
Use with Other Ophthalmic Drugs Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.
Potential for Decreased Mental Alertness As with other similar medications, brimonidine tartrate ophthalmic solution may cause fatigue and/or drowsiness in some patients.
Caution patients who engage in hazardous activities of the potential for a decrease in mental alertness.
Manufactured by Alcon Laboratories, Inc.
Fort Worth, TX 76134 for Sandoz Inc.
Princeton, NJ 08540 Rev.
October 2025 300074220-1025

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Ophthalmic solution containing (0.1%) 1 mg/mL brimonidine tartrate. Ophthalmic solution containing (0.1%) 1 mg/mL brimonidine tartrate. ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

Brimonidine tartrate ophthalmic solution, 0.1% is supplied sterile, in a white LDPE plastic bottle with a natural LDPE dropper tip and a purple polypropylene cap as follows:
5 mL in 8 mL bottle NDC 0781-7177-75 10 mL in 10 mL bottle NDC 0781-7177-70 15 mL in 15 mL bottle NDC 0781-7177-85 Storage:
Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “How Supplied”.

How to store it

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “Storage and Handling”.

What is in it

Brimonidine tartrate ophthalmic solution, 0.1%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist for topical ophthalmic use.
The structural formula of brimonidine tartrate is:
5-Bromo-6-(2-Imidazolin-2-ylamino)quinoxaline Tartrate;
MW =
442.22 In solution, brimonidine tartrate ophthalmic solution, 0.1% has a clear, greenish-yellow color.
It has an osmolality of 255 to 300 mOsmol/kg and a pH of 7.5 to 7.8.
Brimonidine tartrate appears as an white to off-white, pale yellow to yellow powder and is soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7.
Each mL of brimonidine tartrate ophthalmic solution, 0.1% contains:
Active ingredient:
brimonidine tartrate 0.1% (1 mg/mL).
Preservative: sodium chlorite 0.005% (0.05 mg/mL).
Inactives:
boric acid; calcium chloride; magnesium chloride; potassium chloride; sodium borate; sodium carboxymethylcellulose; sodium chloride and purified water.
Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (11)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 11 of 11

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

European UnionNo exact match for this strength and form

Every strength and form (1)

CanadaNo exact match for this strength and form

Every strength and form (11)

Details

Made by	Sandoz Inc
Active substance	Brimonidine Tartrate
Strength	1 mg/mL
Form	Solution/ Drops
Route	Ophthalmic
Packs	1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER · 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER
NDC	0781-7177

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Gel2 products
- 5 mg/g2
  5 mg/g · 2 companies
  - Bryant Ranch Prepack
  - Padagis Israel Pharmaceuticals Ltd
Solution/ Drops1 products
- 1 mg/mL

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Alphagan P1.5 mg/mLPrescription onlySolution/ Drops Allergan, Inc. · Brimonidine Tartrate Alphagan P1 mg/mLPrescription onlySolution/ Drops Allergan, Inc. · Brimonidine Tartrate Brimonidine Tartrate1 mg/mLPrescription onlySolution/ Drops Upsher-Smith Laboratories, LLC · Brimonidine Tartrate Brimonidine Tartrate2 mg/mgPrescription onlySolution/ Drops Indoco Remedies Limited · Brimonidine Tartrate Brimonidine Tartrate2 mg/mLPrescription onlySolution/ Drops Bausch & Lomb Incorporated · Brimonidine Tartrate Brimonidine Tartrate2 mg/mLPrescription onlySolution/ Drops Micro Labs Limited · Brimonidine Tartrate

See every product with Brimonidine Tartrate