Alphagan P Side Effects

Generic name: brimonidine ophthalmic

Note: This document contains side effect information about brimonidine ophthalmic. Some of the dosage forms listed on this page may not apply to the brand name Alphagan P.

Some side effects of Alphagan P may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to brimonidine ophthalmic: ophthalmic solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking brimonidine ophthalmic (the active ingredient contained in Alphagan P) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• eye pain or increased watering; or

• severe swelling, redness, burning, or discomfort in or around your eye.

Common side effects may include:

• drowsiness, tired feeling;

• dry mouth, blurred vision;

• mild itching, redness, or irritation of your eyes; or

• mild stinging or burning when using the eye drops.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to brimonidine ophthalmic: ophthalmic solution

Ocular

Ocular side effects reported in 10% to 30% of patients have included ocular hyperemia, burning and stinging, blurring, foreign body sensation, conjunctival follicles, ocular allergic reactions and pruritus. Those reported in 3% to 9% of patients have included corneal staining/erosion, photophobia, eyelid erythema, ocular ache/pain, ocular dryness, tearing, eyelid edema, blepharitis, ocular irritation, conjunctival blanching, and abnormal vision. Lid crusting, uveitis, conjunctival hemorrhage, and conjunctival discharge have been reported in less than 3%. Brimonidine has been associated with elevated intraocular pressure (32 to 34 mmHg) in conjunction with a local allergic reaction.

Anterior uveitis has been reported in at least 4 patients after 11 to 15 months of brimonidine treatment. Causality was confirmed by rechallenge.

There are no data on cases of uveitis involving brimonidine ophthalmic products with Purite as a preservative. Rather, case reports involve brimonidine products incorporating benzalkonium chloride as a preservative.

Gastrointestinal

Gastrointestinal side effects have most frequently included oral dryness (10% to 30%). Other gastrointestinal side effects are uncommon.

Nervous system

Nervous system side effects including fatigue/drowsiness and headache have occurred in 10% to 30% of patients. Other central nervous system side effects including dizziness have occurred in 3% to 9% of patients. Anxiety and insomnia have occurred in less than 3% of patients. Somnolence has been reported in infants.

Respiratory

A study in young healthy adult males reported no change in pulmonary function after a single ophthalmic dose of 0.2% brimonidine.

Upper respiratory symptoms were reported in 3% to 9% of patients receiving brimonidine ophthalmic. Nasal dryness was reported in less than 3% of patients.

Cardiovascular

One study in young healthy adult men reported small decreases in systolic blood pressure during recovery from exercise and four hours after administration of a single ophthalmic dose of 0.2% brimonidine. The changes did not produce clinically significant effects in the population studied.

Cardiovascular side effects have included asthenia in 3% to 9% of patients. Other cardiovascular side effects such as hypertension, palpitations and syncope have occurred in less than 3% of patients.

Psychiatric

Psychiatric side effects including depression and anxiety have been reported in less than 3% of patients.

Musculoskeletal

Musculoskeletal side effects including muscular pain have been reported in 3% to 9% of patients.

Hypersensitivity

Hypersensitivity reactions including sore red eyes, follicular reaction, conjunctival and episcleral injection, have rarely been reported.

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