Alphagan P Side Effects

Generic name: brimonidine ophthalmic

Please note - some side effects for 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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Alphagan P - for the consumer

Alphagan P

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Alphagan P:

Abnormal vision; cough; dizziness; drowsiness; dry eyes; dry mouth; eye irritation; flu; foreign body sensation; headache; inflamed eyelids; irritation near the eyelashes; loss of color in the eye; muscular pain; rash; redness of eyelid; runny nose; sensitivity to light; sinus infection; sore throat; staining and erosion of the cornea; stomach upset; swelling of the conjunctiva; tearing; tiredness; upper respiratory tract symptoms; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; changes in heart rate; difficulty breathing; eyelid crusting; fainting; nasal dryness; palpitations; pounding in the chest.

For the professional

Alphagan P

Adverse events occurring in approximately 10-20% of the subjects receiving brimonidine ophthalmic solution (0.1-0.2%) included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritus. Adverse events occurring in approximately 5-9% included: burning sensation, conjunctival folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance.

Adverse events occurring in approximately 1-4% of the subjects receiving brimonidine ophthalmic solution (0.1-0.2%) included: 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 events were reported in less than 1% of subjects: corneal erosion, hordeolum, nasal dryness, and taste perversion.

The following events have been identified during post-marketing use of brimonidine tartrate ophthalmic solutions in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to brimonidine tartrate ophthalmic solutions, or a combination of these factors, include: bradycardia; depression; iritis; keratoconjunctivitis sicca; miosis; nausea; skin reactions (including erythema, eyelid pruritus, rash, and vasodilation) and tachycardia. Apnea; bradycardia; hypotension; hypothermia; hypotonia; and somnolence have been reported in infants receiving brimonidine tartrate ophthalmic solutions.

By body system

Ocular side effects

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.

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.

Gastrointestinal side effects

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

Nervous system side effects

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 side effects

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 side effects

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.

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.

Psychiatric side effects

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

Musculoskeletal side effects

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

Hypersensitivity side effects

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

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