Applies to brimonidine/timolol ophthalmic: ophthalmic solution.

Serious side effects

Along with its needed effects, brimonidine/timolol ophthalmic may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking brimonidine / timolol ophthalmic:

More common

• Burning, dry, or itching eyes
• discharge or excessive tearing
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• stinging in the eyes
• tiny bumps on lining of the eyelid

Less common

• Blurred or loss of vision
• disturbed color perception
• dizziness
• double vision
• feeling of having something in the eye
• halos around lights
• headache
• nervousness
• night blindness
• pounding in the ears
• sensitivity of the eyes to light
• slow, fast, or irregular heartbeat
• tunnel vision
• watery eyes

Get emergency help immediately if any of the following symptoms of overdose occur while taking brimonidine / timolol ophthalmic:

Symptoms of overdose

• Chest pain or discomfort
• cough
• difficulty breathing
• lightheadedness, dizziness or fainting
• no blood pressure or pulse
• noisy breathing
• stopping of heart
• tightness in the chest
• unconsciousness

Other side effects

Some side effects of brimonidine / timolol ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Dry mouth
• feeling sad or empty
• irritability
• lack of appetite
• lack or loss of strength
• loss of interest or pleasure
• sleepiness or unusual drowsiness
• trouble concentrating
• trouble sleeping

For Healthcare Professionals

Applies to brimonidine / timolol ophthalmic: ophthalmic solution.

Ocular

Very common (10% or more): Conjunctival hyperemia, burning sensation

Common (1% to 10%): Stinging sensation in the eye, allergic conjunctivitis, corneal erosion, superficial punctuate keratitis, eye pruritus, conjunctival folliculosis, visual disturbance, blepharitis, epiphora, eye dryness, eye discharge, eye pain, eye irritation, foreign body sensation, eyelid edema, eyelid pruritus, eyelid erythema

Uncommon (0.1% to 1%): Worsened visual acuity, conjunctival edema, conjunctivitis, vitreous floater, asthenopia, photophobia, papillary hypertrophy, eyelid pain, conjunctival blanching, corneal edema, corneal infiltrates, vitreous detachment, allergic contact dermatitis

Postmarketing reports: Blurred vision, keratoconjunctivitis sicca

Brimonidine:

-Frequency not reported: Iritis, iridocyclitis (anterior uveitis), miosis, cataract, conjunctival blanching, hordeolum, lid crusting, lid disorder

Timolol:

-Rare (less than 0.1%): Corneal calcification (with the use of phosphate containing eye drops in some patients with significantly damaged corneas)

-Frequency not reported: Keratitis, choroidal detachment following filtration surgery, decreased corneal sensitivity, corneal erosion, ptosis, diplopia, cystoid macular edema, pseudopemphigoid, refractive changes, blepharoptosis^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension

Uncommon (0.1% to 1%): Congestive heart failure, palpitations

Postmarketing reports: Arrhythmia, bradycardia, tachycardia, hypotension, pallor

Brimonidine:

-Frequency not reported: Vasodilation

Timolol:

-Frequency not reported: Chest pain, atrioventricular block, cardiac arrest, cardiac failure, Raynaud's phenomenon, cold hands and feet, claudication, worsening of angina pectoris^[Ref]

Gastrointestinal

Common (1% to 10%): Oral dryness

Uncommon (0.1% to 1%): Nausea, diarrhea

Brimonidine:

-Frequency not reported: Gastrointestinal symptoms

Timolol:

-Frequency not reported: Dyspepsia, abdominal pain, vomiting^[Ref]

Immunologic

Brimonidine:

-Frequency not reported: Systemic allergic reactions, systemic lupus erythematosus, flu syndrome

Timolol:

-Frequency not reported: Systemic allergic reactions including angioedema, urticaria, localized and generalized rash, pruritus, anaphylactic reaction^[Ref]

Nervous system

Common (1% to 10%): Somnolence, headache

Uncommon (0.1% to 1%): Dizziness, syncope, taste perversion

Postmarketing reports: Coma, lethargy

Timolol:

-Frequency not reported: Cerebrovascular accident, cerebral ischemia, increases in signs and symptoms of myasthenia gravis, paresthesia, disorientation, memory loss, tinnitus^[Ref]

Psychiatric

Common (1% to 10%): Depression

Brimonidine:

-Frequency not reported: Insomnia

Timolol:

-Frequency not reported: Insomnia, nightmare, behavioral changes and psychic disturbances including confusion, hallucination^[Ref]

Respiratory

Uncommon (0.1% to 1%): Rhinitis, nasal dryness

Postmarketing reports: Respiratory depression

Brimonidine:

-Frequency not reported: Upper respiratory symptoms, dyspnea, apnea

Timolol:

-Frequency not reported: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), dyspnea, cough, upper respiratory infection, nasal congestion^[Ref]

Genitourinary

Timolol:

-Frequency not reported: Sexual dysfunction, decreased libido, Peyronie's disease, retroperitoneal fibrosis^[Ref]

General

The commonly reported side effects were allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging.^[Ref]

Musculoskeletal

Postmarketing reports: Hypotonia

Timolol:

-Frequency not reported: Myalgia^[Ref]

Other

Common (1% to 10%): Asthenic conditions

Postmarketing reports: Facial erythema

Timolol:

-Frequency not reported: Edema, fatigue^[Ref]

Dermatologic

Brimonidine:

-Frequency not reported: Skin reaction including erythema, pruritus, rash

Timolol:

-Frequency not reported: Alopecia, psoriasiform rash or exacerbation of psoriasis, rash^[Ref]

Hepatic

Common (1% to 10%): Abnormal Liver Function Tests^[Ref]

Metabolic

Brimonidine:

-Frequency not reported: Masked symptoms of hypoglycemia in diabetes patients, hypercholesterolemia

Timolol:

-Frequency not reported: Hypoglycemia^[Ref]