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The most frequently reported ocular event in clinical trials was burning/stinging on instillation and was comparable between Betimol® and timolol maleate (approximately one in eight patients).

The following adverse events were associated with use of Betimol® (timolol ophthalmic solution) in frequencies of more than 5% in two controlled, double-masked clinical studies in which 184 patients received 0.25% or 0.5% Betimol® (timolol ophthalmic solution) :

Ocular

Dry eyes, itching, foreign body sensation, discomfort in the eye, eyelid erythema, conjunctival injection, and headache.

Body as a whole

Headache.

The following side effects were reported in frequencies of 1 to 5%:

Ocular

Eye pain, epiphora, photophobia, blurred or abnormal vision, corneal fluorescein staining, keratitis, blepharitis and cataract.

Body as a whole

Allergic reaction, asthenia, common cold and pain in extremities.

Cardiovascular

Hypertension.

Digestive

Nausea.

Metabolic/nutritional

Peripheral edema.

Nervous System/Psychiatry

Dizziness and dry mouth.

Respiratory

Respiratory infection and sinusitis.

In addition, the following adverse reactions have been reported with ophthalmic use of beta blockers:

Ocular

Conjunctivitis, blepharoptosis, decreased corneal sensitivity, visual disturbances including refractive changes, diplopia and retinal vascular disorder.

Body as a whole

Chest pain.

Cardiovascular

Arrhythmia, palpitation, bradycardia, hypotension, syncope, heart block, cerebral vascular accident, cerebral ischemia, cardiac failure and cardiac arrest.

Digestive

Diarrhea.

Endocrine

Masked symptoms of hypoglycemia in insulin dependent diabetics (See WARNINGS).

Nervous system/psychiatry

Depression, impotence, increase in signs and symptoms of myasthenia gravis and paresthesia.

Respiratory

Dyspnea, bronchospasm, respiratory failure and nasal congestion.

Skin

Alopecia, hypersensitivity including localized and generalized rash, urticaria.