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Clinical Studies 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.

In clinical trials, the most frequent adverse reaction associated with the use of BETOPTIC S® (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% has been transient ocular discomfort. The following other adverse reactions have been reported in small numbers of patients:

Ocular: blurred vision, corneal punctate keratitis, foreign body sensation, photophobia, tearing, itching, dryness of eyes, erythema, inflammation, discharge, ocular pain, decreased visual acuity and crusty lashes.

Systemic adverse reactions include: Cardiovascular: Bradycardia, heart block and congestive failure.

Pulmonary: Pulmonary distress characterized by dyspnea, bronchospasm, thickened bronchial secretions, asthma and respiratory failure.

Central Nervous System: Insomnia, dizziness, vertigo, headaches, depression, lethargy, and increase in signs and symptoms of myasthenia gravis.

Other: Hives, toxic epidermal necrolysis, hair loss, and glossitis. Perversions of taste and smell have been reported.

In a 3-month, double-masked, active-controlled, multicenter study in pediatric patients, the adverse reaction profile of BETOPTIC S® (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% was comparable to that seen in adult patients.

Additional Potential Adverse Reactions Associated with Betaxolol

Additional medical events reported with other formulations of betaxolol include allergic reactions, decreased corneal sensitivity, corneal punctate staining which may appear in dendritic formations, edema and anisocoria.