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.
Ocular: In clinical trials, the most frequent event associated with the use of BETAXON™ (levobetaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.5% has been transient ocular discomfort upon instillation (11%). Transient blurred vision has been reported in approximately 2% of patients. Other ocular events have been reported in less than 2% of patients and include: cataracts, and vitreous disorders.
Systemic: Systemic reactions following administration of BETAXON™ (levobetaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.5% and other topical ocular formations of betaxolol have been at an incidence of less than 2%. These include:
Cardiovascular: Bradycardia, heart block, hypertension, hypotension, tachycardia, and vascular anomaly.
Central Nervous System: Anxiety, dizziness, hypertonia, and vertigo.
Digestive: Constipation and dyspepsia.
Endocrine: Diabetes and hypothyroidism.
Metabolic and Nutritional Disorders: Gout, hypercholesteremia, and hyperlipidemia.
Musculoskeletal: Arthritis and tendonitis.
Pulmonary: Pulmonary distress characterized by bronchitis, dyspnea, pharyngitis, pneumonia, rhinitis, and sinusitis.
Skin and Appendages: Alopecia, dermatitis, and psoriasis.
Special Senses: Ear pain, otitis media, taste perversion, and tinnitus.
Urogenital: Breast abscess and cystitis.
Other: Accidental injury, headache, and infection.
In a three-month, multi-center, double-masked, active-controlled trial in pediatric patients, the adverse event profile of BETAXON™ (levobetaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension was comparable to that seen in adult and elderly patients.