In the previous long-term clinical studies of 1108 patients treated with DORZOLAMIDE HCl (TRUSOPT) Ophthalmic Solution alone or as adjunctive therapy with ophthalmic beta-blockers, the most frequently reported drug-related adverse effects and local symptoms were: Bitter taste, burning and stinging, blurred vision, eye itching, tearing, headache, conjunctivitis, eyelid inflammation, nausea, eyelid irritation and asthenia/fatigue. The most frequent cause of discontinuation (approximately 3%) from treatment with Ophthalmic Solution was drug-related ocular adverse effects, primarily conjunctivitis and lid reactions. Iridocyclitis and rash were each reported rarely. There was one report of urolithiasis.
The following adverse reactions have been reported in post-marketing experience: Hypersensitivity: Signs and symptoms of local reactions including palpebral reactions and systemic allergic reactions including angioedema, bronchospasm, urticaria and pruritus.
Nervous System: Dizziness, paresthesia.
Ocular: Pain, redness, superficial punctate keratitis, transient myopia (which resolved upon discontinuation of therapy), eyelid crusting, choroidal detachment following filtration surgery.
Skin/ Mucous Membranes: Contact dermatitis epistaxis, throat irritation, dry mouth.
Urogenital: Urolithiasis.
Laboratory Findings: DORZOLAMIDE HCl (TRUSOPT) was not associated with clinically meaningful electrolyte disturbances.
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