Cosopt-S Adverse Reactions

In a clinical study for Cosopt-S, the observed adverse reactions have been consistent with those that were reported previously with COSOPT (preserved formulation), dorzolamide hydrochloride and/or timolol maleate.
During clinical studies, 1035 patients were treated with COSOPT (preserved formulation). Approximately 2.4% of all patients discontinued therapy with COSOPT (preserved formulation) because of local ocular adverse reactions; approximately 1.2% of all patients discontinued because of local adverse reactions suggestive of allergy or hypersensitivity (such as lid inflammation and conjunctivitis).
Cosopt-S has been shown to have a similar safety profile to COSOPT (preservative-containing formulation) in a repeat-dose, double-masked, comparative study.
Like other topically-applied ophthalmic medicines, timolol is absorbed into the systemic circulation. This may cause similar undesirable effects as seen with systemic beta-blocking agents. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration.
The following adverse reactions have been reported with Cosopt-S or one of its components either during clinical trials or during post-marketing experience [Very Common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10,000, <1/1000), and Not Known (cannot be estimated from the available data)]: See Tables A and B.

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