Exuber 10 Adverse Reactions

Adverse Events Associated with Discontinuation of Treatment Major Depressive Disorder: Among the 715 depressed patients who received Escitalopram oxalate tablets in placebo-controlled trials, 6% discontinued treatment due to an adverse event, as compared to 2% of 592 patients receiving placebo. In two fixed-dose studies, the rate of discontinuation for adverse events in patients receiving 10 mg/day Escitalopram oxalate tablets was not significantly different from the rate of discontinuation for adverse events in patients receiving placebo. The rate of discontinuation for adverse events in patients assigned to a fixed dose of 20 mg/day Escitalopram oxalate tablets was 10%, which was significantly different from the rate of discontinuation for adverse events in patients receiving 10 mg/day Escitalopram oxalate tablets (4%) and placebo (3%). Adverse events that were associated with the discontinuation of at least 1% of patients treated with Escitalopram oxalate tablets, and for which the rate was at least twice that of placebo, were nausea (2%) and ejaculation disorder (2% of male patients).
Generalized Anxiety Disorder: Adverse events that were associated with the discontinuation of at least 1% of patients treated with Escitalopram oxalate tablets, and for which the rate was at least twice the placebo rate, were nausea (2%), insomnia (1%), and fatigue (1%).
Dose Dependency of Adverse Events: The potential dose dependency of common adverse events was examined on the basis of the combined incidence of adverse events in two fixed-dose trials. The overall incidence rates of adverse events in 10 mg Escitalopram oxalate tablets-treated patients (66 %) was similar to that of the placebo-treated patients (61%), while the incidence rate in 20 mg/day Escitalopram oxalate tablets-treated patients was greater (86%).