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The most commonly observed adverse events consistently associated with the use of Zyban (bupropion) were dry mouth and insomnia. The most commonly observed adverse events were defined as those that consistently occurred at a rate of 5 percentage points greater than that for placebo across clinical studies.
Adverse events were sufficiently troublesome to cause discontinuation of treatment in 8% of the 706 patients treated with Zyban and 5% of the 313 patients treated with placebo. The more common events leading to discontinuation of treatment with Zyban included nervous system disturbances (3.4%), primarily tremors, and skin disorders (2.4%), primarily rashes.
Zyban (bupropion) was well-tolerated in the long-term maintenance trial that evaluated chronic administration of Zyban for up to 1 year and in the trial that evaluated patients with mildto-moderate chronic obstructive pulmonary disease (COPD) for a 12-week period. Adverse events in both studies were quantitatively and qualitatively similar to those observed in the dose-response and comparative trials.
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