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Side Effects & Drug Interactions
ADVERSE REACTIONS
(See also WARNINGS and PRECAUTIONS.) The information included under the Incidence in Controlled Trials subsection of ADVERSE REACTIONS is based primarily on data from controlled clinical trials with WELLBUTRIN SR Tablets. Information on additional adverse events associated with the sustained-release formulation of bupropion in smoking cessation trials, as well as the immediate-release formulation of bupropion, is included in a separate section (see Other Events Observed During the Clinical Development and Postmarketing Experience of Bupropion). Text Continues Below
Incidence in Controlled Trials With WELLBUTRIN SR: Adverse Events Associated With Discontinuation of Treatment Among Patients Treated With WELLBUTRIN SR Tablets: In placebo-controlled clinical trials, 9% and 11% of patients treated with 300 and 400 mg/ day, respectively, of WELLBUTRIN SR Tablets and 4% of patients treated with placebo discontinued treatment due to adverse events. The specific adverse events in these trials that led to discontinuation in at least 1% of patients treated with either 300 or 400 mg/ day of WELLBUTRIN SR Tablets and at a rate at least twice the placebo rate are listed in Table 3. 
Adverse Events Occurring at an Incidence of 1% or More Among Patients Treated With WELLBUTRIN SR Tablets: Table 4 enumerates treatment-emergent adverse events that occurred among patients treated with 300 and 400 mg/ day of WELLBUTRIN SR Tablets and with placebo in placebo-controlled trials. Events that occurred in either the 300-or 400-mg/ day group at an incidence of 1% or more and were more frequent than in the placebo group are included. Reported adverse events were classified using a COSTART-based Dictionary. Accurate estimates of the incidence of adverse events associated with the use of any drug are difficult to obtain. Estimates are influenced by drug dose, detection technique, setting, physician judgments, etc. Page: 1 | 2 | 3 | 4 | 5 | Next >>
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