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The figures cited cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. These incidence figures also cannot be compared with those obtained from other clinical studies involving related drug products as each group of drug trials is conducted under a different set of conditions. Finally, it is important to emphasize that the tabulation does not reflect the relative severity and/ or clinical importance of the events. A better perspective on the serious adverse events associated with the use of WELLBUTRIN SR Tablets is provided in the WARNINGS and PRECAUTIONS sections. 
Incidence of Commonly Observed Adverse Events in Controlled Clinical Trials: Adverse events from Table 4 occurring in at least 5% of patients treated with WELLBUTRIN SR Tablets and at a rate at least twice the placebo rate are listed below for the 300-and 400-mg/ day dose groups. Text Continues Below
WELLBUTRIN SR 300 mg/ day: Anorexia, dry mouth, rash, sweating, tinnitus, and tremor.
WELLBUTRIN SR 400 mg/ day: Abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency. Other Events Observed During the Clinical Development and Postmarketing Experience of Bupropion: In addition to the adverse events noted above, the following events have been reported in clinical trials and postmarketing experience with the sustained-release formulation of bupropion in depressed patients and in nondepressed smokers, as well as in clinical trials and postmarketing clinical experience with the immediate-release formulation of bupropion. Adverse events for which frequencies are provided below occurred in clinical trials with the sustained-release formulation of bupropion. The frequencies represent the proportion of patients who experienced a treatment-emergent adverse event on at least one occasion in placebo-controlled studies for depression (n = 987) or smoking cessation (n = 1,013), or patients who experienced an adverse event requiring discontinuation of treatment in an open-label surveillance study with WELLBUTRIN SR Tablets (n = 3,100). All treatment-emergent adverse events are included except those listed in Tables 1 through 4, those events listed in other safety-related sections, those adverse events subsumed under COSTART terms that are either overly general or excessively specific so as to be uninformative, those events not reasonably associated with the use of the drug, and those events that were not serious and occurred in fewer than 2 patients. Events of major clinical importance are described in the WARNINGS and PRECAUTIONS sections of the labeling. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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