Effexor XR

[venlafaxine hydrochloride]

5 Incidence is based on the number of men (Effexor XR = 158, placebo = 153).

Adverse Events Occurring at an Incidence of 2% or More Among Effexor XR-Treated Patients

Tables 3, 4, and 5 enumerate the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy of major depressive disorder (up to 12 weeks; dose range of 75 to 225 mg/ day), of GAD (up to 8 weeks; dose range of 37.5 to 225 mg/ day), and of Social Anxiety Disorder (up to 12 weeks; dose range of 75 to 225 mg/ day), respectively, in 2% or more of patients treated with Effexor XR (venlafaxine hydrochloride) where the incidence in patients treated with Effexor XR was greater than the incidence for the respective placebo-treated patients. The table shows the percentage of patients in each group who had at least one episode of an event at some time during their treatment. Reported adverse events were classified using a standard COSTART-based Dictionary terminology.

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The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect
incidence rate in the population studied.

Commonly Observed Adverse Events from Tables 3, 4, and 5:
Major Depressive Disorder
Note in particular the following adverse events that occurred in at least 5 of the Effexor XR patients and at a rate at least twice that of the placebo group for all placebo-controlled trials for the major depressive disorder (Table 3): Abnormal ejaculation, gastrointestinal complaints (nausea, dry mouth, and anorexia), CNS complaints (dizziness, somnolence, and abnormal dreams), and sweating.

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