Effexor XR

[venlafaxine hydrochloride]

Side Effects & Drug Interactions
ADVERSE REACTIONS

The information included in the Adverse Findings Observed in Short-Term, Placebo-Controlled Studies with Effexor XR subsection is based on data from a pool of three 8-and 12-week controlled clinical trials in major depressive disorder (includes two U. S. trials and one European trial), on data up to 8 weeks from a pool of five controlled clinical trials in GAD with Effexor XR , and on data up to 12 weeks from a pool of two controlled clinical trials in Social Anxiety Disorder.

Information on additional adverse events associated with Effexor XR in the entire development program for the formulation and with Effexor (the immediate release formulation of venlafaxine) is included in the Other Adverse Events Observed During the Premarketing Evaluation of Effexor and Effexor XR subsection (see also WARNINGS and PRECAUTIONS).

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Adverse Findings Observed in Short-Term, Placebo-Controlled Studies with Effexor XR Adverse Events Associated with Discontinuation of Treatment Approximately 11 of the 357 patients who received Effexor XR (venlafaxine hydrochloride) extended-release capsules in placebo-controlled clinical trials for major depressive disorder discontinued treatment due to an adverse experience, compared with 6 of the 285 placebo-treated patients in those studies. Approximately 18 of the 1381 patients who received Effexor XR capsules in placebo-controlled clinical trials for GAD discontinued treatment due to an adverse experience, compared with 12 of the 555 placebo-treated patients in those studies.

Approximately 17% of the 277 patients who received Effexor XR capsules in placebo-controlled clinical trials for Social Anxiety Disorder discontinued treatment due to an adverse experience, compared with 5% of the 274 placebo-treated patients in those studies. The most common events leading to discontinuation and considered to be drug-related (ie, leading to discontinuation in at least 1 of the Effexor XR-treated patients at a rate at least twice that of placebo for either indication) are shown in Table 2.

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