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U.S. Department of Health and Human Services

Safety

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Effexor XR (Venlafaxine Hydrochloride) Extended-release Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012

Summary View

 

PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility
Impairment of Fertility
  • Reproduction and fertility studies of Venlafaxine in rats showed no adverse effects on male or female fertility at oral doses of up to 2 times the maximum recommended human dose of 225 mg/day on a mg/m2 basis.
  • However, reduced fertility was observed in a study in which male and female rats were treated with O-desmethylvenlafaxine (ODV), the major human metabolite of venlafaxine, prior to and during mating and gestation. This occurred at an ODV exposure (AUC) approximately 2 to 3 times that associated with a human venlafaxine dose of 225 mg/day.