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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)

 

July 2014

Summary View

PRECAUTIONS

Abnormal Bleeding
  • SSRIs and SNRIs, including Effexor XR, may increase the risk of bleeding events, ranging from  ecchymoses, hematomas, epistaxis, petechiae, and  gastrointestinal hemorrhage to life-threatening hemorrhage. Concomitant use… of or other drugs known to affect platelet function may add to this risk… 

 

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.