Skip to Content

Venlafaxine Pregnancy and Breastfeeding Warnings

Venlafaxine is also known as: Effexor, Effexor XR

Medically reviewed on May 4, 2018

Venlafaxine Pregnancy Warnings

Studies in animals have shown reproductive toxicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

Comments:
-Patients should notify their healthcare provider if they become pregnant or intend to become pregnant during treatment.
-Some newborns exposed to this drug late in the third trimester have developed complications requiring tube-feeding, respiratory support or prolonged hospitalization.
-When treating a pregnant woman with this drug during the third trimester, the healthcare provider should carefully consider the potential risks and benefits of therapy.

See references

Venlafaxine Breastfeeding Warnings

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-There have been post-marketing reports of breast-fed infants who experienced crying, irritability, and abnormal sleep patterns.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Effexor (venlafaxine)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Effexor (venlafaxine)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide