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Vardenafil Pregnancy and Breastfeeding Warnings

Vardenafil is also known as: Levitra, Staxyn

Medically reviewed on March 30, 2018

Vardenafil Pregnancy Warnings

This drug is not indicated for use in female patients.

AU TGA pregnancy category: B3
US FDA pregnancy category: B

No evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that received vardenafil at up to 18 mg/kg/day during organogenesis. There are no studies of the use of this drug in pregnant women.

AU TGA pregnancy category B3: 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 have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Vardenafil Breastfeeding Warnings

Following a single oral dose of 3 mg/kg, 3.3% of the administered dose was excreted into the milk within 24 hours.

This drug is not indicated for use in female patients.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Staxyn (vardenafil)." Merck & Company Inc, Whitehouse Station, NJ.
  4. "Product Information. Levitra (vardenafil)." Bayer, West Haven, CT.

References for breastfeeding information

  1. "Product Information. Staxyn (vardenafil)." Merck & Company Inc, Whitehouse Station, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Levitra (vardenafil)." Bayer, West Haven, CT.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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

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