Vardenafil Pregnancy and Breastfeeding Warnings

Brand names: Levitra, Staxyn

Medically reviewed by Drugs.com. Last updated on Mar 21, 2023.

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

This drug is not indicated for use in female patients.

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

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

See references

Further information

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