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Sildenafil Pregnancy and Breastfeeding Warnings

Sildenafil is also known as: Revatio, Viagra

Medically reviewed on October 12, 2017.

Sildenafil Pregnancy Warnings

This drug is not indicated for use in women. Safety has not been established.

Revatio (R):
This drug should be used only if clearly needed. (UK)

AU TGA pregnancy category: B1
US FDA pregnancy category: B

Comments: Revatio (R) is not recommended for women of childbearing potential unless using appropriate contraceptive measures.

No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits during organogenesis at doses 32- and 68-times the recommended human dose (RHD) of this drug. There were no observed adverse effects in pre and postnatal rats at 5-times the RHD. There are no adequate and well-controlled studies of this drug in pregnant women.

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

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

Sildenafil Breastfeeding Warnings

Use should be avoided.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

See references

References for pregnancy information

  1. "Product Information. Revatio (sildenafil)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  2. "Product Information. Viagra (sildenafil)." Pfizer US Pharmaceuticals, New York, NY.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Viagra (sildenafil)." Pfizer US Pharmaceuticals, New York, NY.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Revatio (sildenafil)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

Further information

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

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