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Avanafil Pregnancy and Breastfeeding Warnings

Brand names: Stendra

Medically reviewed by Drugs.com. Last updated on Sep 25, 2023.

Avanafil Pregnancy Warnings

Not indicated for use in females.

US FDA pregnancy category: Not assigned.

Risk Summary: No data exists regarding use in pregnant women.

Animal studies have revealed reduced offspring growth and maturation at exposures greater than or equal to 17 times the human exposure at the maximum recommended human dose (MRHD). There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Avanafil Breastfeeding Warnings

Not indicated for use in females.

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

Comments: The effects in the nursing infant are unknown.

See references

See also

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2012) "Product Information. Stendra (avanafil)." Vivus Inc

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2012) "Product Information. Stendra (avanafil)." Vivus Inc

Further information

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

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