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Silodosin Pregnancy and Breastfeeding Warnings

Silodosin is also known as: Rapaflo

Silodosin Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity or fetotoxicity. Animal studies have revealed decreased fertility at about twice the maximum recommended human dose (MRHE), decreased sperm count and viability at about 65 times the MRHE, and histopathological changes in the testes and epididymides at about 30 times the MRHE. Decreased fertility was reversible following a 2 week recovery period. There are no controlled data in human pregnancy. 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.

This drug is not indicated for use in female patients. US FDA pregnancy category: B

See references

Silodosin Breastfeeding Warnings

Major: This drug is not indicated for use in female patients. Excreted into human milk: Data not available Excreted into animal milk: Data not available

See references

References for pregnancy information

  1. "Product Information. Rapaflo (silodosin)." Watson Pharmaceuticals, Corona, CA.

References for breastfeeding information

  1. "Product Information. Rapaflo (silodosin)." Watson Pharmaceuticals, Corona, CA.

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