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Flavoxate Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Aug 24, 2022.

Flavoxate is also known as: Urispas

Flavoxate Pregnancy Warnings

Animal studies have failed to reveal evidence of impaired fertility and fetal harm. 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.

Use is recommended only if clearly needed.

US FDA pregnancy category: B

See references

Flavoxate Breastfeeding Warnings

Caution is recommended.

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

Comments: During long-term use, observe the breastfeeding infant for signs of decreased lactation (e.g., insatiety, poor weight gain).

See references

References for pregnancy information

  1. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate" (2013):
  2. "Product Information. FlavoxATE Hydrochloride (flavoxATE)." PuraCap Pharmaceutical (2022):

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT" (2013):
  2. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate" (2013):
  3. "Product Information. FlavoxATE Hydrochloride (flavoxATE)." PuraCap Pharmaceutical (2022):

Further information

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