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Flavoxate Pregnancy and Breastfeeding Warnings

Brand names: Urispas

Medically reviewed by Drugs.com. Last updated on Aug 11, 2023.

Flavoxate Pregnancy Warnings

Use is recommended only if clearly needed.

US FDA pregnancy category: B

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.

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

References for breastfeeding information

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

Further information

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