Solifenacin Pregnancy and Breastfeeding Warnings

Solifenacin is also known as: VESIcare

Solifenacin Pregnancy Warnings

Animal studies have failed to reveal evidence of embryotoxicity or teratogenicity when exposed to 1.2 times the maximum recommended human dose (30 mg/kg/day). Reduced fetal body weight has been observed in mice when exposed to 3.6 times the maximum recommended human dose (100 mg/kg). An increase incidence in cleft palate has been reported in mice exposed to 7.9 the maximum recommended human dose (250 mg/kg).

Solifenacin has been assigned to pregnancy category C by the FDA. There are no controlled data in human pregnancy. Solifenacin is only recommended for use during pregnancy when benefit outweighs risks.

Solifenacin Breastfeeding Warnings

There are no data on the excretion of solifenacin into human milk. Solifenacin is excreted into the milk of mice. The manufacturer recommends that solifenacin not be used during nursing. A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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