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Pregnancy: Pregnancy risk factor B.
There have been no adequate and well-controlled studies of the use of ursodiol in pregnant woman, but inadvertent exposure of 4 women to therapeutic doses of the drug in the first trimester of pregnancy during the ursodiol trials led to no evidence of effects on the fetus or newborn baby. Although it seems unlikely, the possibility that ursodiol can cause fetal harm cannot be ruled out; hence, the drug is not recommended for use during pregnancy.
Lactation: It is not known whether ursodiol is excreted in human milk. Because many drugs are excreted in human milk, exercise caution when ursodiol is administered to a breastfeeding mother.
