Pregnancy: There are no or limited amount of data from the use of ursodeoxycholic acid in pregnant women. Studies in animals have shown reproductive toxicity during the early gestation phase. Ursodeoxycholic acid must not be used during pregnancy, unless clearly necessary.
Women of childbearing potential: Women of childbearing potential should be treated with ursodeoxycholic acid, only if they practice reliable contraception, non-hormonal contraceptives or oral contraceptives with low oestrogen dose are recommended. However, in patients taking ursodeoxycholic acid for dissolving gallstones, an effective non-hormonal contraception should be used, since hormonal oral contraceptives may increase biliary lithiasis. The possibility of a pregnancy must be excluded before beginning treatment.
Breastfeeding: According to few documented cases of breastfeeding women, milk levels of ursodeoxycholic acid levels in milk are very low and probably no adverse reactions are to be expected in breastfed infants.
Fertility: Animal studies did not shown an influence of ursodeoxycholic acid on fertility. Human data on fertility treatment with ursodeoxycholic acid are not available.