Tridelta Use In Pregnancy & Lactation

Pregnancy: There are no adequate data on the use of Ursodeoxycholic acid, particularly in the first trimester of pregnancy. Animal studies have provided evidence of a teratogenic effect during the early phase of gestation. Ursodeoxycholic acid must not be used during pregnancy unless clearly necessary.
Lactation: There are no clinical data available on the safety of Ursodeoxycholic acid in women who are breastfeeding. Therefore, Ursodeoxycholic acid is not recommended in this patients group.
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.
Fertility: Animal studies did not show an influence of Ursodeoxycholic acid on fertility. Human data on fertility treatment with Ursodeoxycholic acid are not available.