Ursobil Use In Pregnancy & Lactation

If the patient is pregnant or breast-feeding, thinks she may be pregnant or planning to have a baby, advise patient before taking this medicine.
Pregnancy: There are no or limited amounts of data from the use of ursodeoxycholic acid in pregnant women. Studies in animals have shown reproductive toxicity. Ursodeoxycholic acid must not be used during pregnancy unless clearly necessary.
Women of child-bearing potential: Even if the patient is not pregnant, the doctor should still be consulted.
Women of childbearing potential should be treated only if they use reliable contraception: non-hormonal or low-oestrogen oral contraceptive measures are recommended.
However, if the patient is taking Ursodeoxycholic acid to dissolve the gallstones, she should use effective, non-hormonal contraceptive measures, as hormonal oral contraceptives may promote the formation of gallstones.
The doctor must exclude the possibility of a pregnancy before beginning of treatment.
Breast-feeding: According to few documented cases of breastfeeding women milk levels of ursodeoxycholic acid are very low and probably no adverse reactions are to be expected in breastfed infants.
Fertility: Animal studies did not show an influence of ursodeoxycholic acid on fertility. Human data on fertility effects following treatment with ursodeoxycholic acid are not available.