The Basics
What is Ursodiol?
Decreases the amount of cholesterol produced by the liver and absorbed by the intestines.
Brand names for Ursodiol
Urso
How Ursodiol is classified
Bile Acids and Salts, Cholagogues and Choleretics, Cholic Acids, Gastrointestinal Agents
Ursodiol During Pregnancy
Ursodiol pregnancy category
Category BNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Ursodiol while pregnant
Reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. There are no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Taking Ursodiol While Breastfeeding
What are recommendations for lactation if you're taking Ursodiol?
Because of the low levels of ursodiol (ursodeoxycholic acid) in breastmilk, amounts ingested by the infant are small and are not expected to cause any adverse effects in breastfed infants. No special precautions are required.
Maternal / infant drug levels
Because of the low levels of ursodiol (ursodeoxycholic acid) in breastmilk, amounts ingested by the infant are small and are not expected to cause any adverse effects in breastfed infants. No special precautions are required.
Possible effects of Ursodiol on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Ursodiol
None listed
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Rudi J, Schonig T, Stremmel W. [Therapy with ursodeoxycholic acid in primary biliary cirrhosis in pregnancy]. Zentralbl Gastroenterol. 1996;34:188-91. PMID: 8650973
2. Brites D, Rodrigues CMP. Elevated levels of bile acids in colostrum of patients with cholestasis of pregnancy are decreased following ursodeoxycholic acid therapy. J Hepatol. 1998;29:743-51. PMID: 9833912
3. Vitek L, Zelenkova M, Bruha R. Safe use of ursodeoxycholic acid in a breast-feeding patient with primary biliary cirrhosis. Dig Liver Dis. 2010;42:911-2. PMID: 20619755
4. Goh SK, Gull SE, Alexander GJ. Pregnancy in primary biliary cirrhosis complicated by portal hypertension: report of a case and review of the literature. BJOG. 2001;108:760-2. PMID: 11467706
5. Erol-Coskun H, Karagur N, Akyol F et al. Ursodiol use during breastfeeding: A case report. Reprod Toxicol. 2018;80:59. Abstract. DOI: doi:10.1016/j.reprotox.2018.07.070
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
