Use of Ursodiol in Infants and Children

Marcia L. Buck, Pharm.D., FCCP

Pediatr Pharm. 2009;15(2) 

In This Article


Ursodiol was approved by the Food and Drug Administration (FDA) in 1987 for the prevention and treatment of gallstones and for the treatment of primary biliary cirrhosis in adults.[1] Although not approved by the FDA for use in pediatric patients, ursodiol has been used for two decades as adjunctive therapy in the management of children with hepatobiliary disease.[2] Initially studied in adolescents with cystic fibrosis, ursodiol has also been found to be useful in the management of infants and children with hereditary cholestasis syndromes, biliary atresia, and parenteral nutrition-associated cholestasis. This issue of Pediatric Pharmacotherapy will provide an overview of recent studies conducted with ursodiol in infants and children with hepatobiliary diseases, as well as review its mechanism of action, pharmacokinetics, and adverse effects.


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