Monitor serum liver function tests & bilirubin level every mth for 3 mth after start of therapy & every 6 mth thereafter. Not indicated for the treatment of decompensated cirrhosis. Patients w/ variceal bleeding, hepatic encephalopathy, ascites, or in need of urgent liver transplant. Caution when administered in a setting of partial biliary obstruction of extra-hepatic origin. Exercise caution to maintain bile flow of the patients taking ursodiol. Should not be used in women who are or may become pregnant. Lactation. Ped patients.