Capsule: Hypersensitivity or intolerance to ursodeoxycholic acid, bile acid or any of the components of the formulations.
Do not use ursodeoxycholic acid for dissolution of calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones.
Do not use in patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-GI fistula.
Oral suspension: UDCA suspension should not be used in patients with: Acute inflammation of the gall bladder or biliary tract.
Occlusion of the biliary tract (occlusion of the common bile duct or cystic duct)
Frequent episodes of biliary colic.
Radio-opaque calcified gallstones.
Impaired contractility of the gall bladder.
Hypersensitivity to bile acids or any excipient of the formulation.
When used in hepatobiliary disorders associated with cystic fibrosis in children aged 1 month to 18 years: Unsuccessful portoenterostomy or without recovery of good bile flow in children with biliary atresia.
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