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ALIMENTARY TRACT AND METABOLISM › BILE AND LIVER THERAPY › BILE THERAPY › Bile acids and derivatives
ursodeoxycholic acid
A05AA02
Forms & Strengths
- Capsule: 250 mg
- Tablet: 250 mg, 500 mg
- Oral Suspension: 250 mg/5 mL
Adult Dosing
- Gallstone dissolution: 8-10 mg/kg/day divided in 2-3 doses
- Primary biliary cholangitis (PBC): 13-15 mg/kg/day administered in 2-4 divided doses
Pediatric Dosing
- Biliary atresia (post-Kasai): 10-20 mg/kg/day divided 2-3 times daily (off-label)
- Pediatric cholestatic liver disease: 10-15 mg/kg/day divided 2-3 times daily (off-label)
Indications
- Dissolution of radiolucent gallstones in patients with functioning gallbladders
- Treatment of patients with primary biliary cholangitis (PBC)
Mechanism of Action
- Hydrophilic bile acid that replaces hydrophobic toxic endogenous bile acids in the bile acid pool
- Reduces hepatic synthesis and secretion of cholesterol
- Inhibits intestinal absorption of cholesterol
- Protects cholangiocytes against toxic bile acid-induced injury and modulates immune response
Contraindications
- Complete biliary obstruction
- Radiopaque calcified gallstones
- Pigment gallstones
- Frequent episodes of biliary colic
- Known hypersensitivity to ursodiol or bile acids
- Non-functioning gallbladders
Adverse Reactions
- Headache
- Dizziness
- Diarrhea
- Nausea
- Vomiting
- Dyspepsia
- Abdominal pain
- Pruritus
- Back pain
- Hair thinning
Drug Interactions
- Bile acid sequestrants (e.g., cholestyramine, colestipol) bind ursodiol and decrease its absorption; separate administration by at least 2 hours
- Aluminum-containing antacids (e.g., aluminum hydroxide) bind bile acids and may reduce efficacy
- Estrogens, oral contraceptives, and clofibrate increase hepatic cholesterol secretion and counteract the efficacy of ursodiol for gallstone dissolution
Curated Content: Needs Vetting Before Put to Clinical Use