Obeticholic acid — Uses, Dosage, Side Effects & Safety

Drug class: Digestive & Gastrointestinal

Overview

Obeticholic acid is a prescription medication used to treat primary biliary cholangitis (PBC), a chronic liver disease that damages the bile ducts and can lead to liver scarring (cirrhosis). It is often prescribed when patients have not responded adequately to, or cannot tolerate, ursodeoxycholic acid (UDCA), the standard first-line treatment. Obeticholic acid works by activating a protein in the liver called the farnesoid X receptor (FXR). This helps reduce the production of bile acids in the liver and increases their removal from the body, thereby decreasing inflammation and damage to the bile ducts. Key points for patients: Obeticholic acid is not a cure for PBC but can help slow disease progression and improve liver function. Regular blood tests are needed to monitor your liver while on this medication. Always take it exactly as prescribed and report any side effects to your healthcare provider.

Therapeutic uses

• Primary biliary cholangitis (PBC)
• Non-alcoholic steatohepatitis (NASH) with liver fibrosis (investigational)

Common side effects

• Pruritus
• Fatigue
• Abdominal pain
• Diarrhea
• Constipation
• Peripheral edema
• Gallstones

Frequently Asked Questions about Obeticholic acid

What is obeticholic acid?

Semi-synthetic bile acid; brand name Ocaliva.

What is Ocaliva used for?

Primary biliary cholangitis (PBC, formerly primary biliary cirrhosis) in adults — alone or added to UDCA in inadequate responders.

How does obeticholic acid work?

Potent FXR agonist — reduces bile acid synthesis, increases bile flow, decreases inflammation in the liver.

What is the most common side effect of Ocaliva?

Pruritus (intense itching) — up to 80% of patients.

Why does Ocaliva cause itching?

FXR activation affects bile acid transport and possibly opioid pathways.

What dose of Ocaliva is used for PBC?

Start 5 mg daily; titrate to 10 mg after 3–6 months if tolerated and ALP still elevated.

Is obeticholic acid safe in cirrhosis?

Contraindicated in decompensated cirrhosis (Child-Pugh B/C) due to risk of liver failure.

When is obeticholic acid contraindicated?

Complete biliary obstruction; decompensated cirrhosis; previous severe pruritus reaction.

Educational information only. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.