Overview

Ocaliva is a prescription drug approved by the FDA to treat primary biliary cholangitis (PBC). In September 2025, Ocaliva manufacturer Intercept Pharmaceuticals voluntarily withdrew the drug from the U.S. markets. This decision comes after new FDA safety data showed the drug may cause serious liver injury — including cases requiring a liver transplant — even in people without cirrhosis (late-stage liver disease where scar tissue replaces healthy liver tissue). Read more about the withdrawal here.

Ocaliva is given in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone for adults who cannot tolerate UDCA. Ocaliva is also referred to by its drug name, obeticholic acid.

Ocaliva is a member of a class of drugs called farnesoid X receptor agonists. Ocaliva is believed to work by decreasing bile production and increasing bile removal from the liver.

How do I take it?

Prescribing information states that Ocaliva is taken orally once daily. Ocaliva comes in tablet form.

Side effects

The FDA-approved label for Ocaliva lists common side effects, including itching, tiredness, stomach pain, rash, joint pain, mouth and throat pain, dizziness, constipation, swelling in hands or feet, fast or irregular heartbeat, fever, changes in how your thyroid gland works, and eczema.

Rare yet serious side effects of Ocaliva may involve the deterioration of liver conditions, possibly leading to liver failure. In some instances, particularly among individuals with PBC and liver cirrhosis, these effects have resulted in liver transplants or even death. Ocaliva can also lower high levels of HDL‑C (“good” cholesterol) or cause severe itching.

For more details about this treatment, visit:

Ocaliva — Intercept Pharmaceuticals

Obeticholic Acid — MedlinePlus