Ocaliva (Obeticholic Acid)

Description

Ocaliva is a medicine for adults with primary biliary cholangitis (PBC), a long-term disease in which the immune system damages small bile ducts in the liver. This damage can cause bile to build up, leading to liver scarring. It is used with ursodeoxycholic acid when that treatment alone is not working well enough after at least one year, or by itself when patients are unable to take ursodeoxycholic acid. Ocaliva may help the liver make less bile acid and remove more of it, which may lead to lower blood levels of alkaline phosphatase, a sign of bile duct damage.

Note: The FDA withdrew its US approval in November 2025, as studies did not show a confirmed patient benefit. They also found more liver transplants and deaths in people with early-stage PBC than in those taking a placebo.

Directions

Take Ocaliva once per day, with or without food. Treatment usually starts at 5 mg daily for the first three months. If blood tests show that liver markers have not improved enough and you are tolerating the medicine well, your healthcare provider may increase the dose to no more than 10 mg once daily. You will need regular blood tests to check your liver, side effects, and how your primary biliary cholangitis (PBC) is progressing.

If you take a bile acid binding medicine, such as cholestyramine, colestipol, or colesevelam, take it at least four hours before or after Ocaliva whenever possible. These medicines can prevent your body from absorbing Ocaliva. Stop Ocaliva permanently if your liver function worsens or shows signs of failure, and pause treatment during a serious illness.

Ingredients

The active ingredient in Ocaliva is obeticholic acid. Inactive ingredients may include microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The yellow film coating contains partly hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol 3350), talc, and iron oxide yellow.

Cautions

• Before using this medication, you may want to consult a healthcare provider about the following:
  • Any existing health conditions
  • Any allergies
  • A list of all medications currently being taken
• Read the boxed warning first. Liver decompensation and liver failure, sometimes fatal or leading to a transplant, have occurred on Ocaliva in PBC patients with cirrhosis, whether that cirrhosis was compensated or decompensated.
• Weigh the current status with your healthcare provider. The FDA withdrew Ocaliva’s US approval in November 2025, as the confirmatory trial did not verify a clinical benefit and found more liver transplants and deaths among early-stage patients than placebo.
• Have your specialist stage your liver disease before you start, since the contraindications are relevant whether you have cirrhosis and whether portal hypertension is present.
• Expect regular blood tests. Your team tracks liver enzymes, bilirubin, and alkaline phosphatase to catch decompensation early.
• Tell your provider about any severe infection or other serious illness, since treatment will need to pause until you recover.
• Report itching that becomes hard to live with. Although it is the most common reason people stop this drug, your healthcare provider can add a bile acid binding resin or an antihistamine, lower the dose, or pause treatment.
• Tell your healthcare provider if you take warfarin so your INR can be monitored and the warfarin dose adjusted as needed.
• Report any thyroid symptoms, as abnormal thyroid tests showed up during clinical trials.

Contraindications

Avoid taking or using this medication if any of the following apply:

• Decompensated cirrhosis, meaning Child-Pugh Class B or C
• Any previous decompensation event, such as an episode of ascites, variceal bleeding, or hepatic encephalopathy
• Compensated cirrhosis alongside signs of portal hypertension, including ascites, gastroesophageal varices, or a persistently low platelet count
• Complete blockage of the bile ducts

Side Effects

Common side effects of Ocaliva include:

• Itching
• Fatigue
• Abdominal pain or discomfort
• Rash
• Sore throat
• Dizziness
• Constipation
• Joint pain
• Abnormal thyroid blood tests
• Eczema

Get immediate medical help if your belly starts filling with fluid, your ankles or legs swell, your skin or the whites of your eyes turn yellow, or your urine darkens, since all of those could indicate liver problems. Go to an emergency department if you vomit blood, pass black tarry stools, or become confused or drowsy. Tell your provider if itching keeps you awake or wears you down, and get checked if a rash spreads or blisters. Seek emergency care for signs of an allergic reaction, such as swelling of the face, lips, or throat, along with any trouble breathing.

References

Ocaliva Prescribing Information. Morristown, NJ: Intercept Pharmaceuticals, Inc.; 2022.

Ocaliva Withdrawal of Approval Notice. Silver Spring, MD: US Food and Drug Administration; 2025.

About Dr. Gerardo Sison (Page Author)

An honors graduate of the University of Florida, Dr. Sison started his pharmacy career in a community setting, extending his services to hospitals and clinics over time. He has also worked in medication therapy management, advising patients on proper medication use for their chronic health conditions. Read More....