Ocaliva (Obeticholic Acid)
Ocaliva (obeticholic acid) is a treatment for primary biliary cholangitis (PBC), but Intercept Pharmaceuticals pulled it off the market in the U.S. because of serious liver side effects, such as liver failure and the need for transplants. Liver side effects have led to potential Ocaliva lawsuits.
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- Last update: January 16, 2026
- Est. Read Time: 4 min read
What Is Ocaliva?
Ocaliva (obeticholic acid) is a prescription medication for adults that doctors use to treat primary biliary cholangitis. PBC is a disease that affects the bile ducts in the liver, causing them to become damaged until the liver stops working.
Intercept Pharmaceuticals, Inc. — a subsidiary of Alfasigma — manufactured the drug. The U.S. Food and Drug Administration (FDA) initially approved Ocaliva for adults with PBC in 2016.
How Ocaliva Works in the Liver
Ocaliva increases bile flow from the liver and suppresses the production of toxic bile acids, which can harm the liver.
Research has shown that the drug can improve blood tests that measure liver problems in PBC patients. Ocaliva can prevent or delay the progression of PBC.
Is Ocaliva Still Available?
Ocaliva is no longer available in the U.S. Intercept withdrew the drug from the market in September 2025 at the request of the FDA. There was a 60-day transition period, and Ocaliva officially stopped being available for sale on Nov. 14, 2025.
Side Effects and Liver Injury Risks of Ocaliva
Ocaliva’s side effects range from minor issues like skin itching to major problems like liver failure. Because it could affect the liver, people with cirrhosis or biliary obstruction shouldn’t use Ocaliva.
Common Ocaliva Side Effects
The most common Ocaliva side effect is pruritus, or itching, which can occur in the ear, eye, genitals and other places on the body.
- Itching (70%)
- Fatigue (25%)
- Abdominal Pain (10%)
- Rash (10%)
- Joint Pain (10%)
- Throat Pain (8%)
- Dizziness (7%)
- Constipation (7%)
- Peripheral Edema (7%)
- Palpitations (7%)
- Fever (7%)
- Thyroid Function Abnormality (4%)
- Eczema (3%)
Serious Liver Injury and Boxed Warning for Ocaliva
Although it’s a medication intended to help the liver, Ocaliva also has a black box warning (the FDA’s most serious medication alert) for liver failure. These instances of liver failure can be fatal or require a transplant.
Signs and Symptoms of Liver Problems
Warning signs of potential liver complications while taking Ocaliva may include fatigue, diarrhea or jaundice.
- Abdominal pain
- Abdominal swelling
- Anxiety or unease
- Bloody stools
- Confusion or change in behavior
- Decreased appetite
- Diarrhea
- Nausea and vomiting
- New or worsening fatigue
- Weight loss
- Yellow eyes or skin
The FDA recommends contacting your doctor immediately if you take Ocaliva and experience any of these symptoms.
Who May Have Higher Risks for Ocaliva Complications
People with cirrhosis in its early or advanced stages have a significant risk of liver injury from Ocaliva.
The FDA received dozens of reports of liver failure or liver decompensation in people with cirrhosis who took Ocaliva at recommended doses.
Ocaliva Withdrawal, FDA Warnings and Regulatory Oversight
The FDA has taken a series of escalating safety actions on Ocaliva since its approval, including dosing-related liver injury warnings, use restrictions, communications about serious liver injury in patients without cirrhosis and withdrawal of approval for the PBC indication.
Why Intercept Pulled Ocaliva From the U.S. Market
Intercept withdrew Ocaliva from the market after the FDA determined that postmarketing clinical trials did not indicate medical benefits for people with PBC. The agency also found that PBC patients with early-stage disease who took Ocaliva had an excess of liver transplants and related deaths.
The FDA withdrew its approval for Ocaliva, and Intercept announced the drug’s withdrawal from the market in September 2025.
Timeline of Ocaliva News and Key FDA Decisions
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2016 – Initial FDA Approval
The FDA approved Ocaliva for the treatment of adults with primary biliary cholangitis (PBC).
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2017 – First Drug Safety Communication (Incorrect Dosing, Serious Liver Injury)
The FDA warned that some patients with impaired liver function were receiving doses of Ocaliva too frequently, resulting in liver injury and death.
-
2018 – Boxed Warning Added for Correct Dosing
The FDA updated Ocaliva’s labeling to include a boxed warning emphasizing correct dosing in people with liver impairment.
-
2021 – FDA Restricts Use in Patients With Advanced Cirrhosis
The FDA issued a new Drug Safety Communication restricting the use of Ocaliva in PBC patients with advanced cirrhosis because of cases of liver failure, transplant and death.
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2024 – Serious Liver Injury in Patients Without Cirrhosis
The FDA issued another Drug Safety Communication announcing that it had identified serious liver injuries, including cases that led to liver transplant or liver‑related death, in PBC patients taking Ocaliva who did not have cirrhosis.
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2025 – FDA’s Withdrawal of Ocaliva Approval for PBC
The FDA withdrew Ocaliva’s approval as a treatment for PBC due to safety concerns and a lack of proven clinical benefit for patients with PBC.
What Ocaliva Withdrawal Means for Current and Former Patients
Ocaliva’s withdrawal from the market means that people with PBC will lose a second-line therapy option. Doctors had previously prescribed Ocaliva for some patients who didn’t respond to the first-line therapy, ursodeoxycholic acid, but the FDA determined that the benefits no longer outweighed the risks.
Patients who were taking Ocaliva should speak to their doctors about alternative therapies.
Ocaliva Lawsuits and Legal Options
Lawyers are investigating Ocaliva lawsuits on behalf of people who received serious injuries from the drug or family members who lost a loved one because of Ocaliva side effects.
Ocaliva injuries included in lawsuits include liver damage, liver failure and death as a result of these complications.
You may qualify for an Ocaliva lawsuit if you took Ocaliva and suffered one of the liver injuries listed above.
If you are interested in filing a lawsuit, sign up for a free case review on Drugwatch, and we’ll connect you with one of our trusted, vetted legal partners. They can tell you if you qualify to file a lawsuit for potential compensation.
Living With PBC After Ocaliva
With Ocaliva off the market, people living with PBC must work closely with their liver specialists to choose other treatments and conduct ongoing monitoring.
It can be scary to lose one of your treatment options. The good news is that there are a couple of new drug alternatives to Ocaliva.
Current Treatment Options for Primary Biliary Cholangitis (PBC)
The first-line choice for PBC patients since 1994 has been ursodeoxycholic acid (UDCA), but not all patients respond to it. Previously, patients who didn’t respond to UDCA could take Ocaliva.
Two new drugs, Livdelzi (seladelpar) and Iqirvo (elafibranor), have shown promise in treating PBC and could replace Ocaliva as second-line therapies.
Questions To Ask Your Doctor if You Took Ocaliva
If you took Ocaliva, it may help to ask your doctor some specific questions so they can assess your liver health, adjust your PBC treatment plan and explain what the drug’s withdrawal means for you.
- “Do you see any signs that Ocaliva may have worsened my liver disease?”
- Ask your doctor to review your history of symptoms, hospitalizations and any episodes of decompensation or portal hypertension, a complication that involves high blood pressure in the veins that flow through the liver.
- “What tests should I take to check my liver function?”
- Discuss liver blood tests, imaging tests and whether you need follow‑up scans or more frequent monitoring.
- “Have my labs changed since before I started Ocaliva?”
- Request a comparison of your lab trends before, during and after Ocaliva to see whether there are patterns suggesting drug‑related worsening.
- “Could my fatigue, itching, abdominal pain or swelling be related to Ocaliva use or PBC progression?”
- Ask your doctor to help distinguish drug side effects from worsening liver problems so you know which symptoms are most concerning.
- “What is my treatment plan now that Ocaliva is off the market?”
- Ask which medicine will be your main therapy (for example, UDCA alone or other second‑line options) and how often they will reassess your disease.
The FDA recommends reporting any side effects or injuries from Ocaliva to its MedWatch program.
Ocaliva FAQs
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