Ocaliva (Obeticholic Acid) - Oral

Warning:

A decrease in liver function and liver failure, sometimes fatal or requiring a liver transplant, has been reported by people taking Ocaliva with either compensated or decompensated cirrhosis (liver scarring). For this reason, Ocaliva shouldn't be used by people with primary biliary cholangitis (PBC) (an autoimmune disease that destroys the bile ducts) with decompensated cirrhosis (progressed cirrhosis that shows symptoms), a prior decompensation event, or with compensated cirrhosis (cirrhosis without symptoms yet) who have signs of portal hypertension (high blood pressure in the portal vein system). Ocaliva should be permanently stopped in people who develop clinical evidence of liver failure or decompensation or have compensated cirrhosis and develop portal hypertension.

What Is Ocaliva?

Ocaliva (obeticholic acid) is a prescription medication used to treat adults with primary biliary cholangitis (PBC) without cirrhosis (scarring of the liver) or with compensated cirrhosis (cirrhosis without symptoms yet) who do not have signs of portal hypertension (high blood pressure in the portal vein system). Ocaliva is combined with ursodeoxycholic acid (UDCA) or by itself if people cannot tolerate UDCA. Ocaliva is a farnesoid X receptor (FXR) agonist, and it works to treat PBC by reducing the amount of circulating bile acid in the liver.

Drug Facts

Generic Name: Obeticholic Acid

Brand Name(s): Ocaliva

Drug Availability: Prescription

Therapeutic Classification: Farnesoid X receptor (FXR) agonist

Available Generically: No

Controlled Substance: N/A

Administration Route: Oral

Active Ingredient: Obeticholic Acid

Dosage Form(s): Oral tablet

What Is Ocaliva Used For?

Ocaliva treats adults with primary biliary cholangitis (PBC) without cirrhosis or with compensated cirrhosis who do not have signs of portal hypertension.

The Fibrotic Liver Disease Consortium suggested that PBC prevalence in the U.S. was 23.9 per 100,000 persons. However, this number can vary by geographic region (where people live) and demographics (ex., age, income, etc.).

How to Take Ocaliva

Take Ocaliva by mouth with or without food as directed by your healthcare provider. If you take Ocaliva with a bile acid sequestrant (ex., cholestyramine, colestipol, or colesevelam), you'll need to take Ocaliva at least four hours before or four hours after the bile acid sequestrant.

Storage

Store Ocaliva in a closed container at room temperature, away from heat, moisture, and direct light. Do not store in the bathroom.

Keep your medications out of the reach of children and pets, ideally locked in a cabinet or closet.

If you plan to travel with Ocaliva, get familiar with your final destination's regulations. Checking with the U.S. embassy or consulate might be a helpful resource. In general, however, make sure to copy your Ocaliva prescription. If possible, keep your medication in its original container from your pharmacy with your name on the label. Ask your pharmacist or healthcare provider if you have any questions about traveling with your medicine.

You can also ask your pharmacist or healthcare provider about the best ways to dispose of your medications. The Food and Drug Administration's (FDA) website is a potentially helpful resource for knowing where and how to discard all unused and expired drugs. You can also find disposal boxes in your area.

How Long Does Ocaliva Take to Work?

Ocaliva levels will peak in your blood around 1.5 hours after taking it. The time it takes Ocaliva to work may be different for everyone. Check with your healthcare provider or pharmacist if you have any questions.

Off-Label Uses

There are no reported off-label uses of Ocaliva.

What Are the Side Effects of Ocaliva?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

  • Fatigue (tiredness)
  • Itchy skin (pruritus)
  • Stomach pain and discomfort
  • Rash
  • Dizziness
  • Constipation
  • Joint pain
  • Eczema

Severe Side Effects

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or think you have a medical emergency. Serious side effects and their symptoms can include the following:

  • Signs of an allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Severe itchy skin (pruritus)
  • Ascites (excess fluid in the stomach area that causes swelling)
  • Jaundice (yellowing of the skin or eyes)
  • Worsening of primary biliary cholangitis (PBG)
  • Signs of liver failure: dark-colored urine or pale stools, nausea, vomiting, loss of appetite, stomach pain or discomfort, fever, chills, change in how much or how often you urinate, dry mouth, increased thirst, dizziness, lightheadedness, rapid weight gain, swelling in your hands, ankles, or feet
  • Death

Due to Ocaliva's black box warning for severe liver injury, you should immediately report any signs and symptoms of liver failure to your healthcare provider. You may need to stop treatment with Ocaliva.

Long-Term Side Effects

Long-term effects of Ocaliva including cardiovascular events are lacking.

Report Side Effects

Ocaliva may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Ocaliva Should I Take?

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The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For treatment of primary biliary cholangitis:
      • Adults—At first, 5 milligrams (mg) once a day for the first 3 months. Your doctor may adjust your dose as needed and tolerated. However, the dose is not more than 10 mg once a day.
      • Children—Use and dose must be determined by your doctor.

Modifications

The following modifications (changes) should be kept in mind when using Ocaliva:

Severe allergic reaction: Avoid using Ocaliva if you have a known allergy to it or its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.

Pregnancy and breast-feeding: There's not enough scientific evidence to tell whether there would be a risk to your fetus when used during pregnancy or to your child during breastfeeding. If pregnant or breastfeeding, please talk with your healthcare provider before starting Ocaliva.

Children: The safety and effectiveness of using Ocaliva in children have not been established.

Adults over the age of 65: Based on the clinical studies of Ocaliva, no overall differences in safety or effectiveness were found between adults over 65 years and adults less than 65. However, some adults over 65 may be more sensitive to Ocaliva.

Missed Dose

If you miss your dose of Ocaliva, take the dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.

Overdose: What Happens If I Take Too Much Ocaliva?

There is limited information available about Ocaliva overdose.

The symptoms of a suspected overdose of Ocaliva include increased liver biochemical tests, ascites, jaundice, portal hypertension, and primary biliary cholangitis flares.

If you think you're experiencing an overdose or life-threatening symptoms, seek immediate medical attention.

What Happens If I Overdose on Ocaliva?

If you think you or someone else may have overdosed on Ocaliva, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Ocaliva, call 911 immediately.

Precautions

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It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have dark urine or pale stools, fever, chills, change in how much or how often you urinate, dry mouth, increased thirst, dizziness, lightheadedness, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes. These may be symptoms of a serious liver problem.

Check with your doctor right away if you have severe itching skin.

This medicine may increase the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to lower the cholesterol and fats. Talk to your doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What Are Reasons I Shouldn’t Take Ocaliva?

You should not take Ocaliva if you have one of the following:

  • A known allergic reaction to obeticholic acid or any of its ingredients
  • Complete biliary obstruction (a blockage in the tubes that carry bile from the liver to the gallbladder and small intestine)
  • Decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event (the stage of liver failure that begins to show symptoms) that includes: ascites, variceal hemorrhage (bleeding of abnormal veins in the gastrointestinal tract such as the stomach, esophagus, or rectum), hepatic encephalopathy (severe liver disease affecting the brain), or jaundice (yellowing of the skin or eyes)
  • Compensated cirrhosis (stage of liver failure without symptoms) with signs of portal hypertension (high blood pressure in the blood vessel that carries blood from the gastrointestinal tract, gallbladder, pancreas, and spleen to the liver)

Please let your healthcare provider know if you have liver problems, severe itching skin, or high cholesterol levels because taking Ocaliva may worsen your condition.

What Other Medications Interact With Ocaliva?

While taking this medication you should ask your healthcare provider or pharmacist before using any other medicine, including over-the-counter medicines, vitamins and herbal products. Use caution when taking Ocaliva with the following medications:

  • Cyclosporine
  • Theophylline
  • Tizanidine
  • Blood thinners (including warfarin)
  • Bile acid sequestrants

If you are taking bile acid sequestrants like cholestyramine, colestipol, or colesevelam, take Ocaliva at least four hours before or four hours after these medicines.

What Medications Are Similar?

There are no medications that share a similar efficacy profile as Ocaliva.

Frequently Asked Questions

  • What is Ocaliva used for?

    Ocaliva (Obeticholic Acid) is a prescription medicine used to treat adults with primary biliary cholangitis (PBC) without cirrhosis (scarring of the liver) or with compensated cirrhosis who do not have signs of portal hypertension.

  • Who should not take Ocaliva?

    People with one of the following:

    • A known allergic reaction to obeticholic acid or any of its ingredients
    • Complete biliary obstruction (a blockage in the tubes that carry bile from the liver to the gallbladder and small intestine)
    • Decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event (when liver failure begins to show symptoms) that include: ascites, variceal hemorrhage (bleeding of abnormal veins in the gastrointestinal tract such as the stomach, esophagus, or rectum), hepatic encephalopathy (severe liver disease affecting the brain), or jaundice (yellowing of the skin or eyes)
    • Compensated cirrhosis (stage of liver failure without symptoms) with signs of portal hypertension (high blood pressure in the blood vessel that carries blood from the gastrointestinal tract, gallbladder, pancreas, and spleen to the liver.)
  • When should you take Ocaliva if you are also taking a bile acid sequestrant?

    You must take Ocaliva at least four hours before or four hours after the bile acid sequestrant.

How Can I Stay Healthy While Taking Ocaliva?

If you're taking Ocaliva, chances are primary biliary cholangitis has been negatively affecting your quality of life. You may've tried different approaches or treatments. While living with primary biliary cholangitis does have its challenges, there are ways to help improve your quality of life. Refer below for some general tips to support your health:

  • Avoid alcohol and medications, including herbal products (ex., kava) that can cause liver injury.
  • Stay up to date with hepatitis vaccinations and lab testing for liver function.
  • Continue to follow up with your healthcare provider to ensure your success with the treatment of your disease.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

3 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Food and Drug Administration. Ocaliva label.

  2. Neuschwander-Tetri B A, Loomba R, Sanyal AJ, et al. Farnesoid X nuclear receptor ligand obeticholic acid for non-cirrhotic, non-alcoholic steatohepatitis (FLINT): a multicentre, randomised, placebo-controlled trial. Lancet (London, England). 2015;385(9972):956–965. doi:10.1016/S0140-6736(14)61933-4

  3. Galoosian A, Hanlon C, Zhang J, Holt EW, Yimam KK. Clinical updates in primary biliary cholangitis: trends, epidemiology, diagnostics, and new therapeutic approachesJ Clin Transl Hepatol. 2020;8(1):49-60. doi:10.14218/JCTH.2019.00049