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Ocaliva

obeticholic acid

Used for Liver Disease

Ocaliva (obeticholic acid) is used to treat primary biliary cholangitis, which is liver damage caused by bile build-up. It can be used alone or with another medication called ursodiol (Actigall). There's currently no available generic version of Ocaliva (obeticholic acid), and it's typically found at specialty pharmacies only. Common side effects include itchiness, fatigue, and stomach pain, but it also has a warning for liver problems.

Reviewed by:

Robert Chad Hakim, PharmD, BCCCP

Kristianne Hannemann, PharmD

Last reviewed on September 7, 2023

Basics Side effects Pros & cons Pharmacist tips FAQs Warnings Dosage Contraindications Alternatives Images References Prices Medicare

What is Ocaliva (obeticholic acid)?

What is Ocaliva (obeticholic acid) used for?

Primary biliary cholangitis

How Ocaliva (obeticholic acid) works

Primary biliary cholangitis is an autoimmune condition that damages the bile ducts in the liver that typically carry bile to the intestine. This causes bile to build up in the liver, which can lead to liver damage.

Ocaliva (obeticholic acid) is a farnesoid X receptor agonist that works in the liver. It turns on a protein in your body called farnesoid X receptor. As a result, the medication lowers how much bile your body makes and moves bile out of the liver to protect your liver.

Drug Facts

Common BrandsOcaliva

Drug ClassFarnesoid X receptor agonist

Controlled Substance ClassificationNot a controlled medication

Generic StatusNo lower-cost generic available

AvailabilityPrescription only

What are the side effects of Ocaliva (obeticholic acid)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

Itching (up to 70%)
Fatigue (up to 25%)
Stomach pain and discomfort (up to 19%)
Rash (up to 10%)
Joint pain (up to 10%)
Throat pain (up to 8%)
Dizziness (up to 7%)
Constipation (up to 7%)
Swelling in arms or legs (up to 7%)
Feeling of chest pounding (up to 7%)
Fever (up to 7%)

Other Side Effects

Change in thyroid function
Eczema

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.

Worsening liver problems or liver failure: swelling of your stomach; yellowing of your skin or the whites of your eyes; stool changes (black, tarry, or bloody stools); coughing or vomiting up blood; confusion; slurred speech; changes in personality

Source: DailyMed

The following side effects have also been reported

Side effects that you should report to your care team as soon as possible:

Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

Pros and cons of Ocaliva (obeticholic acid)

Pros

Only need to take once per day

Can take with or without food

Good option if you can't tolerate ursodiol (Actigall) well

Cons

Can cause intense itching or itching over much of your body

Can lower your "good" cholesterol (HDL)

Can't use if you have severe liver problems or liver failure

Not a first-choice option for treating primary biliary cholangitis

Pharmacist tips for Ocaliva (obeticholic acid)

Mark your appointments to see your provider and get any blood tests done on your calendar. These blood tests check your liver function and cholesterol levels. These follow-ups make sure Ocaliva (obeticholic acid) is working well and is safe for you.

Ocaliva (obeticholic acid) can cause itchiness and fatigue. Speak to your provider if these side effects prevent you from doing your normal daily activities, are unbearable, or get worse. Your provider might give you medication to help with these side effects, lower your dose of Ocaliva (obeticholic acid), or stop treatment.

If you're taking colesevelam (Welchol), colestipol (Colestid), or cholestyramine (Prevalite), take them at least 4 hours before or 4 hours after Ocaliva (obeticholic acid). If this isn't doable, try to take them as far apart as possible from Ocaliva (obeticholic acid). Taking them too close to Ocaliva (obeticholic acid) can lower how much Ocaliva (obeticholic acid) gets into your body, which can make it not work as well.

If you're taking warfarin (Coumadin), tell the provider who's managing your blood thinner medication that you're taking Ocaliva (obeticholic acid). This medication can affect your blood clotting time international normalized ratio (INR) when it's taken with the blood thinner, so your provider might want to follow up with you more often. If your INR changes, your warfarin (Coumadin) dose might be adjusted.

You might need to get blood tests done regularly to check your cholesterol levels. This is because Ocaliva (obeticholic acid) can lower your "good" cholesterol levels. It's important to have a healthy and balanced diet and to regularly exercise while taking this medication to help with your cholesterol levels.

Frequently asked questions about Ocaliva (obeticholic acid)

How well does Ocaliva (obeticholic acid) work for primary biliary cholangitis?

Studies show that Ocaliva (obeticholic acid) lowers the amount of a protein called alkaline phosphatase (ALP) in the blood. People with primary biliary cholangitis typically have high levels of ALP in the blood, which can be a sign of liver damage. As of right now, it's not clear how lowering ALP is related to better survival or improving symptoms in people with primary biliary cholangitis. There's ongoing research to confirm the benefits of Ocaliva (obeticholic acid) treatment for people with primary biliary cholangitis.

Is Ocaliva (obeticholic acid) approved for NASH?

No, Ocaliva (obeticholic acid) isn't approved for non-alcoholic steatohepatitis (NASH), a type of fatty liver disease. In fact, the FDA rejected the manufacturer's application to get Ocaliva (obeticholic acid) approved for NASH. They rejected the manufacturer's proposal because studies showed that the medication's benefits weren't greater than the risks for people with NASH.

How do you take Ocaliva (obeticholic acid)?

Take Ocaliva (obeticholic acid) tablets by mouth with or without food. If it's hurting your stomach, taking it with food might help. Take Ocaliva (obeticholic acid) at least 4 before or 4 hours after any bile acid sequestrants like cholestyramine (Prevalite) or colesevelam (Welchol). This helps prevent the bile acid sequestrants from interfering with how well Ocaliva (obeticholic acid) gets absorbed into your body and makes sure Ocaliva (obeticholic acid) works the best it can.

Does Ocaliva (obeticholic acid) cause weight gain?

Weight gain wasn't a reported side effect from people taking Ocaliva (obeticholic acid) in clinical studies. Speak with your provider if you experience unexpected weight changes while you're taking Ocaliva (obeticholic acid) to discuss possible causes.

Is Ocaliva (obeticholic acid) safe for people with liver problems?

It generally depends on the type and severity of your liver problem. Let your provider know of your liver problems before starting Ocaliva (obeticholic acid). Your provider might consider Ocaliva (obeticholic acid) for you if you have mild liver damage. But the medication can't be used if you have certain moderate-to-severe liver problems because it can worsen your liver function, which can lead to liver failure requiring a transplant or even death. Your provider will monitor you closely and order lab tests called liver function tests before and during treatment. They'll probably stop treatment if the medication is harming your liver.

Where can I get Ocaliva (obeticholic acid)?

Ocaliva (obeticholic acid) is available through specialty pharmacies. They might ship it directly to your home or they might send it to your local pharmacy. Talk to your provider or call 1-844-622-4278 to learn more about where to find Ocaliva (obeticholic acid) and how to coordinate with your pharmacies to get the medication to you.

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What are the risks and warnings for Ocaliva (obeticholic acid)?

Ocaliva (obeticholic acid) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

Worsening liver problems and liver failure

Risk factors: Cirrhosis (scarring of the liver) | History of liver problems

Ocaliva (obeticholic acid) can cause serious liver problems. In addition, some people with primary biliary cholangitis and cirrhosis (liver scarring) had worsening liver problems during treatment with Ocaliva (obeticholic acid). In some cases, these worsening problems led to the need for liver transplant or death.

You'll need to get regular blood tests done so your provider can check your liver health throughout treatment. Get medical help right away if you notice signs of serious liver damage, such as swelling of your stomach; yellowing of your skin or the whites of your eyes; black or bloody stools; bloody cough or vomit; confusion; or changes in personality or mood. You might need to stop using the medication to prevent further liver damage.

Severe itchiness

Ocaliva (obeticholic acid) can cause intense or widespread itching that can interfere with your daily activities, cause sleep problems, or cause discomfort. Talk to your provider if you notice these symptoms or if the itching gets worse. Your provider might recommend other medications to take to help manage the itchiness. They also might lower your Ocaliva (obeticholic acid) dose or decide to stop treatment with Ocaliva (obeticholic acid).

Lower levels of "good" cholesterol (HDL)

Ocaliva (obeticholic acid) can lower your levels of "good" cholesterol (high-density lipoprotein, HDL) in the body. You'll need to get regular lab tests while you're taking the medication to make sure your cholesterol levels don't drop. If your HDL levels become too low and your liver doesn't get better after taking Ocaliva (obeticholic acid) for 1 year, you might have to stop taking the medication.

Ocaliva (obeticholic acid) dosage forms

Typical dosing for Ocaliva (obeticholic acid)

The typical starting dose is 5 mg by mouth once per day for the first 3 months.

After 3 months of treatment, your provider might raise the dose to 10 mg by mouth once per day depending on the results of lab tests that measure your liver's health.

Ocaliva (obeticholic acid) contraindications

Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Ocaliva (obeticholic acid) will not be safe for you to take.

History of worsening liver function or liver failure
Certain types of cirrhosis (severe liver scarring)
Complete bile duct blockage

What are alternatives to Ocaliva (obeticholic acid)?

There are a number of medications that your doctor can prescribe in place of Ocaliva (obeticholic acid). Compare a few possible alternatives below.

Ocaliva (obeticholic acid)

Used for:

Primary biliary cholangitis

View Prices

Ursodiol (Actigall)

Used for:

Dissolve gallstones
Prevention of gallstone formation in overweight people experiencing rapid weight loss
Liver disease (primary biliary cirrhosis)

$15.60 Lowest GoodRx priceView Prices

Ocaliva (obeticholic acid) images

This medicine is Yellow, Round Tablet Imprinted With "5" And "Int".Yellow Round Int And 5 - OCALIVA 5mg Tablet

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References

Best studies we found

American Liver Foundation. (2024). Primary biliary cholangitis (PBC).

Claudel, T., et al. (2005). The Farnesoid X receptor. Arteriosclerosis, Thrombosis, and Vascular Biology.

Hegade, V. S., et al. (2015). Drug treatment of pruritus in liver diseases. Clinical Medicine.

View All References (10)

Intercept Pharmaceuticals, Inc. (2023). Intercept receives complete response letter from FDA for obeticholic acid as a treatment for pre-cirrhotic fibrosis due to NASH. Globe Newswire.

Intercept Pharmaceuticals Inc. (2022). Specialty Pharmacy Brochure.

Intercept Pharmaceuticals Inc. (2022). Ocaliva- obeticholic acid tablet, film coated [package insert]. DailyMed.

Lindor, K. D., et al. (2018). Primary biliary cholangitis: 2018 practice guidance from the American Association for the Study of Liver Diseases. Hepatology.

MedlinePlus. (2022). Alkaline phosphatase.

MedlinePlus. (2022). Bile.

National Institute of Diabetes and Digestive and Kidney Diseases. (2021). Definition & facts of primary biliary cholangitis (primary biliary cirrhosis).

Nevans, F., et al. (2016). A placebo-controlled trial of obeticholic acid in primary biliary cholangitis. The New England Journal of Medicine.

U.S. Food and Drug Administration, Division of Hepatology and Nutrition/Office of Immunology and Inflammation. (2023). FDA briefing document: NDA# 212833. Drug name: Obeticholic acid (OCA).

U.S. Food and Drug Administration. (2016). FDA approves Ocaliva for rare, chronic liver disease.

GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.

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