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Ocaliva Side Effects

Generic name: obeticholic acid

Medically reviewed by Drugs.com. Last updated on Jun 7, 2023.

Note: This document contains side effect information about obeticholic acid. Some dosage forms listed on this page may not apply to the brand name Ocaliva.

Applies to obeticholic acid: oral tablet.

Warning

Oral route (Tablet)

Warning: Hepatic Decompensation and Failure in Primary Biliary Cholangitis Patients with CirrhosisHepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with obeticholic acid treatment in primary biliary cholangitis (PBC) patients with either compensated or decompensated cirrhosis.Obeticholic acid is contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal hypertension.Permanently discontinue obeticholic acid in patients who develop laboratory or clinical evidence of hepatic decompensation; have compensated cirrhosis and develop evidence of portal hypertension; or experience clinically significant hepatic adverse reactions while on treatment.

Serious side effects of Ocaliva

Along with its needed effects, obeticholic acid (the active ingredient contained in Ocaliva) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking obeticholic acid:

More common

Incidence not known

Other side effects of Ocaliva

Some side effects of obeticholic acid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

For Healthcare Professionals

Applies to obeticholic acid: oral tablet.

General

The most commonly reported side effects include pruritus, fatigue, and abdominal pain/discomfort.[Ref]

Dermatologic

Very common (10% or more): Pruritus (up to 70%), rash (up to 10%)

Common (1% to 10%): Eczema

Frequency not reported: Cholinergic urticaria, generalized pruritus, heat rash, macular rash, maculopapular rash, papular rash, prurigo, pruritic rash, skin eruptions, urticaria[Ref]

Pruritus occurred most frequently in patients given 10 mg than in patients titrated to 10 mg and in those given placebo; these patients were more likely to develop pruritus within the first month. Discontinuation due to pruritus was also more common in patients given 10 mg.

Severe pruritus includes skin eruptions, prurigo, pruritus, pruritus generalized, eye pruritus, ear pruritus, anal pruritus, vulvovaginal pruritus, and rash pruritus.

Rash includes urticaria, rash, rash macular/papular/maculopapular, heat rash, and urticaria cholinergic.[Ref]

Other

Fatigue includes fatigue, tiredness, and asthenia.[Ref]

Very common (10% or more): Fatigue (up to 25%)

Common (1% to 10%): Pyrexia

Frequency not reported: Asthenia, ear pruritus, tiredness[Ref]

Metabolic

Very common (10% or more): High-density lipoprotein-cholesterol (HDL-C) reduction (up to 20%)[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain/discomfort (up to 19%)

Common (1% to 10%): Constipation, oropharyngeal pain

Frequency not reported: Abdominal tenderness, anal pruritus, ascites, gastrointestinal pain, lower abdominal pain, new/worsening ascites, upper abdominal pain, variceal bleeding[Ref]

Abdominal pain/discomfort includes upper/lower abdominal pain, abdominal pain, abdominal discomfort, abdominal tenderness, and gastrointestinal pain.[Ref]

Cardiovascular

Common (1% to 10%): Palpitations, peripheral edema[Ref]

Nervous system

Common (1% to 10%): Dizziness

Frequency not reported: Hepatic encephalopathy, presyncope, syncope

Postmarketing reports: New/worsening hepatic encephalopathy[Ref]

Dizziness includes dizziness, syncope, and presyncope.[Ref]

Endocrine

Thyroid function abnormality includes thyroxine free decreased, blood thyroid stimulating hormone increased, and hypothyroidism.[Ref]

Common (1% to 10%): Thyroid function abnormality

Frequency not reported: Decreased free thyroxine, hypothyroidism, increased blood thyroid stimulating hormone[Ref]

Musculoskeletal

Common (1% to 10%): Alkaline phosphatase (ALP) increased, arthralgia[Ref]

Hepatic

Frequency not reported: Hepatic decompensation, liver failure, liver-related adverse reactions

Postmarketing reports: Increased direct bilirubin, increased total bilirubin, new onset cirrhosis, new/worsening jaundice[Ref]

Genitourinary

Frequency not reported: Vulvovaginal pruritus[Ref]

Ocular

Frequency not reported: Eye pruritus[Ref]

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Ocaliva (obeticholic acid). Intercept Pharmaceuticals, Inc. 2016.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer