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Obeticholic acid Side Effects

In Summary

Commonly reported side effects of obeticholic acid include: severe pruritus, eye pruritus, pruritic rash, pruritus, pruritus ani, skin rash, vulvovaginal pruritus, decreased hdl cholesterol, macular eruption, maculopapular rash, miliaria, papular rash, urticaria, and pruritus of ear. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to obeticholic acid: oral tablet

Along with its needed effects, obeticholic acid 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
  • Fever
  • severe itching skin
Incidence not known
  • Abdominal or stomach pain
  • chills
  • clay-colored stools
  • dark urine
  • dizziness
  • headache
  • loss of appetite
  • nausea
  • rash
  • stomach pain and bloating
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting of blood
  • yellow eyes or skin

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
  • Abdominal or stomach discomfort
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • fast, irregular, pounding, or racing heartbeat or pulse
  • muscle pain or stiffness
  • pain in the joints
  • rapid weight gain
  • sore throat
  • tingling of the hands or feet
  • unusual weight gain or loss
Less common

For Healthcare Professionals

Applies to obeticholic acid: oral tablet


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

Very common (10% or more): Severe pruritus (up to 70%), rash (up to 10%)
Common (1% to 10%): Eczema
Frequency not reported: Skin eruptions, prurigo, pruritus generalized, rash pruritus, urticaria, rash macular/papular/maculopapular, heat rash, cholinergic urticaria[Ref]


Very common (10% or more): Fatigue (up to 25%)
Common (1% to 10%): Pyrexia
Frequency not reported: Tiredness, asthenia, ear pruritus[Ref]

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


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


Very common (10% or more): Abdominal pain/discomfort (up to 19%)
Common (1% to 10%): Oropharyngeal pain, constipation
Frequency not reported: Ascites, variceal bleeding, upper/lower abdominal pain, abdominal tenderness, gastrointestinal pain, anal pruritus[Ref]

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


Common (1% to 10%): Peripheral edema, palpitations[Ref]

Nervous system

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

Common (1% to 10%): Dizziness
Frequency not reported: Hepatic encephalopathy, syncope, presyncope[Ref]


Common (1% to 10%): Thyroid function abnormality
Frequency not reported: Decreased free thyroxine, increased blood thyroid stimulating hormone, hypothyroidism[Ref]

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


Common (1% to 10%): Arthralgia[Ref]


Frequency not reported: Liver-related adverse reactions (ascites, hepatic encephalopathy, variceal bleeding)[Ref]


Frequency not reported: Vulvovaginal pruritus[Ref]


Frequency not reported: Eye pruritus[Ref]


1. "Product Information. Ocaliva (obeticholic acid)." Intercept Pharmaceuticals, Inc., New York, NY.

Some side effects of obeticholic acid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.