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Ocaliva Side Effects

Generic Name: obeticholic acid

Note: This page contains side effects data for the generic drug obeticholic acid. It is possible that some of the dosage forms included below may not apply to the brand name Ocaliva.

For the Consumer

Applies to obeticholic acid: oral tablet

As well as its needed effects, obeticholic acid (the active ingredient contained in Ocaliva) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking obeticholic acid, check with your doctor immediately:

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

Minor Side Effects

Some obeticholic acid side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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:
  • Skin rash, encrusted, scaly and oozing

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

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]

Other

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]

Metabolic

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

Gastrointestinal

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]

Cardiovascular

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]

Endocrine

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]

Musculoskeletal

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

Hepatic

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

Genitourinary

Frequency not reported: Vulvovaginal pruritus[Ref]

Ocular

Frequency not reported: Eye pruritus[Ref]

References

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

It is possible that some side effects of Ocaliva may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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. Drugs.com 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.

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