Obeticholic acid Side Effects
Medically reviewed by Drugs.com. Last updated on Jun 5, 2021.
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
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.
Side effects requiring immediate medical attention
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:
- severe itching skin
Incidence not known
- clay-colored stools
- dark urine
- loss of appetite
- stomach pain and bloating
- unpleasant breath odor
- unusual tiredness or weakness
- vomiting of blood
- yellow eyes or skin
Side effects not requiring immediate medical attention
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:
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- difficulty having a bowel movement
- 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
- Skin rash, encrusted, scaly and oozing
For Healthcare Professionals
Applies to obeticholic acid: oral tablet
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.
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]
Very common (10% or more): Fatigue (up to 25%)
Common (1% to 10%): Pyrexia
Frequency not reported: Asthenia, ear pruritus, tiredness[Ref]
Fatigue includes fatigue, tiredness, and asthenia.[Ref]
Very common (10% or more): High-density lipoprotein-cholesterol (HDL-C) reduction (up to 20%)[Ref]
Abdominal pain/discomfort includes upper/lower abdominal pain, abdominal pain, abdominal discomfort, abdominal tenderness, and gastrointestinal pain.[Ref]
Very common (10% or more): Abdominal pain/discomfort (up to 19%)
Common (1% to 10%): Constipation, oropharyngeal pain
Common (1% to 10%): Dizziness
Frequency not reported: Hepatic encephalopathy, presyncope, syncope
Common (1% to 10%): Thyroid function abnormality
Frequency not reported: Decreased free thyroxine, hypothyroidism, increased blood thyroid stimulating hormone[Ref]
Thyroid function abnormality includes thyroxine free decreased, blood thyroid stimulating hormone increased, and hypothyroidism.[Ref]
Common (1% to 10%): Alkaline phosphatase (ALP) increased, arthralgia[Ref]
Frequency not reported: Hepatic decompensation, liver failure, liver-related adverse reactions
Frequency not reported: Vulvovaginal pruritus[Ref]
Frequency not reported: Eye pruritus[Ref]
More about obeticholic acid
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- 2 Reviews
- Drug class: miscellaneous GI agents
- Latest FDA Alerts (3)
- Other brands
Related treatment guides
1. Cerner Multum, Inc. "Australian Product Information." O 0
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. "Product Information. Ocaliva (obeticholic acid)." Intercept Pharmaceuticals, Inc., New York, NY.
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.