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. Continue reading for a comprehensive list of adverse effects.
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 Obeticholic acid
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
- 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
Other side effects of Obeticholic acid
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
- 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
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): 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]
Other
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]
Metabolic
Very common (10% or more): High-density lipoprotein-cholesterol (HDL-C) reduction (up to 20%)[Ref]
Gastrointestinal
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
Frequency not reported: Abdominal tenderness, anal pruritus, ascites, gastrointestinal pain, lower abdominal pain, new/worsening ascites, upper abdominal pain, variceal bleeding[Ref]
Cardiovascular
Common (1% to 10%): Palpitations, peripheral edema[Ref]
Nervous system
Dizziness includes dizziness, syncope, and presyncope.[Ref]
Common (1% to 10%): Dizziness
Frequency not reported: Hepatic encephalopathy, presyncope, syncope
Postmarketing reports: New/worsening hepatic encephalopathy[Ref]
Endocrine
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]
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]
