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Note: This document contains side effect information about obeticholic acid. Some of the dosage forms listed on this page may not apply to the brand name Ocaliva.
Common side effects of Ocaliva 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.
Applies to obeticholic acid: oral tablet
Oral route (Tablet)
Warning: Hepatic Decompensation and Failure in Incorrectly Dosed PBC Patients with Child-Pugh Class B or C or Decompensated CirrhosisIn postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with primary biliary cholangitis (PBC) with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when obeticholic acid was dosed more frequently than recommended.The recommended starting dosage of obeticholic acid is 5 mg once weekly for patients with Child-Pugh Class B or C hepatic impairment or a prior decompensation event.
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:
Incidence not known
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:
Applies to obeticholic acid: oral tablet
The most commonly reported side effects include pruritus, fatigue, and abdominal pain/discomfort.
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.
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
Very common (10% or more): Fatigue (up to 25%)
Common (1% to 10%): Pyrexia
Frequency not reported: Asthenia, ear pruritus, tiredness
Fatigue includes fatigue, tiredness, and asthenia.
Very common (10% or more): High-density lipoprotein-cholesterol (HDL-C) reduction (up to 20%)
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
Abdominal pain/discomfort includes upper/lower abdominal pain, abdominal pain, abdominal discomfort, abdominal tenderness, and gastrointestinal pain.
Common (1% to 10%): Palpitations, peripheral edema
Dizziness includes dizziness, syncope, and presyncope.
Common (1% to 10%): Dizziness
Frequency not reported: Hepatic encephalopathy, presyncope, syncope
Postmarketing reports: New/worsening hepatic encephalopathy
Common (1% to 10%): Thyroid function abnormality
Frequency not reported: Decreased free thyroxine, hypothyroidism, increased blood thyroid stimulating hormone
Thyroid function abnormality includes thyroxine free decreased, blood thyroid stimulating hormone increased, and hypothyroidism.
Common (1% to 10%): Arthralgia
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
Frequency not reported: Vulvovaginal pruritus
Frequency not reported: Eye pruritus
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