Ocaliva Side Effects
Generic Name: obeticholic acid
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.
For the Consumer
Applies to obeticholic acid: oral tablet
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:
- 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
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): 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
Abdominal pain/discomfort includes upper/lower abdominal pain, abdominal pain, abdominal discomfort, abdominal tenderness, and gastrointestinal pain.[Ref]
Common (1% to 10%): Dizziness
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: Vulvovaginal pruritus[Ref]
Frequency not reported: Eye pruritus[Ref]
1. "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.
More about Ocaliva (obeticholic acid)
- Ocaliva Side Effects
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- Drug class: miscellaneous GI agents