Obeticholic Acid: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Obeticholic Acid. Educational only — not medical advice.

Labeled uses

OCALIVA® is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP) [see Clinical Studies (14) ] . An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Source: FDA labeling via NIH DailyMed (set cdfbe0cd…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.