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Obeticholic Acid: uses, dosing, side effects & brands

Obeticholic Acid is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Available as
Tablet
Sold as
Ocaliva
Prescription?
Prescription only
Generic available?
Not in our catalog

Every obeticholic acid product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Ocaliva.

What people report to the FDA about obeticholic acid

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 166 reports naming obeticholic acid, and the FDA flagged 90% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • pruritus19 reports
  • fatigue11 reports
  • diarrhoea10 reports
  • abdominal pain upper8 reports
  • cholelithiasis8 reports
  • jaundice8 reports
  • cholecystitis acute7 reports
  • blood alkaline phosphatase abnormal6 reports

Read these as a signal, not a rate. A report does not mean obeticholic acid caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

Related calculators

Frequently asked questions

Can you take obeticholic acid with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run obeticholic acid against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does obeticholic acid come in?

Across the brands we track, obeticholic acid is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic obeticholic acid?

We do not currently list a generic-labelled obeticholic acid product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page
APA
pharmaranks. (2026, July 24). Obeticholic Acid: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/obeticholic-acid
MLA
“Obeticholic Acid: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/obeticholic-acid.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for obeticholic acid on DailyMed (NIH) ↗.