Obeticholic acid
Pronunciation: oh-BET-i-KOL-ik AS-id.
- Generic name
- obeticholic acid
- Brand names
- OCALIVA
- Drug class
- Farnesoid X receptor agonist; bile-acid derivative
- Form
- Tablet in countries where an authorised product remains available
- Route
- Oral
- Legal status
- Regulatory status differs by country; withdrawn in the United States, revoked in the European Union, and actively registered in Australia as of 22 July 2026
Supply Rules Vary
Trade names by country: United States · Canada · Australia
Australia: OCALIVA (4) · Full directory
What obeticholic acid is and how it works
Obeticholic acid is a farnesoid X receptor agonist that was developed for primary biliary cholangitis (PBC). It was formerly authorised in the United States and European Union under the brand Ocaliva, but those authorisations are no longer current. Australia retains an active registered product at the audit date. (1) (3) (5) (4)
Regulators reached different current outcomes, so this page cannot give a global statement that the medicine is approved, available, beneficial, or suitable. Existing patients require individual hepatology review of liver status, local authorisation, access, benefit, risks, and alternatives.
Mechanism of action: how obeticholic acid works
Obeticholic acid is a farnesoid X receptor agonist. Mechanism alone does not establish clinical benefit or current authorisation. (2) (3)
What obeticholic acid is used for
Former United States indication
Ocaliva formerly had accelerated approval for PBC with ursodeoxycholic acid in adults with an inadequate response, or alone in adults unable to tolerate ursodeoxycholic acid. That indication was withdrawn on 24 November 2025 and must not be presented as current US use. (1)
European Union status
The EU conditional marketing authorisation was revoked after confirmatory evidence failed to establish clinical benefit and regulators concluded that benefits no longer outweighed risks. New patients should not be started outside a clinical trial; exceptional existing-patient access may depend on national named-patient or compassionate-use arrangements. (3)
Australian registered indication
Australian regulator records support use for PBC with ursodeoxycholic acid in adults with inadequate response or alone in adults unable to tolerate ursodeoxycholic acid. This is Australian status only and still requires the current Product Information and specialist assessment. (5) (4)
Before taking obeticholic acid
Do not take / not appropriate for
- Do not start or obtain obeticholic acid in a country where it is withdrawn, revoked, unapproved, or unavailable through a lawful specialist pathway. (country-specific) (1) (3)
- Do not use historical US or EU dosing information as current treatment guidance. (all public users) (1) (3)
Tell your clinician about
- Your country and how the medicine was supplied.
- Cirrhosis, portal hypertension, liver decompensation, ascites, variceal bleeding, encephalopathy, jaundice, or a liver transplant assessment.
- New or worsening itching, dark urine, pale stools, swelling, confusion, bleeding, infection, or abdominal distension.
- Every medicine, bile-acid binder, supplement, alcohol use, pregnancy, or breastfeeding.
- Any interruption, dose change, access problem, or advice received after a regulatory withdrawal or revocation.
How to take obeticholic acid
- This page does not provide a dose or schedule because current authorisation differs by country and historical labels are unsafe substitutes for current local Product Information.
- Existing patients should contact their hepatology team promptly and continue only according to that team's current lawful plan.
- Do not restart after an interruption, alter a dose for itching, or combine it with bile-acid medicines without specialist instructions.
- Do not purchase Ocaliva online or import it based on information from another country.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5)
Missed dose
Do not use an old leaflet or online schedule. Contact the hepatology or dispensing team for country- and product-current instructions, particularly after any treatment interruption or regulatory access change.
Overdose
Seek urgent poison-information and medical advice for a possible overdose. Because serious liver injury is a central risk, provide the product, amount, timing, liver history, and current symptoms. Do not wait for jaundice or confusion. (2)
Side effects
Historical and current-country product information identifies important liver and pruritus risks. The current local label and hepatology team must control individual counselling.
Pruritus (itching)
What to notice: New, worsening, persistent, or sleep-disrupting itching or skin injury from scratching.
What to do: Contact the hepatology team. Do not alter or skip doses using a historical regimen. (2)
Possible worsening liver function
What to notice: New fatigue, nausea, poor appetite, dark urine, pale stools, worsening itch, jaundice, swelling, or abdominal enlargement.
What to do: Obtain urgent hepatology assessment; emergency care is needed for confusion, bleeding, collapse, or severe illness. (2)
Serious warnings
Serious liver injury or hepatic decompensation — emergency
Symptoms: Jaundice, confusion or drowsiness, vomiting blood, black stools, marked abdominal swelling, severe weakness, collapse, or rapidly worsening illness.
Action: Seek emergency medical care and tell the team about obeticholic acid and the underlying liver disease. (2)
Use after withdrawal or revocation — urgent_regulatory
Symptoms: A new prescription, online offer, cross-border supply, or old stock in the United States or European Union after the applicable authorisation ended.
Action: Do not start or purchase it. Contact the national regulator, pharmacist, and hepatology team to verify lawful status and alternatives. (1) (3)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Bile-acid binding resins and other PBC treatment | Timing and co-treatment can affect exposure or treatment planning, but historical label instructions must not be generalised after withdrawal or revocation. | The hepatology pharmacist must review the exact current local product information and complete medicine list. (4) |
| Medicines affected by liver function or with narrow therapeutic ranges | Progressive liver disease and product-specific interactions can alter safety and monitoring needs. | Obtain specialist medication reconciliation and liver-function review; do not use an automated interaction result as clearance. (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Cirrhosis or portal hypertension
This is a high-risk context for serious liver harm. Historical warnings and current local labeling require specialist staging and may prohibit treatment. A general page cannot determine eligibility. (2)
Pregnancy and breastfeeding
Current country-specific evidence and treatment necessity require hepatology and obstetric review. Do not rely on a withdrawn or revoked label. (4)
Existing patients in withdrawn or revoked markets
Contact the treating specialist promptly to discuss status, benefit, risk, monitoring, lawful access if exceptional pathways exist, and alternatives. Do not stop abruptly without clinical advice unless emergency care directs you. (3) (1)
Monitoring
Before starting
- Do not initiate from this page. Verify current national authorisation and lawful supply.
- Confirm PBC diagnosis, prior ursodeoxycholic-acid response or intolerance, cirrhosis stage, portal-hypertension or decompensation history, liver tests, symptoms, interactions, and alternatives using current local guidance.
During treatment
- Use the current local Product Information and hepatology plan for liver biochemistry, symptoms, decompensation signs, pruritus, lipids, adherence, and ongoing benefit-risk review.
- Recheck regulatory status and access when treatment crosses borders or a regulator issues a new decision.
Storage
Do not retain, share, import, or use old or cross-border stock without pharmacist and specialist verification of the exact product, expiry, storage history, and current lawful status.
Professional regulatory and clinical context
Do not prescribe from this summary. Verify the live national register, current Product Information, hepatology guideline, patient access pathway, and local withdrawal/revocation communications.
United States and European Union
Indication: PBC
Dose summary: No current authorised regimen is displayed because the US indication was withdrawn and the EU marketing authorisation revoked.
Renal context: Not applicable as prescribing guidance; manage existing-patient transition through current national and specialist pathways. (1) (3)
Australia
Indication: Country-defined PBC indication
Dose summary: Active registration is verified, but dosing is intentionally omitted until the current Australian Product Information is independently extracted, versioned, and clinically reviewed.
Renal context: Use current Australian Product Information and individual hepatic status; no web-derived adjustment. (4) (5)
Hepatic guidance
Advanced liver disease, portal hypertension, decompensation, and changing liver status are central safety determinants requiring specialist management.
Overdose note
Provide urgent toxicology and hepatology assessment with liver-focused monitoring and supportive care. (2) (3)
Frequently asked questions
Is Ocaliva still approved?
It depends on the country. The US indication was withdrawn in November 2025 and the EU authorisation was revoked. Australia still showed active registration on 22 July 2026. Always verify the current national register. (1) (3) (4)
Should I stop Ocaliva if I currently take it?
Contact your hepatology team promptly. Do not stop or change it solely from a web page unless an emergency clinician directs you; your local status, liver condition, benefit, risk, access pathway, and alternatives must be reviewed. (3)
Can I buy Ocaliva from another country?
Do not use online or cross-border supply. Authorisation, legal import, product authenticity, monitoring, and safety differ, and the medicine is withdrawn or revoked in major markets. (1) (3)
What is the mechanism of action of obeticholic acid?
Obeticholic acid is a farnesoid X receptor agonist. Mechanism alone does not establish clinical benefit or current authorisation. (2) (3)
References
- Withdrawn non-malignant accelerated approvals — OcalivaU.S. Food and Drug Administration · United States · dated 2025-11-24 · accessed 2026-07-22 · source 1
- FDA drug safety communications — Ocaliva serious liver injuryU.S. Food and Drug Administration · United States · dated 2024-12-12 · accessed 2026-07-22 · source 2
- Ocaliva Article 20 referral — revocation of conditional marketing authorisationEuropean Medicines Agency · European Union · dated 2025-01-07 · accessed 2026-07-22 · source 3
- OCALIVA obeticholic acid 10 mg tablet bottle — ARTG 293378Therapeutic Goods Administration · Australia · accessed 2026-07-22 · source 4
- OCALIVA prescription medicine registrationTherapeutic Goods Administration · Australia · dated 2018-07-18 · accessed 2026-07-22 · source 5
Brand names by country
Single-ingredient obeticholic acid names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Ocaliva (1)indication withdrawn 2025-11-24 · Not represented as currently authorised
Canada
- OCALIVA
Australia
- OCALIVA (4)active register product · 10 mg · Amdipharm Mercury Australia Pty Ltd
View brands in additional countries.
European Union
Ocaliva (3)