obeticholic acid at a glance
Medicine class
Farnesoid X receptor agonist used in bile and liver therapy
Usual role
Specialist treatment for adults with primary biliary cholangitis when ursodeoxycholic acid is insufficient or unsuitable
Food
The tablet may be taken with or without food
Important monitoring
Liver status and treatment response require clinical assessment and blood tests
What is obeticholic acid used for?
The selected UK product information licenses obeticholic acid for adults with primary biliary cholangitis.
Used with ursodeoxycholic acid when the response to ursodeoxycholic acid is inadequate.
Used alone when ursodeoxycholic acid cannot be tolerated.
How does obeticholic acid work?
Obeticholic acid activates FXR, a receptor in the liver and intestine that regulates bile acids. This reduces new bile-acid production, promotes movement of bile acids out of liver cells and influences inflammatory and fibrotic pathways, reducing liver exposure to bile acids.
obeticholic acid preparations and strengths
Tablet
Route: Oral
Strengths: 5 mg, 10 mg
How to take obeticholic acid
Swallow the film-coated tablet by mouth as prescribed. It can be taken with or without food.
Take it consistently according to the prescriber's instructions.
Separate it from bile-acid-binding medicines such as cholestyramine, colestipol or colesevelam by at least 4 to 6 hours, allowing as much separation as possible.
Do not stop treatment without discussing it with the specialist team.
obeticholic acid side effects
Common or expected effects
- Itching, which can be severe
- Tiredness
- Abdominal pain or discomfort
- Constipation
- Dizziness
- Palpitations
- Rash or eczema
- Joint pain
- Swelling of the hands or feet
- Fever
Get urgent medical advice
- Yellow skin or eyes, rising bilirubin or other signs of worsening liver function
- New abdominal swelling, confusion or bleeding that could indicate liver decompensation
- Persistent or widespread itching that is difficult to tolerate and needs prompt clinical review
obeticholic acid in pregnancy
Human pregnancy data are unavailable. UK product information advises avoiding obeticholic acid during pregnancy as a precaution; anyone pregnant or planning pregnancy should discuss treatment with their specialist prescriber.
obeticholic acid while breastfeeding
It is unknown whether obeticholic acid enters human milk. A specialist should weigh the benefits of breastfeeding against the benefits and potential risks of continuing treatment.
obeticholic acid interactions
Tell the prescriber and pharmacist about all medicines being taken, particularly the following.
Cholestyramine, colestipol or colesevelam
These bind bile acids and may reduce obeticholic acid's effect, so administration should be separated by at least 4 to 6 hours.
Warfarin
Obeticholic acid can reduce INR, so anticoagulation monitoring and warfarin adjustment may be required.
Narrow-therapeutic-index CYP1A2 substrates, including theophylline and tizanidine
Exposure may increase, so therapeutic or clinical monitoring is recommended.
Common questions about obeticholic acid
Answers are fully visible for fast scanning and source review.
Why is obeticholic acid prescribed with ursodeoxycholic acid?
It may be added when ursodeoxycholic acid alone has not produced an adequate response in an adult with primary biliary cholangitis.
Can obeticholic acid be used without ursodeoxycholic acid?
Yes. Its licensed role includes use alone in adults who cannot tolerate ursodeoxycholic acid.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.