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Chenodeoxycholic acid oral

Updated 2 Feb 2023 | Biliary composition and flow


Oral formulations of chenodeoxycholic acid.

Drugs List

  • chenodeoxycholic acid 250mg capsules
  • Therapeutic Indications


    Cerebrotendinous xanthomatosis

    Unlicensed Uses

    Inborn errors of bile acid synthesis
    Smith-Lemli-Opitz syndrome


    The lowest dose of chenodeoxycholic acid that effectively reduces the serum cholestanol and/or the urine bile alcohols to within the normal range should be chosen.


    Initial dose: 750mg daily in three divided doses. The dose may be increased in 250mg increments to a maximum of 1000mg daily.


    Treatment of cerebrotendinous xanthomatosis (CTX)
    Children aged 1 month to 18 years
    Initial dose: 5mg/kg daily in three divided doses. The dose may be increased to a maximum of 15mg/kg daily.

    Smith-Lemli-Opitz syndrome (unlicensed)
    7mg/kg daily.

    Inborn error of bile acid synthesis (unlicensed)
    Initial dose: 5mg/kg three times daily.
    Maintenance dose: 2.5mg/kg three times daily.


    Smith-Lemli-Opitz syndrome (unlicensed)
    7mg/kg daily.

    Inborn error of bile acid synthesis (unlicensed)
    Initial dose: 5mg/kg three times daily.
    Maintenance dose: 2.5mg/kg three times daily.


    For infants and children who are unable to swallow capsules, the capsules may be opened and the contents added to 50ml of sodium bicarbonate 8.4% (1mmol/ml) to form a suspension containing chenodeoxycholic acid 5mg/ml.


    Neonates under 1 month
    Non-functioning gallbladder
    Radio-opaque gallstones

    Precautions and Warnings

    Females of childbearing potential
    Hepatic impairment
    Renal impairment

    Long term prophylaxis may be required to prevent recurrence
    Treatment to be initiated and supervised by a specialist
    Administer 1 hour before or 4 hours after any bile acid sequestrant
    Perform liver function tests before commencing therapy and during therapy
    Monitor hepatic function in patients with hepatic impairment
    Monitor renal function in patients with renal impairment
    Monitor serum and/or urine bile acid levels prior & during dose adjustment
    Pregnancy confirmed: Advise patient to discontinue and consult doctor
    Maintain treatment at the lowest effective dose
    Avoid antacids within 2 hours of dose
    Female: Barrier or non-hormonal contraception required during treatment
    Female: Ensure adequate contraception during treatment

    During the initial and dose adjustment period, serum cholestanol and/or urine bile alcohols should be monitored every 3 months and then annually.

    Liver function should be monitored regularly as overdose of chenodeoxycholic acid may be indicated by elevation of liver enzymes.

    Additional monitoring may be required during growth spurts, concomitant disease and pregnancy.

    In case of persistent lack of therapeutic response to chenodeoxycholic acid monotherapy, other treatment options should be considered.

    Oral contraceptives reduce the effectiveness of chenodeoxycholic acid in CTX and are not recommended.

    Pregnancy and Lactation


    Chenodeoxycholic acid is contraindicated during pregnancy.

    The manufacturer recommends chenodeoxycholic acid is not used in pregnancy and in women of child bearing potential not using contraception.

    Animal studies have shown reproductive toxicity with chenodeoxycholic acid. At the time of writing there is limited human data available.


    Use chenodeoxycholic acid with caution during breastfeeding.

    The manufacturer advises that as a precautionary measure, it is preferable to either discontinue breastfeeding or to discontinue chenodeoxycholic acid therapy taking into account the benefits for the child and mother.

    It is unknown whether chenodeoxycholic acid is excreted in human milk.

    Side Effects

    Abnormal liver function tests


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: August 2019

    Reference Sources

    Summary of Product Characteristics: Chenodeoxycholic acid Leadiant 250 mg hard capsules. Leadiant GmbH. Revised September 2017.

    NICE Evidence Services Available at: Last accessed: 9 August 2019

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