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Tretinoin oral

Updated 2 Feb 2023 | Tretinoin


Capsules containing tretinoin

Drugs List

  • tretinoin 10mg capsules
  • Therapeutic Indications


    Leukaemia - acute promyelocytic


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.

    The association of tretinoin with chemotherapy increases the duration of survival and reduces the risk of relapse compared to chemotherapy alone.


    Total daily dose 45 mg/square metre body surface, divided into 2 equal doses. Approximately 8 capsules per adult dose.

    Treatment should be continued until complete remission is achieved, or for a maximum of 90 days.


    Total daily dose 45 mg/square metre body surface, divided into 2 equal doses. Approximately 8 capsules per adult dose.

    Treatment should be continued until complete remission is achieved, or for a maximum of 90 days.


    Paediatric patients can be treated with 45 mg/square metre body surface area unless severe toxicity is apparent.

    The dose should be reduced in children with intractable headache.

    Treatment should be continued until complete remission is achieved, or for a maximum of 90 days.

    Patients with Renal Impairment

    In patients with renal impairment the dose should be reduced to 25mg/square metre body surface area.

    Patients with Hepatic Impairment

    In patients with hepatic impairment the dose should be reduced to 25mg/square metre body surface area.

    Additional Dosage Information

    Full-dose anthracycline-based chemotherapy should be added to the tretinoin regimen as follows:

    Leucocyte count at the start of therapy is greater than 5 x 10 to the power of 9/litre chemotherapy should be started together with tretinoin on day 1.

    Leucocyte count at the start of therapy is less than 5 x 10 to the power of 9/litre but rapidly increases during tretinoin therapy, anthracycline chemotherapy should be immediately added to the tretinoin if:
    leucocyte count greater than 6 x 10 to the power of 9/litre by day 5,
    leucocyte count greater than 10 x 10 to the power of 9/litre by day 10 or
    leucocyte count greater than 15 x 10 to the power of 9/litre by day 28.

    All other patients should receive chemotherapy immediately after complete remission is attained.

    If chemotherapy is added to tretinoin because of hyperleukocytosis, it is not necessary to modify the dose of tretinoin.

    After completion of tretinoin therapy and the first chemotherapy course, consolidation anthracycline-based chemotherapy should be given, for example, a further 2 courses at 4 to 6 week intervals.

    In some patients the plasma levels of tretinoin may fall significantly in spite of continued administration.


    Hereditary fructose intolerance

    Precautions and Warnings

    Children under 18 years
    Females of childbearing potential
    Predisposition to thromboembolic disease
    Severe headache
    Hepatic impairment
    Renal impairment

    Advise ability to drive/operate machinery may be affected by side effects
    Contains soya or soya derivative
    Consult local policy on the safe use of oral anti-cancer drugs
    Treatment to be administered under the supervision of a specialist
    Exclude pregnancy prior to initiation of treatment
    Monitor blood lipids before and during treatment
    Ensure negative monthly pregnancy tests throughout treatment
    Initiate chemotherapy immediately if leucocyte count increases rapidly
    Monitor coagulation values
    Monitor haematological parameters periodically
    Monitor hepatic function
    Monitor patients at risk for signs & symptoms of thromboembolism
    Monitor serum calcium levels
    Children may experience increased frequency of certain side effects
    Consider interrupting treatment if pseudotumour cerebri occurs
    If retinoic-acid syndrome occurs initiate treatment with dexamethasone
    Risk of developing retinoic-acid syndrome
    Consider interrupting treatment if moderate retinoic-acid syndrome occurs
    Consider dose reduction in intractable headache in children
    Advise patient not to take vitamin A or beta carotene supplements
    Female: Contraception required during and for 1 month after treatment
    If oral contraception appropriate use combined oestrogen-progestogen

    There is a risk of thrombosis which may involve any organ system during the first month of treatment

    The incidence of retinoic acid syndrome is diminished when full dose chemotherapy is added to the treatment regimen based on the white blood cell count. ( see Additional dosage )

    If the patient presents any signs or symptoms of retinoic acid syndrome, treatment with dexamethasone (10 mg every 12 hours for up to a maximum of 3 days, or until resolution of the symptoms) should be given immediately.

    Treatment with tretinoin should only be initiated in women of child bearing potential if the following conditions are met:
    The patient should be informed of the hazards of pregnancy during treatment and for 1 month after treatment.
    The patient is willing to comply with the mandatory effective contraceptive measures i.e. to use adequate contraception during treatment and for 1 month after.
    Pregnancy tests must be performed at monthly intervals.

    Pregnancy and Lactation


    Tretinoin is contraindicated during pregnancy.

    Tretinoin is teratogenic. Tretinoin should only be used during pregnancy, or in women who might become pregnant during therapy, if the benefit outweighs the risk of foetal abnormalities, due to the severity of the patient's condition and the urgency of treatment.

    If pregnancy does occur during treatment, or 1 month after the discontinuation of treatment, there is a high risk of malformation of the foetus (especially if given during the first trimester) regardless of the given dose or duration of treatment.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Tretinoin is contraindicated in breastfeeding.

    The effect of concurrent therapies must also be considered.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Acute febrile dermatosis (Sweet's syndrome)
    Acute respiratory distress
    Bone pain
    Cerebrovascular accident
    Chest pain
    Decreased appetite
    Dry mouth
    Erythema nodosum
    Genital ulceration
    Hearing disturbances
    Hepatic failure
    Hypervitaminosis A
    Increase in creatinine
    Increase in plasma cholesterol
    Increase in plasma triglyceride concentration
    Increase in serum transaminases
    Multiorgan failure
    Myocardial infarction
    Nasal dryness
    Necrotising fasciitis
    Pericardial effusion
    Pleural effusion
    Pseudotumour cerebri syndrome (mainly in children)
    Pulmonary infiltrates
    Raised intracranial pressure
    Renal failure
    Renal infarct
    Respiratory failure
    Retinoic acid syndrome
    Visual disturbances
    Weight gain


    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: April 2014

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press [Accessed on 15 April 2014].

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

    Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications [Accessed on 15 April 2014].

    Summary of Product Characteristics: Vesanoid 10mg soft capsules. Intrapharm Laboratories Limited. Revised November 2013

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