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Adapalene topical


Topical formulations of adapalene

Drugs List

  • adapalene 0.1% cream
  • adapalene 0.1% gel
  • DIFFERIN 0.1% cream
  • DIFFERIN 0.1% gel
  • Therapeutic Indications


    Topical treatment of mild to moderate acne vulgaris

    Topical treatment of mild to moderate acne vulgaris of the face, chest and back, where comedones, papules and pustules predominate. Cream is best suited for use on dry and fair skin.

    Unlicensed Uses

    Infantile acne: treatment



    1 application sparingly to the affected area once daily before retiring and after washing.


    Children aged 12 to 18 years:
    1 application sparingly to the affected area once daily before retiring and after washing.

    Infantile acne (unlicensed use)

    Children aged 1 month to 1 year:
    1 application sparingly at night.


    Females attempting to conceive

    Precautions and Warnings

    Children under 12 years
    Females of childbearing potential

    Contains parabens
    Some formulations contain propylene glycol
    Avoid administration to eczematous or inflamed skin
    Avoid application to broken skin
    Avoid contact with eyes, lips or mouth
    Avoid contact with mucous membranes
    Breastfeeding: Do not treat the breast area if patient breastfeeding
    Do not use over large areas of the body
    Dry skin thoroughly before application
    Re-evaluate the patient every 3 months following treatment
    Pregnancy confirmed: Discontinue this medication
    Reduce application frequency/temporarily discontinue if irritation occurs
    Female: Ensure adequate contraception during treatment
    Advise patient to avoid exposure to sunlight and UV rays during treatment

    Pregnancy and Lactation


    Adapalene is contraindicated in pregnancy.

    The manufacturer notes that as there is little data available regarding the use of adapalene during pregnancy and absorption through unbroken skin is possible, this product should not be used during pregnancy.

    Animal studies have shown that high systemic exposure by the oral route can result in reproductive toxicity, but teratogenic effects have not been noted in two experimental animal species. Available data does not indicate harmful effects on human pregnancy or on the health of the foetus exposed during early pregnancy and it is unknown if adapalene crosses the human placenta, but the molecular weight (about 413) and low plasma concentrations suggest that minimal amounts of drug would be expected to cross the placenta (Briggs et al, 2015). In the case of topical exposure a risk-grounded termination of the pregnancy is not necessarily indicated, but individual consultation should take place and a detailed foetal ultrasound investigation must be offered (Schaeffer et al, 2015).

    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 ( ).


    Adapalene is considered safe for use in breastfeeding.

    Systemic availability of adapalene from topical application is negligible, therefore the amount found in breast milk should be very low and no effect on the suckling child is anticipated. However, adapalene should not be used on the chest while breastfeeding to avoid contact exposure to the infant.

    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


    Advise patients if using cosmetics, these should be non-comedogenic and non-astringent.

    Side Effects

    Contact dermatitis
    Dry skin
    Eye irritation
    Eyelid oedema
    Irritation (localised)
    Local burning
    Scaling of skin
    Skin exfoliation
    Skin pain
    Skin photosensitivity


    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: October 2016

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    Summary of Product Characteristics: Differin Cream. Galderma (UK) Ltd. Revised May 2018.

    Summary of Product Characteristics: Differin Gel. Galderma (UK) Ltd. Revised May 2018.

    NICE Evidence Services Available at: Last accessed: 16 January 2019

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Last revised: 07 September 2013
    Last accessed: 13 October 2016

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