Roaccutane (R)

Isotretinoin is a derivative of vitamin A:

• is used in the treatment of acne, reducing sebum production and surface propionibacterium acnes
• use of oral retinoids is contra-indicated in pregnancy due to a high risk of serious congenital malformations
  • isotretinoin has the potential to cause severe fetal harm, including major congenital malformations, spontaneous abortions, and premature births
    • suggested that even brief exposure during pregnancy can result in life-threatening congenital disabilities (1)
• neuropsychiatric reactions have been reported in patients taking oral retinoids
• may cause sexual side-effects, including erectile dysfunction and decreased libido
• achieves its highest plasma concentration around 6.4 hours after food intake, whereas the peak occurs about 2.9 hours after an empty stomach (1)
  • food may enhance the absorption of isotretinoin - however, this variation is not considered clinically crucial, so that isotretinoin can be taken with or without meals

NICE state (2):

• oral isotretinoin should be considered for people older than 12 years who have a severe form of acne that is resistant to adequate courses of standard therapy with systemic antibiotics and topical therapy (see table below). For example:
  • nodulo-cystic acne
  • acne conglobata
    • a severe form of nodulo-cystic acne with interconnecting sinuses and abscesses
  • acne fulminans
    • a very serious form of acne conglobata associated with systemic symptoms
  • acne at risk of permanent scarring
• if a person with acne is likely to benefit from oral isotretinoin treatment:
  • follow the MHRA guidance on new safety measures for isotretinoin. This includes:
    • guidance on roles and responsibilities of referrers (usually the primary care clinician) and prescribers initiating, continuing and monitoring isotretinoin treatment
    • requirements for counselling people about potential mental health and sexual function side effects
    • requirements for assessing and monitoring mental health and sexual function
    • use of compulsory regulatory documents to minimise risk
• when considering oral isotretinoin for acne take into account the person's psychological wellbeing, and refer them to mental health services before starting treatment if appropriate
• if a person for whom oral isotretinoin treatment is being considered has the potential to become pregnant:
  • explain that isotretinoin can cause serious harm to a developing baby if taken during pregnancy and
  • inform them that they will need to follow the MHRA pregnancy prevention programme as detailed on the isotretinoin acknowledgement of risk form
• prescribe oral isotretinoin for acne treatment at a standard daily dose of 0.5 to 1 mg/kg.
  • consider a reduced daily dose of isotretinoin (less than 0.5 mg/kg) for people at increased risk of, or experiencing, adverse effects
• when giving isotretinoin as a course of treatment for acne:
  • continue until a total cumulative dose of 120 to 150 mg/kg is reached, but
  • if there has been an adequate response and no new acne lesions for 4 to 8 weeks, consider discontinuing treatment sooner
• if a person is taking oral isotretinoin for acne:
  • review their psychological wellbeing during treatment, and monitor them regularly for symptoms or signs of developing or worsening mental health problems or sexual dysfunction
  • tell them to seek medical advice if they feel their mental health or sexual function is affected or is worsening, and to stop their treatment and seek urgent medical advice if these problems are severe

Use of oral corticosteroids in addition to oral isotretinoin (1)

• if an acne flare (acute significant worsening of acne) occurs after starting oral isotretinoin, consider adding a course of oral prednisolone
• when a person with acne fulminans is started on oral isotretinoin, consider adding a course of oral prednisolone to prevent an acne flare

Isotretinoin is contraindicated in (3):

• hypervitaminosis A
• hyperlipidaemia
• during pregnancy or lactation

Before commencement on isotretinoin therapy:

• baseline investigations are required (FBC, fasting lipid profile, liver function tests)

Adverse effects (1):

• cheilitis (dry lips) is the most common dose-dependent adverse effect
  • affects approximately 90% of patients taking isotretinoin
• other common adverse effects of isotretinoin include:
  • xerosis (dry skin)
  • xerostomia (dry mouth)
  • rhinitis sicca (dry nose)
  • photosensitivity
• hypertriglyceridaemia and increased erythrocyte sedimentation rate are very common adverse effects of isotretinoin therapy

Pregnancy prevention (3)

• effective contraception must be used
• in females of childbearing potential, exclude pregnancy a few days before treatment, every month during treatment (unless there are compelling reasons to indicate that there is no risk of pregnancy), and 1 month after stopping treatment
• females of childbearing age must practise effective contraception for at least 1 month before starting treatment, during treatment, and for at least 1 month after stopping treatment
  • should be advised to use at least 1 highly effective method of contraception (i.e. a user-independent form such as an intra-uterine device or implant) or 2 complementary user-dependent forms of contraception (e.g. oral contraceptives and barrier method)
• females should be advised to discontinue treatment and to seek prompt medical attention if they become pregnant during treatment or within 1 month of stopping treatment

Treatment choices for mild to moderate and moderate to severe acne vulgaris (2):

Notes:

• patients should avoid all skin resurfacing procedures, such as waxing, dermabrasion, and laser therapy, during treatment and for at least 6 months after treatment to prevent skin irritation and scarring (1)

References:

1. Pile HD, Patel P. Isotretinoin. [Updated 2025 Dec 13]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-.
2. NICE (May 2026). Acne vulgaris: management
3. British National Formulary. Isotretinoin (Accessed May 6th 2026)