Roaccutane® (Isotretinoin)

Isotretinoin — best known by the brand name Roaccutane® — is a highly effective treatment for severe acne, or acne at risk of permanent scarring, when other treatments have not worked. It is a powerful medicine with important safety considerations, so it is prescribed and monitored carefully. This guide explains the benefits, the possible side effects, and why it must never be taken in pregnancy.

What is isotretinoin and how does it work?

Isotretinoin is a retinoid — part of the same family as vitamin A. Brand names include Roaccutane®, Accutane® (USA) and Reticutan®. It works in two ways:

• It reduces the production of sebum, the oily substance made by the skin
• It reduces the production of keratin in the outer layer of skin, which can block pores

What is it used for?

Isotretinoin is licensed to treat severe acne in people over 12 years when other treatments have not worked, or where there is a risk of permanent scarring. Occasionally it may be recommended outside its licensed use — if so, your doctor will tell you and discuss whether you still want to take it.

Deciding whether isotretinoin is right for you

Read this guide carefully and ask any questions before deciding. To help your doctor decide with you, please tell them about:

• Treatments you have already tried
• How the acne affects you
• Any plans for pregnancy
• Other medical problems
• Any history of mental health problems

What should I expect?

Most people find isotretinoin helps their acne and, for many, it clears the skin. Your acne may get worse for a few days or weeks before it starts to improve. Most people find their skin stays better for several years after finishing treatment.

Dose and length of treatment

• Your starting dose is worked out from your weight, after discussing possible side effects
• The dose is reviewed at every follow-up appointment
• Treatment usually continues until your acne has been clear for a few weeks; some specialists treat to a fixed total amount (generally 120–150 mg/kg)
• A course is generally around 24 weeks (6 months), but may be longer if low doses are used

How to take it

• Usually taken once a day
• Take it with a main meal or a drink containing some fat (milk, butter, oil) — this helps it absorb
• Swallow the capsules whole; do not crush or split them
• Store in a cool (below 25°C), dark place, away from children
• If you have difficulty swallowing, ask your doctor about the best way to take it

Important things to know

• Must not be taken in pregnancy or if you are trying to get pregnant — it can cause serious harm to the baby (see the pregnancy section below)
• Capsules must never be shared with anyone else
• Do not donate blood during treatment or for at least 1 month after stopping, as the blood could be given to a pregnant person
• Isotretinoin and alcohol can both affect the liver — keep alcohol to a minimum and stay well within the HSE low-risk guidelines
• The capsules contain highly processed soya — tell your doctor if you are allergic to peanut or soya
• Avoid waxing, epilation, dermabrasion, tattoos and piercings during treatment and for up to 6 months afterwards, as they could cause scarring, irritation or skin colour changes
• Isotretinoin can reduce night vision. If your job needs you to see well at night (drivers, pilots, military, heavy machinery), discuss this with your employer before starting

Other medicines

Most medicines are safe to take with isotretinoin, but some are not. Avoid:

• Tetracycline antibiotics (including lymecycline and doxycycline)
• Vitamin A supplements, including multivitamins containing vitamin A
• Some acne creams, because of a higher risk of irritation

This is not a complete list. Always tell your doctor and pharmacist you are taking isotretinoin before starting any new prescription or over-the-counter medicine, and read the leaflet in the packet.

Side effects

Isotretinoin can cause serious side effects. These are rare, but you need to understand the risks to make an informed decision.

Common side effects

• Dry lips (sometimes chapped or split)
• Dry skin, which may be more delicate than usual
• Dry eyes
• Increased sensitivity to the sun, with more chance of sunburn
• Back pain and muscle or joint aches, especially after exercise
• Changes in blood tests (mildly raised liver enzymes, changes in blood fats) — monitored by your team and not usually serious in healthy people
• Headaches

These usually settle a few weeks after stopping isotretinoin.

What can I do to help?

• Use a non-greasy moisturiser designed for acne-prone skin, and a lip balm
• Avoid exfoliating or anti-acne products, which can irritate the skin
• Use lubricating eye drops for dry eyes; if contact lenses are uncomfortable, wear glasses instead
• Avoid too much sun: cover up, wear a hat and sunglasses, and use SPF 30+ sunscreen. Never use sun lamps or sun beds
• If you get muscle or joint pains, cut down on intensive exercise
• Paracetamol or ibuprofen may be taken for aches or headaches

Other possible side effects

Isotretinoin and mental health

Isotretinoin has been associated with mental health problems in some people, although current research does not give a clear answer as to whether it is the cause. People with acne are already more likely to experience anxiety and depression, and several studies show isotretinoin can improve mood changes caused by acne.

However, there are reports of worsening mood or behaviour changes — anxiety, low mood, depression, agitation, aggression, or loss of contact with reality (psychosis). Extremely rarely, isotretinoin may be associated with self-harm or suicide. We do not know how often these occur.

• If you have ever had low mood, suicidal thoughts or any other mental health issue, tell your doctor before starting
• If you, your friends or family notice changes in your feelings or behaviour during treatment, stop taking it and contact us
• If you have thoughts of harming yourself, stop taking isotretinoin and seek medical help immediately

Sexual function

There are rare reports of sexual function problems with isotretinoin — low libido, vaginal dryness, difficulty getting or keeping an erection, or reduced genital sensation. Rarely, men have reported breast tissue development. Some people report these problems continued after stopping. These problems can also relate to mental health or other medicines such as antidepressants. Discuss any concerns with your doctor before starting.

If you could become pregnant

This section applies to anyone with child-bearing potential — you have a uterus and at least one ovary — unless you have had surgical sterilisation or are post-menopausal, confirmed by a healthcare professional.

The Pregnancy Prevention Programme (PPP)

If you could become pregnant you will be enrolled in the PPP — a set of rules doctors, nurses and pharmacists must follow to protect unborn babies:

• You will be asked about contraception and monitored for pregnancy before, during, and for 1 month after treatment
• Contraception must be discussed before you start — with us, or a sexual health / contraception clinic
• You must have used suitable contraception (or not had sex with someone who could make you pregnant) for 4 weeks before starting, and have a negative pregnancy test
• If you have periods, treatment ideally starts on day 2 or 3 of your period

What counts as suitable contraception?

• One highly effective method (failure rate under 1%): the copper coil (IUD), hormonal coil (IUS) or contraceptive implant, in place for at least 4 weeks — or
• Two methods together: the contraceptive pill or injection plus a barrier method (condom, femidom or cap)

Hormonal pills and implants may not work properly if you start new medicines (including antibiotics or herbal remedies), have diarrhoea or vomiting, or miss pills. Check with your GP or pharmacist whenever you start a new medicine. We can fit coils and implants at our Mirena Clinic and Implanon Clinic.

Who does not need contraception?

Only if there is expected to be no chance of pregnancy during treatment and for 1 month after — because you are medically unable to get pregnant, are abstaining from sex for the whole period, or only have sex with a partner who cannot make you pregnant (for example a same-sex partner, or a partner with a vasectomy confirmed sperm-free by two tests). This must be agreed with your doctor before starting and reviewed at every visit.

Pregnancy tests and prescriptions

• Pregnancy tests are usually done every month during treatment
• Prescriptions are for 30 days and must be collected and dispensed within 7 days
• With highly effective contraception, tests may be less frequent and prescriptions longer — you may still choose to test monthly at home, as no contraception is 100% effective

Unprotected sex, a missed period, or possible pregnancy

• After unprotected sex during treatment or in the month after: you need emergency contraception (the emergency pill or an emergency IUD) — contact us, a pharmacy or a sexual health clinic urgently, and stop taking isotretinoin
• If you miss a period, think you may be pregnant or find you are pregnant: stop isotretinoin immediately, seek medical advice as soon as possible, and tell your dermatology team

Female-to-male transgender people who have not had a hysterectomy can still become pregnant and should also be enrolled in the PPP.

Monitoring at Salutem Clinic

• Blood tests before you start and during treatment, to check liver function and blood fats
• Regular reviews to check your progress, side effects and wellbeing, and to adjust your dose
• Pregnancy testing and contraception review at each visit where applicable

Where can I find out more?

This page does not cover every benefit and side effect. Discuss any concerns with your GP, dermatology team or pharmacist, and always read the leaflet that comes with your medicine.

• BAD Isotretinoin Patient Guide (PDF) — the full guide this page is based on
• Isotretinoin patient video — understanding the benefits and risks
• Oral isotretinoin guide for young people — recommended if you are under 18
• Isotretinoin and mental health leaflet
• BAD position statement on isotretinoin and soya allergy
• BAD acne information · Acne Support
• Roaccutane patient information leaflets: 10 mg · 20 mg

Source: British Association of Dermatologists, Patient Guide: Isotretinoin, produced October 2023 (next review October 2026). Individual circumstances differ and may change the advice your doctor gives you.

Key messages

• Isotretinoin is the most effective treatment for severe acne and often clears the skin for years
• Take it once daily with a main meal; a course is usually around 6 months
• Dry lips, dry skin and sun sensitivity are expected — use moisturiser, lip balm and SPF 30+
• It must not be taken in pregnancy; if you could become pregnant you will follow the Pregnancy Prevention Programme
• Tell us about any mood changes, and stop and seek help if you have thoughts of harming yourself
• No blood donation, waxing, tattoos, vitamin A supplements or tetracycline antibiotics during treatment

See also: Acne Clinic · Topical treatment · Oral treatment · Roaccutane · Fees