Isotretinoin capsules (Roaccutane)

  1. About isotretinoin capsules

    Isotretinoin capsules are a very effective treatment for severe acne (spots).

    This medicine can have serious side effects, however, so it must be prescribed and supervised by a doctor.

  2. Key facts

    • Isotretinoin capsules start to work after a week to 10 days.
    • Isotretinoin capsules work very well - 4 out of 5 people who use them have clear skin after 4 months.
    • Your skin may become very dry and sensitive to sunlight during treatment. Using lip balm and moisturisers will help.
    • If you're a woman, it's very important not to become pregnant while using isotretinoin capsules and for at least 1 month after stopping. This is because isotretinoin can harm an unborn baby.
    • Isotretinoin capsules are also called by the brand names Roaccutane and Rizuderm.
  3. Who can and can't take isotretinoin capsules

    Isotretinoin capsules are for teenagers and adults with severe acne.

    Don't give isotretinoin capsules to children under the age of 12 years or before puberty.

    Isotretinoin capsules aren't suitable for some people.

    Don't take isotretinoin capsules if you:

    • have had an allergic reaction to isotretinoin, soya (the capsules contain soya) or any other medicines in the past
    • have an inherited digestive disorder called fructose intolerance (the capsules contain sorbitol)

    To make sure isotretinoin capsules are safe for you, tell your doctor if you:

    • have had a mental health illness like depression
    • are pregnant or think you could be, or you're breastfeeding
    • have ever had an allergic reaction to isotretinoin or any other medicine
    • have liver or kidney disease
    • have high levels of cholesterol or other fats in your blood
    • have high levels of vitamin A
    • have Crohn's disease or ulcerative colitis

    If you have diabetes, talk to your doctor before beginning treatment with isotretinoin capsules. You may need extra monitoring while you take isotretinoin capsules as this medicine can cause a rise in blood sugar levels.

  4. Side effects

    Like all medicines, isotretinoin capsules can cause side effects, although not everyone gets them. Side effects will usually go away when you stop treatment.

    Dry skin and lips are very common side effects. For safety, don't have any waxing, dermabrasion, or laser skin treatment while you're taking this medicine and for at least 6 months after you stop, as this could cause scarring or skin irritation.

    Common side effects

    The common side effects of isotretinoin capsules happen in more than 1 in 10 people. Talk to your doctor or pharmacist if these side effects bother you or don’t go away:

    • skin becoming more sensitive to sunlight
    • dry eyes
    • dry throat
    • dry nose and nosebleeds
    • headaches and general aches and pains

    Serious side effects

    Serious side effects are rare and happen in less than 1 in 1,000 people.

    Stop taking isotretinoin capsules and tell a doctor straight away if you get:

    • anxiety, aggression and violence, changes in mood, or suicidal thoughts - these can be signs of depression or  other mental health problems
    • severe pain in your tummy with or without bloody diarrhoea, feeling sick, and vomiting - these can be signs of a serious problem called pancreatitis
    • a serious skin rash that peels or has blisters - the skin rash may come with eye infections, ulcers, a fever, and headaches
    • difficulty moving your arms or legs, and painful, swollen or bruised areas of the body, or dark pee - these can be signs of muscle weakness
    • yellow skin or eyes, difficulty peeing, or feeling very tired - these are signs of liver or kidney problems
    • a bad headache that doesn't go away and makes you feel sick or vomit
    • sudden changes in eyesight, including not seeing as well at night

    It's very rare, but isotretinoin capsules can sometimes cause depression or make it worse, and even make people feel suicidal.

    Tell your doctor straight away if you become depressed or think about ending your life while taking isotretinoin capsules.

    Serious allergic reaction

    In rare cases, it’s possible to have a serious allergic reaction to isotretinoin capsules.

    A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

    The warning signs of a serious allergic reaction are:

    • getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
    • wheezing
    • tightness in the chest or throat
    • having trouble breathing or talking
    • swelling of the mouth, face, lips, tongue, or throat

    These are not all the side effects of isotretinoin. For a full list see the leaflet inside your medicines packet.

    You can report any suspected side effect to the UK safety scheme.

  5. How to cope with side effects

    What to do about:

    • dry skin or lips - apply a moisturiser and lip balm often (the best type of moisturiser is an oil-free face moisturiser for sensitive skin). Try to keep your showers shorter than 2 minutes, using lukewarm water rather than hot.
    • skin becoming more sensitive to sunlight - stay out of bright sun and use a high factor, oil-free sun cream (SPF 15 or above) even on cloudy days. Don't use a sunlamp or sunbeds.
    • dry eyes - ask your pharmacist or optician to recommend some eye drops. If you wear contact lenses and these become uncomfortable, you might have to wear glasses instead while you're taking this medicine.
    • dry mouth or throat - try chewing sugar-free gum or sweets
    • dry nose and nosebleeds - try applying a thin layer of Vaseline to the inside edges of your nose
    • headaches and joint, muscle and back pain - ask your pharmacist to recommend a painkiller. Light exercise shouldn't be a problem, but try to avoid heavy exercise as it may make joint or muscle pain worse.
  6. How and when to take it

    It's important to take the capsules as instructed by your doctor.

    As a general rule, the starting dose is 0.5mg per kilogram body weight per day (0.5 mg/kg/day). So if you weigh 60kg, your dose will usually start at 30mg a day.

    Usually, you take isotretinoin capsules once or twice a day. Each capsule contains a dose of 10mg or 20mg of isotretinoin.

    The dose of isotretinoin capsules varies from person to person, and depends on your weight.

    Swallow the capsules whole with a drink of water. It's best to take them straight after a meal or snack to make sure they work properly.

    What if I forget to take it?

    If you take the capsules once a day and remember you've missed a dose on that day, take it as soon as you remember. If it's the next day when you remember, skip the missed dose and take the next capsule at the usual time.

    If you take the capsules twice a day and forget to take a dose, take it as soon as you remember, unless this is within 2 hours of your next dose. In this case, skip the missed dose and take the next capsule at the usual time.

    Never take a double dose. Never take an extra dose to make up for a missed one.

    If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

    What if I take too much?

    If you take too many isotretinoin capsules or someone else takes them by accident, call your pharmacist or doctor or go to your nearest accident and emergency (A&E) department straight away.

    If you need to go to hospital, take the isotretinoin packet or leaflet inside it plus any remaining medicine with you.

    Will the dose I take go up or down?

    After a few weeks, your doctor may change your dose of capsules. You may need a higher dose if your acne isn't getting better. You may need a lower dose if you have side effects that bother you.

  7. Advice for women

    • This medicine is likely to harm a baby. It also increases the risk of miscarriage.
    • If you become pregnant during treatment with isotretinoin capsules, stop taking the capsules and tell your doctor as soon as possible.
    • It's very important that you don't get pregnant while you're taking isotretinoin capsules. You'll be asked by your doctor to follow strict rules to prevent pregnancy during treatment and for 1 month afterwards.

    Before starting treatment with isotretinoin capsules, women who are able to become pregnant must agree to:

    • use at least 1, and ideally 2, reliable methods of contraception for 1 month before starting isotretinoin capsules, and for 1 month after treatment has stopped - the second contraceptive should be a barrier method of contraception (for example, a condom), but you shouldn't use barrier methods on their own
    • have a pregnancy test before, during, and 5 weeks after the end of treatment - some doctors may ask you to have monthly pregnancy tests

    Do not take isotretinoin capsules if you think you're pregnant, you know you're pregnant, or if you're breastfeeding.

    Men and isotretinoin capsules

    Men can safely take isotretinoin capsules if they and their partner are trying for a baby, or their partner is pregnant.

    Isotretinoin capsules don't seem to damage sperm. Only tiny amounts of isotretinoin get into semen, which is too little to harm the unborn baby of your partner.

  8. Cautions with other medicines

    Some medicines and isotretinoin capsules can interfere with each other, and make it more likely that you'll have side effects.

    Tell your doctor if you're taking these medicines before you start treatment with isotretinoin capsules:

    • supplements that contain vitamin A
    • tetracycline antibiotics such as doxycycline, oxytetracycline, minocycline, and lymecycline
    • other acne medicines (using both together may make skin irritation worse)

    Mixing isotretinoin capsules with herbal remedies or supplements

    There's very little information about taking herbal remedies and supplements while you use isotretinoin capsules.

    Tell your doctor or pharmacist if you're taking any other medicines, including herbal remedies, vitamins or supplements.

  9. Common questions

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