ACCUTANE Resource

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  • Skin Care

    Accutane Medication Guide - Accutane Capsules (isotretinoin)


    Read this Medication Guide every time you get a prescription or a refill for Accutane (ACK-u-tane). There may be new information. This information does not take the place of talking with your prescriber (doctor or other health care provider).

    What is the most important information I should know about Accutane?
    Accutane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics. However, Accutane can cause serious side effects. Before starting Accutane, discuss with your prescriber how bad your acne is, the possible benefits of Accutane, and its possible side effects, to decide if Accutane is right for you. Your prescriber will ask you to read and sign a form or forms indicating you understand some of the serious risks of Accutane.

    Possible serious side effects of taking Accutane include birth defects and mental disorders.
    1. Birth defects. Accutane can cause birth defects (deformed babies) if taken by a pregnant woman. It can also cause miscarriage (losing the baby before birth), premature (early) birth, or death of the baby. Do not take Accutane if you are pregnant or plan to become pregnant while you are taking Accutane. Do not get pregnant for 1 month after you stop taking Accutane. Also, if you get pregnant while taking Accutane, stop taking it right away and call your prescriber. All females should read the section in this Medication Guide "What are the important warnings for females taking Accutane?"

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    2. Mental problems and suicide. Some patients, while taking Accutane or soon after stopping Accutane, have become depressed or developed other serious mental problems. Symptoms of these problems include sad, "anxious" or empty mood, irritability, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. Some patients taking Accutane have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives. There were reports that some of these people did not appear depressed. No one knows if Accutane caused these behaviors or if they would have happened even if the person did not take Accutane. - FDA/Center for Drug Evaluation and Research

    Continued - Females Taking ACCUTANE
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