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ACCUTANE (ISOTRETINOIN) CAPSULES: MEDICATION GUIDE - MOST IMPORTANT INFORMATION

What is the most important information I should know about Accutane?

  • This medication is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.
  • Because Accutane (Isotretinoin) can cause birth defects, Accutane is only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE program.
  • This drug may cause serious mental health problems.

    1. Birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Female patients who are pregnant or who plan to become pregnant must not take Accutane. Female patients must not get pregnant:

  • for 1 month before starting Isotretinoin (Accutane)
  • while taking this medicine
  • for 1 month after stopping Accutane.

    If you get pregnant while taking Accutane (Isotretinoin) capsules, stop taking it right away and call your doctor. Doctors and patients should report all cases of pregnancy to U.S. FDA or iPLEDGE pregnancy registry.

    2. Serious mental health problems. Accutane may cause:

  • depression
  • psychosis (seeing or hearing things that are not real)
  • suicide. Some patients taking Isotretinoin (Accutane) capsules 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.

    Stop Accutane and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis:

  • start to feel sad or have crying spells
  • sleep too much or have trouble sleeping
  • lose interest in activities you once enjoyed
  • become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
  • have trouble concentrating
  • have a change in your appetite or body weight
  • withdraw from your friends or family
  • have feelings of worthlessness or guilt
  • feel like you have no energy
  • start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
  • start seeing or hearing things that are not real
  • start acting on dangerous impulses

    After stopping Accutane (Isotretinoin) pills, you may also need follow-up mental health care if you had any of these symptoms.

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