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Isotretinoin is a powerful and effective medicine derived from vitamin A (retinoid medicine). Doctors prescribe it to treat severe acne only after other treatments have failed. Isotretinoin can cause some rare but serious side effects. Just one dose of isotretinoin can cause severe birth defects if a woman is pregnant when taking this medicine.¹

Isotretinoin usually needs to be taken for 3 to 6 months.

How It Works

Isotretinoin works by unclogging skin pores and shrinking oil glands.

Why It Is Used

Doctors use isotretinoin to treat people who:

• Have severe acne that does not get better with other treatments.
• Develop scars (particularly deep scars) after their pimples or cystic lesions heal.

How Well It Works

Isotretinoin is very effective for controlling most types of acne and for clearing it up for long periods of time.²

Side Effects

Retinoid medicines may have side effects, such as:

• Miscarriage and serious birth defects. The most dangerous side effects of retinoid medicine are miscarriage and serious birth defects in babies whose mothers took the medicines during pregnancy. Women who can get pregnant need to use two forms of birth control so that they do not become pregnant while they are taking retinoid medicine. The risk of birth defects and miscarriage goes away about 1 month after the medicine is stopped.
• Changes in mood or thoughts. The Center for Drug Evaluation and Research division of the U.S. Food and Drug Administration (FDA) warns that isotretinoin may be linked with depression, psychosis, and, in rare cases, thoughts of suicide, suicide attempts, and suicide. The link between isotretinoin and these mood changes is not clear and is being watched very closely. Talk to your doctor for more information on whether isotretinoin is right for you or your child. If you or your child is taking isotretinoin and has signs of depression, see your doctor for treatment. Even if you stop taking isotretinoin, depression may not improve.
• Increase in triglycerides in the blood. A person who takes retinoid medicine may have higher-than-normal levels of certain fats (triglycerides) in his or her blood. High levels of triglycerides may make a person more likely to develop certain health problems, such as heart disease. For this reason, all people need to have their blood checked for triglyceride levels before starting this medicine and every 4 to 6 weeks while taking it.
• Liver damage. Some people who have certain liver conditions may develop liver damage if they take retinoid medicine. For this reason, all people need to have blood tests to check their liver function before starting this medicine and at regular checkups while they are taking it.
• Other side effects. Other common side effects of retinoid medicines can include chapped lips, dry skin, dry eyes, and dryness inside the nose and mouth. People also complain of fatigue, sensitivity to the sun, problems with night vision, and thinning of hair.

See Drug Reference for a full list of side effects. (Drug Reference is not available in all systems.)

What To Think About

Isotretinoin is strictly regulated for use in women by the U.S. Food and Drug Administration (FDA) because of the danger of miscarriage and of serious birth defects in babies whose mothers took the medicine during pregnancy. Doctors may only prescribe these medicines for a female who is not pregnant and who does not intend to become pregnant while taking the medicine. You must also use two methods of birth control and have pregnancy tests on a regular basis while using this medicine.

The FDA has announced that the companies that make isotretinoin have a program to register doctors who prescribe isotretinoin and the people who take it. The program is to ensure that women taking this drug understand the risk of birth defects, take precautions to avoid pregnancy, and know what to do if they become pregnant. If your doctor suggests that you take isotretinoin, you must be registered with iPLEDGE in order to get the drug. You can get more information and register at www.ipledgeprogram.com or by telephone at 1-866-495-0654 (toll-free).

Complete the new medication information form (PDF)(What is a PDF document?) to help you understand this medication.

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