The iPLEDGE REMS is a safety program to manage the risk of isotretinoin’s teratogenicity and to minimize fetal exposure. The REMS is required by the U.S. Food and Drug Administration (FDA) to ensure the benefits of isotretinoin outweigh its risks. Isotretinoin, also known as 13-cis-retinoic acid and sold under the brand name Accutane among others, is a medication used to treat skin diseases like harlequin-type ichthyosis, lamellar ichthyosis, and severe cystic acne or moderate acne that is unresponsive to antibiotics. [5] Isotretinoin is used to treat severe, disfiguring nodular acne. It should be used only after other acne medicines or antibiotics have been tried and have failed to help the acne. Isotretinoin may also be used to treat other skin diseases as determined by your doctor. Isotretinoin is a prescription medication that can treat deep, painful acne cysts and nodules. Treatment usually takes about six months but may be longer or shorter. The U.S. Food and Drug Administration (FDA) has approved isotretinoin to treat patients 12 years of age and older. Isotretinoin is used to treat severe or nodular acne, especially when other treatments like oral antibiotics and topical medications have failed. While Accutane was once a popular brand name for isotretinoin, it’s no longer sold. People may still use the term “Accutane” to refer to isotretinoin. Overview: Isotretinoin is used to treat acne. It reduces oil on your skin and changes how your skin cells grow and shed so they do not clog pores or form acne. Common side effects may include. What It Is: Isotretinoin, often known by its brand name Accutane ®, is an oral medication approved for severe, scarring acne that is normally prescribed for 15-20 weeks. What is Accutane? Accutane is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly. Accutane is used to treat severe nodular acne that has not responded to other treatments, including antibiotics. Accutane is a medicine that is used to treat a severe type of acne called nodular acne, this is when you have acne with red, swollen and tender lumps in the skin. It should only be used if your acne has not improved using other acne treatments including antibiotics. Accutane® (Isotretinoin) is a type of retinoid medication that treats severe acne. A healthcare provider may prescribe this medication if other acne medications don’t work.