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Isotretinoin ( eye-soe-TRET-ih-noyn ) (13-Cis-Retinoic Acid, Retinoic Acid, Accutane®) What is this medication used for? Isotretinoin is a natural substance related to vitamin A that affects the growth of cells and their development into different types of cells. It can be used to treat certain types of cancer.
• Severe skin rash with blisters and peeling, which can involve the mouth and other parts of the body • Fainting • Seizure • Stroke, which may cause paralysis or weakness Special instructions: • This medicine increases sensitivity to sunlight, so those taking this medication should use sunscreen and wear protective clothing when outdoors. • Use lotion for dry skin and lip moisturizer for dry lips. • Blood tests will be done to check the blood cell count and liver function. • This medicine is related to vitamin A. Taking extra vitamin A or eating foods that contain vitamin A may increase the side effects of this medicine. • To increase absorption, this medicine may be taken by mouth with milk or with high-fat foods like peanut butter or ice cream. Isotretinoin should not be removed from the capsules for more than 1 hour before taking the medicine. • Patients with an allergy to parabens (what the medicine is preserved with) should not take this medicine. • People who could become pregnant, or are already pregnant, should wear gloves when handling the capsules because this medicine can cause birth defects. In utero exposure may cause fetal harm. • Patients who are able to become pregnant or are of child-
What does it look like? • Capsule How is it given? • By mouth (oral or po) What are the common side effects? • Dry mouth or redness and pain around eyes and lips • Increased risk of sunburn • Hair loss (alopecia) • Itching (pruritis) • Muscle aches and weakness • Headache What are the less common side effects? • Mood changes such as change in personality, depression, sense of loss of contact with reality, or violent behavior • Thoughts of suicide • Changes in liver function tests • Low blood counts (white blood cells [neutropenia], red blood cells/hemoglobin [anemia], or platelets [thrombocytopenia]) • Fever and increased risk of infection (especially when white blood cell count is low) • Blurred vision or other visual disturbances with chance of blindness • Cloudiness of the eye • Hearing loss and/or ringing in the ears • Internal bleeding, which may cause black tarry stool or blood in vomit • Blood clots • Allergic reaction, which may cause rash, low blood pressure, wheezing, shortness of breath, or swelling of the face or throat • Inflammation of the liver, which may cause yellowing of the eyes and skin (jaundice) • Damage to the muscles • Nail changes
bearing age and taking isotretinoin must: • Use two forms of reliable birth control
• Sign patient information/informed consent form(s) • Take pregnancy tests before and during treatment and keep appointments. • Follow the iPLEDGE program, a U.S. Food and Drug Administration (FDA) designed to reduce the risk of fetal exposure to isotretinoin. The program requirements will be explained by healthcare providers.
Not all of the possible side effects of this medicine and precautions related to taking it are covered in this information sheet. For a complete list of side effects and precautions, ask your healthcare professional (doctor, nurse, pharmacist) for a manufacturer’s package insert or another reference.
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