Accutane contains the active ingredient isotretinoin, which is a retinoid. It is formulated as soft gelatin capsules available in 10 mg, 20 mg, 30 mg, and 40 mg for oral administration. Key inactive ingredients include butylated hydroxyanisole and edetate disodium. Isotretinoin is intended for use as a medication related to vitamin A, though its specific purpose is not stated.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Do not cut, crush, or chew this medication. Swallow the capsules whole. Keep taking it unless your care team tells you to stop. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Change in vision such as blurry vision, seeing halos around lights, vision loss -Hearing loss, ringing in ears -Increased pressure around the brain—severe headache, blurry vision, change in vision, nausea, vomiting -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue -Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression -Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting -Redness, blistering, peeling, or loosening of the skin, including inside the mouth -Stomach pain, rectal bleeding, severe diarrhea Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Dryness or irritation of the eyes, lips, mouth, or nose -Joint pain -Muscle pain -Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Diabetes -Eating disorders, such as anorexia -Heart disease -High cholesterol -Inflammatory bowel disease -Liver disease -Lung or breathing disease, such as asthma -Mental health conditions -Osteoporosis, weak bones -Suicidal thoughts, plans, or attempt -An unusual or allergic reaction to isotretinoin, aspirin, tartrazine, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

-Certain antibiotics, such as doxycycline or tetracycline -Certain medications for seizures, such as phenytoin -St. John's wort -Steroid medications, such as prednisone or cortisone -Vitamin A

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication. Your acne may flare when you start taking this medication. This should only last for a short period of time. Talk to your care team if this is a concern for you. You may need blood work done while you are taking this medication. This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths. Do not have cosmetic procedures such as waxing, dermabrasion, or laser therapy while taking this medication and for at least 6 months the last dose. It can increase the risk of scarring from these procedures. Tell your care team right away if you have any change in your eyesight. Avoid driving at night until you know how it has affected your vision. This medication may cause dry eyes. If you wear contact lenses, you may feel some discomfort. Lubricating eye drops may help. See your care team if the problem does not go away or is severe. This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication. This medication can increase bad cholesterol and fats (such as LDL, triglycerides) and decrease good cholesterol (HDL) in your blood. You may need blood tests to check your cholesterol. Ask your care team what you can do to lower your risk of high cholesterol while taking this medication. Your care team may tell you to stop taking this medication if you develop muscle problems. If your muscle problems do not go away after stopping this medication, contact your care team. Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 1 month after the last dose. You will need 2 negative pregnancy tests before starting this medication. Two forms of contraception are recommended for 1 month before starting this medication, while taking this medication, and for 1 month after the last dose. Your care team can help you find the option that works for you. Do not breastfeed while taking this medication and for 1 month after the last dose. Do not donate blood while taking this medication and for 1 month after the last dose. Donated blood may contain enough of this medication to cause fetal birth defects if transfused to someone who is pregnant.

What are the most serious risks of this medication?

This medication may cause serious birth defects if taken during pregnancy. Do not take this medication if you are pregnant.