Accutane is used to treat severe nodular acne. It is usually given after other acne medicines or antibiotics have been tried without successful treatment of symptoms.

Accutane may also be used for other purposes not listed in this medication guide.

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

Accutane can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy. Even one dose of Accutane can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use Accutane if you are pregnant.

Women of child-bearing potential must agree in writing to use two specific forms of birth control and have regular pregnancy tests before, during, and after taking Accutane. Unless you have had a total hysterectomy or have been in menopause for at least a year, you are considered to be of child-bearing potential.

Accutane is available only under a special program called iPLEDGE. You must be registered in the program and sign agreements to use birth control and undergo pregnancy testing as required by the program. Read all program brochures and agreements carefully.

It is dangerous to try and purchase Accutane on the Internet or from vendors outside of the United States. The sale and distribution of Accutane outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.

What should I discuss with my healthcare provider before taking Accutane?

Accutane is available only under a special program called iPLEDGE. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control as required by the program. Read all of the iPLEDGE program brochures and agreements carefully. Ask your doctor or call the drug maker if you have questions about the program or the written requirements.

It is dangerous to try and purchase Accutane on the Internet or from vendors outside of the United States. The sale and distribution of Accutane outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.

Do not use this medication if you are allergic to Accutane or to parabens, or if you are pregnant or may become pregnant.

Before taking Accutane, tell your doctor if you are allergic to any foods or drugs, or if you have:

- a personal or family history of depression or mental illness;

- heart diease, high cholesterol or triglycerides;

- osteoporosis or other bone disorders;

- diabetes;

- asthma;

- an eating disroder (anorexia nervosa);

- or liver disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Accutane.

Accutane can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy. Even one dose of Accutane can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use Accutane if you are pregnant.

For Women: Unless you have had your uterus and ovaries removed (total hysterectomy) or have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential.

Even women who have had their tubes tied are required to use birth control while taking Accutane.

You must have a negative pregnancy test 30 days before you start taking Accutane. A pregnancy test is also required before each prescription is refilled, right after you take your last dose of Accutane, and again 30 days later. All pregnancy testing is required by the iPLEDGE program.

You must agree in writing to use two specific forms of birth control beginning 30 days before you start taking Accutane and ending 30 days after you stop taking it. Both a primary and a secondary form of birth control must be used together.

Primary forms of birth control include:

- tubal ligation (tubes tied);

- vasectomy of the male sexual partner;

- an IUD (intrauterine device);

- estrogen-containing birth control pills (not mini-pills);

- and hormonal birth control patches, implants, injections, or vaginal ring.

Secondary forms of birth control include:

- a male latex condom plus spermicidal foam or gel;

- a diaphragm plus spermicidal foam or gel;

- a cervical cap plus spermicidal foam or gel; and

- a vaginal sponge containing spermicide.

Do not take St. John's wort, an herbal supplement, if you are using any type of hormonal birth control, including pills, patches, implants, injections, or a vaginal ring. Breakthrough bleeding may occur.

Stop using Accutane and call your doctor at once if you have unprotected sex, if you quit using birth control, if your period is late, or if you think you might be pregnant.

It is not known whether Accutane passes into breast milk. Do not take Accutane without first talking to your doctor if you are breast-feeding a baby.