Brand Names: Accutane, Amnesteem, Claravis, Sotret

Generic Name: isotretinoin (oral) (Pronunciation: EYE so TRET i noyn)

• What is isotretinoin (Accutane)?
• What are the possible side effects of isotretinoin (Accutane)?
• What is the most important information I should know about isotretinoin (Accutane)?
• What should I discuss with my healthcare provider before taking isotretinoin (Accutane)?
• How should I take isotretinoin (Accutane)?
• What happens if I miss a dose (Accutane)?
• What happens if I overdose (Accutane)?
• What should I avoid while taking isotretinoin (Accutane)?
• What other drugs will affect isotretinoin (Accutane)?
• Where can I get more information?

What is isotretinoin (Accutane)?

Isotretinoin 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.

Isotretinoin is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.

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

Accutane 10 mg

oval, pink, imprinted with ACCUTANE 10 ROCHE

Accutane 20 mg

oval, maroon, imprinted with ACCUTANE 20 ROCHE

Accutane 40 mg

oval, yellow, imprinted with ACCUTANE 40 ROCHE

Amnesteem 10 mg

oval, brown, imprinted with I10

Amnesteem 20 mg

oval, white, imprinted with I20

Amnesteem 40 mg

oval, brown, imprinted with I40

Isotretinoin 10 mg-BAR

gray, imprinted with barr, 935

Isotretinoin 20 mg-BAR

brown, imprinted with barr, 935

Isotretinoin 40 mg-BAR

orange, imprinted with barr, 936

What are the possible side effects of isotretinoin (Accutane)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:

• depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
• sudden numbness or weakness, especially on one side of the body;
• blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting;
• hearing problems, hearing loss, or ringing in your ears;
• seizure (convulsions);
• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
• loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• severe diarrhea, rectal bleeding, black, bloody, or tarry stools;
• fever, chills, body aches, flu symptoms, purple spots under your skin, easy bruising or bleeding; or
• joint stiffness, bone pain or fracture.

Less serious side effects may include:

• joint pain, back pain;
• feeling dizzy, drowsy, or nervous;
• dryness of the lips, mouth, nose, or skin; or
• cracking or peeling skin, itching, rash, changes in your fingernails or toenails.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

Isotretinoin can cause severe, life-threatening birth defects. Never use isotretinoin 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 isotretinoin.

Isotretinoin is available only under a special program called iPLEDGE. It is dangerous to try and purchase isotretinoin on the Internet or from vendors outside of the United States.

Do not take vitamin supplements containing vitamin A while you are taking isotretinoin.

Do not donate blood while taking isotretinoin and for at least 30 days after you stop taking it.