Accutane (isotretinoin) is a popular drug for severe acne. The active ingredient of Accutane is isotretinoin. It works by reducing skin oil production, changing the characteristics of the skin oil, and preventing abnormal hardening of the skin. It also has some effect on the growth of the bacteria that cause acne.

Accutane is available only from a certified pharmacy under a special program called iPLEDGE. It is dangerous to try and purchase Accutane on the Internet or from vendors outside of the United States. Be sure to talk with your doctor about all the risks and benefits of Accutane (isotretinoin).

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

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 Accutane (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 anger, changes in behavior, thinking about harming or killing yourself;
  • hearing things that are not there;
  • seizures (convulsions);
  • joint pain, back pain;
  • muscle weakness;
  • tired feeling, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
  • loss of interest in sex, impotence, or difficulty having an orgasm;
  • dry eyes, blurred vision, seeing flashes of light or "floaters" in your vision;
  • increased sensitivity of your skin to the sun, wind, or cold, or you may sunburn more easily;
  • nosebleeds, changes in your voice, sore throat, cough;
  • increased sweating, thinning skin, skin sores, or
  • easy bruising or bleeding, unusual weakness.

Less serious side effects may include:

  • joint pain, back pain;
  • stomach pain, diarrhea;
  • dry skin, cracked lips, dry eyes, itching;
  • changes in your fingernails or toenails;
  • increased sensitivity of your skin to the sun, wind, or cold, or you may sunburn more easily;
  • nosebleeds;
  • thinned skin, easy bruising or bleeding;
  • red, swollen, blistered, or peeling skin;
  • muscle aches;
  • headache, dizziness, tired feeling; or
  • increased sweating.

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 Accutane (isotretinoin)?

Accutane (isotretinoin) can cause serious side effects. Some of these may go away with time, but some may be permanent.

Before starting Accutane (isotretinoin), tell your doctor if you are also taking:

  • tetracycline antibiotics such as doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap);
  • vitamin A-type drugs such as Accutane (isotretinoin), etretinate (Tegison), or acitretin (Soriatane);
  • seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), phenobarbital (Luminal), or phenytoin (Dilantin); or
  • steroid medicine such as prednisone (Deltasone, Sterapred) or methylprednisolone (Medrol).

If you are using any of these drugs, you may not be able to use Accutane (isotretinoin), or you may need dosage adjustments or special tests during treatment.

There are many other drugs that can interact with Accutane (isotretinoin). Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Keep all appointments with your doctor and the laboratory. Accutane (isotretinoin) can cause birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Do not take vitamin supplements containing vitamin A while you are taking Accutane (isotretinoin). Do not use wax hair removers or have dermabrasion or laser skin treatments while you are taking Accutane (isotretinoin) and for at least 6 months after you stop taking it. Accutane (isotretinoin) can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun. Do not use Accutane (isotretinoin) if you are pregnant. Women of childbearing potential must agree in writing to use 2 effective forms of birth control at least 1 month before, during, and for 1 month after isotretinoin therapy. Effective forms of birth control include both primary and secondary forms of contraception:
  • hormonal birth control

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