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What is isotretinoin?
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. It is usually given after other acne medicines or antibiotics have been tried without successful treatment of symptoms. Isotretinoin may also be used for other purposes not listed in this medication guide.

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What are the possible side effects of 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 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:

• discomfort with contact lenses;

• 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. Tell your doctor about any unusual or bothersome side effect.

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How should I take isotretinoin?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Each prescription of isotretinoin must be filled within 7 days of the date it was prescribed by your doctor. You will receive no more than a 30-day supply of isotretinoin at one time. Always take isotretinoin with a full glass of water to prevent the capsule from melting in your esophagus (food pipe), causing irritation. Do not chew or suck on the capsule. Swallow it as quickly as possible.

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What is the most important information I should know about isotretinoin?
Isotretinoin can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. 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. 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.

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What happens if I miss a dose?
Skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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What other drugs will affect isotretinoin?
Before taking isotretinoin, tell your doctor if you are also taking: steroids (prednisone and others); seizure medication such phenytoin (Dilantin); or a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Minocin), or tetracycline (Brodspec, Sumycin, Tetracap). This list is not complete and there may be other drugs that can interact with isotretinoin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Isotretinoin has been assigned to pregnancy category X by the FDA. Isotretinoin is known to be teratogenic and its use is contraindicated during pregnancy or in anyone planning on becoming pregnant. When used during pregnancy, isotretinoin causes central nervous system, skull, external ear, eye, and cardiovascular abnormalities, as well as facial dysmorphia, thymus gland abnormalities, and parathyroid hormone deficiencies.

In an FDA Public Health Advisory, the FDA announced the approval of the Strengthened Risk Management Program for Isotretinoin to reduce the risk of exposure during pregnancy. The new program is called iPLEDGE. Beginning December 31, 2005, all prescribers and patients must be registered in iPLEDGE in order to prescribe or receive isotretinoin. This registration process ensures that prescribers and patients agree to assume specific responsibilities to ensure that patients do not become pregnant while taking isotretinoin and do not get prescribed the medicine if they are pregnant. For further details on iPLEDGE go to: http://www.fda.gov/cder/drug/infopage/accutane/default.htm. Isotretinoin was first marketed in the US in September of 1982. In July of 1983, the first reports of malformed infants were received by the manufacturer prompting a "Dear Doctor" letter reiterating the dangers of isotretinoin use in pregnancy. Despite further educational efforts by the manufacturer, unintentional exposures of pregnant women to isotretinoin continue to occur. Cardiovascular abnormalities observed include interrupted aortic arch, ventricular septal defect, atrial septal defect, transposition of the great vessels, and Tetralogy of Fallot. Ear abnormalities include low-set, micropinnae or absent ears. Central nervous system abnormalities include cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, and cranial nerve deficit. Craniofacial abnormalities frequently include occipital vaulting, and/or a sharply sloping, narrow forehead, wide-spaced eyes, small chin, and flat, depressed nasal bridge. Dai et al. 1992 reported 433 first-trimester exposures to isotretinoin of which pregnancy outcomes was known in 409 cases. Elective abortion was performed in 222 (54%) of these pregnancies and 29 (7%) ended in spontaneous abortions. Of 151 births, 72 (48%) were normal and 71 (47%) had congenital malformations. Malformations and spontaneous abortions occurred in women whose exposure to isotretinoin had been less than one week. Limb reduction defects have been reported in at least two infants, along with other multiple malformations characteristic to isotretinoin exposure. One infant with isotretinoin embryopathy, including thymic hypoplasia, demonstrated progressive attrition of T cells following her birth. She died after several bouts with pneumonia. It is suggested that isotretinoin may provide insult to the immune system as well as other teratogenic effects. Another infant with isotretinoin embryopathy and bilateral major ear deformities also demonstrated significant bilateral conductive hearing loss and left sided sensorineural loss. Peripheral and central vestibular dysfunction was also present.

There are no data on the excretion of isotretinoin into human milk. Because of the potential for adverse effects in nursing infants, breast-feeding is considered contraindicated by the manufacturer.

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Who should NOT use this medication?

• Female patients who are or may become pregnant. (See Fetal/Neonatal Morbidity and Mortality under Cautions and also see Boxed Warning.)
• Nursing women.
• Female patients of childbearing potential, unless they comply with all the special conditions required by the manufacturer and the iPLEDGE restricted distribution program. (See Boxed Warning and see Restricted Distribution under Dosage and Administration.)
• Known hypersensitivity to isotretinoin or any ingredient in the formulation. Some formulations contain parabens; contraindicated in sensitive patients.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include headache, dizziness, vomiting, stomach pain, warmth or tingling under the skin, swelling of the lips, and loss of balance or coordination.

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What should I discuss with my healthcare provider before taking isotretinoin?
Isotretinoin 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 isotretinoin on the Internet or from vendors outside of the United States. The sale and distribution of isotretinoin outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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