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Isotretinoin is a powerful and effective medicine derived
from vitamin A (retinoid medicine). Doctors prescribe it to treat severe
acne only after other treatments have failed.
Isotretinoin can cause some rare but serious side effects.
needs to be taken for 3 to 6 months.
Isotretinoin works by unclogging skin
pores and shrinking oil glands.
Doctors use isotretinoin to treat
Isotretinoin is very effective for controlling most types of acne and for clearing it up for long periods of time.1
All medicines have side effects. But many people don't feel the side effects, or they are able to deal with them. Ask your pharmacist about the side effects of each medicine you take. Side effects are also listed in the information that comes with your medicine.
Here are some important things to think about:
dangerous side effects of this medicine are miscarriage and serious birth
defects in babies whose mothers took the medicines during pregnancy. Women who
can get pregnant need to use two forms of birth control so that they do not
become pregnant while they are taking retinoid medicine. The risk of birth
defects and miscarriage goes away about 1 month after the medicine is
Call 911 or other emergency services right away if you have:
Call your doctor right away if you have:
Common side effects of this medicine include:
See Drug Reference for a full list of side effects.
(Drug Reference is not available in all systems.)
Taking this medicine can cause high triglyceride levels. It can also cause liver damage. So you will have a blood test before starting this medicine and while you are taking this medicine to check your triglyceride levels and your liver function.
The Center for Drug
Evaluation and Research division of the U.S. Food and Drug Administration (FDA)
warns that isotretinoin may be linked to depression, psychosis, and, in rare
cases, thoughts of suicide, suicide attempts, and suicide. The link between
isotretinoin and these mood changes is not clear and is being watched very
closely. Talk with your doctor about whether isotretinoin is
right for you or your child. If you or your child is taking isotretinoin and
has signs of
depression, see your doctor for treatment. Even if you
stop taking isotretinoin, depression may not improve.
Medicine is one of the many tools your doctor has to treat a health problem. Taking medicine as your doctor suggests will improve your health and may prevent future problems. If you don't take your medicines properly, you may be putting your health (and perhaps your life) at risk.
There are many reasons why people have trouble taking their medicine. But in most cases, there is something you can do. For suggestions on how to work around common problems, see the topic Taking Medicines as Prescribed.
Do not use this medicine if you are pregnant, breast-feeding, or planning to get pregnant. If you need to use this medicine, talk to your doctor about how you can prevent pregnancy.
Isotretinoin is strictly regulated for use in women
by the U.S. Food and Drug Administration (FDA) because of the danger of
miscarriage and of serious birth defects in babies whose mothers took the
medicine during pregnancy. Doctors may prescribe these medicines only for a
female who is not pregnant and who does not intend to become pregnant while
taking the medicine. You must also use two methods of birth control and have
pregnancy tests on a regular basis while using this medicine.
The FDA has announced that the companies that make
isotretinoin have a program to register doctors who prescribe isotretinoin and
the people who take it. The program is to ensure that women taking this drug
understand the risk of birth defects, take precautions to avoid pregnancy, and
know what to do if they become pregnant. If your doctor suggests that you take
isotretinoin, you must be registered with iPLEDGE in order to get the drug. You
can get more information and register at www.ipledgeprogram.com or by telephone
at 1-866-495-0654 (toll-free).
Follow-up care is a key part of your treatment and safety. Be sure to make and go to all appointments, and call your doctor if you are having problems. It's also a good idea to know your test results and keep a list of the medicines you take.
Complete the new medication information form (PDF)(What is a PDF document?) to help you understand this medication.
Habif TP (2010). Acne, rosacea, and related disorders. In Clinical Dermatology: A Color Guide to Diagnosis and Therapy, 5th ed., pp. 217–263. Philadelphia: Mosby.
January 23, 2013
Kathleen Romito, MD - Family Medicine & E. Gregory Thompson, MD - Internal Medicine
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