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. Just one dose of
isotretinoin can cause severe birth defects if a woman is pregnant when taking
needs to be taken for 3 to 6 months.
How It Works
Isotretinoin works by unclogging skin
pores and shrinking oil glands.
Why It Is Used
Doctors use isotretinoin to treat
Have severe acne that does not get better with
Isotretinoin is very effective for controlling most types of acne and for clearing it up for long periods of time.2
Retinoid medicines may have side
effects, such as:
Miscarriage and serious birth defects. The most
dangerous side effects of retinoid 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
Changes in mood or thoughts. The Center for Drug
Evaluation and Research division of the U.S. Food and Drug Administration (FDA)
warns that isotretinoin may be linked with 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 to your doctor for more information on 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.
Increase in triglycerides in the blood. A person
who takes retinoid medicine may have higher-than-normal levels of certain fats
(triglycerides) in his or her blood. High levels of triglycerides may make a
person more likely to develop certain health problems, such as heart disease.
For this reason, all people need to have their blood checked for triglyceride
levels before starting this medicine and every 4 to 6 weeks while taking
Liver damage. Some people who have certain liver
conditions may develop liver damage if they take retinoid medicine. For this
reason, all people need to have blood tests to check their liver function
before starting this medicine and at regular checkups while they are taking
Other side effects. Other common side effects of
retinoid medicines can include chapped lips, dry skin, dry eyes, and dryness
inside the nose and mouth. People also complain of fatigue, sensitivity to the
sun, problems with night vision, and thinning of hair.
See Drug Reference for a full list of side effects.
(Drug Reference is not available in all systems.)
What To Think About
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 only prescribe these medicines 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).
Del Rosso JQ (2007). Acne vulgaris and rosacea. In DC
Dale, DD Federman, eds., ACP Medicine, section 2, chap.
12. New York: WebMD.
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.
How this information was developed to help you make better health decisions.