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Who should not use isotretinoin?

Allergies to Ingredients. People who are allergic to any of the following should not use isotretinoin.

• Absorica
• Absorica LD
• Accutane
• Amnesteem
• Claravis
• Isotretinoin
• Myorisan
• Vitamin A
• Zenatane

Pregnancy. Do not take isotretinoin if you are pregnant. If you become pregnant, stop taking isotretinoin and contact your healthcare provider right away. See the Pregnancy section below for more details.

What should I know about isotretinoin before using it?

Do not take isotretinoin unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share isotretinoin with other people, even if they have the same condition as you. It may harm them.

Keep isotretinoin out of the reach of children.

Isotretinoin can make it more difficult to see at night. Do not drive at night until you know how isotretinoin affects you.

Isotretinoin may make it harder to use contact lenses.

You should not donate blood while taking isotretinoin or for one month after stopping isotretinoin.

Isotretinoin can increase the risk of scarring after some procedures that are used to smooth the skin, such as waxing, dermabrasion, and laser resurfacing. Avoid these procedures while taking isotretinoin.

Isotretinoin can make your skin more sensitive to light from the sun, sunlamps, and tanning beds. This is called photosensitivity. Exposure to this light can cause severe sunburns, blisters, and swelling. If you need to be in sunlight, wear sunscreen, a hat, and clothing that covers your skin.

Isotretinoin can cause serious harm to an unborn baby. To reduce the risk of this happening, isotretinoin is only available through a restricted program called iPLEDGE. As part of this program, people who can become pregnant must have two negative pregnancy tests before starting isotretinoin. In order to continue taking isotretinoin, people who can become pregnant must commit to using two forms of birth control and also take a pregnancy test each month.

What should I tell my healthcare provider before using isotretinoin?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if isotretinoin is right for you.

In particular, make sure that you discuss any of the following.

• Anorexia nervosa
• Diabetes
• Asthma 
• History of bone conditions, such as osteomalacia, osteopenia, or osteoporosis
• Liver disease
• Mental health conditions
• Suicidal thoughts

Pregnancy. Isotretinoin may cause death or serious harm to an unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant. A negative pregnancy test is necessary before starting isotretinoin. Pregnancy tests must be repeated monthly during treatment and 1 month after stopping isotretinoin. If you can become pregnant, use effective birth control for at least 1 month before starting isotretinoin, while you are taking isotretinoin, and for 1 month after your last dose. Talk to your healthcare provider about your birth control options.

There is a Pregnancy Exposure Registry that monitors the health of you and your unborn baby if you are exposed to isotretinoin during pregnancy or within 1 month after stopping isotretinoin. Talk to your healthcare provider right away if you think you or your partner may have been exposed to isotretinoin during pregnancy. If you become pregnant during treatment with isotretinoin, you or your healthcare provider should report your pregnancy to the FDA via the MedWatch telephone number 800-FDA-1088 and also to the iPLEDGE pregnancy registry at 866-495-0654 or www.ipledgeprogram.com.

Breastfeeding. Do not take isotretinoin while you are breastfeeding. It is not known if isotretinoin passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.