Isotretinoin is a kind of prescription medicine called an oral retinoid. It’s often used to treat a severe kind of acne called nodular acne.
Taking isotretinoin or other oral retinoids during pregnancy can cause serious birth defects in babies.
If you’re pregnant or planning to get pregnant, don’t take isotretinoin.
If you’re taking isotretinoin, use effective birth control to prevent pregnancy.
If you’re taking an oral retinoid and think you’re pregnant, call your provider right away.
What is isotretinoin?
Isotretinoin is a prescription medicine used to treat a severe type of acne called nodular acne. Nodular acne causes large, painful lumps in the skin. If it’s not treated, it can leave lasting scars. Providers prescribe isotretinoin only when other acne treatments don’t work. Sometimes it’s used to treat other skin conditions and certain types of cancer.
Isotretinoin is a kind of medicine called an oral retinoid. Retinoids are man-made forms of vitamin A used to treat certain skin conditions and blood cancers. Oral means that you take it by mouth. Accutane® is the original brand of isotretinoin. Accutane is no longer sold, but these brands are still used: Absorica®, Amnesteem®, Claravis®, Myorisan® and Zenatane®.
Taking isotretinoin or other oral retinoids during pregnancy can cause serious problems for your baby. These medicines are so dangerous for a baby that users have to agree to use birth control while they’re on the medicine so they don’t get pregnant.
How can isotretinoin affect your baby during pregnancy?
Taking isotretinoin during pregnancy increases your baby’s risk of:
- Miscarriage. This is when a baby dies in the womb before 20 weeks of pregnancy.
- Premature birth. This is birth that happens too soon, before 37 weeks of pregnancy. Premature babies may have more health problems and birth and later in life than babies born full term.
- Birth defects. Birth defects are health conditions that are present at birth. They change the shape or function of one or more parts of the body. Birth defects can cause problems in overall health, how the body develops or how the body works.
- Intellectual and developmental disabilities later in life. These are problems with how the brain works that can cause a person to have trouble or delays in physical development, learning, communicating, taking care of himself or getting along with others.
Birth defects caused by isotretinoin include:
- Cleft palate and other birth defects of the face. Cleft palate is a birth defect in which a baby’s palate (roof of the mouth) doesn’t form completely and has an opening in it.
- Congenital heart defects. These are heart conditions that can affect the heart’s shape, how it works or both.
- Ear problems. Babies may be born with small ears or missing ears. Some babies have hearing loss.
- Eye problems. These can include microphthalmia, which is when one or both eyeballs are very small. It may lead to vision loss. Some babies may seem to be missing eyes, but they usually have some eye tissue.
- Microcephaly. This is a birth defect in which a baby’s head is smaller than expected, compared to babies of the same sex and age. Children with severe microcephaly may have physical, intellectual and developmental disabilities.
- Problems with the thymus gland. This gland is in the upper chest. It makes white blood cells to protect the body from infection.
- Problems with the parathyroid glands. These glands make parathyroid hormone, which helps keep the right balance of calcium in the body.
How can you prevent birth defects caused by isotretinoin?
You can prevent these birth defects by planning your pregnancy so you’re not taking the medicine while you’re pregnant.
If you’re planning to use isotretinoin:
- Use effective birth control to prevent pregnancy.
- If you take birth control pills, tell your provider what you take. Some may not work if you take them with isotretinoin, so you may need to switch to a different pill. For example, progestin-only birth control pills (also called mini-pills) may not work with isotretinoin. Progestin is a female hormone.
If you’re using isotretinoin and thinking about getting pregnant:
- Use effective birth control to prevent pregnancy.
- Tell your provider. You can work together to manage your treatment to stop taking the medicine before you get pregnant.
If you’re using isotretinoin and you get pregnant, tell your provider right away. If you’re pregnant, don’t take isotretinoin.
Because isotretinoin is so harmful to a baby during pregnancy, the Food and Drug Administration (also called FDA) requires isotretinoin users to register with the iPLEDGE Program. The FDA is the government agency that checks the safety of food and medicine in this country. Anyone—both women and men—who plans to take isotretinoin must register with iPLEDGE and follow strict rules about taking the medicine. The goals of iPLEDGE are to:
- Prevent pregnancy in women who take isotretinoin
- Prevent pregnant women from taking isotretinoin
Only health care providers who are registered in iPLEDGE can prescribe isotretinoin to patients. And you can get it only at registered pharmacies.
If you’re taking isotretinoin, you must agree:
- To use two different forms of birth control. Your provider can help you choose two effective forms of birth control that work well together. The most effective forms of birth control are implants and intrauterine devices (also called IUDs). Your provider places these in your body, and they help prevent pregnancy for a long time. When you’re ready to get pregnant, your provider takes them out. Talk to your provider about what kinds of birth control to use.
- To take regular pregnancy tests before, during and after treatment.
- To not get pregnant for at least 1 month before you start taking the medicine, while you’re taking the medicine or for at least 1 month after you stop taking the medicine
Men who take isotretinoin can have a very small amount of it in their semen (fluid that contains sperm). Experts don’t know if semen with isotretinoin can lead to birth defects. If your partner takes isotretinoin and you’re pregnant or planning to get pregnant, talk to your provider. Use a male latex condom every time you have sex to help prevent pregnancy while your partner is taking isotretinoin and for 1 month after he stops taking it.
If you’re taking isotretinoin:
- Don’t share it or other oral retinoids with anyone else. You don’t want someone else to take it and be at risk for birth defects. You need a prescription (an order from your provider) to get these medicines.
- Don’t donate blood while you’re taking it or other oral retinoids and for 1 month after your last dose. If a pregnant woman gets your donated blood, there may be enough medicine in it to cause birth defects in her baby.
Are there any exceptions to the birth control rule for iPLEDGE?
Yes. You may not have to use two different forms of birth control while taking isotretinoin if:
- Your health care provider confirms you can’t get pregnant because you don’t have a uterus or ovaries or because of menopause. The uterus is the place inside you where your baby grows during pregnancy. Ovaries are the organs that make and release eggs in a woman’s body each month as part of the menstrual cycle. Menopause is when a woman hasn’t had a period for 1 year. It usually happens in women after age 45, when the ovaries stop making the hormones estrogen and progesterone.
- You promise to have no sexual contact with a man for at least 1 month before you start taking the medicine, while you’re taking the medicine and for at least 1 month after you stop taking the medicine.
What do you do if you’re taking isotretinoin and think you may be pregnant?
Stop taking isotretinoin and call your provider right away if:
- You think you’re pregnant.
- You have a late or missed menstrual period.
- You have sex without using two forms of effective birth control.
If you get pregnant while taking isotretinoin or within 1 month after taking isotretinoin, your provider must report it to the company that makes isotretinoin, iPLEDGE and the FDA.
Can oral retinoids other than isotretinoin cause birth defects?
Yes. Other oral retinoids can cause birth defects similar to those caused by isotretinoin. There’s no program like iPLEDGE for other oral retinoids. But if you’re taking any oral retinoid, following the iPLEDGE rules can help prevent birth defects. If you’re thinking about pregnancy, work with your health care provider to manage your treatment and plan to stop taking your medicine before you try to get pregnant.
Other oral retinoids include:
- Acitretin (brand name Soriatane®). This medicine treats severe psoriasis, a skin disease that causes itchy or sore patches of red skin with thick, silvery scales. To help reduce the risk of birth defects, don’t try to get pregnant 1 month before taking acitretin, while taking acitretin and for 3 years after you stop taking it.
- Tretinoin (brand name Vesanoid®). This medicine treats a type of blood cancer called acute promyelocytic leukemia. To help reduce the risk of birth defects, don’t try to get pregnant 1 month before taking tretinoin, while taking tretinoin and for 1 month after you stop taking it.
- Bexarotene (brand name Targretin®). This medicine treats a rare type of cancer that affects the skin called cutaneous T-cell lymphoma. To help reduce the risk of birth defects, don’t try to get pregnant 1 month before taking bexarotene, while taking bexarotene and for 1 month after you stop taking it.
Can topical retinoids affect your baby during pregnancy?
Topical retinoids are medicines you put directly on your skin. We don’t know if topical retinoids are safe during pregnancy. But small amounts may be absorbed by the skin, so it’s best not to take them if you’re pregnant or thinking about getting pregnant. Topical retinoids that are used to treat acne include:
- Tretinoin (brand names Altreno®, Atralin®, Avita®, Renova®, Retin-A®, Retin-A Micro®)
- Adapalene (brand name Differin®)
- Tazarotene (brand names Avage®, Fabior®, Tazorac®)
Is it safe to breastfeed while using isotretinoin or other retinoids?
Can vitamin A cause birth defects?
Retinoids are man-made forms of vitamin A. Your baby needs vitamin A for healthy growth and development during pregnancy. But too much may cause birth defects.
Your body makes its own vitamin A when you eat certain yellow and green vegetables. This form of vitamin A is safe during pregnancy. Getting too much preformed vitamin A can cause birth defects. Preformed vitamin A is found in foods like meat (especially liver), fish and dairy foods.
Talk to your provider to make sure you get the right amount of vitamin A during pregnancy. Most women can get the right amount from healthy eating and their prenatal vitamin.
Last reviewed: June, 2019