Isotretinoin and other retinoids during pregnancy

Isotretinoin is a prescription medicine used to treat a severe type of acne called nodular or cystic acne. Cystic acne causes many red, swollen lumps in the skin and leaves lasting scars. 

Isotretinoin is used when other treatments for cystic acne don’t work. Sometimes isotretinoin is used to treat other skin conditions, like rosacea. Rosacea causes redness and pimples. 

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 it’s a medicine that’s taken by mouth. Accutane® was the original brand of isotretinoin. Accutane is no longer sold, but these brands are still used: Absorica®, Amnesteem®, Claravis®, Myorisan® and Sotret®.

Taking isotretinoin or other retinoids during pregnancy can cause serious health problems for your baby. Here’s how to protect your baby:

  • If you’re pregnant or could get pregnant, don’t take isotretinoin or other retinoids. 
  • If you take these medicines and could get pregnant, both you and your partner should use birth control
  • If you take these medicines and are planning to get pregnant, talk to your health care provider about stopping the medicine before you get pregnant. 
  • If you get pregnant and you’re taking a retinoid, tell your health care provider right away. 

How can isotretinoin affect your baby during pregnancy?

Taking isotretinoin during pregnancy increases the 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 early, before 37 weeks of pregnancy. 
  • Your baby having birth defects. Birth defects are health conditions that are present at birth that change the shape or function of one or more parts of the body. They can cause problems in overall health, how the body develops, or in how the body works. 
  • Your baby having 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 that can be caused by isotretinoin include: 

  • Cleft palate and other birth defects of the face. Cleft palate is when 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 or how it works, or both.
  • Ear problems. Some babies also are born with small ears or are born missing ears. Some babies have hearing loss
  • Eye problems. Some babies have microphthalmia, a condition that happens when one or both eyeballs are very small. It may lead to vision loss. Some babies are born missing eyes. 
  • Hydrocephalus. This is fluid buildup in the brain. Extra fluid can cause the head to swell and put too much pressure on the brain. Hydrocephalus can cause intellectual disabilities. In some cases, a surgeon needs to drain the extra fluid from a baby’s brain. 
  • Microcephaly. Babies born with microcephaly have a smaller-than-normal head because the brain doesn’t develop properly or has stopped growing. Babies with microcephaly may have intellectual and developmental disabilities, hyperactivity (trouble sitting still or paying attention), short height, seizures and problems with coordination and balance. 
  • Small or missing thymus gland. This gland is in the upper chest. It makes white blood cells to protect the body from infection.

How can you prevent birth defects from isotretinoin? 

Because isotretinoin can be so harmful to a developing baby, both women and men must register with the iPLEDGE program before they can take it. iPLEDGE is sponsored by the company that makes isotretinoin. iPLEDGE is approved by the Food and Drug Administration (also called FDA), the government agency that checks the safety of medicine and food in this country.

Both men and women who take isotretinoin must agree to follow strict iPLEDGE rules to help prevent pregnant women and women who may become pregnant from having contact with isotretinoin. Only doctors and pharmacists who are registered in the program may prescribe and give isotretinoin to patients.

If you’re taking isotretionoin, you must agree to use two different forms of effective birth control. Your provider can help you choose two effective forms of birth control that work together. You also must take regular pregnancy tests and agree not to get pregnant: 

  • For at least 4 weeks before you start using the medicine
  • While taking the medicine
  • For at least 4 weeks after you stop using the medicine

Men who take isotretinoin can have it in their semen (fluid that contains sperm). Experts don’t know if semen with isotretinoin can lead to birth defects. Talk to your provider if your partner takes isotretinoin and you’re planning to get pregnant.

What should you do if you’re taking isotretinoin and think you may be pregnant?

 If you take isotretinoin, call your provider right away if:

  • You think you’re pregnant.
  • You have a late, irregular or missed menstrual period.
  • You have a change in your menstrual bleeding.
  • You have sex without using two forms of effective birth control.
  • You have unprotected sex with a man taking isotretinoin.

If you get pregnant while taking isotretenoin, your provider must call 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 other oral retinoids, following the iPLEDGE rules can help prevent birth defects. 

Oral retinoids include: 

  • Acitretin (Soriatane®). This medicine treats severe psoriasis, a skin disease that causes itchy or sore patches of thick, red skin with silvery scales.
  • Tretinoin (Vesanoid®). This medicine treats a type of blood cancer called acute promyelocytic leukemia.
  • Bexarotene (Targretin®). This medicine treats a type of blood cancer called T-cell lymphoma.

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 to avoid them. Topical retinoids include tretinoin, which treats acne and other skin problems. Tretinoin is sold as these brand names: Altinac®, Atralin®, Avita®, Retin-A®, Renova® and TretinX®.

Is it safe to breastfeed while using isotretinoin or other retinoids?

We’re not sure if using isotretinoin or other retinoids while breastfeeding is safe for your baby. It’s best not to breastfeed while using these medicines. 

Can vitamin A cause birth defects?

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, eggs, poultry and dairy foods.  

Talk to your health care provider about getting the right amount of vitamin A from healthy eating and your prenatal vitamin.

Last reviewed: July, 2014