Does Accutane Use in Pregnancy Cause Birth Defects?

Last Updated: December 18, 2019

Authored by Sharon Levy, MD, MPH

Accutane is a fairly popular pharmaceutical product used to treat severe cases of acne. Its generic name is Isotretinoin sold under other brand names like Amnesteem, Claravis, and Sotret.
Acne can emerge in several forms, and Accutane is usually given after other medicines or antibiotics become ineffective. It is a form of vitamin A, which aids skin renewal.
Acne is a skin condition caused by the formation of clog-ups in the deeper layers of the skin. Oil produced by oil glands only enhances this problem, which is why Accutane was designed to significantly decreases the amount of oil released.
If Accutane is so efficient in acne treatment (70%-80% efficiency rate) and its main ingredient is a vitamin which is already present in the body in small amounts, why is it only available under a special program called iPLEDGE?

Accutane Use Side Effects in Pregnant

Because of the high success rate in treating the most severe forms of acne, this drug is often used by many women even at the risk of suffering Accutane side effects, such as dry mouth, lips, and skin, itching, rash, nosebleeds, upset stomach, dizziness, changes in fingernails or toenails. Accutane can also affect physical and psychological health.
Although every medicine comes with risk factors and side effects, there are some substances you should never use during pregnancy. That is the case with Accutane.

Accutane Use in Pregnancy

The most important fact everybody should be well aware of is that Accutane or Isotretinoin is a teratogenic substance. Teratogenic means that it disturbs the growth and development of an embryo or fetus.
According to the FDA’s pregnancy drug categorization system, Accutane is a category X drug, which means it is proven to cause high numbers of birth defects in babies whose mothers used this substance during pregnancy.
Accutane can cause birth defects as soon as the first weeks of pregnancy, even before the mother even knows she’s carrying a child.

Accutane and Birth Defects

Recent data suggest that Accutane has an incidence rate of circa 42% of neonatal defects, which include:
sad pregnant woman

  • Facial and oral malformations – Cleft Palate and Cleft Lip
  • Heart defects which persist during the baby’s whole life
  • Eye abnormalities
  • Ear abnormalities
  • Hydrocephaly – unusually large fluid spaces in the baby’s brain
  • Microcephaly – abnormally small head and brain
  • Central nervous system malformations, which can result in intellectual and mental disabilities
  • Abnormality of the thymus gland
  • Parathyroid hormone deficiency

Any fetus exposed to Accutane during pregnancy can be affected.
Miscarriage, premature delivery, and infant death are also very common if women use Accutane during their pregnancy.

iPLEDGE Program

This program was instituted by the U.S Food and Drug Administration in 2005 to make sure the drug is not prescribed to anyone who is pregnant and that no one becomes pregnant during the treatment.
Women under the iPLEDGE program should respect the following rules while using Accutane:

  • Consult your doctor before using Accutane
  • Be acutely aware of the risks of taking Accutane
  • Before starting Accutane medication, women should have two negative pregnancy tests
  • Accutane users should use effective birth control methods at least one month before and after their treatment due to the Accutane half-life timeline.

What To Know Before Taking Accutane While Pregnant?

Because Accutane use is hazardous and can lead to serious consequences, make sure to carefully consider the following:

  • Never use Accutane if you are pregnant.
  • Women with child-bearing potential must agree in writing to use specific forms of birth control and have regular pregnancy tests; even women who had their tubes tied are obligated to use birth control.
  • It is very dangerous to purchase this medicine online or without medical consultation.
  • Never take vitamin A in the form of other vitamin supplements while taking Accutane.
  • Never take Accutane while breastfeeding – this drug is lipophilic, which means it dissolves in milk fat.
  • Do not donate blood at least 30 days after the last use of Accutane.

Make sure to take this drug responsibly to give your unborn child their best chance at a healthy life.

Page Sources

  1. Acmaz G, Cınar L, Acmaz B, Aksoy H, Kafadar YT, Madendag Y, Ozdemir F, Sahin E, Muderris I. The Effects of Oral Isotretinoin in Women with Acne and Polycystic Ovary Syndrome. Biomed Res Int. 2019.
  2. Ozyurt S, Kaptanoglu AF. Systemic Isotretinoin Treatment and Pregnancy: A Longitudinal Cohort Study from Turkey. Eurasian J Med. 2015.
  3. Abroms L, Maibach E, Lyon-Daniel K, Feldman SR. What is the best approach to reducing birth defects associated with isotretinoin? PLoS Med. 2006;

Published on: June 16th, 2017

Updated on: December 18th, 2019

About Author

Sharon Levy, MD, MPH

After successful graduation from Boston University, MA, Sharon gained a Master’s degree in Public Health. Since then, Sharon devoted herself entirely to the medical niche. Sharon Levy is also a certified addiction recovery coach.


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