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Generic Name
Isotretinoin
Trade Name
Accutane Roche
Risk Category
X
  • Positive evidence of human fetal risk exists.
  • Potential benefits may warrant use of the drug in pregnant women despite potential risks (e.g. life threatening situations or serious illness).
  • Studies in animals and/or humans have demonstrated fetal abnormalities.
  • Fetal risk involved in use of drug, clearly outweighs potential benefit.
  • Contraindicated in women who are or may become pregnant. Don’t use.
FDA Pregnancy Risk Categories

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Indication
Indication
  • Vitamin A isomer for treatment of severe cystic acne.
  • Fetal Risk
    Fetal Risk
  • teratogenic in animals causing craniofacial and limb malformations.
  • It is a human teratogen causing central nervous system, craniofacial, cardiovascular, thymic defects and others (hepatic, urinary, musculo-skeletal, spina bifida, nystagmus, simian crease).
  • Fetotoxic causing fetal loss and abortions.
  • After discontinuation of treatment, subsequent pregnancy outcomes may be adversely affected.
  • Breast Feeding
    Breast Feeding
  • There are no adequate studies in women for determining infant risk when using this medication during breastfeeding.
  • Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
  • Other Trade Names
     
    The information on this Web site is not intended as a substitute for the advice and care of your doctor or other health-care provider. Always consult your doctor if you have any questions about exposures during pregnancy and lactation, and before you take any medications. Please read the Terms and Conditions before using this website.
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