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Generic Name
Trade Name
Risk Category
  • 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).
FDA Pregnancy Risk Categories

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  • anti-convulsant.
  • Fetal Risk
    Fetal Risk
  • 1st trimester exposure to the drug causes fetal hydantoin syndrome (FHS): craniofacial, limb, heart defects, oral clefts and impaired mental and physical growth.
  • In association with phenobarbital, and amitriptyline throughout pregnancy, it causes thanatophoric dwarfism.
  • The drug is suggested to be human transplacental carcinogen and infants exposed in utero may have: Neuroblastoma, Extrarenal Wilm’s tumor, lymphangioma, ganglioneuroblastoma, ependymoblastoma, mesenchymoma and melanotic neuroectodermal tumors.
  • Anticonvulsant agents including phenytoin can cause hemorrhagic disease of the newborn by inducing thrombocytopenia or suppression of vitamin k dependant coagulation factors of the fetus.
  • Causes maternal folic acid deficiency.
  • Teratogenicity of the drug may be dose-related, so in pregnancy should be maintained at lowest effective dose.
  • Breast Feeding
    Breast Feeding
  • Excreted into milk.
  • Safe in breast feeding at therapeutic doses.
  • Reported single case of drowsiness, decreased suckling, meth-hemoglobinemia in exposed infant.
  • 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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