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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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  • Anticonvulsant.
  • Sedative.
  • Barbiturate.
  • Fetal Risk
    Fetal Risk
  • Suggested teratogenic effects of the drug as monotherapy or if used in comination with other anticovulsant agents including microcephaly and some features of fetal hydantoin syndrome (FHS).
  • It affects the fetal central nervous system development in animals causing sexual dysfunction, adverse changes in learning and attention in the off springs.
  • Children exposed in utero to the drug may have impairment of cognitive development
  • Suggested possible association between 1st trimester exposure and down’s syndrome, cardiovascular defects and in combination with phenytoin and amitriptyline it may cause thanatophoric dwarfism.
  • Chronic use of Phenobarbital during gestation can cause neonatal withdrawal and hemorrhagic disease of the newborn.
  • It induces maternal folic acid deficiency.
  • Breast Feeding
    Breast Feeding
  • Excreted into milk and accumulates in infants' blood causing sedation, withdrawal symptoms, so should be used with caution by lactating women.
  • 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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