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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).
  • 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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  • antineoplastic, folic acid antagonist.
  • Fetal Risk
    Fetal Risk
  • Crosses human placenta.
  • Teratogenic in human causing multiple anomalies during 1st trimester exposure including: growth retardation, limb, digital, craniofacial defects and dextroposition of the heart.
  • reported single case of pulmonary disorder (desquamating fibrosing alveolitis) in infant whose mother received methotrexate before conception , suggested that methotrexate can be stored in body tissues causing this defects in subsequent pregnancies.
  • reported bone marrow hypoplasia in newborns exposed in utero to the drug.
  • Can cause chromosomal gaps and rings in newborns exposed to the drug in utero, that may lead to increased risk of cancer later in life and genetic damage in the next generation.
  • Occupational exposure to antineoplastic agents during pregnancy may present risk to the fetus including fetal loss and malformations.
  • Breast Feeding
    Breast Feeding
  • Excreted into milk in small amounts.
  • Because of possible immuno-suppression and carcinogenesis in infants exposed to this drug, it is contraindicated in breast feeding.
  • 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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