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Generic Name
Danazol
Trade Name
Syntozal
Manufacturer
Codal Synto.
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
  • Synthetic androgen for treatment of endometriosis, fibrocystic breast disease and hereditary angioedema.
  • Fetal Risk
    Fetal Risk
  • Crosses the placenta in animals.
  • Teratogenic in human causing virilization with ambigeous genitalia of female fetuses exposed to the drug in utero, without major birth defects.
  • No evidence of virilization when danazol was stopped before conception or before the eighth week of embryogenesis.
  • Virilization of the behavior of young females exposed in utero to danazol has been reported.
  • Breast Feeding
    Breast Feeding
  • Drug contraindicated in breast-feeding 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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