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Generic Name
Clomiphene Citrate
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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  • fertility agent for induction of ovulation.
  • Fetal Risk
    Fetal Risk
  • teratogenic in animals causing cataract, genital tract anomalies, hydramnios, and fetal death if used early in pregnancy .
  • Clomiphene used immediately before conception in animals may cause growth retardation, exencephaly and reduced implantation rate.
  • Some congenital malformations were reported with clomiphene use before conception including: Hydatidiform mole, oral clefts, ovarian dysplasia, hypospadias, microcephaly, heart defects, anencephaly, digital defects, retinal aplasia, hemangioma, down’s syndrome and pigmentation defects.
  • Acardius acephalus in monozygotic twin reported in pregnancy after clomiphene induction.
  • Sinle case of infant hepatoblastoma was reported with clomiphene and follicle-stimulating luteinizing hormone used before conception.
  • Use of clomiphene should be started after exclusion of pregnancy because inadvertent use in 1st trimester may cauase meningomyelocele, esophageal atresia with fistula, heart defects, hypospadias and absent kidney.
  • Breast Feeding
    Breast Feeding
  • Unknown excretion into breast milk.
  • Clomiphene suppresses lactation.
  • 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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