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Generic Name
Diphenhydramine Hydrochloride
Trade Name
Risk Category
  • Controlled studies done on animals in reproduction do not indicate risk to the fetus.
  • No adequate and well-controlled studies done on pregnant women.
FDA Pregnancy Risk Categories

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  • antihistamine.
  • Fetal Risk
    Fetal Risk
  • No fetal adverse effects in animals.
  • No well controlled human data but suggested possible association with congenital defects in first trimester exposure including: genitourinary, eye, ear, cardiac defects, cleft palate, hypospadias, inguinal hernia, polydactyly, malformations of the diaphragm and hypoplasia of cerebral hemisphere.
  • Chronic maternal ingestion of the drug can cause neonatal withdrawal.
  • Exposure during the last two weeks of pregnancy to antihistamines in general is associated with retrolental fibroplasia in premature infants.
  • Has oxytocic effect on uterus.
  • Breast Feeding
    Breast Feeding
  • Excreted into milk.
  • Contraindicated in breast feeding because of increased sensitivity of newborn to antihistamines.
  • 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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