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Cocaine hydrochloride was administered to pregnant Sprague‐Dawley rats as a single intraperitoneal dose or as two doses 1–4 hours apart. A single dose administered on day 16 of gestation was teratogenic in a dose‐dependent manner, with 40 mg/kg being a no‐effect dose and 50 mg/kg the lowest teratogenic dose; 80 mg/kg was lethal to the dam. Forty‐eight hours after exposure to a teratogenic dose on day 16 of pregnancy, the fetuses showed severe hemorrhage and edema in the their extremities, particularly the footplates, tail, genital tubercle, and upper lip/nose. When the fetuses were examined on day 21 of gestation, the main externally visible malformations were reduction deformities of the limbs and tail. When two doses of cocaine were administered 1–4 hours apart, the incidence of affected fetuses increased as the time interval between the two doses decreased. Two doses of cocaine administered 2 …