[Teratogenicity study on ranitidine hydrochloride in rats]

A teratogenicity study was carried out in Crj: CD (SD) rats orally administered ranitidine hydrochloride, a histamine H2-receptor antagonist, at dose levels of 50, 200 and 800 mg/kg/day as base weight for a period of 11 days from day 7 to day 17 of gestation. Two-thirds of the pregnant females in each group were sacrificed on day 20 of gestation and their fetuses were examined. The remaining dams were allowed to litter naturally, and the postnatal development of the offspring was observed. The incidences of external, internal, and skeletal anomalies were not significantly increased in the fetuses of any treated group. Ranitidine treatment caused no effects on parturition, lactation, postnatal growth and reproductive ability of the male and female offspring.