INTRODUCTION:: Single-dose oral secnidazole 2 g, has recently been approved in the US for treatment of bacterial vaginosis (BV) in adult women. BV is associated with an increased risk of several pathological gynecological conditions as well as major adverse outcomes during pregnancy, where it is associated with a two-fold increased risk of preterm birth and a six-fold increased risk of miscarriage. In order to inform patient labeling, reproductive toxicology studies have been conducted. METHODS:: A complete reproductive toxicology program required for patient labeling was conducted. Rats and rabbits were fed varying doses of secnidazole, 0 to 1000 mg/kg/day and 0 to 100 mg/kg/day, respectively, leading up to and throughout gestation. Maternal examinations included clinical observations and survival, food consumption, and parturition. Data obtained from the first-generation (F1) pups included viability, body weight, neurobehavioral and reproductive function. Data including clinical signs, survival and body weights were also obtained for the second generation pups derived from F1 offspring. Adverse events associated secnidazole were measured. RESULTS:: Secnidazole showed no reproductive toxicity in animal models. There was no effect on weight, growth, and food consumption for animals administered secnidazole, up to 300 mg/kg/day. There were no effects on survival, intrauterine growth, or external fetal morphology at any dose. CONCLUSION:: There was no evidence of secnidazole toxicity in fertility and pre- and postnatal reproductive toxicology. In addition, there were no adverse developmental outcomes when secnidazole was administered orally to pregnant rats and rabbits during organogenesis at doses up to 4 times the clinical dose.