Oral LD50 (rat): >8 gm/kg; Oral LD50 (mouse): >8 gm/kgMSDS

A note on the use in pregnancy

There are no available data on triclabendazole use in pregnant women to calculate a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Reproductive studies in animals (rat and rabbits) have not demonstrated an increased risk of increased fetal abnormalities with exposure to triclabendazole during the organogenesis period at doses which were about 0.3 to 1.6 times the maximum recommended human dose (MRHD) of 20 mg/kg.^{FDA label}

Carcinogenesis/Mutagenesis

No genotoxic risk was noted for triclabendazole tested in 6 genotoxicity in vitro and in vivo assays.^{FDA label}

Impairment of Fertility

No drug-related effects on reproductive performance, mating ratios or indices of fertility have been observed in a 2-generation reproductive and developmental toxicity study in rats.^{FDA label}

A note on use in breastfeeding

There are no human findings on the presence of triclabendazole in milk, the effects on a nursing infant, or the effects on maternal milk production. The results of animal studies indicate that triclabendazole is found in goat milk when given as a single dose to a lactating female goat. When a drug is found to be present in animal milk, the likelihood that it will be found in human milk is high. Excercise caution if this drug is administered during nursing.^{FDA label}