Teratology studies conducted in pregnant rats at doses up to about 35 times the human dose (body mass basis) and in pregnant rabbits at doses up to approximately 22 times the maximum approved human dose (23 mg/day) did not disclose any evidence for teratogenic potential. However, in a study in which pregnant rats were given approximately 22 times the human dose from Day 17 of gestation through Day 20 postpartum, there was a slight increase in stillbirths and a slight decrease in pup survival through day 4 postpartum. No effect was observed at the next lower dose tested, approximately 6.5 times the human dose. There are no adequate or well controlled studies in pregnant women. Donepezil hydrochloride should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Donepezil is excreted in the milk of rats. It is not known whether donepezil hydrochloride is excreted in human breast milk and there are no studies in lactating women. Therefore, women on donepezil should not breast feed.