Use in Pregnancy: Category C according to US pregnancy category; either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
Teratology studies conducted in pregnant rats at doses up to approximately 80 times the human dose and in pregnant rabbits at doses up to approximately 50 times the human dose did not disclose any evidence for a teratogenic potential. However, in a study in which pregnant rats were given approximately 50 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 15 times the human dose. Donepezil hydrochloride should not be used during pregnancy because no clinical data of it on exposed pregnancies are available.
Use in Lactation: 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 hydrochloride should not breast feed.