Can I take donepezil while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary There are no adequate data on the developmental risks associated with the use of donepezil hydrochloride in pregnant women. In animal studies, developmental toxicity was not observed when donepezil was administered to pregnant rats and rabbits during organogenesis, but administration to rats during the latter part of pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at clinically relevant doses [see Data]. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. The background risks of major birth defects and miscarriage for the indicated population are unknown.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): donepezil hydrochloride (oral), REMEDYREPACK INC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

8.2 Lactation Risk Summary There are no data on the presence of donepezil or its metabolites in human milk, the effects on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for donepezil hydrochloride and any potential adverse effects on the breastfed infant from donepezil hydrochloride or from the underlying maternal condition.

Prescribing label, section “8.2 Lactation”: donepezil hydrochloride (oral), REMEDYREPACK INC. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.