Donepezil / memantine Pregnancy and Breastfeeding Warnings

Brand names: Namzaric

Medically reviewed by Drugs.com. Last updated on Oct 31, 2023.

Donepezil / memantine Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: C

Animal studies with memantine have revealed evidence of slight maternal toxicity, decreased offspring weights, and increased incidence of non-ossified cervical vertebrae at an oral dose 6 times the maximum recommended human dose (MRHD). Animal studies with donepezil showed an increase in stillbirths and reduced offspring survival at oral doses up to 7 times the MRHD. Other doses of memantine and donepezil examined in animal studies, including doses up to 21 and 15 times the MRHD, did not show any teratogenic effects. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Donepezil / memantine Breastfeeding Warnings

Caution is recommended; safety has not been established

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

See references

Further information

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