Donepezil Pregnancy and Breastfeeding Warnings
Donepezil is also known as: Aricept, Aricept ODT
Medically reviewed by Drugs.com. Last updated on Feb 8, 2019.
Donepezil Pregnancy Warnings
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. (AU, US)
This drug should be used only if clearly needed. (UK)
AU TGA pregnancy category: B3
US FDA pregnancy category: C
Animal studies have not revealed evidence of teratogenicity; however, toxicity was observed in the peri and post natal period, slight increase in the incidence of stillborn births and a slight reduction in postpartum survival. There are no controlled data in human pregnancy.
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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.
Donepezil Breastfeeding Warnings
Use is not recommended. (AU,UK)
Caution is recommended. (US)
Excreted into human milk: Unknown
Excreted into animal milk: Yes
The effects in the nursing infant are unknown.
References for pregnancy information
- "Product Information. Aricept (donepezil)." Pfizer US Pharmaceuticals, New York, NY.
- Cerner Multum, Inc. "Australian Product Information." O 0
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
References for breastfeeding information
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Cerner Multum, Inc. "Australian Product Information." O 0
- "Product Information. Aricept (donepezil)." Pfizer US Pharmaceuticals, New York, NY.
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Further information
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