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Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-.

Cover of Drugs and Lactation Database (LactMed®)

Drugs and Lactation Database (LactMed®) [Internet].

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Last Revision: April 15, 2024.

Estimated reading time: 1 minute

CASRN: 163222-33-1

image 135107180 in the ncbi pubchem database

Drug Levels and Effects

Summary of Use during Lactation

Data from 2 mothers indicate that levels of ezetimibe and its active metabolite appear in very low amounts in milk and serum levels in infants predicted by a pharmacokinetic model are considerably lower than in adults. Ezetimibe appears to be acceptable during breastfeeding. Ezetimibe in combination with a statin (e.g., atorvastatin, simvastatin) should be avoided in nursing mothers.

Drug Levels

Maternal Levels. Two nursing mothers taking ezetimibe 10 mg daily donated a total of 15 milk samples for analysis of ezetimibe and ezetimibe glucuronide. In one mother, the highest drug concentrations were found in hindmilk at 2.08 hours after a dose. The ezetimibe concentration was 0.95 mcg/L and the glucuronide concentration was 1.39 mcg/L. In the second mother, the highest ezetimibe concentration of 0.98 mcg/L occurred 5.22 hours after a dose between feedings and the highest ezetimibe glucuronide concentration of 2.65 mcg/L occurred 8.47 hours after a dose just after feeding. These values result in a total ezetimibe plus ezetimibe glucuronide relative infant dosages of about 0.16% and 0.25%, respectively. A computer model of ezetimibe during nursing was consistent with the observed levels and indicated that predicted serum levels in infants were considerably lower than in adults.[1]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Cholestyramine, Colesevelam, Colestipol


Yeung CHT, Autmizguine J, Dalvi P, et al. Maternal ezetimibe concentrations measured in breast milk and its use in breastfeeding infant exposure predictions. Clin Pharmacokinet 2024;63:317-32. [PubMed: 38278872]

Substance Identification

Substance Name


CAS Registry Number


Drug Class

Breast Feeding


Milk, Human

Anticholesteremic Agents

Antilipemic Agents

Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

Copyright Notice

Attribution Statement: LactMed is a registered trademark of the U.S. Department of Health and Human Services.

Bookshelf ID: NBK501635PMID: 30000696


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