Can I take ezetimibe while pregnant or breastfeeding?

A plain-words look at what the NHS, the US drug label and LactMed say about ezetimibe.

In short

Pregnancy: Ezetimibe is not usually recommended in pregnancy, as there is very little information about its safety.

Breastfeeding: Ezetimibe may be OK for you to take while breastfeeding. If it is not, your doctor or pharmacist may ask you to stop it until you've finished breastfeeding. How much ezetimibe reaches breast milk is not yet known, but the amount is probably small. It's unlikely to cause side effects in your baby or to affect their cholesterol.

Your doctor, midwife or pharmacist can help you decide.

What this means for you

Pregnancy

Breastfeeding

Talk to your doctor or pharmacist

This page is educational, not advice for your own situation. Talk to your doctor, midwife or pharmacist before you start, stop or change any medicine in pregnancy or while breastfeeding.

The details: what each source says

Ezetimibe in pregnancy

The NHS says

Ezetimibe is not usually recommended in pregnancy, as there is very little information about its safety. Specialists may, however, prescribe it if you're pregnant and have very high cholesterol.

If you take ezetimibe and are planning a pregnancy or are pregnant now, speak to your doctor about your treatment. They may want you to carry on with ezetimibe or to change to another medicine.

In our words, from the NHS page Ezetimibe (nhs.uk). Contains public sector information licensed under the Open Government Licence v3.0 (OGL v3.0). The NHS does not endorse this site.

The US drug label says

8.1 Pregnancy Risk Summary There are insufficient data on ezetimibe use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse developmental effects were observed in pregnant rats and rabbits orally administered ezetimibe during the period of organogenesis at doses that resulted in up to 10 and 150 times, respectively, the human exposure at the MRHD, based on AUC (see Data). Ezetimibe should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When ezetimibe is administered with a statin, refer to the Prescribing Information for the statin. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

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

Ezetimibe while breastfeeding

The NHS says

Ezetimibe may be OK for you to take while breastfeeding. If it is not, your doctor or pharmacist may ask you to stop it until you've finished breastfeeding. How much ezetimibe reaches breast milk is not yet known, but the amount is probably small. It's unlikely to cause side effects in your baby or to affect their cholesterol.

If you have any worries about your baby, contact your health visitor, midwife, doctor or pharmacist promptly. This includes if your baby is not feeding as well as they usually do, or is not gaining weight as you'd expect.

In our words, from the NHS page Ezetimibe (nhs.uk). Contains public sector information licensed under the Open Government Licence v3.0 (OGL v3.0). The NHS does not endorse this site.

LactMed says

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.

“Summary of Use during Lactation”, LactMed record “Ezetimibe” (LM736), quoted verbatim. Everything LactMed reports about Ezetimibe while breastfeeding.

The US prescribing label says

8.2 Lactation Risk Summary There is no information about the presence of ezetimibe in human milk. Ezetimibe is present in rat milk (see Data). When a drug is present in animal milk, it is likely that the drug will be present in human milk. There is no information about the effects of ezetimibe on the breastfed infant or the effects of ezetimibe on milk production. Ezetimibe should not be used in nursing mothers unless the potential benefit justifies the potential risk to the infant. Data Ezetimibe was present in the milk of lactating rats. The pup to maternal plasma ratio for total ezetimibe was 0.5 on lactation day 12.

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

Other names

UK brand names (per the NHS): Ezetrol.

Sources

  1. NHS, Ezetimibe (nhs.uk), page last reviewed 1 March 2023. Paraphrased. Contains public sector information licensed under the Open Government Licence v3.0.
  2. US drug label: Ezetimibe (oral), AvPAK, human prescription drug, label effective 13 January 2026, set ID 6fcbfbd9-6e09-8224-e053-2a91aa0a8226. DailyMed (National Library of Medicine). Public domain; quoted verbatim.
  3. Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Ezetimibe” (LM736), bulk release of 22 September 2026. LactMed on NCBI Bookshelf. Public domain; quoted verbatim. LactMed is a registered trademark of the U.S. Department of Health and Human Services.

Sources checked 26 September 2026. How we source and check every page.

Educational summary of named sources, not medical advice.