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Ezetimibe / simvastatin Pregnancy and Breastfeeding Warnings

Ezetimibe / simvastatin is also known as: Vytorin

Medically reviewed by Last updated on May 8, 2018.

Ezetimibe / simvastatin Pregnancy Warnings

There are no studies of ezetimibe-simvastatin use during pregnancy; however, there are rare reports of congenital anomalies in infants exposed to statins in utero. Animal reproduction studies of simvastatin in rats and rabbits showed no evidence of teratogenicity. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development.

Lipid-lowering drugs offer no benefit during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development. Atherosclerosis is a chronic process, and discontinuation of lipid-lowering drugs during pregnancy has little impact on long-term outcomes.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use of ezetimibe-simvastatin is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: X

Women of childbearing potential should be encouraged to use adequate contraception.

See references

Ezetimibe / simvastatin Breastfeeding Warnings

Use of ezetimibe-simvastatin is contraindicated.

Excreted into human milk: Yes (ezetimibe); Unknown (simvastatin, but a small amount of another drug in the same class as simvastatin is excreted into human milk)

The effects in the nursing infant are unknown.

Ezetimibe-simvastatin should not be used during breastfeeding because of a concern with disruption of infant lipid metabolism.

See references

References for pregnancy information

  1. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL:" ([1999]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Vytorin (ezetimibe-simvastatin)." Merck & Company Inc, West Point, PA.

References for breastfeeding information

  1. "Product Information. Vytorin (ezetimibe-simvastatin)." Merck & Company Inc, West Point, PA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.