[Skip navigation] FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug Administration U.S. Food and Drug Administration Center for Drug Evaluation and Research
  HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER

horizonal rule
CDER Home About CDER Drug Information Regulatory Guidance CDER Calendar Specific Audiences CDER Archives
 
Powered by Google
 
 

Patient Information Sheet
Ezetimibe (marketed as Zetia)

This is a summary of the most important information about Ezetimibe. For details, talk to your health care professional.


What is Zetia used for?

Zetia is a medicine used to lower levels of total cholesterol and LDL (bad) cholesterol in the blood. It is used for patients who cannot control their cholesterol levels by diet alone. It can be used by itself or with certain other medicines to treat high cholesterol. 

You should stay on a cholesterol-lowering diet while taking this medicine. Zetia works by reducing the amount of cholesterol your body absorbs. Zetia does not help you lose weight. 

Who should not take Zetia?

Do not take Zetia if you are allergic to ezetimibe, the active ingredient in Zetia, or to any of the inactive ingredients in Zetia. 

Do not take Zetia with other cholesterol-lowering medicines called statins if you have active liver disease. 

What should I tell my health care provider?

Tell your doctor if you:

  • have or had liver problems 
  • are pregnant, plan to become pregnant, or are breastfeeding 

Tell your health care provider about all your medical conditions. Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how Zetia works, or Zetia may affect how your other medicines work. 

What are some possible side effects of Zetia?
(This is NOT a complete list of side effects reported with Zetia. Your health care provider can discuss with you a more complete list of side effects.)

Side effects include: 

  • stomach pain 
  • tiredness 
  • muscle problems. Very rarely, patients have experienced severe muscle problems while taking Zetia, usually when Zetia was added to a statin drug. If you experience unexplained muscle pain, tenderness, or weakness while taking Zetia, contact your doctor immediately. You need to do this promptly, because on rare occasions, these muscle problems can be serious, with muscle breakdown resulting in kidney damage.
  • allergic reactions, including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing, rash and hives.
  • joint pain

For more detailed information about Zetia, ask your health care provider or pharmacist.

Zetia approved label [PDF]

Back to Top     Back to Drug Index

PDF requires the free Adobe Acrobat Reader

Date created: July 21, 2006

horizonal rule