VYTORIN (ezetimibe/simvastatin) Side Effects
Important Risk Information About VYTORIN (ezetimibe/simvastatin) | Patient Information | Prescribing Information | For Health Care Professionals
VYTORIN Treats the 2 sources of cholesterol
Possible Side Effects When Taking VYTORIN
See your doctor regularly to check your cholesterol level and to check for side effects. Your doctor should do blood tests to check your liver before you start taking VYTORIN and if you have any symptoms of liver problems while you take VYTORIN. Call your doctor right away if you have the following symptoms of liver problems:
  • Feel tired or weak
  • Loss of appetite
  • Upper belly pain
  • Dark urine
  • Yellowing of your skin or the whites of your eyes

In clinical studies, patients reported the following common side effects while taking VYTORIN:
  • Headache
  • Muscle pain
  • Diarrhea

The following side effects have been reported in general use with VYTORIN or with ezetimibe or simvastatin tablets (tablets that contain the active ingredients of VYTORIN):
  • Allergic reactions including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing (which may require treatment right away), rash, hives
  • Raised red rash, sometimes with target-shaped lesions
  • Joint pain
  • Muscle pain, tenderness, or weakness
  • Alterations in some laboratory blood tests
  • Liver problems (sometimes serious)
  • Inflammation of the pancreas
  • Nausea
  • Dizziness
  • Tingling sensation
  • Depression
  • Gallstones
  • Inflammation of the gallbladder
  • Trouble sleeping
  • Poor memory
  • Memory loss
  • Confusion
  • Erectile dysfunction
  • Breathing problems including persistent cough and/or shortness of breath or fever
Tell your doctor if you are having these or any other medical problems while on VYTORIN. This is not a complete list of side effects. For a complete list, ask your doctor or pharmacist.

VYTORIN contains two cholesterol medicines, Zetia (ezetimibe) and Zocor (simvastatin), in a single tablet. VYTORIN has not been shown to reduce heart attacks or strokes more than Zocor alone.

Important Risk Information About
VYTORIN (ezetimibe/simvastatin)
VYTORIN is a prescription tablet and isn't right for everyone. This includes anyone taking certain medicines or foods that may increase your risk of serious muscle problems with VYTORIN. These medicines include certain antifungals and antibiotics, HIV protease inhibitors, certain hepatitis C virus protease inhibitors, nefazodone, gemfibrozil, cyclosporine, and danazol. So, tell your doctors about any other medications you are taking. VYTORIN also isn't right for people who are allergic to any of its ingredients, women who are nursing or pregnant or who may become pregnant, and anyone with liver problems.

Unexplained muscle pain or weakness could be a sign of a rare but serious side effect and should be reported to your doctor right away. This side effect can rarely cause kidney damage that can lead to death. Also notify your doctor if you have muscle problems that do not go away even after your doctor has advised you to stop taking VYTORIN. The risk of serious muscle problems is greater with higher doses of VYTORIN, particularly the highest dose (10/80 mg). The highest dose should only be used by people who have been taking it chronically (such as 12 months or more) without having muscle damage and who don't need to take certain other medicines.

Your doctor should do simple blood tests to check for liver problems before treatment with VYTORIN and if you have symptoms of liver problems during treatment. Tell your doctor right away if you feel tired or weak or if you have loss of appetite, upper belly pain, dark urine, or yellowing of your skin or the whites of your eyes. Side effects of VYTORIN included headache, muscle pain, and diarrhea.

For more information, see FAQs About VYTORIN.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the Patient Information for VYTORIN and discuss it with your doctor. The physician Prescribing Information also is available.

This site is intended only for residents of the United States, its territories, and Puerto Rico.

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