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.
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, medicines containing cobicistat, 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.
Additional Important Risk Information About VYTORIN (ezetimibe/simvastatin)
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 have loss of appetite, upper belly pain, dark urine, or yellowing of your skin or the whites of your eyes, or if you feel tired or weak. Side effects of VYTORIN included headache, increased liver enzyme levels, muscle pain, upper respiratory infection, 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.
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