Ezetimibe reduces the amount of cholesterol absorbed by the body. Simvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins."

Ezetimibe and simvastatin is a combination medicine that is used to lower blood levels of "bad" cholesterol (low-density lipoprotein, or LDL), to increase levels of "good" cholesterol (high-density lipoprotein, or HDL), and to lower triglycerides (a type of fat in the blood).

Ezetimibe and simvastatin is used together with a low-fat diet and other treatments to lower total cholesterol in adults and children who are at least 10 years old. It is not known whether this medicine reduces your risk of heart disease.

Ezetimibe and simvastatin may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to simvastatin (Zocor) or ezetimibe (Vytorin, Zetia), or if you have:

• active liver disease; or
• abnormal liver function tests.

Do not use if you are pregnant. This medicine can harm an unborn baby. Use effective birth control to prevent pregnancy. Stop taking this medicine and tell your doctor at once if you become pregnant.

Do not breastfeed while taking ezetimibe and simvastatin.

Ezetimibe and simvastatin can cause the breakdown of muscle tissue, which can lead to kidney failure. This happens more often in women, in older adults, in people of Chinese descent, and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Other medicines may increase your risk of serious muscle problems if you take them together with ezetimibe and simvastatin. Do not take these medicines at the same time:

• cyclosporine;
• danazol;
• gemfibrozil;
• nefazodone;
• an antibiotic--clarithromycin, erythromycin, telithromycin;
• antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;
• hepatitis C medications--boceprevir, telaprevir; or
• HIV/AIDS medication--atazanavir, cobicistat, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir.

Your doses of certain other medicines may need to be adjusted while you are taking ezetimibe and simvastatin. This includes:

• amiodarone or dronedarone;
• amlodipine (sometimes in combination medicines--Azor, Caduet, Consensi, Exforge, Lotrel, Prestalia, Twynsta, Tribenzor);
• colchicine;
• diltiazem, verapamil;
• fenofibrate, fenofibric acid;
• lomitapide;
• ranolazine; or
• medicines that contain niacin, nicotinic acid, or vitamin B3, such as Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others.

Tell your doctor if you have ever had:

• unexplained weakness or muscle pain;
• a thyroid disorder;
• liver or kidney disease;
• liver problems caused by alcohol;
• a habit of drinking more than 2 alcoholic drinks per day; or
• if you are older than 65.

Ezetimibe and simvastatin is not approved for use by anyone younger than 10 years old.

This medicine should not be given to a girl who has not yet had menstrual periods.

Use Ezetimibe And Simvastatin (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• unexplained muscle pain, tenderness, or weakness;
• muscle weakness in your hips, shoulders, neck, and back;
• trouble lifting your arms, trouble climbing or standing;
• fever, unusual tiredness;
• upper stomach pain, loss of appetite;
• dark colored urine; or
• jaundice (yellowing of the skin or eyes).

Common side effects may include:

• headache;
• muscle pain;
• abnormal liver function tests;
• diarrhea; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Grapefruit may interact with ezetimibe and simvastatin and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Avoid eating foods high in fat or cholesterol, or ezetimibe and simvastatin will not be as effective.