Zocor belongs to a group of drugs called HMG CoA reductase inhibitors, or "statins."

Zocor 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).

Zocor is also used to lower the risk of stroke, heart attack, and other heart complications in people with diabetes, coronary heart disease, or other risk factors.

Zocor is used in adults and children who are at least 10 years old.

In rare cases, Zocor can cause a condition that results in the breakdown of skeletal muscle tissue, potentially leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Never take Zocor in larger amounts, or for longer than recommended by your doctor. Follow your doctor's dosing instructions very carefully. Taking too much of this medication may cause serious or life-threatening side effects.

Before taking Zocor, tell your doctor if you have ever had liver or kidney disease, diabetes, or a thyroid disorder, if you are of Chinese descent, or if you drink more than 2 alcoholic beverages daily.

Zocor can harm an unborn baby or cause birth defects. Do not use if you are pregnant or planning to become pregnant.

Grapefruit and grapefruit juice may interact with simvastatin and lead to potentially dangerous effects. Do not consume grapefruit products while taking this medication.

Some medicines can cause unwanted or dangerous effects when used with Zocor. Your doctor may need to change your treatment plan if you use certain antibiotics or antifungal medicines, hepatitis C medication, heart medication, or medicines to treat HIV/AIDS.

Stop taking this medication and tell your doctor right away if you become pregnant.

Take Zocor exactly as prescribed. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. Taking too much of this medication may cause serious or life-threatening side effects.

Zocor is usually taken at bedtime or with an evening meal. If you take this medicine more than once daily, take it with meals. Your doctor may occasionally change your dose to make sure you get the best results.

While using Zocor, you may need frequent blood tests at your doctor's office.

You may need to take Zocor on a long-term basis for the treatment of high cholesterol. You may need to stop using this medicine for a short time if you have surgery or a medical emergency. Do not stop taking this medicine unless your doctor tells you to.

Zocor is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture, heat, and light.

You should not take Zocor if you are allergic to simvastatin, or if:

• you have active liver disease; or

• you are pregnant or breastfeeding .

The following drugs can increase your risk of serious muscle problems if you take them together with Zocor. These drugs should not be used while you are taking Zocor:

• 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 (Stribild, Tybost), darunavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir.

Before you start taking Zocor, tell your doctor if you are already using any of these other medicines:

• lomitapide; or

• heart medication - amiodarone, amlodipine, diltiazem, dronedarone, ranolazine, verapamil.

To make sure Zocor is safe for you, tell your doctor if you have:

• history of liver disease;

• history of kidney disease;

• diabetes;

• a thyroid disorder; or

• if you drink more than 2 alcoholic beverages daily.

Zocor can cause a condition that results in the breakdown of skeletal muscle tissue, potentially leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

FDA pregnancy category X. This medicine can harm an unborn baby or cause birth defects. Do not take Zocor if you are pregnant. Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking this medicine.

Simvastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking Zocor.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit and grapefruit juice may interact with simvastatin and lead to unwanted side effects. Avoid the use of grapefruit products while taking Zocor.

Avoid eating foods that are high in fat or cholesterol. Zocor will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

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

Get emergency medical help if you have signs of an allergic reaction to Zocor: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Simvastatin can cause the breakdown of muscle tissue, which can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark urine.

Also call your doctor at once if you have:

• signs of a kidney problem - little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or

• muscle weakness in your hips, shoulders, neck, and back;

• trouble lifting your arms, trouble climbing or standing; or

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Zocor side effects may include:

• headache;

• constipation, nausea, stomach pain; 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.

Many drugs can interact with simvastatin. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Zocor, especially:

• delavirdine;

• fenofibrate; or

• fluconazole.

This list is not complete and many other drugs can interact with simvastatin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.