Do NOT use Zetia if:

• you are allergic to any ingredient in Zetia
• you have moderate to severe liver problems.

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Zetia. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of liver problems or unexplained muscle pain, tenderness, or weakness
• if you have kidney problems or thyroid problems
• if you are taking other cholesterol-lowering medicines.

Some medicines may interact with Zetia. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Fibrates (eg, fenofibrate, gemfibrozil) because the risk of gallstones may be increased
• Cholestyramine because it may decrease Zetia's effectiveness
• Anticoagulants (eg, warfarin) or cyclosporine because the risk of their side effects may be increased by Zetia.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zetia may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

• Zetia may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Zetia with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
• For best results, Zetia should be used along with exercise, a low-cholesterol and low-fat diet, and a weight loss program if you are overweight. Follow the diet and exercise program given to you by your health care provider.
• Do NOT take more than the recommended dose without checking with your doctor.
• If you experience unexplained muscle pain, weakness, or tenderness, contact your doctor.
• Lab tests, including liver function and cholesterol levels, may be performed while you use Zetia. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Zetia should not be used in children younger 10 years; safety and effectiveness in these children have not been confirmed.
• Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zetia while you are pregnant. It is not known if Zetia is found in breast milk. If you are or will be breast-feeding while you use Zetia, check with your doctor. Discuss any possible risks to your baby.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Diarrhea; dizziness; headache; joint pain; sinus inflammation; tiredness.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; dark urine; depression; fever, chills, or persistent sore throat; numbness or tingling of the skin; severe or persistent joint pain; severe stomach or back pain with nausea and vomiting; unexplained muscle pain, tenderness, or weakness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.