Ezetimibe is a medicine used to lower cholesterol in people who have high blood cholesterol. Ezetimibe works by reducing the amount of cholesterol your body absorbs from your intestines. High cholesterol can cause fatty deposits to form in your blood vessels which increases your risk of heart disease.

Ezetimibe is used in patients who cannot control their cholesterol levels by diet and exercise alone.

You can take ezetimibe as a single ingredient tablet or it is also available in a tablet that contains both ezetimibe and another cholesterol lowering medication called simvastatin. 

Ezetimibe 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.

Some cholesterol medications should not be taken at the same time. If you take ezetimibe with another cholesterol medicine, follow your doctor's dosing instructions very carefully.

You should not use ezetimibe if you have moderate to severe liver disease. You should not use this medicine with a "statin" cholesterol medicine if you have active liver disease, or if you are pregnant or breast-feeding a baby.

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.

Before taking this medicine

You should not use ezetimibe if you are allergic to it, or if you have:

• moderate to severe liver disease.

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

You should not use ezetimibe with a "statin" cholesterol medicine (Zocor, Lipitor, Crestor, and others) if:

• you have active liver disease;

• you are pregnant; or

• you are breastfeeding a baby.

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

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

• liver disease;

• kidney disease; or

• unexplained muscle pain or weakness.

Tell your doctor if you are pregnant or breastfeeding.

Use effective birth control to prevent pregnancy while you are using ezetimibe with a statin medicine. Tell your doctor if you plan to become pregnant.

Do not breastfeed if you take ezetimibe with a statin medicine.

Take ezetimibe exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Ezetimibe is usually taken once daily at the same time each day.

You may take this medicine with or without food.

Ezetimibe may be taken at the same time with fenofibrate, or with a statin medication such as atorvastatin, lovastatin, simvastatin, pravastatin, or fluvastatin.

Your treatment may also include diet, exercise, weight control, and blood tests.

You may need frequent medical tests, even if you have no symptoms.

Your cholesterol levels may not improve for up to 2 weeks.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Hyperlipidemia:

10 mg orally once a day.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

10 mg orally once a day

Usual Adult Dose for Sitosterolemia:

10 mg orally once a day.

Usual Pediatric Dose for Hyperlipidemia:

10 years or older: 10 mg orally once a day.

Usual Pediatric Dose for Homozygous Familial Hypercholesterolemia:

10 years or older: 10 mg orally once a day.

Usual Pediatric Dose for Sitosterolemia:

10 years or older: 10 mg orally once a day.

You should not use ezetimibe if you are allergic to it, or if you have:

• moderate to severe liver disease.

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

You should not use ezetimibe with a "statin" cholesterol medicine (Zocor, Lipitor, Crestor, and others) if:

• you have active liver disease;

• you are pregnant; or

• you are breastfeeding a baby.

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

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

• liver disease;

• kidney disease; or

• unexplained muscle pain or weakness.

Tell your doctor if you are pregnant or breastfeeding.

Use effective birth control to prevent pregnancy while you are using ezetimibe with a statin medicine. Tell your doctor if you plan to become pregnant.

Do not breastfeed if you take ezetimibe with a statin medicine.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.

Avoid eating foods high in fat or cholesterol, or this medicine will not be as effective.

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

Ezetimibe 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.

Side effects may be more likely in older adults.

Common ezetimibe side effects may include:

• diarrhea;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• pain in an arm or leg;

• joint pain; or

• muscle pain while taking ezetimibe with a statin.

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.

If you also take other cholesterol medication: Take ezetimibe 2 hours before or 4 hours after taking cholestyramine, colestipol, or colesevelam.

Tell your doctor about all your other medicines, especially:

• cyclosporine;

• fenofibric acid;

• gemfibrozil; or

• a blood thinner - warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may interact with ezetimibe, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during treatment to check your body's response to ezetimibe.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Liptruzet® (containing Atorvastatin, Ezetimibe)
• Nexlizet® (containing Bempedoic Acid, Ezetimibe)
• Vytorin® (containing Ezetimibe, Simvastatin)