Fluvastatin is used together with diet 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).

Fluvastatin is used to slow the build-up of plaque (fatty deposits) in your blood vessels.

Fluvastatin is also used to lower the risk of heart complications in certain people with coronary heart disease.

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

Fluvastatin may also be used for purposes not listed in this medication guide.

You should not take fluvastatin if you are allergic to it, or if:

• you have active liver disease; or
• you are pregnant or breastfeeding.

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 using this medicine.

Tell your doctor if you have ever had:

• liver disease;
• muscle pain or weakness;
• kidney disease;
• diabetes;
• a thyroid disorder; or
• if you drink more than 2 alcoholic beverages daily.

Fluvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, 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).

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

Use Lescol XL (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; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, fluvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, 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, or dark colored urine.

Also call your doctor at once if you have:

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

Common side effects may include:

• muscle pain;
• headache; or
• stomach pain, nausea, or indigestion.

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.

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

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