What are the possible side effects of ZETIA?

In clinical studies patients reported few side effects while taking ZETIA. These included diarrhea, joint pains, and feeling tired.

Patients have experienced severe muscle problems while taking ZETIA, usually when ZETIA was added to a statin drug. If you experience unexplained muscle pain, tenderness, or weakness while taking ZETIA, contact your doctor immediately. You need to do this promptly, because on rare occasions, these muscle problems can be serious, with muscle breakdown resulting in kidney damage.

Additionally, the following side effects have been reported in general use:

• Allergic reactions (which may require treatment right away) including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing, rash, and hives
• Raised red rash, sometimes with target-shaped lesions
• Joint pain
• Muscle aches
• Alterations in some laboratory blood tests
• Liver problems
• Stomach pain
• Inflammation of the pancreas
• Nausea
• Dizziness
• Tingling sensation
• Depression
• Headache
• Gallstones
• Inflammation of the gallbladder

Tell your doctor if you are having these or any other medical problems while on ZETIA. For a complete list of side effects, ask your doctor or pharmacist.

Unlike some statins, ZETIA has not been shown to prevent heart disease or heart attacks.

Additional Important Risk Information About ZETIA
ZETIA is a prescription medicine and should not be taken by people who are allergic to any of its ingredients. ZETIA can be taken alone or with a statin. Statins should not be taken by women who are nursing or pregnant or who may become pregnant, or by anyone with liver problems. If you have ever had liver problems or are pregnant or nursing, your doctor will decide if ZETIA alone is right for you. Your doctor may do blood tests to check your liver before you start taking ZETIA with a statin and during treatment.

Unexplained muscle pain or weakness could be a sign of a rare but serious side effect and should be reported to your doctor right away. In clinical studies, patients reported few side effects while taking ZETIA. These included diarrhea, joint pains, and tiredness.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the Patient Information and discuss it with your doctor. Also available is the physician Prescribing Information.