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The following safety information outlines critical warnings and precautions associated with the use of Zetia (ezetimibe). It is important to review these details carefully and consult with your healthcare provider if you have any concerns or questions.

• Risk of Severe Muscle Damage (Rhabdomyolysis): Zetia (ezetimibe), particularly when used in conjunction with statins, may lead to a rare but serious condition called rhabdomyolysis. This involves the breakdown of muscle tissue, which can subsequently cause severe kidney complications. If you experience symptoms such as intense muscle pain, dark urine, general weakness, or fatigue, discontinue the medication immediately and seek urgent medical attention. Individuals at higher risk include those aged 65 and older, those with existing kidney issues, individuals combining Zetia with statins, and those with uncontrolled hypothyroidism.

• Liver Damage Risk When Combined with Statins: The combination of Zetia (ezetimibe) with statins can result in liver damage. It is important to undergo liver function tests before and during treatment to ensure liver health is maintained. Often, any liver damage improves once the medication is discontinued. Seek medical help promptly if you observe symptoms such as jaundice (yellowing of the skin or eyes), nausea, vomiting, or dark-colored urine. If these symptoms occur, it may be necessary to stop taking Zetia to prevent further liver damage. Increased risk factors include a history of liver problems and concurrent use of Zetia with statins.

Please ensure to follow these guidelines and maintain regular communication with your healthcare provider throughout your treatment with Zetia.

Common side effects:

• Upper respiratory tract infections
• Diarrhea
• Joint pain
• Inflamed sinuses
• Pain in the arms or legs
• Rash
• Tiredness
• Headache
• Dizziness

Serious side effects:

• Liver damage
• Muscle pain, tenderness, or weakness
• Serious allergic reactions

Ezetimibe is a medication used to lower cholesterol levels by reducing the absorption of cholesterol in the intestines. While it is generally well-tolerated, it's important to be aware of potential interactions with other medications:

• Cyclosporine: Combining ezetimibe with cyclosporine can increase the levels of both drugs in the body. Patients taking both medications should have their cyclosporine levels closely monitored to avoid potential side effects.

• Fibrates: Ezetimibe's safety and effectiveness when used with fibrates other than Fenofibrate have not been thoroughly studied. Fibrates may increase cholesterol excretion into the bile, potentially leading to gallstones. Therefore, using ezetimibe with fibrates other than fenofibrate is not recommended until more research is available.

• Fenofibrate: If a patient taking both ezetimibe and fenofibrate experiences symptoms suggestive of gallstones, such as abdominal pain, further evaluation is necessary. Alternative cholesterol-lowering therapies should be considered in such cases.

• Bile Acid Sequestrants: Medications like Cholestyramine can reduce the absorption of ezetimibe, potentially decreasing its effectiveness. To minimize this interaction, ezetimibe should be taken at least two hours before or four hours after administering a bile acid sequestrant.

• Warfarin and Other Anticoagulants: Adding ezetimibe to warfarin therapy may affect blood clotting times. Patients on this combination should have their International Normalized Ratio (INR) monitored to ensure proper anticoagulation.

Always inform your healthcare provider about all medications you are taking to manage potential interactions effectively.