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The following safety warnings and precautions are essential for the safe use of Vytorin (ezetimibe/simvastatin). It is important to review these carefully and consult your healthcare provider with any concerns or questions.

• Severe Muscle Pain and Damage: Vytorin may lead to muscle pain, tenderness, or weakness. In severe cases, it can cause muscle breakdown (rhabdomyolysis), which can be life-threatening. Contact your healthcare provider immediately if you experience fever, muscle pain, or weakness. Be cautious about starting new medications without consulting your provider, as some drugs may increase the risk of rhabdomyolysis. Those at higher risk include older adults, individuals taking 80 mg of simvastatin, those with kidney problems, people on other medications that affect muscles, and individuals with a history of uncontrolled hypothyroidism.

• Liver Problems: Vytorin may cause liver irritation, often detected only through blood tests. While liver enzyme levels usually normalize after stopping the medication, serious liver issues have been reported. Your healthcare provider might conduct liver function tests before and during treatment. Seek immediate medical attention if you notice symptoms such as nausea, abdominal pain, jaundice, or changes in stool color. Risk factors include a history of liver issues and consuming large amounts of alcohol.

• High Blood Sugar: Some individuals may experience increased blood sugar levels, potentially leading to elevated hemoglobin A1C levels. Inform your healthcare provider if you have a history of high blood sugar before starting Vytorin. Maintaining a healthy diet and regular exercise is advised. Regular monitoring of blood sugar levels may be necessary.

Contraindications: Avoid using Vytorin if any of the following conditions apply, as they may pose significant health risks:

• Concurrent use with specific medications, such as azole antifungals, macrolide antibiotics, certain antiviral drugs, nefazodone, cyclosporine, or gemfibrozil.
• Existing liver problems.
• Pregnancy and breastfeeding.

Adhering to these guidelines is critical for your safety while on Vytorin. Always follow your healthcare provider’s advice and report any unusual symptoms or concerns.

Common side effects:

• Headaches
• Muscle pain
• Runny nose
• Cough
• Diarrhea

Less common but important to monitor:

• Tiredness
• Pain in the arms, hands, legs, and feet
• Skin rashes or changes

Serious side effects:

• Rhabdomyolysis (muscle breakdown)
• Serious liver problems
• Allergic reaction

Interactions with high risk of serious adverse effects and should be avoided:

• red yeast rice products
• niacin (in doses of 1 gram or more)

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• warfarin
• cyclosporine
• danazol
• daptomycin
• gemfibrozil
• azole antifungals (such as itraconazole, ketoconazole, posaconazole, voriconazole)
• cobicistat
• colchicine
• macrolide antibiotics (such as clarithromycin, erythromycin)
• nefazodone
• HIV protease inhibitors (such as nelfinavir)
• ritonavir
• telithromycin