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The safety of fenofibrate is of utmost importance, and it is essential to understand the potential risks, precautions, and steps to take in case of adverse reactions. Please review the following information and consult your healthcare provider if you have any questions or concerns:

• Liver Damage: Fenofibrate may cause severe liver damage, potentially leading to liver failure or even death. This risk can occur at any time during treatment and may resolve upon discontinuation. Regular blood tests are necessary to monitor liver health. Discontinue use and seek immediate medical attention if you experience symptoms such as abdominal swelling, pain, nausea, vomiting, jaundice, changes in stool color, or confusion. Avoid use if you have existing liver issues. Higher doses increase the risk.

• Muscle Damage: This medication may increase the risk of muscle injury, including severe breakdown (rhabdomyolysis), which can affect other organs. The risk is heightened if used with other muscle-affecting drugs like statins or in individuals with specific conditions such as diabetes. Notify your healthcare provider about all medications you are taking. Seek help if you experience fever, sudden muscle pain, cramps, weakness, or dark urine. Risks are higher for older adults, those with kidney failure, diabetes, low thyroid hormones, or on other muscle-damaging drugs.

• Kidney Effects: Some patients might show elevated creatinine levels, suggesting potential kidney issues. The exact impact on kidneys is unclear, but monitoring through blood tests is recommended. Start with a lower dose if you are 65 or older, have diabetes, or kidney problems. Report any changes in urination or urine color to your provider.

• Allergic Reactions: Possible life-threatening allergic reactions include swelling of the mouth or face and anaphylaxis. Discontinue use and seek emergency medical attention if you experience hives, swelling of lips or tongue, or breathing difficulties.

• Gallstones: Fenofibrate may increase the risk of gallstones. Do not use if you have gallbladder issues. Alert your provider if you experience stomach or back pain, nausea, or vomiting for gallstone evaluation.

• Pancreatitis: Rare cases of pancreatitis have been reported. Causes may include high triglyceride levels or the medication itself. Contact your provider if you experience sudden abdominal pain, nausea, vomiting, or fluid buildup.

• Blood Clots: There is a potential risk for blood clots in the lungs (pulmonary embolism) or legs (deep vein thrombosis). Seek immediate medical assistance if you have chest pain, breathing difficulties, leg swelling, or tender, warm skin.

It is critical to avoid fenofibrate if you have severe kidney disease or are on dialysis, have liver or gallbladder diseases, or are a nursing mother. Always consult your healthcare provider if any of these conditions apply to you before starting this medication.

Common side effects:

• back pain
• headaches
• stuffy nose
• nausea
• constipation
• rashes

Serious side effects:

• significant liver damage
• severe muscle issues (rhabdomyolysis)
• severe drop in HDL cholesterol
• blood clots
• infections
• very serious allergic reaction

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

• Ciprofibrate

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

• Acenocoumarol
• Anisindione
• Atorvastatin
• Colchicine
• Dicumarol
• Fluvastatin
• Lovastatin
• Phenprocoumon
• Pitavastatin
• Pravastatin
• Rosuvastatin
• Simvastatin
• Warfarin

Interactions with low risk that usually do not require a change in therapy:

• Colestipol
• Cyclosporine
• Ezetimibe
• Rosiglitazone