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The following safety information and warnings are essential for anyone considering the use of fenofibrate. Please review and discuss with your healthcare provider to ensure safe usage.

• Liver Concerns: Fenofibrate may lead to serious liver damage, potentially resulting in liver failure or death. Liver damage can occur at any point during treatment but may resolve upon discontinuation of the medication. Regular blood tests are necessary before and during treatment to monitor liver health. If you experience stomach swelling, pain, nausea, vomiting, jaundice, changes in stool, or confusion, seek immediate medical attention. Avoid using fenofibrate if you have existing liver conditions.

• Muscle Issues (Myopathy and Rhabdomyolysis): There is an increased risk of muscle damage, which can progress to muscle breakdown affecting other organs. This risk is heightened when taking medications like statins or if you have conditions such as diabetes. Consult your provider if you're using other medications that could lead to muscle damage. Immediate medical help is essential if you notice fever, sudden muscle pain, cramps, weakness, or dark urine. Higher risks exist for older adults, those with kidney failure, diabetes, or hypothyroidism, and those on other muscle-damaging medications.

• Kidney Effects: Some individuals may exhibit increased creatinine levels, indicating possible kidney damage. It's uncertain if fenofibrate directly affects kidney function. A lower starting dose and regular kidney function tests are recommended, especially for individuals over 65, or those with diabetes or existing kidney issues. Report any changes in urination or dark urine to your provider.

• Allergic Reactions: Life-threatening allergic reactions can occur. Symptoms include mouth or facial swelling and anaphylaxis. Discontinue use and seek immediate medical help if you experience hives, lip or tongue swelling, or breathing difficulties.

• Gallstones: Fenofibrate can increase the risk of gallstones, contraindicating its use in individuals with gallbladder issues. Notify your provider if you experience stomach or back pain, nausea, or vomiting.

• Pancreatitis: Rare cases of pancreatic inflammation have been reported, possibly due to lingering high triglyceride levels or the medication itself. Sudden stomach pain, nausea, vomiting, or abdominal fluid buildup should prompt medical evaluation.

• Blood Clots: The risk of blood clots in the lungs (pulmonary embolism) or legs (deep vein thrombosis) may increase. Seek urgent care if you experience chest pain, difficulty breathing, leg swelling, or tender, warm skin.

Contraindications: Fenofibrate should not be used by individuals with severe kidney disease, those on dialysis, with liver or gallbladder disease, or nursing mothers. Always consult your healthcare provider if any of these conditions apply to you before starting treatment.

Common side effects:

• Stomach pain
• Liver issues
• Lung problems
• Back pain
• Headache
• Nasal congestion
• Nausea
• Constipation
• Skin rash

Serious side effects:

• Severe allergic reactions
• Liver damage
• Muscle problems
• Blood clots in the lungs or legs
• 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