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Fenofibrate Safety and Warning Information

When using fenofibrate, it is essential to be aware of several important safety considerations. The following information outlines potential risks, necessary precautions, and actions to take in case of adverse reactions. 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 death. Regular blood tests are required before and during treatment to monitor liver health. Discontinue use and seek immediate medical attention if you experience symptoms such as abdominal swelling, pain, nausea, vomiting, jaundice, stool changes, or confusion. Avoid fenofibrate if you have existing liver conditions. Higher doses increase the risk.

• Muscle Damage (Myopathy and Rhabdomyolysis): This medication can increase the risk of muscle damage, which may lead to rhabdomyolysis, affecting other organs. The risk is heightened if taken with other muscle-impacting drugs like statins or if you have conditions such as diabetes. Contact medical professionals promptly if you experience fever, sudden muscle pain, cramps, weakness, or dark urine. Increased risk factors include advanced age, kidney failure, diabetes, and hypothyroidism.

• Kidney Function: Some patients have shown elevated creatinine levels, indicating possible kidney impairment. Although it's uncertain if fenofibrate directly affects kidney function, your provider may prescribe a lower dose and monitor kidney health through blood tests. Notify your provider if you notice changes in urination or dark urine. Those over 65, with diabetes, or pre-existing kidney issues, are at greater risk.

• Allergic Reactions: Severe allergic reactions, including anaphylaxis, can occur. Symptoms may include swelling of the mouth or face, hives, and breathing difficulties. Discontinue use immediately and seek emergency medical care if these occur.

• Gallstones: Fenofibrate may increase the risk of gallstones. It is contraindicated for individuals with gallbladder issues. Report any abdominal or back pain, nausea, or vomiting to your provider promptly.

• Pancreatitis: Though rare, fenofibrate has been associated with pancreatitis. This may be due to high triglyceride levels or other factors. Seek medical advice if you experience acute abdominal pain, nausea, vomiting, or fluid accumulation in the abdomen.

• Blood Clots: There is an increased risk of blood clots, including pulmonary embolism and deep vein thrombosis. Immediate medical help is necessary if you experience chest pain, difficulty breathing, leg swelling, or warm, tender skin.

Contraindications: Fenofibrate should not be used if you have severe kidney disease, are on dialysis, have liver disease, gallbladder disease, or are nursing. Consult your healthcare provider for guidance if any of these apply to you.

When taking this medication, it is essential to be aware of possible side effects. Commonly reported mild side effects include liver damage, lung issues, and stomach pain, which may occur in a small percentage of users. Other mild side effects may include back pain, headache, stuffy nose, nausea, constipation, and rash. These are generally not cause for concern but should be discussed with a healthcare provider if they persist.

There are rare but serious side effects associated with this medication that require immediate medical attention. These include the risk of gallstones, liver problems such as jaundice or dark urine, severe muscle problems potentially leading to rhabdomyolysis, and severe lowering of HDL cholesterol levels. If you experience persistent nausea, loss of appetite, abdominal pain, muscle pain combined with fever or unusual tiredness, or changes in urination, seek medical advice promptly.

Additionally, be alert to symptoms of severe allergic reactions, such as rash, itching, swelling, severe dizziness, and difficulty breathing, as these require urgent care. Blood clots in the lungs or legs are another serious concern, marked by chest pain, swelling, and redness, particularly in the legs. Always consult your healthcare provider for persistent or severe symptoms, and ensure your HDL levels are regularly checked to prevent paradoxical reactions.

When taking fenofibrate, it is important to be aware of potential drug interactions. Avoid using fenofibrate with medications containing fenofibric acid, as they are very similar. Also, be cautious with "blood thinners" like warfarin, as they can interact with fenofibrate.

Other medications that may interact with fenofibrate include ciprofibrate, which is generally not recommended to be used together. However, for certain medications like acenocoumarol, anisindione, atorvastatin, colchicine, dicumarol, fluvastatin, lovastatin, phenprocoumon, pitavastatin, pravastatin, rosuvastatin, simvastatin, and warfarin, a doctor might adjust the dosage or usage frequency if both are prescribed.

Additionally, using fenofibrate with colestipol, cyclosporine, ezetimibe, or rosiglitazone may increase the risk of side effects. In such cases, your healthcare provider may need to modify how you take these medications. Always inform your doctor and pharmacist about all other medicines and supplements you are taking to manage these interactions safely.