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Febuxostat is associated with certain serious risks and requires careful consideration before use. It is crucial to review the following safety information and discuss any concerns with your healthcare provider.

• Cardiovascular Risks: Febuxostat may lead to severe heart-related side effects, including heart attacks and strokes. Inform your doctor if you have a history of heart disease, experience chest pain, or have previously suffered a heart attack or stroke. Immediate medical attention is necessary if you experience symptoms such as chest, jaw, or left arm pain, unusual sweating, shortness of breath, irregular heartbeat, dizziness, fainting, weakness on one side, sudden vision changes, confusion, trouble speaking, or an intense headache. Febuxostat is generally recommended only when allopurinol is ineffective or unsuitable.

• Gout Flare-ups: Initial treatment with febuxostat may increase the frequency of gout attacks due to changes in uric acid levels. Your healthcare provider may prescribe additional medication to help manage these attacks during the early stages of treatment.

• Liver Damage: Although rare, febuxostat can cause serious liver damage. Regular liver function tests will be conducted by your provider, and the medication may be discontinued if abnormalities are found. Report any signs of liver issues, such as yellowing of the skin or eyes, to your healthcare provider immediately.

• Skin Reactions: Severe skin reactions have been reported in rare cases. If you have previously experienced such reactions with allopurinol, you may be at risk with febuxostat as well. Discontinue use and seek medical advice if you notice symptoms like red, swollen, blistered, or peeling skin.

• Contraindications: Avoid using febuxostat if you are taking medications like azathioprine or mercaptopurine, as these combinations can pose serious health risks. Discuss any current medications with your healthcare provider.

Always ensure open communication with your healthcare provider regarding your medical history and any other medications you are taking to safely manage your treatment with febuxostat.

Common side effects:

• Nausea
• Rash
• Joint pain
• Changes in liver labs

Less common but important to monitor:

• Ringing in the ears
• Blurry vision
• Vomiting
• Upset stomach
• Gas
• Heartburn
• Stomach ulcers
• Changes in taste and appetite
• Dehydration
• Low blood cells
• Muscle pain
• Stiffness
• Anxiety
• Trouble sleeping
• Mood changes
• Cold or flu-like symptoms

Serious side effects:

• Severe skin reactions (red, swollen, blistered, or peeling skin)
• Liver problems (yellowing of the skin or eyes, persistent nausea, vomiting, dark urine, and itchiness)
• Chest pain

When taking febuxostat, it's important to be aware of potential interactions with other medications:

• Azathioprine and Mercaptopurine: These medications are metabolized by xanthine oxidase, the enzyme that febuxostat inhibits. Combining them with febuxostat can lead to increased levels of these drugs in the blood, raising the risk of severe toxicity. Therefore, concurrent use is contraindicated.

• Theophylline: As theophylline is also metabolized by xanthine oxidase, using it alongside febuxostat may result in elevated theophylline levels, potentially leading to adverse effects. Concurrent use is contraindicated.

• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Studies have shown that febuxostat can be co-administered with NSAIDs like Indomethacin and Naproxen without significant interactions. While naproxen may slightly increase febuxostat levels, this effect is not considered clinically significant, and no dose adjustments are necessary.

• Hydrochlorothiazide: Co-administration with hydrochlorothiazide does not require dose adjustments for febuxostat.

• Warfarin: Febuxostat does not significantly affect the pharmacokinetics of warfarin, so they can be used together without dose modifications.

• Desipramine: Febuxostat has a weak inhibitory effect on CYP2D6, the enzyme that metabolizes desipramine. However, this interaction is not considered clinically significant, and no dose adjustment is typically required.

Always inform your healthcare provider about all medications and supplements you are taking to ensure safe and effective use of febuxostat.