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The following safety information outlines critical warnings and precautions for using this medication. Review the details carefully and consult your healthcare provider with any questions or concerns.

• Liver Issues: Zileuton (Zyflo CR) may lead to liver problems. Your healthcare provider will monitor your liver function tests before you begin treatment, every two to three months during the first year, and periodically afterward. It is important to limit alcohol consumption. Immediately contact your provider if you experience symptoms like severe nausea, vomiting, fatigue, loss of appetite, pale stools, or yellowing of the skin or eyes, as these could indicate liver damage. This medication is not suitable for individuals with active liver disease or impaired liver function.

• Sleep Disorders and Mood Changes: Individuals taking zileuton (Zyflo CR) may be at an increased risk of experiencing sleep disturbances, unusual behavior, or mood alterations. If you detect any changes in your sleep patterns, behavior, or mood, notify your healthcare provider promptly.

• Asthma Symptom Worsening: Should you find yourself needing your rescue inhaler more often, it might suggest that your asthma is not properly managed with this medication. Discuss your symptoms with your healthcare provider to consider alternative asthma treatments.

There are currently no contraindications listed for this medication.

When taking this medication, some individuals may experience mild side effects such as stomach upset or abdominal pain. These symptoms are generally not severe, but if they persist or worsen, it is advisable to consult a healthcare provider. Additionally, some people may experience sinus inflammation, nausea, or throat pain, which are typically mild and manageable.

There are also more serious side effects that, although rare, require immediate medical attention. These include symptoms indicative of liver issues, such as persistent nausea or vomiting, loss of appetite, stomach pain, yellowing of the eyes or skin, and dark urine. Serious allergic reactions, such as rash, swelling, severe dizziness, or trouble breathing, also necessitate urgent care.

Moreover, changes in mental or mood conditions can occur, including trouble sleeping, agitation, hallucinations, depression, or even thoughts of self-harm. If you notice any of these symptoms, it is crucial to seek medical assistance promptly to ensure your safety and well-being. Always stay informed about the potential side effects and communicate with your healthcare provider as needed.