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What is the most important information I should know about zileuton?

Call your doctor at once if you have nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These may be early signs of liver problems. Do not use zileuton to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medication to treat an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks. It may take up to a few weeks of using this medicine before your symptoms improve. For best results, keep using zileuton as directed, even if you feel fine. Having no asthma symptoms is a sign that the medication is working.

Call your doctor right away if you feel that this medicine is not working as well as usual, or if it makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.

Avoid drinking alcohol while you are taking zileuton. Alcohol can increase your risk of liver damage.

What is zileuton?

Zileuton is a leukotriene (loo-koe-TRY-een) inhibitor. Leukotrienes are chemicals your body releases when you breathe in an allergen (such as pollen). These chemicals cause swelling in your lungs and tightening of the muscles around your airways, which can result in asthma symptoms.

Zileuton is used to prevent asthma attacks in adults and children as young as 12 years old.

Zileuton may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking zileuton?

Do not use this medication if you are allergic to zileuton, or if you have liver disease.

Before using zileuton, tell your doctor if you are allergic to any drugs, if you have liver disease, or if you drink alcohol. You may not be able to use zileuton, or you may need a dose adjustment or special tests to safely take zileuton

Zileuton is in the FDA pregnancy category C. This means that it is not known whether zileuton will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is not known whether zileuton passes into breast milk. Do not take zileuton without first talking to your doctor if you are breast-feeding a baby. Do not give this medication to a child without a doctor's advice.