Patients should be told that a rare side effect of Accolate is hepatic dysfunction, and to contact their physician immediately if they experience symptoms of hepatic dysfunction (eg. right upper quadrant abdominal pain, nausea, fatigue, lethargy, pruritus, jaundice, flu-like symptoms, and anorexia). Liver failure resulting in liver transplantation and death has occurred in patients taking Accolate .

What is Accolate used for?

Accolate is indicated for the chronic treatment of asthma and should be taken regularly as prescribed, even during symptom-free periods. Accolate is not a bronchodilator and should not be used to treat acute episodes of asthma. Patients receiving Accolate should be instructed not to decrease the dose or stop taking any other antiasthma medications unless instructed by a physician. Women who are breast-feeding should be instructed not to take Accolate. Alternative antiasthma medication should be considered in such patients.

The bioavailability of Accolate may be decreased when taken with food. Patients should be instructed to take Accolate at least 1 hour before or 2 hours after meals.

What are some possible side effects of Accolate?
(This is not a complete list of side effects reported with Accolate.� Your health care provider can discuss with you a more complete list of side effects.)

� headache
� infection
� GI upset
� pain
� fever
� hepatic dysfunction (esp. in females)
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