ZYFLO CR® is not appropriate for all asthma patients1
  • ZYFLO CR® is contraindicated for patients with active liver disease or persistent hepatic function enzyme elevations 3X the upper limit of normal. ZYFLO CR® is also contraindicated for patients with a history of allergic reactions to zileuton or any of the other ingredients
  • ALT elevations were observed in 1.8% of patients treated with ZYFLO CR® vs 0.7% treated with placebo in a 6-month study
  • 82% of elevations were reported during the first 3 months of treatment
  • Most elevations resolved within 21 days after discontinuation



  • No jaundice, chronic liver disease, or deaths occurred in clinical trials with               ZYFLO CR®

Treating patients with ZYFLO CR

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If clinical signs and/or symptoms of liver dysfunction develop (eg, right upper quadrant pain, nausea, fatigue, lethargy, pruritus, jaundice, or “flu-like” symptoms) or transaminase elevations 5 times the upper limit of normal occur, discontinue ZYFLO CR® and follow hepatic function enzymes until normal. Use with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.

Please see Important Safety Information and full Prescribing Information.




Important Safety Information


ZYFLO CR® is a leukotriene synthesis inhibitor indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Do not use ZYFLO CR® to treat an acute asthma attack.

ZYFLO CR® is contraindicated for patients with active liver disease or persistent hepatic function enzyme elevations 3 times the upper limit of normal. Assessment of hepatic function enzymes prior to and during ZYFLO CR® therapy should be undertaken. ZYFLO CR® is also contraindicated for patients with a history of allergic reactions to zileuton or any of the other ingredients.

The active ingredient in ZYFLO CR® increases theophylline, warfarin, and propranolol levels. Dose adjustment of these other drugs and patient monitoring may be required. ZYFLO CR® should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease. Neuropsychiatric events, including sleeping disorders and behavioral changes, may occur with ZYFLO CR®.

The most common adverse reactions (>5%) include: sinusitis, nausea, and pharyngolaryngeal pain.