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Zyflo Oral Precautions and Side Effects


IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate or effective for you. Consult your healthcare professional before using this drug.

Table of Contents

Generic Name: ZILEUTON - ORAL
Pronounced: (zye-LOO-ton)

Zyflo Oral Side Effects

Nausea, drowsiness, constipation, dizziness, trouble sleeping, gas, joint pain, eye redness, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

  • chest pain
  • neck pain/stiffness


Tell your doctor immediately if any of these rare but very serious side effects occur:

  • mental/mood changes (e.g., agitation, aggression, hallucinations, abnormal dreams, depression, suicidal thoughts/suicide)
  • yellowing skin/eyes
  • dark urine
  • severe stomach/abdominal pain
  • unusual tiredness
  • flu-like symptoms (e.g., headache, fever, chills, muscle aches)


A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing


This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Zyflo Oral Precautions

Before taking zileuton, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

  • active liver disease


Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • liver disease
  • alcohol use


This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages because alcohol may add to this drug's drowsiness/dizziness effects and possible liver problems.

Caution is advised when using this drug in elderly women because they may be more sensitive to the effects of the drug, especially liver toxicity.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Therefore, breast-feeding is not recommended while using zileuton. Consult your doctor before breast-feeding.

Zyflo Oral Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).


CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Copyright 2007 First DataBank, Inc.

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