Precautions and Warnings With Zileuton CR

To ensure a safe treatment process, it is important to be aware of the precautions and warnings with zileuton CR. Some of these precautions include possible drug interactions, the safety of using zileuton CR while pregnant or breastfeeding, and the risk of this drug causing liver damage. You should not use zileuton CR if you have liver disease, high liver enzymes, or if you are allergic to any of the components used to make the medicine.

Zileuton CR: What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking zileuton CR (Zyflo CR™) if you have:
  • Liver disease, such as liver failure or cirrhosis
  • Any allergies, including allergies to food, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
Make sure to tell your healthcare provider about any other medicines you are taking, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Some Precautions and Warnings With Zileuton CR

Some of the warnings and precautions to be aware of with zileuton CR include the following:
  • Zileuton CR is not a fast-acting asthma medication and cannot replace fast-acting rescue inhalers. Do not use zileuton CR to treat an asthma attack after it starts. Everyone taking zileuton CR for asthma should also have a rescue asthma medication available at all times. Let your healthcare provider know if you need to use your rescue inhaler more often than normal, as this may be a sign that your asthma is getting worse.
  • Zileuton CR can cause liver damage, which can result in liver failure or death. Let your healthcare provider know right away if you have signs of liver problems, such as:
    • Upper right abdominal pain (stomach pain)
    • Nausea
    • Fatigue
    • Flu symptoms (such as fever or chills)
    • Loss of appetite
    • Yellowing of the whites of the eyes or skin
    • Dark urine.


Zileuton CR is not recommended for people who already have liver disease or for people who regularly drink large amounts of alcohol (which can also damage the liver).
  • Your healthcare provider should check your liver enzymes (using a simple blood test) before you start zileuton CR and regularly while you are taking zileuton CR, in order to detect any liver damage.
  • Zileuton CR can interact with other medications (see Drug Interactions With Zileuton CR).
  • Zileuton CR is considered a pregnancy Category C medication. This means that zileuton CR may not be safe for use in pregnancy, although the full risks are not known. Talk to your healthcare provider about the risks and benefits of using zileuton CR during pregnancy (see Zyflo CR and Pregnancy for more information).
  • It is not known if zileuton CR passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, be sure to talk with your healthcare provider about using zileuton CR (see Zyflo CR and Breastfeeding for more information).
ADHD and Girls

Zileuton CR for Asthma

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