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Zileuton Side Effects

For the Consumer

Applies to zileuton: oral tablet, oral tablet extended release

Along with its needed effects, zileuton may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking zileuton:

Rare
  • Flu-like symptoms
  • itching
  • right upper stomach pain
  • unusual tiredness or weakness
  • yellow eyes or skin
Incidence not known
  • Attack, assault, or force
  • attempts at killing oneself
  • discouragement
  • dry mouth
  • fear or nervousness
  • feeling sad or empty
  • hyperventilation
  • irregular heartbeats
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • sleeplessness
  • tiredness
  • trembling or shaking of the hands or feet
  • trouble with concentrating
  • trouble with sleeping
  • unable to sleep

Some side effects of zileuton may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Cough
  • fever
  • headache
  • nausea
  • pain or tenderness around the eyes and cheekbones
  • stuffy or runny nose
  • tightness of the chest or wheezing
  • troubled breathing
  • upset stomach
Less common
  • Abdominal or stomach pain
  • sore throat
  • weakness

For Healthcare Professionals

Applies to zileuton: oral tablet, oral tablet extended release

General

The most commonly occurring adverse reactions are sinusitis, nausea, and pharyngolaryngeal pain.[Ref]

Nervous system

Very common (10% or more): Headache (up to 24.6%)
Common (1% to 10%): Hypertonia, nervousness, dizziness, somnolence[Ref]

Dermatologic

Common (1% to 10%): Pruritus, urticaria[Ref]

Gastrointestinal

Common (1% to 10%): Dyspepsia (8.2%), nausea (5.5%), diarrhea (5%), abdominal pain, upper abdominal pain, vomiting, constipation, flatulence[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, vaginitis[Ref]

Hematologic

Common (1% to 10%): Low white blood cell count (2.6%)[Ref]

The WBC counts returned to normal or baseline following discontinuation of this drug. The clinical significance of these findings is not known.[Ref]

Hepatic

Common (1% to 10%): Hepatotoxicity, ALT elevations (1.8%)
Postmarketing reports: Hepatic injury, including death, life-threatening liver injury with recovery, symptomatic jaundice, hyperbilirubinemia, and elevations of ALT more than 8 times ULN[Ref]

The majority of ALT elevations (82%) were reported within the first 3 months of treatment and resolved within 21 days for most of these patients after discontinuation of the drug. In the extended release group, the majority of ALT elevations (60%) occurred in the first month of treatment; in a few patients, the levels returned to less than 2 times ULN or normal within 9 and 12 days.
The hepatic function enzyme elevations did not result in any cases of jaundice, development of chronic liver disease, or death in this clinical trial. In patients who discontinued this drug, ALT levels dropped below 2 times ULN in approximately one month.[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity, rash[Ref]

Immunologic

Common (1% to 10%): Lymphadenopathy[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia (7%), arthralgia, neck pain/rigidity[Ref]

Ocular

Common (1% to 10%): Conjunctivitis[Ref]

Other

Common (1% to 10%): Pain (7.8%), asthenia (3.8%), accidental injury (3.4%), fever, malaise[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Postmarketing reports: Sleep disorders, behavior changes[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infections (9%), sinusitis (6.5%), pharyngolaryngeal pain (5%), chest pain[Ref]

References

1. "Product Information. Zyflo (zileuton)." Abbott Pharmaceutical, Abbott Park, IL.

2. "Product Information. Zyflo CR (zileuton)." Cornerstone Therapeutics, Cary, NC.

3. "Product Information. Zylo Filmtab (zileuton)." Abbott Pharmaceutical, Abbott Park, IL.

4. Hackshaw KV, Shi Y, Brandwein SR, Jones K, Westcott JY "A pilot study of zileuton, a novel selective 5-lipoxygenase inhibitor, in patients with systemic lupus erythematosus." J Rheumatol 22 (1995): 462-8

5. Weinblatt ME, Kremer JM, Coblyn JS, Helfgott S, Maier AL, Petrillo G, Henson B, Rubin P, Sperling R "Zileuton, a 5-lipoxygenase inhibitor in rheumatoid arthritis." J Rheumatol 19 (1992): 1537-41

6. Israel E, Rubin P, Kemp JP, Grossman J, Pierson W, Siegel SC, Tinkelman D, Murray JJ, Busse W, Segal AT, et al "The effect of inhibition of 5-lipoxygenase by zileuton in mild-to- moderate asthma." Ann Intern Med 119 (1993): 1059-66

7. Israel E, Cohn J, Dube L, Drazen JM "Effect of treatment with zileuton, a 5-lipoxygenase inhibitor, in patients with asthma. A randomized controlled trial. Zileuton Clinical Trial Group." JAMA 275 (1996): 931-6

Some side effects of zileuton may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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