Zileuton Side Effects

Brand Names: Zyflo CR, Zyflo

Please note - some side effects for Zileuton may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Zileuton - for the Consumer

Zileuton

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zileuton:

Nausea; stomach pain or upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; fever, chills, or persistent sore throat; flu-like symptoms; pale stools; right upper stomach pain; severe or persistent nausea or stomach pain; unusual tiredness or weakness; yellowing of the skin or eyes.

Zileuton Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zileuton Extended-Release Tablets:

Diarrhea; headache; muscle aches; nausea; nose or throat irritation; sinus inflammation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; fever, chills, or persistent sore throat; flu-like symptoms; pale stools; right upper stomach pain; severe or persistent nausea or stomach pain; unusual tiredness or weakness; yellowing of the skin or eyes.

Side Effects by Body System

Nervous system

Nervous system side effects have included headache in 24.6% and asthenia in 3.8% of patients. Other nervous system effects were dizziness, insomnia, nervousness, and somnolence in less than 1% of patients.

Gastrointestinal

Gastrointestinal side effects have most frequently included dyspepsia (8.2%), nausea (5.5%), and abdominal pain (4.6%). Constipation and flatulence were noted in less than 1% of patients.

Hepatic

Hepatic side effects have included elevation of liver transaminase ALT(SGPT) levels to greater than three times the upper normal limit in up to 3.2% of patients in clinical trials. One patient developed symptomatic hepatitis and three patients developed mild hyperbilirubinemia.

Females over the age of 65 appear to be at the greatest risk for zileuton-induced transaminase elevations. With continued zileuton therapy, 52% of patients with ALT elevations between 3 and 5 times the upper normal limit had ALT levels drop below two times the upper normal limit, while 21% continued to demonstrate rising levels to greater than five times the upper normal limit. In patients in whom zileuton was discontinued, ALT levels dropped below two times the upper normal limit in approximately one month.

Hematologic

Hematologic side effects have included reduced white blood cell counts in 1% of patients in clinical trials. Most cases were either transient or reversed upon discontinuation of zileuton.

Musculoskeletal

Musculoskeletal side effects have included myalgia and arthralgia.

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