Zileuton Side Effects

Brand Names: Zyflo, Zyflo CR

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.

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:

Mild stomach pain or upset; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fever, chills, or persistent sore throat; mental or mood changes; sleep problems; symptoms of liver problems (eg, dark urine; flu-like symptoms; pale stools; persistent loss of appetite; right upper stomach pain; unusual nausea, sluggishness, or tiredness; yellowing of the skin or eyes); unusual changes in behavior.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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 irritation; sinus pain; symptoms of upper respiratory tract infection (eg, cough, mild sore throat, runny or stuffy nose, sneezing); throat pain or irritation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fever, chills, or persistent sore throat; mental or mood changes; sleep problems; symptoms of liver problems (eg, dark urine; flu-like symptoms; pale stools; persistent loss of appetite; right upper stomach pain; unusual nausea, sluggishness, or tiredness; yellowing of the skin or eyes); unusual changes in behavior.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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.

Psychiatric

Psychiatric side effects have postmarketing reports of sleep disorders and behavior changes.

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 information does not endorse drugs, diagnose patients, or recommend therapy. This drug 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 drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information 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 drugs you are taking, check with your doctor, nurse, or pharmacist.