Zyflo and Death - a phase IV clinical study of FDA data

Summary:

Death is reported as a side effect among people who take Zyflo (zileuton), especially for people who are female, 60+ old, have been taking the drug for 6 - 12 months also take Acetaminophen, and have Immunodeficiency common variable.

The study is created by eHealthMe based on reports of 979 people who have side effects when taking Zyflo from the FDA, and is updated regularly.

What is Zyflo?

Zyflo has active ingredients of zileuton. eHealthMe is studying from 1,004 Zyflo users. Check the latest studies of Zyflo.

eHealthMe: drug outcomes in the real world

eHealthMe runs one of the largest post-marketing drug safety studies in the world. We study millions of patients and 5,000 more each day. Our data-driven phase IV clinical trials have been referenced on 800+ peer-reviewed medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. Tools to study our phase IV findings are available to the public, anonymous and free >>>.

On Jul, 09, 2026

979 people reported to have side effects when taking Zyflo.
Among them, 14 people (1.43%) died.

Among these 14 people:

How long have people been on Zyflo when they died? *

What is the gender of people who died when taking Zyflo? *

female: 61.54 %
male: 38.46 %

What is the age of people who died when taking Zyflo? *

What are other drugs people take besides Zyflo? *

What are other side effects people have before they died? *

Viral Infection: 1 person, 7.14%
Vasculitis (inflammation of a blood vessel or blood vessels): 1 person, 7.14%
Bronchitis (inflammation of the mucous membrane in the bronchial tubes): 1 person, 7.14%
Diarrhea: 1 person, 7.14%
Drug Ineffective: 1 person, 7.14%
Fall: 1 person, 7.14%
Fatigue (feeling of tiredness): 1 person, 7.14%
Fever: 1 person, 7.14%
Headache (pain in head): 1 person, 7.14%
Heart Palpitations (feelings or sensations that your heart is pounding or racing): 1 person, 7.14%

What are the existing conditions these people have? *

Immunodeficiency Common Variable: 5 people, 35.71%
Cystic Fibrosis (disease of the secretary glands): 2 people, 14.29%
Asthma: 2 people, 14.29%
Multiple Myeloma (cancer of the plasma cells): 1 person, 7.14%
Lung Neoplasm Malignant (cancer tumour of lung): 1 person, 7.14%
Infection: 1 person, 7.14%
Chronic Obstructive Pulmonary Disease (a progressive disease that makes it hard to breathe): 1 person, 7.14%

* Approximation only. Some reports may have incomplete information.

Related studies:

Effectiveness of, long term effects of, and alternative drugs to Zyflo:

Zyflo (1,004 reports)

Expand to all the drugs that have ingredients of zileuton:

Death and drugs with ingredients of zileuton (16 reports)

Sub-studies by gender and age:

Female: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Male: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Browse all side effects of Zyflo:

a b c d e f g h i j k l m n o p q r s t u v w x y z

Browse all the drugs that are associated with Death:

Death (3,107 drugs)

Browse all the conditions that are associated with Death:

Death (3,686 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on zileuton (the active ingredients of Zyflo) and Zyflo (the brand name). Other drugs that have the same active ingredients (e.g. generic drugs) are not considered. Dosage of drugs is not considered in the study.

How to use the study?

DO NOT STOP MEDICATIONS without first consulting your doctor. If there are any serious or long term adverse effects discovered in the study, discuss the study with your doctor to ensure that proper medication management will be in place if applicable.

Who is eHealthMe?

With medical big data and proven AI/ML algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. We study millions of patients and 5,000 more each day. Results of our real-world drug study have been referenced on 800+ peer-reviewed medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. Our analysis results are available to researchers, health care professionals, patients (testimonials), and software developers (open API).

WARNING, DISCLAIMER, USE FOR PUBLICATION

WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health.

DISCLAIMER: All material available on eHealthMe.com is for informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment provided by a qualified healthcare provider. All information is observation-only. Our phase IV clinical studies alone cannot establish cause-effect relationship. Different individuals may respond to medication in different ways. Every effort has been made to ensure that all information is accurate, up-to-date, and complete, but no guarantee is made to that effect. The use of the eHealthMe site and its content is at your own risk.

If you use this eHealthMe study on publication, please acknowledge it with a citation: study title, URL, accessed date.