Drug Safety Information for ZYFLO (Zileuton)

Safety-related Labeling Changes for ZYFLO CR (ZILEUTON) Rx Drug: FDA Link

Adverse Drug Reactions for ZYFLO* (Zileuton)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ZYFLO
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea43
2Asthma33
3Nausea24
4Alanine aminotransferase increased22
5Urticaria20
6Fatigue19
7Wheezing18
8Anaphylactic reaction18
9Cough18
10Pneumonia17
11Chest discomfort16
12Headache15
13Aspartate aminotransferase increased14
14Blood pressure increased13
15Condition aggravated13
16Rash13
17Pyrexia13
18Pruritus12
19Malaise12
20Drug ineffective12

* This side effect also appears in "Top 10 Side Effects of ZYFLO " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ZYFLO
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Asthma253
2Product used for unknown indication246
3Non-small cell lung cancer77
4Chronic obstructive pulmonary disease*50
5Bronchial dysplasia17
6Chronic myeloid leukaemia13
7Sinusitis13
8Hypersensitivity8
9Urticaria7
10Bronchial hyperreactivity6

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ZYFLO

Total Reports Filed with FDA: 1354


Number of FDA Adverse Event Reports by Patient Age for ZYFLO

Total Reports Filed with FDA: 1354*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Zileuton (Zyflo cr, Zyflo)

Charts are based on 1354 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and ZYFLO Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on ZYFLO's side effects.