Drug Safety Information for ZYFLO CR (Zileuton)

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

Adverse Drug Reactions for ZYFLO CR* (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 CR
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
4Alanine aminotransferase increased22
8Anaphylactic reaction18
11Chest discomfort16
13Aspartate aminotransferase increased14
14Blood pressure increased13
15Condition aggravated13
20Drug ineffective12

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

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

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

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

Types of Adverse Events for ZYFLO CR

Total Reports Filed with FDA: 1354

Number of FDA Adverse Event Reports by Patient Age for ZYFLO CR

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 CR 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 CR's side effects.