Drug Safety Information for ZYVOX (Linezolid)

Safety-related Labeling Changes for ZYVOX (LINEZOLID) Rx Drug: FDA Link

Safety-related Labeling Changes for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (LINEZOLID) Rx Drug: FDA Link

Adverse Drug Reactions for ZYVOX* (Linezolid)

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 ZYVOX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Thrombocytopenia544
2Platelet count decreased427
3Drug interaction404
4Nausea*359
5Anaemia335
6Serotonin syndrome318
7Diarrhoea298
8Death297
9Pyrexia280
10Vomiting262
11Pancytopenia257
12Drug ineffective254
13Sepsis234
14Pneumonia212
15Renal failure acute208
16Renal failure195
17Rash177
18Staphylococcal infection174
19Multi-organ failure172
20Haemoglobin decreased167

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

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

Reason # of FDA Reports
1Staphylococcal infection*2713
2Product used for unknown indication1666
3Infection850
4Pneumonia741
5Osteomyelitis520
6Pneumonia staphylococcal520
7Enterococcal infection515
8Sepsis484
9Cellulitis429
10Ill-defined disorder327

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


Types of Adverse Events for ZYVOX

Total Reports Filed with FDA: 27029


Number of FDA Adverse Event Reports by Patient Age for ZYVOX

Total Reports Filed with FDA: 27029*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Linezolid (Linezolid, Zyvox)

Charts are based on 27029 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 ZYVOX Reviews and Review Summary .

Historical 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.