Pharmacologic class (EPC) · 3 drug pages

Oxazolidinone antibacterial: adverse event reports filed with FDA

23,623 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

23,623
reports across the class: 0.1% of all reports; 2,229
reports, 12 months to June 2026: 2,100 in the 12 months before; 90%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Oxazolidinone antibacterial is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 23,623 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

2,229 reports arrived in the 12 months to June 2026, close to the 2,100 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 90% of the class's reports are marked serious, 15.9% record death among the outcomes and 37.7% record hospitalisation, as reported.

Across the class the reactions recorded most often are thrombocytopenia (8.7%), off label use (8.5%) and drug ineffective (6.7%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Linezolid	generic	17,985	2,095	94.2%	Off label use
ZyvoxLinezolid	brand	5,108	109	78.9%	Platelet count decreased
SivextroTedizolid phosphate	brand	530	25	53.2%	Product use in unapproved indication

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Thrombocytopenialow platelets8.7%2,063
Off label useused for a purpose or in a way not on the label8.5%2,017
Drug ineffectivethe medicine did not work as expected6.7%1,590
Anaemialow red blood cells6.5%1,546
Drug interactionan interaction between medicines5.5%1,293
Nauseafeeling sick4.9%1,162
Lactic acidosisa build-up of lactic acid in the blood4.3%1,004
Platelet count decreasedlow platelet count4.1%959
Vomitingbeing sick4%944
Neuropathy peripheralnerve damage in hands or feet4%942
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor3.9%926
Pancytopenialow counts of all blood cells3.5%835
Diarrhoealoose or frequent stools3.3%789
Drug resistance2.7%635
Condition aggravatedthe condition being treated got worse2.7%629
Acute kidney injurysudden loss of kidney function2.6%617
Deaththe patient died; cause not stated by this term2.5%595
Electrocardiogram QT prolongeda QT prolongation on the ECG2.4%571
Product use in unapproved indicationused for a purpose not on the label2.4%562
Pyrexiafever2.4%557
Dyspnoeashortness of breath2.2%528
Astheniaweakness or lack of energy2%464
Rashskin rash1.8%426
Toxicity to various agentspoisoning or toxic effect of one or more substances1.7%411
Decreased appetitereduced appetite1.6%388

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death15.9%3,752

Life-threatening10.1%2,393

Hospitalisation (initial or prolonged)37.7%8,912

Disability2.3%540

Congenital anomaly0.2%39

Other serious61.7%14,576

Not serious10%2,373

Patient age

Under 21.1%256

2 to 111.9%459

12 to 171.8%433

18 to 4418.3%4,325

45 to 6422.7%5,373

65 to 7415.2%3,595

75 and over15.8%3,725

Age not given23.1%5,457

Who reported

Physician37.4%8,834

Pharmacist13.3%3,137

Other health professional36.7%8,680

Lawyer0.1%16

Consumer or non-health professional9.8%2,316

Not given2.7%640

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Oxazolidinone antibacterial reports

Which drugs are in the Oxazolidinone antibacterial class on this site?

Linezolid, Zyvox and Sivextro. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

23,623 reports through June 2026, 2,229 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

thrombocytopenia (8.7%), off label use (8.5%), drug ineffective (6.7%), anaemia (6.5%) and drug interaction (5.5%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.