Drugs › Oxazolidinone antibacterial
Generic name
Linezolid: adverse event reports filed with FDA
17,985 reports list it as a suspect or interacting product, 2004–2026. Class: Oxazolidinone antibacterial. Also reported as Linezolid Tablet, Linezolid 600mg, Linezolid Suspension Oral.
- 17,985
- reports as suspect product
- 0.1% of all reports · about 800 a year
- 2,095
- reports, 12 months to June 2026
- 1,959 in the 12 months before
- 94.2%
- marked serious by the reporter
- 90% across the class
- 16.7%
- record death among outcomes, as reported
- 3,009 reports · not verified by FDA
Between January 2004 and June 2026, 17,985 adverse event reports received by FDA list linezolid, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (5,840) are left out of every figure here.
In the 12 months to June 2026, 2,095 reports listed it, close to the 1,959 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 800 reports a year and 0.1% of the 20,646,523 reports in the database, and 76.1% of the reports for the oxazolidinone antibacterial class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are off label use (9.5%), thrombocytopenia (9.1%) and drug ineffective (7.6%). A report can list several reactions, so shares add to more than 100%; 1,682 different terms appear across these reports. Off label use is recorded in 9.5% of these reports, about the same share as in the median oxazolidinone antibacterial drug (9.5%).
94.2% of the reports are marked serious by the reporter (90% across the class); 16.7% record death among the outcomes and 42% record hospitalisation, as reported. 42.4% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (24.6%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Linezolid reports recording the termmedian drug in oxazolidinone antibacterial
- Off label useused for a purpose or in a way not on the label9.5%1,710
- Thrombocytopenialow platelets9.1%1,635
- Drug ineffectivethe medicine did not work as expected7.6%1,364
- Anaemialow red blood cells7.2%1,292
- Drug interactionan interaction between medicines5.7%1,029
- Lactic acidosisa build-up of lactic acid in the blood5%899
- Neuropathy peripheralnerve damage in hands or feet4.6%831
- Nauseafeeling sick4.6%830
- Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor4.3%782
- Vomitingbeing sick4%722
- Pancytopenialow counts of all blood cells3.7%667
- Drug resistance3.4%616
- Acute kidney injurysudden loss of kidney function3.4%606
- Electrocardiogram QT prolongeda QT prolongation on the ECG3.1%557
- Diarrhoealoose or frequent stools3%531
- Condition aggravatedthe condition being treated got worse2.9%525
- Platelet count decreasedlow platelet count2.6%470
- Product use in unapproved indicationused for a purpose not on the label2.5%445
- Dyspnoeashortness of breath2.4%440
- Pyrexiafever2.4%424
- Toxicity to various agentspoisoning or toxic effect of one or more substances2.3%411
- Deaththe patient died; cause not stated by this term2.3%407
- Astheniaweakness or lack of energy1.9%350
- Treatment failurethe treatment did not work1.9%333
- Respiratory failurethe lungs could not supply enough oxygen1.8%330
- Myelosuppression1.8%328
- Multiple organ dysfunction syndromeseveral organs failing1.8%322
- Septic shockshock arising from infection1.8%322
- Decreased appetitereduced appetite1.7%313
- Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement1.7%310
Top 30 of 1,682 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the oxazolidinone antibacterial class; it describes the reports, not the patients. 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."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 23,623 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 21.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Tuberculosis | 2,889 | 16.1% |
| Pulmonary tuberculosis | 862 | 4.8% |
| Staphylococcal infection | 746 | 4.1% |
| Infection | 636 | 3.5% |
| Antibiotic therapy | 456 | 2.5% |
| Pneumonia | 450 | 2.5% |
The indication field is filled in by the reporter and is often blank; shares are of all 17,985 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Linezolid reports |
|---|---|---|
| Clofazimine | 2,794 | 15.5% |
| Meropenem | 2,582 | 14.4% |
| Bedaquiline | 2,332 | 13% |
| Levofloxacin | 2,045 | 11.4% |
| Moxifloxacin | 1,910 | 10.6% |
| Amikacin | 1,677 | 9.3% |
| Vancomycin | 1,418 | 7.9% |
| Cycloserine | 1,409 | 7.8% |
| Pyrazinamide | 1,403 | 7.8% |
| Ciprofloxacin | 1,126 | 6.3% |
Other products listed in reports where Linezolid is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Linezolid | Oxazolidinone antibacterial | All reports |
|---|---|---|---|
| Reports as suspect product | 17,985 | 23,623 | 20,646,523 |
| Share of that pool | — | 76.1% | 0.1% |
| Reports, latest 12 months | 2,095 | — | 1,332,454 |
| Marked serious | 94.2% | 90% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 167 | 159 | 91 |
| Hospitalisation recorded, per 1,000 reports | 420 | 377 | 213 |
| Consumer-filed share | 5.9% | 9.8% | 45.8% |
| Top term, share of reports | Off label use 9.5% | median 9.5% | 4.1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."
Other drugs in the oxazolidinone antibacterial class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Zyvox | brand | 5,108 | 109 | 78.9% |
| Sivextro | brand | 530 | 25 | 53.2% |
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." A brand and its generic are separate rows because reporters name them separately.
Questions about Linezolid reports
How many adverse event reports has FDA received for Linezolid?
17,985 reports list Linezolid as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 2,095 of them arrived in the latest 12 months. Another 5,840 list it only as a concomitant medication.
What reactions are recorded in Linezolid reports?
off label use (9.5%), thrombocytopenia (9.1%), drug ineffective (7.6%), anaemia (7.2%) and drug interaction (5.7%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Linezolid was responsible.
How serious are the reports?
94.2% are marked serious by the reporter. Among the outcomes recorded, 16.7% of reports include death and 42% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (42.4%), physician (39.2%) and pharmacist (11.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Linezolid rising?
2,095 reports in the 12 months to June 2026, close to the 1,959 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Linezolid was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Linezolid?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Linezolid as a suspect or interacting product; reports listing it only as a concomitant medication (5,840) are excluded. 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.