Drugs › Oxazolidinone antibacterial
Brand name · Tedizolid phosphate
Sivextro: adverse event reports filed with FDA
530 reports list it as a suspect or interacting product, 2014–2026. Class: Oxazolidinone antibacterial.
- 530
- reports as suspect product
- 0% of all reports · about 44 a year
- 25
- reports, 12 months to June 2026
- 44 in the 12 months before
- 53.2%
- marked serious by the reporter
- 90% across the class
- 4.5%
- record death among outcomes, as reported
- 24 reports · not verified by FDA
Between August 2014 and June 2026, 530 adverse event reports received by FDA list the brand name Sivextro (tedizolid phosphate) as a suspect or interacting product. Reports that mention it only as a concomitant medication (83) are left out of every figure here.
In the 12 months to June 2026, 25 reports listed it, down 43% from 44 in 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 44 reports a year and 0% of the 20,646,523 reports in the database, and 2.2% 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.
Reporters most often recorded product use in unapproved indication (14.5%), off label use (12.6%) and no adverse event (7%). A report can list several reactions, so shares add to more than 100%; 142 different terms appear across these reports. Product use in unapproved indication is recorded in 14.5% of these reports, a larger share than in the median oxazolidinone antibacterial drug (2.5%).
53.2% of the reports are marked serious by the reporter (90% across the class); 4.5% record death among the outcomes and 21.1% record hospitalisation, as reported. 30.9% of the reports came from consumers, and the largest patient age group is 45 to 64 (19.6%). 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 Sivextro reports recording the termmedian drug in oxazolidinone antibacterial
- Product use in unapproved indicationused for a purpose not on the label14.5%77
- Off label useused for a purpose or in a way not on the label12.6%67
- No adverse eventno adverse event was reported7%37
- Thrombocytopenialow platelets6%32
- Anaemialow red blood cells5.8%31
- Product availability issuethe product was not available5.7%30
- Drug ineffectivethe medicine did not work as expected5.3%28
- Nauseafeeling sick5.1%27
- Product dose omission issuea dose was missed5.1%27
- Pancytopenialow counts of all blood cells3.2%17
- Rashskin rash2.8%15
- Product use issuea problem in how the product was used2.5%13
- Adverse eventan unwanted medical event, type not specified2.1%11
- Cholestatic liver injury2.1%11
- Diarrhoealoose or frequent stools2.1%11
- Vomitingbeing sick2.1%11
- Falla fall1.9%10
- Gait disturbancedifficulty walking1.9%10
- Glomerular filtration rate abnormal1.9%10
- Presbyacusis1.9%10
- Tinnitusringing in the ears1.9%10
- Brain abscess1.7%9
- Cardiac valve vegetation1.7%9
- Embolic cerebral infarction1.7%9
- Haemoperitoneum1.7%9
- Hepatic lesion1.7%9
- Multiple organ dysfunction syndromeseveral organs failing1.7%9
- Nocardiosis1.7%9
- Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor1.7%9
Top 30 of 142 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. 62.5% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Mycobacterium abscessus infection | 40 | 7.5% |
| Staphylococcal infection | 32 | 6% |
| Infection | 18 | 3.4% |
| Cellulitis | 15 | 2.8% |
| Mycobacterium avium complex infection | 15 | 2.8% |
| Device related infection | 14 | 2.6% |
The indication field is filled in by the reporter and is often blank; shares are of all 530 reports.
In context
| Measure | Sivextro | Oxazolidinone antibacterial | All reports |
|---|---|---|---|
| Reports as suspect product | 530 | 23,623 | 20,646,523 |
| Share of that pool | — | 2.2% | 0% |
| Reports, latest 12 months | 25 | — | 1,332,454 |
| Marked serious | 53.2% | 90% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 45 | 159 | 91 |
| Hospitalisation recorded, per 1,000 reports | 211 | 377 | 213 |
| Consumer-filed share | 30.9% | 9.8% | 45.8% |
| Top term, share of reports | Product use in unapproved indication 14.5% | median 2.5% | 1.2% |
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 |
|---|---|---|---|---|
| Linezolid | generic | 17,985 | 2,095 | 94.2% |
| Zyvox | brand | 5,108 | 109 | 78.9% |
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 Sivextro reports
How many adverse event reports has FDA received for Sivextro?
530 reports list Sivextro as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 25 of them arrived in the latest 12 months. Another 83 list it only as a concomitant medication.
What reactions are recorded in Sivextro reports?
product use in unapproved indication (14.5%), off label use (12.6%), no adverse event (7%), thrombocytopenia (6%) and anaemia (5.8%). 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 Sivextro was responsible.
How serious are the reports?
53.2% are marked serious by the reporter. Among the outcomes recorded, 4.5% of reports include death and 21.1% 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?
consumer or non-health professional (30.9%), physician (28.7%) and pharmacist (21.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Sivextro rising?
25 reports in the 12 months to June 2026, down 43% from 44 in 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 Sivextro 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 Sivextro?
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 Sivextro as a suspect or interacting product; reports listing it only as a concomitant medication (83) 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.