What the label lists and what reports show
Tedizolid side effects
Tedizolid's FDA label: “The most common adverse reactions (≥2%) in adult patients are nausea, headache, diarrhea, infusion- or injection-related adverse reactions, vomiting, and dizziness.” FAERS holds 785 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is thrombocytopenia (61 reports).
- No generic listed
Check it at the source: the tedizolid FDA label on DailyMed (effective February 27, 2026, Merck Sharp & Dohme LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of SIVEXTRO?SIVEXTRO may cause serious side effects, including: Serotonin syndrome. Taking SIVEXTRO with certain other medicines can cause a potentially life-threatening problem called serotonin syndrome. See “ Are you taking other medicines? ”. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs or symptoms of serotonin syndrome: high body temperature (hyperthermia) sweating too much agitation difficulty with coordination stiff muscles or muscle twitching unusual eye movement tremors fever Diarrhea from C-diff ( Clostridioides difficile ) infection. Call your healthcare provider right away if you get stomach cramps, fever, watery diarrhea, diarrhea that does not go away, or bloody stools. C-diff infection can happen 2 or more months after you have finished your antibacterial medicine. […]
Source: FDA drug label, NDA205436 (Cubist Pharms Llc), as published by Merck Sharp & Dohme LLC, effective February 27, 2026 (SPL set 75672079-589f-451a-bdbf-eaebcfcc80a9), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥2%) in adult patients are nausea, headache, diarrhea, infusion- or injection-related adverse reactions, vomiting, and dizziness.
Table 5: Selected Adverse Reactions Occurring in ≥2% of Adult Patients Receiving SIVEXTRO in the Pooled Phase 3 ABSSSI Clinical Trials
| Reaction | Adverse Reactions SIVEXTRO (200 mg oral/intravenous once daily for 6 days) (N=1037) | Pooled Phase 3 ABSSSI Clinical Trials Linezolid (600 mg oral/intravenous twice daily for 10 days) (N=1000) |
|---|---|---|
| Nausea | 7% | 10% |
| Diarrhea | 4% | 5% |
| Vomiting | 3% | 5% |
| Headache | 5% | 5% |
| Dizziness | 2% | 2% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Serotonin Syndrome [see Warnings and Precautions (5.1) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥2%) in adult patients are nausea, headache, diarrhea, infusion- or injection-related adverse reactions, vomiting, and dizziness. ( 6.1 ) The most common adverse reactions (>2%) in pediatric patients (12 years to less than 18 years of age) are phlebitis and increased hepatic transaminases. ( 6.1 ) The most common adverse reactions (>2%) in pediatric patients (less than 12 years of age) are infusion- or injection-related adverse reactions and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be compared directly to rates from clinical trials of another drug and may not reflect rates observed in practice. …
Source: FDA drug label, NDA205436 (Cubist Pharms Llc), as published by Merck Sharp & Dohme LLC, effective February 27, 2026 (SPL set 75672079-589f-451a-bdbf-eaebcfcc80a9), via openFDA; the full label on DailyMed
What do FAERS reports show?
785 reports list tedizolid among the medicines taken, each a report of something that happened, not proof the medicine caused it; 51 are coded as a death and 239 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 17 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tedizolid: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions