What the label lists and what reports show
Linezolid side effects
Linezolid's FDA label: “Most common adverse reactions (>5% of adult and pediatric patients treated with Linezolid injection) include diarrhea, vomiting, headache, nausea, and anemia.” FAERS holds 29,594 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 (2,199 reports).
- Generic listed
Check it at the source: the linezolid FDA label on DailyMed (effective June 19, 2026, Hospira, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (>5% of adult and pediatric patients treated with Linezolid injection) include diarrhea, vomiting, headache, nausea, and anemia.
Table 2. Incidence (%) Treatment-Emergent Adverse Reactions Occurring in greater than 1% of Adult Patients Treated with Linezolid in Comparator-Controlled Clinical Trials
| ADVERSE REACTIONS | Linezolid 600 mg every 12 hours (n = 1498) | All Other Comparators Comparators included cefpodoxime proxetil 200 mg by mouth every 12… |
|---|---|---|
| Headache | 5.7 | 4.4 |
| Diarrhea | 8.3 | 6.4 |
| Nausea | 6.6 | 4.6 |
| Vomiting | 4.3 | 2.3 |
| Dizziness | 1.8 | 1.5 |
| Rash | 2.3 | 2.6 |
| Anemia | 2.1 | 1.4 |
| Taste alteration | 1.0 | 0.3 |
| Vaginal moniliasis | 1.1 | 0.5 |
| Oral moniliasis | 1.7 | 1.0 |
| Abnormal liver function tests | 1.6 | 0.8 |
| Fungal infection | 0.3 | 0.2 |
| Tongue discoloration | 0.3 | 0 |
| Localized abdominal pain | 1.2 | 0.8 |
| Generalized abdominal pain | 1.2 | 1.0 |
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: • Myelosuppression [ see Warnings and Precautions (5.1) ] • Peripheral and Optic Neuropathy [ see Warnings and Precautions (5.2) ] • Serotonin Syndrome [ see Warnings and Precautions (5.3) ] • Clostridioides difficile -Associated Diarrhea [ see Warnings and Precautions (5.5) ] • Lactic Acidosis [ see Warnings and Precautions (5.7) ] • Convulsions [ see Warnings and Precautions (5.8) ] • Rhabdomyolysis [ see Warnings and Precautions (5.9) ] • Hypoglycemia [ see Warnings and Precautions (5.10) ] • Hyponatremia and/or Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) [ see Warnings and Precautions (5.11) ] Most common adverse reactions (>5% of adult and pediatric patients treated with Linezolid injection) include diarrhea, vomiting, headache, nausea, and anemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985, 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 the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, Hospira, Inc., effective June 19, 2026 (SPL set c401f1a8-cc37-461b-bfef-f2e156629bf8), via openFDA; the full label on DailyMed
What do FAERS reports show?
29,594 reports list linezolid among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,443 are coded as a death and 12,213 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 18 reactions below, 11 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?
- Linezolid: 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