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Drug side effects

linezolid Side Effects

The reactions most often reported to the FDA for linezolid (also sold as Zyvox), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

28,005
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of linezolid come from 28,005 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 28,005 reports to the FDA Adverse Event Reporting System (FAERS) for linezolid (Zyvox): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

28,005

Reports Mentioning Death

5,204

18.6% of reports — not proof the medicine caused the death

Hospitalizations

11,593

41.4% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

THROMBOCYTOPENIA
2,032
ANAEMIA
1,601
DRUG INTERACTION
1,381
NAUSEA
1,301
VOMITING
1,063
DIARRHOEA
1,003
PLATELET COUNT DECREASED
1,001
PYREXIA
981
LACTIC ACIDOSIS
938
NEUROPATHY PERIPHERAL
901
SEROTONIN SYNDROME
874
ACUTE KIDNEY INJURY
867
PANCYTOPENIA
853
DEATH
762
CONDITION AGGRAVATED
728
DRUG RESISTANCE
728
DYSPNOEA
721
PNEUMONIA
701

Who Reports Side Effects

Gender Distribution

Female 10,740 (43%)
Male 13,828 (56%)
Unknown 180

Age Distribution

0-17 1,724 (8%)
18-44 5,260 (24%)
45-64 6,539 (30%)
65-74 4,192 (19%)
75+ 3,947 (18%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 5,204 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 760
SEPTIC SHOCK 427
RESPIRATORY FAILURE 410
MULTIPLE ORGAN DYSFUNCTION SYNDROME 382
SEPSIS 365
THROMBOCYTOPENIA 347
PNEUMONIA 336
ANAEMIA 285
DYSPNOEA 264
PLATELET COUNT DECREASED 210
ACUTE KIDNEY INJURY 198
PYREXIA 192
LACTIC ACIDOSIS 187
DIARRHOEA 180
HYPOTENSION 175
RENAL FAILURE 172
VOMITING 171
CONDITION AGGRAVATED 169

Reactions in Hospitalization Reports

Top reactions in 11,593 reports where hospitalization was an outcome.

Reaction Reports
THROMBOCYTOPENIA 1,046
ANAEMIA 853
DRUG INTERACTION 653
PYREXIA 633
VOMITING 567
NAUSEA 556
ACUTE KIDNEY INJURY 553
PANCYTOPENIA 524
DIARRHOEA 498
PNEUMONIA 493
LACTIC ACIDOSIS 491
DYSPNOEA 452
SEPSIS 426
SEROTONIN SYNDROME 403
PLATELET COUNT DECREASED 388
RESPIRATORY FAILURE 372
SEPTIC SHOCK 372
CONDITION AGGRAVATED 353

Compare linezolid vs amikacin →

What the FAERS Data Reveals About linezolid Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 28,005 voluntary reports linked to linezolid and its brand equivalents (Zyvox), spanning 2004 through 2025. Of those, 5,204 (18.6%) listed death as an outcome and 11,593 (41.4%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 43% were female and 56% male; age distribution skews toward 45-64, with 6,539 reports in that bracket. The single most reported reaction is thrombocytopenia with 2,032 submissions, followed by anaemia and drug interaction.

How to read these numbers

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.