Linezolid and the risk of lactic acidosis: Data mining and analysis of the FDA Adverse Event Reporting System

J Clin Pharm Ther. 2020 Dec;45(6):1422-1426. doi: 10.1111/jcpt.13245. Epub 2020 Aug 9.


What is known and objective: Lactic acidosis (LA) is a rare but potentially lethal side effect of linezolid (LZD). However, limited by the study population, the number of patients with LA is insufficient to summarize all the clinical characteristics and risk factors.

Methods: We evaluated the association between LZD and LA using the reporting odd ratio (ROR) for mining the adverse event report signals in the FDA Adverse Event Reporting System database from January 2013 to December 2019.

Results and discussion: There were 6218 reports of LZD as the primary suspected drug or secondary suspected drug, of which 275 (4.42%) reports were of LA. The ROR of LA with the use of LZD was 39.976 (95% CI 35.365-45.189). In the age composition of patients, elderly individuals (aged ≥60 years) accounted for the higher proportion, 42.54% (n = 117). LA usually occurred two weeks after LZD administration (n = 33). LZD was the unique suspected drug, accounting for 37.45% (n = 103) of all reports of LA. The drug with the most frequent occurrence of combination with LZD was 'meropenem' and 'warfarin'.

What is new and conclusions: The ROR of LA caused by LZD was very high, and the number of reports about LA caused by other antibiotics was significantly different from that of LA caused by LZD. The drug combined with LZD did not seem to affect the occurrence of LA, and the high occurrence of warfarin in the reports deserves the attention of doctors.

Keywords: data mining; lactic acidosis; linezolid; warfarin.

MeSH terms

  • Acidosis, Lactic / chemically induced*
  • Acidosis, Lactic / epidemiology
  • Adolescent
  • Adult
  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • Age Factors
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / adverse effects*
  • Data Mining
  • Female
  • Humans
  • Linezolid / administration & dosage
  • Linezolid / adverse effects*
  • Male
  • Middle Aged
  • Risk Factors
  • United States
  • United States Food and Drug Administration
  • Warfarin / administration & dosage
  • Warfarin / adverse effects
  • Young Adult


  • Anti-Bacterial Agents
  • Warfarin
  • Linezolid