Post-marketing pharmacovigilance of tedizolid: emerging safety signals.

Abstract

Background: Tedizolid (TED), an oxazolidinone antibiotic, has improved pharmacokinetics compared with linezolid, but its real-world safety profile remains incompletely defined. Post-marketing surveillance helps detect adverse drug reactions (ADRs) not fully captured in clinical trials.

Research design and methods: This retrospective pharmacovigilance study analyzed adverse event (AE) reports listing TED as the primary suspect drug in the U.S. FDA Adverse Event Reporting System (July 2014 - June 2025). Demographics, clinical indications, and outcomes were summarized descriptively. Disproportionality analyses-reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker-were applied at the system-organ class (SOC) and preferred term (PT) levels, requiring simultaneous positivity.

Results: Among 14,919,217 AE reports, 494 involved TED. Hematologic toxicities were consistently detected, aligning with known risks. PT-level analysis identified potential emerging safety signals, including hepatic cytolysis, gamma-glutamyltransferase increased, mental status changes, tooth discoloration, and melena. Median onset among evaluable cases (n = 386) was three days, with nearly one-third occurring as true same-day events (Day 0).

Conclusions: Post-marketing data confirm TED's hematologic risks and reveal additional potential hepatic, neuropsychiatric, and gastrointestinal signals. These findings merit further evaluation and prospective studies to clarify clinical significance, establish causality, and optimize monitoring strategies.