Oritavancin safety: a real-world pharmacovigilance study of the FAERS database.

BACKGROUND: Oritavancin, a long-acting lipoglycopeptide antibiotic, demonstrates bactericidal activity against gram-positive pathogens including drug-resistant strains. Despite its established efficacy and pharmacokinetic advantages, post-marketing safety data remain limited. The growing off-label use of oritavancin for complex infections further underscores the urgent need for large-scale safety evaluation. To address this gap, we conducted a comprehensive pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database to characterize the real-world adverse event profile of oritavancin.

METHODS: This study analyzed all adverse event reports that identified oritavancin as the primary suspected drug since 2014 in the FAERS database. Using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) algorithms, we conducted a comprehensive analysis of oritavancin-related AEs, restricting the analysis to AEs with the role code of primary suspect (PS).

RESULTS: A total of 16, 964, 725 reports were extracted from the FAERS database, among which 1, 088 listed oritavancin as the "primary suspected" drug. We identified seven significant signals at the system organ class (SOC) level and 48 at the preferred term (PT) level. We confirmed multiple established labeled adverse events with strong reporting signals, including chills (n = 156, ROR = 27.84). Notably, multiple signals not documented in the product label emerged, sorted by descending case count: dyspnoea (n = 98, ROR = 3.41), chest discomfort (n = 29, ROR = 5.64), anaphylactic reaction (n = 25, ROR = 9.07), hyperhidrosis (n = 24, ROR = 3.80), neck pain (n = 14, ROR = 4.85), hypoxia (n = 9, ROR = 5.21), throat tightness (n = 7, ROR = 5.40), flank pain (n = 5, ROR = 11.03), tachypnoea (n = 5, ROR = 7.46), groin pain (n = 4, ROR = 8.80), respiratory depression (n = 4, ROR = 6.80). Distinct signal patterns were also observed across sex and age subgroups and should be interpreted with caution.

CONCLUSION: This real-world pharmacovigilance analysis corroborates the known labeled safety profile of oritavancin and identifies multiple underemphasized signals not fully specified in the product label, involving the neurological, respiratory, cardiovascular, and musculoskeletal systems. These disproportionality signals from spontaneous reporting reflect only statistical associations rather than definitive causality, and warrant further verification to inform clinical safety monitoring.