Real-world pharmacovigilance assessment of meropenem-associated adverse events: age stratification and time-to-onset analysis using FAERS.

BACKGROUND: Meropenem is a broad-spectrum carbapenem antibiotic widely used for severe infections; however, its real-world adverse event profile and age-stratified pharmacovigilance signals remain insufficiently characterized. This study aimed to evaluate signals of meropenem-associated adverse events using the FDA Adverse Event Reporting System (FAERS). METHODS: FAERS reports from 2004 Q1 to 2025 Q4 were extracted. Reports listing meropenem as the primary suspect drug were included after standardization and deduplication. Disproportionality analyses were performed at the Preferred Term (PT) level using the reporting odds ratio, proportional reporting ratio, empirical Bayes geometric mean, and information component, with a Bonferroni correction applied to PRR chi-square P-values for multiple PT-level comparisons. Reports were stratified into five age groups: < 18, 18-39, 40-59, 60-79, and ≥80 years. Age-, sex-, seriousness-, fatality-, and time-to-onset stratified analyses were conducted. A healthcare professional (HCP)-only subset analysis was performed using the same statistical framework. RESULTS: A total of 5,018 meropenem primary suspect drug-event records were identified, corresponding to 4,431 deduplicated report-level cases after merging FAERS DEMO, DRUG, and REAC tables. Overall, 254 PT-level signals remained significant after four-algorithm screening and Bonferroni correction. These signals were mainly distributed across infections and infestations, investigations, skin and subcutaneous tissue disorders, blood and lymphatic system disorders, and hepatobiliary disorders. Frequently detected PTs included pyrexia, acute kidney injury, pancytopenia, thrombocytopenia, septic shock, seizure, DRESS, multiple organ dysfunction syndrome, and sepsis. Age-stratified analysis showed a heterogeneous distribution of signals across age groups, with higher numbers of reports and signals observed in the 40-79-year age group. The proportion of reported serious outcomes increased across age strata, exceeding 85% among patients aged ≥40 years. Median time-to-onset was 5 days, and the Weibull shape parameter (β = 0.72) suggested an early-reporting pattern of events. HCP-only analysis demonstrated consistent signal patterns compared with the primary analysis at the PT level. CONCLUSIONS: Meropenem-associated adverse event signals involved multiple organ systems and demonstrated heterogeneous distribution across age groups. Early-onset clustering was observed for several key signals. These findings represent FAERS-based disproportionality signals rather than causal associations and require further sclinical validation.