A pharmacovigilance analysis of carbapenem-related utilizing the FDA adverse event reporting system (FAERS) database from 2013 to 2025.

BACKGROUND

Carbapenem antibiotics are critical therapies for multidrug-resistant infections, but their comparative haematologic safety profiles remain poorly characterized. We systematically evaluated haematologic adverse events associated with meropenem, ertapenem, imipenem and doripenem using pharmacovigilance data.

METHODS

We analyzed the FDA Adverse Event Reporting System (FAERS) database from January 2013 to July 2025. Disproportionality analysis was performed using reporting odds ratios (RORs) with 95% confidence intervals for haematologic adverse events.

RESULTS

Sixteen distinct haematologic adverse events were identified. Meropenem demonstrated the most extensive toxicity profile with significant signals for 15 adverse events, including severe conditions: thrombocytosis (ROR = 24.941), eosinophilia (ROR = 24.663), bone marrow failure (ROR = 13.113), agranulocytosis (ROR = 11.57) and pancytopenia (ROR = 11.131). Imipenem demonstrated signals for nine events, notably thrombocytopenia and eosinophilia. Ertapenem demonstrated nine events: leucopenia (ROR = 3.843) and neutropenia (ROR = 2.469). No reports were identified for doripenem.

CONCLUSIONS

Significant differences exist in haematologic safety profiles among carbapenems. Meropenem shows the broadest spectrum of severe toxicity, while other carbapenems demonstrate fewer reports. demonstrates fewer reported haematologic safety signals and not a most favourable haematologic safety profile. These differential safety profiles should inform further studies on carbapenem selection, including patients with baseline haematologic disorders.