A disproportionality analysis of adverse events associated with ertapenem using the FAERS database from 2004 to 2024

Through an in-depth analysis of ertapenem-associated adverse events (AEs) in the FDA Adverse Event Reporting System (FAERS) database, this study provides a reference for monitoring and safety management of ertapenem. Data from the FAERS database from Q1 2004 to Q1 2024 were analyzed via four nonproportional analysis techniques, including the reporting odds ratio (ROR). Gender, age, and sensitivity analyses were conducted for a more detailed assessment of ertapenem-associated signals. A total of 2,931 reports with ertapenem as the primary suspected drug were collected, covering 27 system organ classes (SOCs). The two SOCs with the strongest signals were nervous system disorders and psychiatric disorders, with overall stronger signals in individuals aged ≥ 65 years. The most frequently reported AEs were confusional state (n = 265) and convulsions (n = 214). Among the strongest signals were oropharyngeal edema (ROR = 191.05, 95% CI: 60.76-601.35) and granulomatous dermatitis (ROR = 150.49, 95% CI: 55.9-405.15). Eleven AEs not listed on the FDA label were identified. The top 20 AEs were predominantly associated with nervous system and psychiatric disorders, with a median time to onset ranging from 3.5 to 8.5 days. This study highlights the neuropsychiatric risks of ertapenem, providing strong evidence for its safety assessment and emphasizing the need for monitoring and individualized management in high-risk patients. Ertapenem, FAERS, Adverse events, Drug safety, Disproportionality analysis.