The real-world safety profile of empagliflozin: a disproportionality analysis based on the FDA Adverse Event Reporting System (FAERS) database.

OBJECTIVE

This study aimed to investigate the entire adverse events (AEs) spectrum and to identify some new or rare AEs associated with empagliflozin based on the FAERS database.

METHODS

A retrospective analysis was conducted on AE reports extracted from the FAERS, spanning from the first quarter of 2004 to that of 2023. Disproportionality analysis methods, including the ROR, PRR, BCPNN, and MGPS, were employed to quantify signals of AEs associated with empagliflozin. Additionally, demographic characteristics and time to onset were further elucidated.

RESULTS

The results showed a total of 20,734 AE reports related to empagliflozin, identifying 322 significant preferred terms (PTs) covering 27 System Organ Classes (SOCs). Empagliflozin was significantly associated with pre-specified AEs compared to other novel antidiabetic medications. Beyond common AEs, unexpected significant AEs such as pancreatitis, gastroenteritis, cerebral infarction, and cardiac operations were identified. The median onset time for empagliflozin-related AEs was 28 days (interquartile range (IQR) 4-154 days), with the majority of AE cases (n = 2,112, 10.19%) occurring within the first month following initiation of empagliflozin therapy.

CONCLUSION

The clinically observed AEs, along with potential new AE signals associated with empagliflozin were identified based on the FAERS database, which could provide valuable evidence for clinical monitoring, risk identification, and further safety studies of identification.