Exploration and evaluation of adverse event signals of droxidopa based on the FAERS database.

Background: This study aims to utilize the FDA's Adverse Event Reporting System (FAERS) for data analysis to explore the potential adverse events associated with Droxidopa in real-world settings, thereby providing reference information for clinical practice.

Methods: Adverse event reports where Droxidopa was the primary suspected drug were collected from the FAERS database from the third quarter of 2014 to the fourth quarter of 2023. Multiple signal quantification techniques were employed, including ROR, PRR, BCPNN, and MGPS.

Results: A total of 19,295 reports directly related to Droxidopa were screened, encompassing 94 Preferred Terms and involving 27 System Organ Classes. In addition to the adverse events already mentioned in the drug's labeling, this study identified new and valuable adverse event signals, such as Gastrointestinal disorders, Infections and infestations, and Musculoskeletal and connective tissue disorders. Notably, Urinary tract infection, Urinary tract infection pseudomonal, and Pneumonia aspiration were associated with Infections and infestations, indicating the need for heightened vigilance when using Droxidopa in clinical settings. These new signals provide a basis and direction for future research.

Conclusion: This study highlights new potential adverse events related to Droxidopa, emphasizing the need for caution, especially concerning Infections and infestations. Further research is warranted to validate these findings.