A real-world pharmacovigilance study and pharmacological analysis of sulfasalazine based on the FDA adverse event reporting system (FAERS) database

Expert Opin Drug Saf. 2025 Apr 13. doi: 10.1080/14740338.2025.2488241. Online ahead of print.

ABSTRACT

OBJECTIVE: The purpose of this study was to use the FDA Adverse Event Reporting System (FAERS) to detect and identify adverse events (AEs) related to sulfasalazine to provide a reference for clinical use.

METHODS: Four algorithms (ROR, PRR, BCPNN and EBGM) were used to detect sulfasalazine-correlated AE signals in real data to calculate the signals associated with sulfasalazine-related AEs.

RESULTS: During the study period, FAERS was used to extract a total of 91,509 sulfasalazine-related(SASP-related) adverse event reports. In total, 6830 sulfasalazine adverse event signals were found, involving 23 organ systems. The analysis revealed several common adverse reactions; the most common were dizziness, malaise, asthenia, decreased appetite, rash, and anemia, and these adverse reactions are listed on the warning label for sulfasalazine. It is worth noting that in our study, in the preferred term (PT), we also found some reactions that were not mentioned on the warning label, such as blurred vision and cardiac failure.

CONCLUSION: This study revealed potential new AEs resulting from sulfasalazine, and further studies are needed to confirm these new AEs.

PMID:40222949 | DOI:10.1080/14740338.2025.2488241