Adverse events of celecoxib associated with the central nervous system and cancer: a disproportionality analysis of the FDA adverse event reporting system.

Abstract

Background: Celecoxib is now clinically recognized as a candidate for treating various neurological disorders and cancers. The recent emergence of some serious adverse reactions is concerning.

Research design and methods: We carried out data mining on the FDA Adverse Event Reporting System (FAERS) for adverse events (AEs) with celecoxib as the main suspect drug and conducted a disproportionality analysis.

Results: 111,155,092 AE reports were extracted from FAERS, and 32,841 AEs with celecoxib as the primary suspected drug were identified. Celecoxib AEs were predominantly reported in cardiac disorders (n = 9602) and nervous system disorders (n = 4045). Cerebrovascular accident (n = 3109, PRR = 3.24) ranked second in the number of reports and cerebrovascular disorder (n = 265, PRR = 5.06) ranked second in signal intensity, was described as rare in the instructions. Nine unexpected and serious AEs were discovered, such as Stevens-Johnson syndrome (n = 175, IC025 = 1.7), breast disease male (n = 4, IC025 = 1.54), and squamous cell carcinoma of the head and neck (n = 4, IC025 = 0.96). At 200 mg, celecoxib was more linked to musculoskeletal and connective AEs; At 400 mg, it was more linked to neurological and cardiovascular AEs.

Conclusions: Unexpected AEs of celecoxib in neurological diseases and cancer have been identified, offering valuable insights for monitoring and risk assessment in future clinical applications.