A real-world disproportionality analysis of FDA adverse event reporting system events for ibuprofen.

INTRODUCTION: Ibuprofen is commonly used as an over-the-counter (OTC) antipyretic and analgesic. As the frequency of its use increases, there has been a corresponding increase in reports of associated adverse events (AEs). However, these events have not been systematically reported in the literature. Meanwhile, the importance of effective pharmacovigilance in evaluating the benefits and risks of drugs is being recognized.

METHODS: Data were obtained indirectly from FAERS using the OpenVigil 2 database, lexically mapped using software such as MySQL, Microsoft Excel, and the R language, and then subjected to four more rigorous algorithms to detect risk signals associated with ibuprofen AEs.

RESULTS: By analyzing data from the past 18 years, 878 ibuprofen-related AEs were identified as primary AEs. Notably, unexpected reproductive system and breast disorders were observed as important system organ classes (SOC) associated with ibuprofen. Among the 651 preferred terms (PTs) that simultaneously satisfied the four arithmetic methods, we propose renal tubular acidosis and lip edema as new signals for AEs of ibuprofen.

CONCLUSION: The study explores the important and valuable potential AEs and ADRs of ibuprofen at the SOC and PT levels, respectively. To provide a reference for decision-making for ibuprofen to promote rational clinical dosing.