Contributions of Pharmacovigilance to the Understanding of Risks Associated with Ibuprofen: Descriptive and Disproportionality Analysis Using FAERS Data

<b>Background/Objectives:</b> The objective of this study was to evaluate real-world evidence (Food & Drug Administration database, FAERS) on ibuprofen adverse events (AE) through descriptive and disproportionality analyses. <b>Methods:</b> Signal assessment involved analyzing the top 30 entries with the most reports. The disproportionality analysis of signals based on Evans' criteria (number of reports > 2, chi-square > 4, and PRR > 2) was performed. A total of 70,792 reports submitted to FAERS by the end of 2024 (collected from 97 countries worldwide) indicate ibuprofen as the main suspect. <b>Results:</b> Of these, the highest percentage was attributed to females (n = 33,262, 47.0%) and adult patients (18-65 years) (n = 22,005, 31.1%). In the elderly group (12.4%) and in children and adolescents (11.2%), similar frequencies were reported. Oral administration was the most frequently mentioned route (n = 25,035, 35.4%). A total of 21,077 reports had an unfavorable outcome, of which 3018 (4.3%) reported death. <b>Conclusions:</b> The results highlight potential risks associated with ibuprofen and emphasize the importance of responsible, clinically well-founded administration. The disproportionality analysis can provide valuable information for effectively selecting drug-adverse-effect pairs that warrant further attention.