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

## TL;DR

This study uses FAERS data to analyze real-world risks of ibuprofen, identifying patterns and severe adverse events.

## Contribution

The study applies disproportionality analysis to FAERS data to highlight new safety signals for ibuprofen.

## Key findings

- Most reports involved female patients and adults aged 18–65 years.
- Oral administration was the most common route for ibuprofen-related adverse events.
- 4.3% of reports resulted in death, indicating significant safety concerns.

## Abstract

Background/Objectives: 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. Methods: 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. Results: 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. Conclusions: 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.