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

ABSTRACT

Introduction

Ibuprofen is commonly used as an over-the-counter (OTC) antipyretic and analgesic. As the frequency of its use has increased, 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

The data was 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 diseases, etc., which were unexpected, were observed as important system organ classes (SOCs) associated with ibuprofen. Among the 651 preferred terms (PTs) that simultaneously satisfy the four arithmetic methods, renal tubular acidosis and lip oedema are proposed as new signals for ibuprofen AEs.

Conclusion

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

KEYWORDS:

• Ibuprofen
• drug
• FAERS
• adverse drug reaction
• pharmacovigilance signal

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

A reviewer on this manuscript has disclosed that within the past 24 months, they have received funding from NIH; institutional support for serving as an investigator from Teva, Abbvie, Trillen, Thermaquil; consultant fees from Silva, Clexio, Pfizer; and royalties from Cambridge University Press and MedLink. A second reviewer has disclosed that they have been PI on multiple studies of different formulations of ibuprofen in acute postsurgical dental pain. Funding has been from Pfizer Consumer Healthcare, The University of Pennsylvania Research Foundation, and The PENN Perelman School of Medicine Center of Precision Medicine. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Author contribution

C Yang and Y Du contributed to the experimental design and financial support for this study. Z Guo, B Xu, Y Yang and M Hu contributed to carry out the wrote the paper and data analysis, Z Wang, Y Huang, Y Yang and Y Hu complete the data proofreading, X Guo, J Zhu, M Zhang and W Zhang contributed to plotted the data and reviewed the literature. Everyone was involved in revising and embellishing this article. All authors read and approved the final manuscript. Y Du and Z Guo contributed equally to this study.

All authors agree to take responsibility and be accountable for the contents of the article and to share responsibility to resolve any questions raised about the accuracy or integrity of the published work.

Acknowledgments

The authors would like to acknowledge B Zhao for his kind support in this study.

Ethical approval

In this paper, we commit ourselves to the fact that we are proceeding in strict compliance with the principles outlined in the Declaration of Helsinki. We did not need the permission of the ethics committee to conduct the study.

Additional information

Funding

This research was funded in part by a grant from the Natural Science Foundation of Guangdong Province (Nos. 2021B1515140012 and 2023A1515010083), the Dongguan Science and Technology of Social Development Program (No. 20211800905342), the Medical Scientific Research Foundation of Guangdong Province (No. A2024398), the Research and Development Fund of Dongguan People’s Hospital (No. k202005), the Guangdong Medical University Students’ Innovation Experiment Program (Nos. 2021ZZDS006, 2022ZYDS003, 2022FYDB009, 2022FCDS003, 2023ZYDS001, 2023FZDS001, 2023FYDB010), the Guangdong Medical University Students’ Innovation and Entrepreneurship Training Program (Nos. GDMU2021003, GDMU2021049, GDMU2022031, GDMU2022047, GDMU2022063, GDMU2022077, GDMU2022078, GDMU2023008, GDMU2023015, GDMU2023026, GDMU2023042, GDMU2023102), the Provincial and National College Students’ Innovation and Entrepreneurship Training Program (Nos. 202210571008, S202210571075, 202310571031, S202310571047, S202310571078, S202310571063, S202310571077), the Guangdong Medical University-Southern Medical University twinning research team project (No. 4SG24028G).