In-depth summary of adverse events associated with Flurbiprofen: A real-world pharmacovigilance study from 2004 to 2024 using the FAERS database.

<h4>Background</h4>Flurbiprofen, as a widely used nonsteroidal anti-inflammatory drug (NSAID), is commonly employed to relieve mild to moderate pain and inflammation. Understanding its adverse reactions in real-world usage is of significant importance.<h4>Methods</h4>Reports...

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Main Authors: Chengkai Yang, Qian Guo, Yang Cheng, Fengjing Liu, Hui Zhang, Huaxiang Wang
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2025-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0329636
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author Chengkai Yang
Qian Guo
Yang Cheng
Fengjing Liu
Hui Zhang
Huaxiang Wang
author_facet Chengkai Yang
Qian Guo
Yang Cheng
Fengjing Liu
Hui Zhang
Huaxiang Wang
author_sort Chengkai Yang
collection DOAJ
description <h4>Background</h4>Flurbiprofen, as a widely used nonsteroidal anti-inflammatory drug (NSAID), is commonly employed to relieve mild to moderate pain and inflammation. Understanding its adverse reactions in real-world usage is of significant importance.<h4>Methods</h4>Reports of all adverse drug events (ADEs) related to flurbiprofen were extracted from the FAERS database, covering the period from Q1 2004 to Q3 2024. These reports were standardized and analyzed using various signal quantification techniques, including Reporting Odds Ratios (ROR), Proportional Reporting Ratios (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinkage (MGPS). Finally, the association between flurbiprofen and ADEs as well as clinical medical events was assessed.<h4>Results</h4>A total of 275 cases from the target population were identified in the FAERS database, with 788 instances of adverse events (AEs) occurring across 46 organ systems. We identified not only some common adverse reactions listed in the drug's package insert, such as acute kidney injury, nausea and vomiting, and facial edema, but also significant signals that were not mentioned in the package insert, including Dysphonia, Drug abuse, and Pancreatitis acute. The median time to onset of flurbiprofen-related AEs was 1 day (interquartile range [IQR] 0-5 days), with most AEs occurring within the first month of flurbiprofen use.<h4>Conclusion</h4>This study confirmed some common adverse reactions listed in the flurbiprofen drug package insert and identified significant unexpected adverse reactions. These findings can assist clinicians in conducting more comprehensive clinical monitoring when using the drug, thereby ensuring patient safety during treatment.
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spelling doaj-art-e3684d0647e54e25bbede6fa1cffec862025-08-23T05:32:11ZengPublic Library of Science (PLoS)PLoS ONE1932-62032025-01-01208e032963610.1371/journal.pone.0329636In-depth summary of adverse events associated with Flurbiprofen: A real-world pharmacovigilance study from 2004 to 2024 using the FAERS database.Chengkai YangQian GuoYang ChengFengjing LiuHui ZhangHuaxiang Wang<h4>Background</h4>Flurbiprofen, as a widely used nonsteroidal anti-inflammatory drug (NSAID), is commonly employed to relieve mild to moderate pain and inflammation. Understanding its adverse reactions in real-world usage is of significant importance.<h4>Methods</h4>Reports of all adverse drug events (ADEs) related to flurbiprofen were extracted from the FAERS database, covering the period from Q1 2004 to Q3 2024. These reports were standardized and analyzed using various signal quantification techniques, including Reporting Odds Ratios (ROR), Proportional Reporting Ratios (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinkage (MGPS). Finally, the association between flurbiprofen and ADEs as well as clinical medical events was assessed.<h4>Results</h4>A total of 275 cases from the target population were identified in the FAERS database, with 788 instances of adverse events (AEs) occurring across 46 organ systems. We identified not only some common adverse reactions listed in the drug's package insert, such as acute kidney injury, nausea and vomiting, and facial edema, but also significant signals that were not mentioned in the package insert, including Dysphonia, Drug abuse, and Pancreatitis acute. The median time to onset of flurbiprofen-related AEs was 1 day (interquartile range [IQR] 0-5 days), with most AEs occurring within the first month of flurbiprofen use.<h4>Conclusion</h4>This study confirmed some common adverse reactions listed in the flurbiprofen drug package insert and identified significant unexpected adverse reactions. These findings can assist clinicians in conducting more comprehensive clinical monitoring when using the drug, thereby ensuring patient safety during treatment.https://doi.org/10.1371/journal.pone.0329636
spellingShingle Chengkai Yang
Qian Guo
Yang Cheng
Fengjing Liu
Hui Zhang
Huaxiang Wang
In-depth summary of adverse events associated with Flurbiprofen: A real-world pharmacovigilance study from 2004 to 2024 using the FAERS database.
PLoS ONE
title In-depth summary of adverse events associated with Flurbiprofen: A real-world pharmacovigilance study from 2004 to 2024 using the FAERS database.
title_full In-depth summary of adverse events associated with Flurbiprofen: A real-world pharmacovigilance study from 2004 to 2024 using the FAERS database.
title_fullStr In-depth summary of adverse events associated with Flurbiprofen: A real-world pharmacovigilance study from 2004 to 2024 using the FAERS database.
title_full_unstemmed In-depth summary of adverse events associated with Flurbiprofen: A real-world pharmacovigilance study from 2004 to 2024 using the FAERS database.
title_short In-depth summary of adverse events associated with Flurbiprofen: A real-world pharmacovigilance study from 2004 to 2024 using the FAERS database.
title_sort in depth summary of adverse events associated with flurbiprofen a real world pharmacovigilance study from 2004 to 2024 using the faers database
url https://doi.org/10.1371/journal.pone.0329636
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