A real-world data analysis of montelukast in FDA Adverse Event Reporting System (FAERS) database
Abstract Background Montelukast(MTK) is a leukotriene receptor antagonist widely used clinically for treating asthma and rhinitis. However, many adverse events (AEs) have been reported. In this study, we aimed to investigate MTK’s adverse drug reactions (ADRs) using real data from the U.S. Food and...
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BMC
2025-07-01
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| Series: | BMC Pharmacology and Toxicology |
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| Online Access: | https://doi.org/10.1186/s40360-025-00959-3 |
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| author | Hesen Huang Kaiqin Chen Yu Du Jing Gao Yixian Ye Wei Lin |
| author_facet | Hesen Huang Kaiqin Chen Yu Du Jing Gao Yixian Ye Wei Lin |
| author_sort | Hesen Huang |
| collection | DOAJ |
| description | Abstract Background Montelukast(MTK) is a leukotriene receptor antagonist widely used clinically for treating asthma and rhinitis. However, many adverse events (AEs) have been reported. In this study, we aimed to investigate MTK’s adverse drug reactions (ADRs) using real data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods We assessed the disproportionality of MTK-associated AEs by calculating metrics such as the ratio of reported ratios (ROR), proportional reporting ratios (PRR), Bayesian Belief Propagation Neural Networks (BCPNN), and Gamma-Poisson Shrinkers (GPS). Results From 2004 to the third quarter of 2023, of the 20,340,254 case reports in the FAERS database, 86,732 MTK reports were recorded as “principal suspect (PS)” AEs.Disproportionate analyses identified 431 preferred terms (PTs) associated with MTK in 27 organ systems. Unexpected major AEs were noted, such as Suffocation feeling, Adrenal suppression, Sudden visual loss and Endocardial fibrosis, none of which were mentioned in the drug insert. Conclusion Our findings are consistent with clinical observations highlighting potential new and unexpected ADR signals associated with MTK. Further prospective clinical studies are needed to confirm and elucidate the relationship between MTK and these ADRs. This study provides a fresh and unique perspective on the study of adverse drug events. |
| format | Article |
| id | doaj-art-c67c6e32183045f8bcc6319ee70ba9cf |
| institution | Kabale University |
| issn | 2050-6511 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pharmacology and Toxicology |
| spelling | doaj-art-c67c6e32183045f8bcc6319ee70ba9cf2025-08-20T04:02:49ZengBMCBMC Pharmacology and Toxicology2050-65112025-07-0126111110.1186/s40360-025-00959-3A real-world data analysis of montelukast in FDA Adverse Event Reporting System (FAERS) databaseHesen Huang0Kaiqin Chen1Yu Du2Jing Gao3Yixian Ye4Wei Lin5Department of Otolaryngology-Head and Neck Surgery, Xiang’an Hospital of Xiamen UniversityDepartment of Neurosurgery, Xiang’an Hospital of Xiamen UniversityDepartment of Otolaryngology-Head and Neck Surgery, Xiang’an Hospital of Xiamen UniversityDepartment of Otolaryngology-Head and Neck Surgery, Xiang’an Hospital of Xiamen UniversityDepartment of Otolaryngology, Zhongshan Hospital (Xiamen), Fudan UniversityDepartment of Otolaryngology-Head and Neck Surgery, The First Affiliated Hospital, Fujian Medical UniversityAbstract Background Montelukast(MTK) is a leukotriene receptor antagonist widely used clinically for treating asthma and rhinitis. However, many adverse events (AEs) have been reported. In this study, we aimed to investigate MTK’s adverse drug reactions (ADRs) using real data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods We assessed the disproportionality of MTK-associated AEs by calculating metrics such as the ratio of reported ratios (ROR), proportional reporting ratios (PRR), Bayesian Belief Propagation Neural Networks (BCPNN), and Gamma-Poisson Shrinkers (GPS). Results From 2004 to the third quarter of 2023, of the 20,340,254 case reports in the FAERS database, 86,732 MTK reports were recorded as “principal suspect (PS)” AEs.Disproportionate analyses identified 431 preferred terms (PTs) associated with MTK in 27 organ systems. Unexpected major AEs were noted, such as Suffocation feeling, Adrenal suppression, Sudden visual loss and Endocardial fibrosis, none of which were mentioned in the drug insert. Conclusion Our findings are consistent with clinical observations highlighting potential new and unexpected ADR signals associated with MTK. Further prospective clinical studies are needed to confirm and elucidate the relationship between MTK and these ADRs. This study provides a fresh and unique perspective on the study of adverse drug events.https://doi.org/10.1186/s40360-025-00959-3MTKReal-world data analysisAdverse eventsPharmacovigilanceDisproportionality analysis |
| spellingShingle | Hesen Huang Kaiqin Chen Yu Du Jing Gao Yixian Ye Wei Lin A real-world data analysis of montelukast in FDA Adverse Event Reporting System (FAERS) database BMC Pharmacology and Toxicology MTK Real-world data analysis Adverse events Pharmacovigilance Disproportionality analysis |
| title | A real-world data analysis of montelukast in FDA Adverse Event Reporting System (FAERS) database |
| title_full | A real-world data analysis of montelukast in FDA Adverse Event Reporting System (FAERS) database |
| title_fullStr | A real-world data analysis of montelukast in FDA Adverse Event Reporting System (FAERS) database |
| title_full_unstemmed | A real-world data analysis of montelukast in FDA Adverse Event Reporting System (FAERS) database |
| title_short | A real-world data analysis of montelukast in FDA Adverse Event Reporting System (FAERS) database |
| title_sort | real world data analysis of montelukast in fda adverse event reporting system faers database |
| topic | MTK Real-world data analysis Adverse events Pharmacovigilance Disproportionality analysis |
| url | https://doi.org/10.1186/s40360-025-00959-3 |
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