Adverse events associated with amlodipine: a pharmacovigilance study using the FDA adverse event reporting system
BackgroundAmlodipine, a widely prescribed clinical medication, is associated with adverse reactions that can impede the proper execution of treatment regimens. The lack of systematic studies on amlodipine's adverse drug reactions (ADRs) necessitates further investigation to facilitate refined p...
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Frontiers Media S.A.
2025-05-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2025.1504671/full |
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| author | Jiazhen Jiang Qian Zhong Xinyu Zhou Lisi Zhou Jiyuan Zheng Bingshuo Liu Xingwei Di |
| author_facet | Jiazhen Jiang Qian Zhong Xinyu Zhou Lisi Zhou Jiyuan Zheng Bingshuo Liu Xingwei Di |
| author_sort | Jiazhen Jiang |
| collection | DOAJ |
| description | BackgroundAmlodipine, a widely prescribed clinical medication, is associated with adverse reactions that can impede the proper execution of treatment regimens. The lack of systematic studies on amlodipine's adverse drug reactions (ADRs) necessitates further investigation to facilitate refined population management and optimize therapeutic outcomes.MethodThis study leveraged the FDA Adverse Event Reporting System (FAERS) database, extracting reports submitted exclusively by healthcare professionals where amlodipine was designated as the primary suspect (PS). Four risk signal detection methods were employed: Ratio of Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and Empirical Bayes Geometric Mean, to conduct a comprehensive analysis of amlodipine-related ADRs. Furthermore, subgroup analyses stratified by gender and age were performed, with multivariable logistic regression utilized to validate the reliability of the findings.ResultsAcross the general population, male cohort, female cohort, elderly group, and younger demographic, the four signal detection methods collectively identified 513, 348, 403, 246, and 260 potential ADRs associated with amlodipine, respectively. Intersection analysis revealed 27 common ADRs, including gingival hypertrophy, vasoplegia syndrome, and distributive shock. Subsequent multivariable logistic regression confirmed amlodipine's role as an independent risk factor for all 27 ADRs (OR > 1, P < 0.05).ConclusionThis study provides compelling evidence that amlodipine poses risks of peripheral edema, shock, and dyspnea, among others. Additionally, it identified previously unreported ADRs such as abnormal full blood count and personality disorder. These findings underscore the importance of exercising caution when prescribing amlodipine to high-risk individuals with a history of hyperkalemia, cardiac structural abnormalities, or airway obstruction. |
| format | Article |
| id | doaj-art-3598cb3262f347beb2c4d4e537495f4d |
| institution | Kabale University |
| issn | 2297-055X |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj-art-3598cb3262f347beb2c4d4e537495f4d2025-08-20T03:27:43ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2025-05-011210.3389/fcvm.2025.15046711504671Adverse events associated with amlodipine: a pharmacovigilance study using the FDA adverse event reporting systemJiazhen Jiang0Qian Zhong1Xinyu Zhou2Lisi Zhou3Jiyuan Zheng4Bingshuo Liu5Xingwei Di6The First Clinical Medical School of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, ChinaDepartment of Cardiovascular Medicine, First Affiliated Hospital of Jinzhou Medical University, Jinzhou, Liaoning, ChinaThe First Clinical Medical School of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, ChinaClinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, ChinaThe First Clinical Medical School of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, ChinaThe Fifth Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, ChinaDepartment of Cardiovascular Medicine, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, ChinaBackgroundAmlodipine, a widely prescribed clinical medication, is associated with adverse reactions that can impede the proper execution of treatment regimens. The lack of systematic studies on amlodipine's adverse drug reactions (ADRs) necessitates further investigation to facilitate refined population management and optimize therapeutic outcomes.MethodThis study leveraged the FDA Adverse Event Reporting System (FAERS) database, extracting reports submitted exclusively by healthcare professionals where amlodipine was designated as the primary suspect (PS). Four risk signal detection methods were employed: Ratio of Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and Empirical Bayes Geometric Mean, to conduct a comprehensive analysis of amlodipine-related ADRs. Furthermore, subgroup analyses stratified by gender and age were performed, with multivariable logistic regression utilized to validate the reliability of the findings.ResultsAcross the general population, male cohort, female cohort, elderly group, and younger demographic, the four signal detection methods collectively identified 513, 348, 403, 246, and 260 potential ADRs associated with amlodipine, respectively. Intersection analysis revealed 27 common ADRs, including gingival hypertrophy, vasoplegia syndrome, and distributive shock. Subsequent multivariable logistic regression confirmed amlodipine's role as an independent risk factor for all 27 ADRs (OR > 1, P < 0.05).ConclusionThis study provides compelling evidence that amlodipine poses risks of peripheral edema, shock, and dyspnea, among others. Additionally, it identified previously unreported ADRs such as abnormal full blood count and personality disorder. These findings underscore the importance of exercising caution when prescribing amlodipine to high-risk individuals with a history of hyperkalemia, cardiac structural abnormalities, or airway obstruction.https://www.frontiersin.org/articles/10.3389/fcvm.2025.1504671/fullamlodipineadverse drug reactionsFDA adverse event reporting systemrisk signal detectionlogistic regression |
| spellingShingle | Jiazhen Jiang Qian Zhong Xinyu Zhou Lisi Zhou Jiyuan Zheng Bingshuo Liu Xingwei Di Adverse events associated with amlodipine: a pharmacovigilance study using the FDA adverse event reporting system Frontiers in Cardiovascular Medicine amlodipine adverse drug reactions FDA adverse event reporting system risk signal detection logistic regression |
| title | Adverse events associated with amlodipine: a pharmacovigilance study using the FDA adverse event reporting system |
| title_full | Adverse events associated with amlodipine: a pharmacovigilance study using the FDA adverse event reporting system |
| title_fullStr | Adverse events associated with amlodipine: a pharmacovigilance study using the FDA adverse event reporting system |
| title_full_unstemmed | Adverse events associated with amlodipine: a pharmacovigilance study using the FDA adverse event reporting system |
| title_short | Adverse events associated with amlodipine: a pharmacovigilance study using the FDA adverse event reporting system |
| title_sort | adverse events associated with amlodipine a pharmacovigilance study using the fda adverse event reporting system |
| topic | amlodipine adverse drug reactions FDA adverse event reporting system risk signal detection logistic regression |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2025.1504671/full |
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