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ORIGINAL RESEARCH article
Front. Cardiovasc. Med.
Sec. Cardiovascular Pharmacology and Drug Discovery
Volume 12 - 2025 | doi: 10.3389/fcvm.2025.1504671
Adverse Events Associated with Amlodipine: A Pharmacovigilance Study Using the FDA Adverse Event Reporting System
Provisionally accepted- 1First Affiliated Hospital of Jinzhou Medical University, Jinzhou, China
- 2Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China
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Background: Amlodipine, 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. Method: This 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. Results: Across 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).This 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.
Keywords: Amlodipine, adverse drug reactions, FDA Adverse Event Reporting System, Risk signal detection, Logistic regression
Received: 01 Oct 2024; Accepted: 08 Apr 2025.
Copyright: © 2025 Di, Zhong, Jiang, Zhou, Zhou, Zheng and Liu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Xingwei Di, First Affiliated Hospital of Jinzhou Medical University, Jinzhou, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.