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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Renal Pharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1509310
This article is part of the Research Topic Reviews in Renal Pharmacology: 2024 View all 4 articles

Safety Assessment of Tolvaptan: Real-World Adverse Event Analysis Using the FAERS Database

Provisionally accepted
Liyuan Yan Liyuan Yan 1*Qian Wang Qian Wang 2*Yan Wang Yan Wang 2*Qing Qiao Qing Qiao 2*Peiyang Cao Peiyang Cao 2*
  • 1 Department of Cardiology, Affiliated Changshu Hospital of Nantong University, suzhou, China
  • 2 Department of Nephrology, The Fourth Affiliated Hospital of Soochow University, suzhou, China

The final, formatted version of the article will be published soon.

    Objective: This study aims to analyze the adverse drug events (ADEs) associated with tolvaptan in the Food and Drug Administration Adverse Event Reporting System database from the fourth quarter of 2009 to the second quarter of 2024. Methods: After standardizing the data, various signal detection techniques, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network, and Multi-Item Gamma Poisson Shrinker, were employed for analysis. Results: Among the 7,486 ADE reports where tolvaptan was the primary suspected drug, a total of 196 preferred terms were identified, spanning 24 different system organ classes. Specifically, hepatobiliary disorders, renal and urinary disorders, and metabolic and nutritional disorders were found to be characteristic adverse reactions associated with tolvaptan. Additionally, uncommon but notable ADE signals were observed, such as renal cyst rupture, renal cyst infection, polycystic liver disease, and renal cyst hemorrhage. These several ADEs have not been referred to in the previous literature. Notably, strong ADE signals were detected for decreased urine osmolality (n = 5, ROR 149.74, PRR 149.7, IC (Information Component) 7.13, EBGM (Empirical Bayes Geometric Mean) 139.79), osmotic demyelination syndrome (n = 38, ROR 128.47, PRR 128.25, IC 6.92, EBGM 120.91), and pulmonary-related tumors such as bronchial metastatic carcinoma, bronchial carcinoma, metastatic small cell lung carcinoma, and small cell lung carcinoma. In the concomitant medication analysis of 7,486 suspected adverse drug reaction reports related to tolvaptan, the top three drugs most commonly used in combination with tolvaptan were furosemide, spironolactone, and amlodipine. Conclusion: While tolvaptan provides therapeutic benefits, it poses a risk of significant adverse reactions.Clinicians should closely monitor the occurrence of events related to hepatobiliary disorders, renal and urinary disorders, metabolic and nutritional disorders, as well as benign, malignant, and indeterminate tumors during its clinical use.

    Keywords: FAERS database, Tolvaptan, Adverse drug events, Real-world data analysis, Pharmacovigilance

    Received: 10 Oct 2024; Accepted: 11 Dec 2024.

    Copyright: © 2024 Yan, Wang, Wang, Qiao and Cao. 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:
    Liyuan Yan, Department of Cardiology, Affiliated Changshu Hospital of Nantong University, suzhou, China
    Qian Wang, Department of Nephrology, The Fourth Affiliated Hospital of Soochow University, suzhou, China
    Yan Wang, Department of Nephrology, The Fourth Affiliated Hospital of Soochow University, suzhou, China
    Qing Qiao, Department of Nephrology, The Fourth Affiliated Hospital of Soochow University, suzhou, China
    Peiyang Cao, Department of Nephrology, The Fourth Affiliated Hospital of Soochow University, suzhou, China

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