A comparative analysis of drug-induced kidney injury adverse reactions between cyclosporine and tacrolimus based on the FAERS database

Abstract Background This study utilizes the FDA Adverse Event Reporting System (FAERS) database to compare the adverse reaction signals of cyclosporine and tacrolimus, two widely used immunosuppressants, in relation to drug-induced kidney injury. The findings aim to inform clinical decision-making....

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Main Authors: Min Xu, Shanggang Xu, Xueliang Yi
Format: Article
Language:English
Published: BMC 2025-05-01
Series:BMC Immunology
Subjects:
Online Access:https://doi.org/10.1186/s12865-025-00714-7
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author Min Xu
Shanggang Xu
Xueliang Yi
author_facet Min Xu
Shanggang Xu
Xueliang Yi
author_sort Min Xu
collection DOAJ
description Abstract Background This study utilizes the FDA Adverse Event Reporting System (FAERS) database to compare the adverse reaction signals of cyclosporine and tacrolimus, two widely used immunosuppressants, in relation to drug-induced kidney injury. The findings aim to inform clinical decision-making. Methods The study retrospectively analyzed data from January 2004 to September 2024, employing both frequency analysis and Bayesian methods. We assessed and compared the mortality rates, hospitalization rates, and the association of cyclosporine and tacrolimus with kidney injury to elucidate the renal toxicity of these two drugs. Results After data processing, we identified a total of 3,449 cyclosporine-related kidney injury reports and 5,538 tacrolimus-related kidney injury reports. The results revealed a stronger association between tacrolimus and kidney injury. Additionally, kidney injuries associated with both cyclosporine and tacrolimus predominantly affected males. Furthermore, the hospitalization rate for cyclosporine-related kidney injury was 34.40%, compared to 44.50% for tacrolimus. The mortality rate associated with cyclosporine-induced kidney injury was higher than that of tacrolimus. Conclusion This study utilized the FDA Adverse Event Reporting System (FAERS) database from January 2004 to September 2024 to perform a comprehensive analysis of adverse drug-related kidney injury reactions to cyclosporine and tacrolimus. The results suggest that both cyclosporine and tacrolimus are associated with renal injury, but tacrolimus appears to reduce mortality while increasing hospitalization rates. This serves as a critical warning for planning future treatment regimens, drug monitoring, and reducing adverse effects.
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spelling doaj-art-dd7ccbe70b924c118e1dfa75a05fd2a12025-08-20T03:52:20ZengBMCBMC Immunology1471-21722025-05-0126111110.1186/s12865-025-00714-7A comparative analysis of drug-induced kidney injury adverse reactions between cyclosporine and tacrolimus based on the FAERS databaseMin Xu0Shanggang Xu1Xueliang Yi2Department of Respiratory, Clinical Medical College & Affliated Hospital of Chengdu University, Chengdu UniversityDepartment of Emergency, Clinical Medical College & Affliated Hospital of Chengdu University, Chengdu UniversityDepartment of Emergency, Clinical Medical College & Affliated Hospital of Chengdu University, Chengdu UniversityAbstract Background This study utilizes the FDA Adverse Event Reporting System (FAERS) database to compare the adverse reaction signals of cyclosporine and tacrolimus, two widely used immunosuppressants, in relation to drug-induced kidney injury. The findings aim to inform clinical decision-making. Methods The study retrospectively analyzed data from January 2004 to September 2024, employing both frequency analysis and Bayesian methods. We assessed and compared the mortality rates, hospitalization rates, and the association of cyclosporine and tacrolimus with kidney injury to elucidate the renal toxicity of these two drugs. Results After data processing, we identified a total of 3,449 cyclosporine-related kidney injury reports and 5,538 tacrolimus-related kidney injury reports. The results revealed a stronger association between tacrolimus and kidney injury. Additionally, kidney injuries associated with both cyclosporine and tacrolimus predominantly affected males. Furthermore, the hospitalization rate for cyclosporine-related kidney injury was 34.40%, compared to 44.50% for tacrolimus. The mortality rate associated with cyclosporine-induced kidney injury was higher than that of tacrolimus. Conclusion This study utilized the FDA Adverse Event Reporting System (FAERS) database from January 2004 to September 2024 to perform a comprehensive analysis of adverse drug-related kidney injury reactions to cyclosporine and tacrolimus. The results suggest that both cyclosporine and tacrolimus are associated with renal injury, but tacrolimus appears to reduce mortality while increasing hospitalization rates. This serves as a critical warning for planning future treatment regimens, drug monitoring, and reducing adverse effects.https://doi.org/10.1186/s12865-025-00714-7CyclosporineTacrolimusKidney injuryAdverse drug eventsFDA adverse event reporting systemReal-world analysis
spellingShingle Min Xu
Shanggang Xu
Xueliang Yi
A comparative analysis of drug-induced kidney injury adverse reactions between cyclosporine and tacrolimus based on the FAERS database
BMC Immunology
Cyclosporine
Tacrolimus
Kidney injury
Adverse drug events
FDA adverse event reporting system
Real-world analysis
title A comparative analysis of drug-induced kidney injury adverse reactions between cyclosporine and tacrolimus based on the FAERS database
title_full A comparative analysis of drug-induced kidney injury adverse reactions between cyclosporine and tacrolimus based on the FAERS database
title_fullStr A comparative analysis of drug-induced kidney injury adverse reactions between cyclosporine and tacrolimus based on the FAERS database
title_full_unstemmed A comparative analysis of drug-induced kidney injury adverse reactions between cyclosporine and tacrolimus based on the FAERS database
title_short A comparative analysis of drug-induced kidney injury adverse reactions between cyclosporine and tacrolimus based on the FAERS database
title_sort comparative analysis of drug induced kidney injury adverse reactions between cyclosporine and tacrolimus based on the faers database
topic Cyclosporine
Tacrolimus
Kidney injury
Adverse drug events
FDA adverse event reporting system
Real-world analysis
url https://doi.org/10.1186/s12865-025-00714-7
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