Current Status of Adverse Event Profile of Cyclosporine in Kidney, Stem Cell, and Heart Transplantations Using the Japanese Pharmacovigilance Database

Iku Niinomi; Saki Oyama; Ayaka Inada; Tomohito Wakabayashi; Tatsuya Iida; Hiroko Kambara; Mayako Uchida; Yukako Sano; Keiko Hosohata

doi:10.7759/cureus.29383

Current Status of Adverse Event Profile of Cyclosporine in Kidney, Stem Cell, and Heart Transplantations Using the Japanese Pharmacovigilance Database

Cureus. 2022 Sep 20;14(9):e29383. doi: 10.7759/cureus.29383. eCollection 2022 Sep.

Authors

Iku Niinomi¹, Saki Oyama¹, Ayaka Inada¹, Tomohito Wakabayashi¹, Tatsuya Iida¹, Hiroko Kambara¹, Mayako Uchida², Yukako Sano¹, Keiko Hosohata¹

Affiliations

¹ Education and Research Center for Clinical Pharmacy, Osaka Medical and Pharmaceutical University, Takatsuki, JPN.
² Education and Research Center for Pharmacy Practice, Doshisha Women's College of Liberal Arts, Kyotanabe-shi, JPN.

Abstract

Background: Cyclosporine is widely used to prevent allograft rejection after transplantation. The purpose of this study was to clarify the adverse events profiles associated with cyclosporine in transplant patients using a spontaneous reporting system database.

Methods: Retrospective pharmacovigilance disproportionality analysis was conducted using the Japanese Adverse Drug Event Report (JADER) database, with the reporting odds ratio (ROR) and 95% confidence interval (CI) for each adverse event.

Results: The database comprised 3,327, 958, and 956 reports associated with cyclosporine in the kidney, stem cell, and heart transplant patients, respectively. Infectious and renal disorders were commonly detected in these transplant patients. The signal scores of cyclosporine for toxic nephropathy were noteworthy in the kidney (ROR: 15.1, 95% CI: 11-20.8) and stem cell (ROR, 216; 95% CI, 29.3-1593) transplantation. Cyclosporine in heart transplantation was strongly associated with gastric cancer (ROR, 39.4; 95% CI, 16.7-93.2), but not kidney or stem cell transplantation.

Conclusion: It was suggested that there is a diversity in the strength of the association between cyclosporine and adverse events in the kidney, stem cell, and heart transplantation. Our results may provide useful information for treatment with cyclosporine, although further research with more data is needed.

Keywords: cyclosporine; japanese adverse drug event report (jader) database; reporting odds ratio (ror); spontaneous reporting system; transplantation.