Objective  Based on the US Food and Drug Administration (FDA) adverse event Reporting System (FAERS), to explore the signal of adverse events of basiliximab in solid organ transplantation, and to provide reference for its clinical safety.

Methods  The adverse drug event (ADE) signals of basiliximab in solid organ transplantation from the first quarter of 2004 to the second quarter of 2024 were retrospectively analyzed in the FAERS database of the FDA. The reporting odds ratio (ROR) method and Bayesian confidence propagation neural network (BCPNN) method were used for signal mining.

Results  A total of 1,581 ADE reports related to the use of basiliximab were obtained, involving 27 system/organ classifications. A total of 460 ADE signals were identified. The top 5 PT signals in terms of report frequency were mainly elevated serum creatinine, fever, cytomegalovirus infection, decreased hemoglobin, and decreased lymphocyte count. The top 5 PT signals in terms of signal intensity were mainly cytomegalovirus infection, elevated serum creatinine, decreased lymphocyte count, increased neutrophil count, and thrombotic microangiopathy. New ADE signals identified included decreased lymphocyte count, thrombotic microangiopathy, eye organ diseases, Kaposi's sarcoma, elevated blood lactate dehydrogenase, elevated transaminases, and shock.

Conclusion  Data mining using FAERS database is helpful to find new ADE signals of basiliximab in solid organ transplantation. Clinicians should focus on new severe ADE signals such as coagulation function, ocular organ diseases, elevated transaminase, shock and so on.

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