A pharmacovigilance study of sirolimus-associated adverse events in organ transplantation

Sirolimus (rapamycin), an antibiotic discovered in the 1970s, can effectively reduce allograft rejection, and plays an important role in the fields of immunosuppressive therapy and organ transplantation. Therefore, this study aimed to analyze adverse drug reactions (ADRs) associated with sirolimus using the FDA Adverse Event Reporting System (FAERS) database to inform clinical risk minimization strategies and guide safer therapeutic use.

ADRs associated with sirolimus were retrospectively extracted from the FAERS database. Following the removal of duplicate entries, the final analytical dataset comprised 8,150,023 unique reports. Statistical analyses for signal detection of disproportionate reporting were performed using established pharmacovigilance metrics.

A total of 4,821 FAERS reports associated with sirolimus as the primary suspect drug were identified. Injury, poisoning and procedural complications (ROR = 1.61) \are the most common reports, followed by investigation (ROR = 2.19), infections and infestations (ROR = 1.74). The top ADRs matched known profiles, including kidney transplant rejection (ROR = 230.41). The analysis also revealed signals not prominently described in current prescribing information, including ovarian adenoma (ROR = 56.6), which should be interpreted cautiously as a hypothesis-generating pharmacovigilance signal rather than evidence of causality.

This analysis details the ADR profile of sirolimus, revealing both known and potentially novel clinically significant adverse event signals that augment its known safety profile. Ongoing pharmacovigilance and targeted investigations are necessary to confirm these pharmacovigilance signals and inform optimal safety management strategies for sirolimus.