Background: Recent case report have highlighted the emergence of Fanconi syndrome as a potentially life-threatening complication linked to tacrolimus.
Methods: We undertook an observational retrospective pharmacovigilance study, leveraging data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database from its inception up to the third quarter of 2023. Our objective was to investigate the potential link between tacrolimus and Fanconi syndrome using statistical methods such as the Information Component (IC) and Reporting Odds Ratio (ROR). All statistical analyses were conducted using R version 3.2.5.
Finding: We identified 39 cases of Fanconi syndrome linked to tacrolimus. The frequency of fanconi syndrome associated with tacrolimus was significantly higher compared to all other drugs in the database (ROR 3.30 [2.40-4.53], IC 1.64[1.17-2.11], Table 2). When comparing to cyclosporine, the signal for tacrolimus-related fanconi syndrome also appears significant (ROR 15.21 [3.68, 62.94], IC 0.73 [0.09-1.37], Table 2). Further analysis revealed that, this signal was only present in the age group of 60 years and older.
Conclusions: Our study has identified a safety signal for tacrolimus in relation to Fanconi syndrome, particularly in individuals aged 60 and above. Additional research is needed to confirm and quantify the risk of tacrolimus-induced Fanconi syndrome.
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