Tacrolimus related diabetic ketoacidosis and hyperglycaemic hyperosmolar nonketotic syndrome: an observational, retrospective, pharmacovigilance study.

Background: Information on the incidence and risk factors for diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar nonketotic syndrome (HHNS) caused by tacrolimus has rarely been reported. This study aims to assess the spectrum of DKA/HHNS associated with tacrolimus.

Methods: We conducted an observational, retrospective pharmacovigilance study using the Food and Drug Administration adverse event reporting system (FAERS) database. We employed the information component (IC) and reporting odds ratio (ROR) to evaluate the association between tacrolimus and DKA/HHNS.

Results: A total of 232 events were identified as tacrolimus-related DKA/HHNS, 186 cases from DKA and 54 cases from HHNS. The frequency of tacrolimus-associated DKA and HHNS was found to be significantly higher compared to all other drugs. Specifically, HHNS was significantly associated with tacrolimus based on its ROR and IC. There were no significant differences in death and non-death cases in gender, age group, year of reporting and region of reporting.

Conclusion: Our study showed that DKA and HHNS were associated with tacrolimus use. Healthcare professionals should be aware of the possibility of DKA/HHNS following tacrolimus administration, as they were associated with an increased risk of mortality in transplant recipients.