Post-marketing safety profile of Ertugliflozin: Insights from a real-world pharmacovigilance analysis based on the FAERS database.

BACKGROUND

Ertugliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor, is approved for glycemic control in type 2 diabetes mellitus (T2DM). Although clinical trials confirm its efficacy, real-world data suggest potential safety concerns. This study evaluates the post-marketing safety profile of ertugliflozin using the FDA Adverse Event Reporting System (FAERS).

METHODS

FAERS data from Q1 2004 to Q4 2024 were analyzed. Reports listing ertugliflozin as the primary suspect drug were included. Duplicate and incomplete records were excluded. Disproportionality analyses were conducted using reporting odds ratio (ROR), proportional reporting ratio (PRR), empirical Bayes geometric mean (EBGM), and information component (IC). Adverse events (AEs) were classified using MedDRA.

RESULTS

A total of 671 reports were analyzed, encompassing 25 system organ classes and 159 preferred terms. Significant safety signals included fungal infections (ROR = 78.6), urinary tract infections (ROR = 11.3), Fournier's gangrene (ROR = 267.2), diabetic ketoacidosis (ROR = 67.6), and ketosis (ROR = 295.5). Renal AEs, notably pollakiuria (ROR = 17.1), were also observed. Serious AEs constituted 31.5 % of reports, primarily hospitalizations (20.1 %). Females (50.8 %) and patients aged ≥45 years (36.5 %) were more frequently affected. Notably, 57.6 % of AEs occurred within 30 days of treatment initiation.

CONCLUSION

Ertugliflozin is associated with increased risks of metabolic, infectious, and renal adverse events, including some that are potentially life-threatening. Clinicians are advised to monitor ketone levels during the initial treatment period and to assess patients for a history of genital fungal infections prior to initiation. These steps may help mitigate early adverse events in high-risk populations. Further investigation is warranted to clarify causal pathways and inform safer clinical use.