Drug-induced glucose metabolism disorders: A disproportionality analysis based on the FAERS database

Background: Glucose metabolism disorders encompass abnormalities in glucose digestion, absorption, transport, utilization, and regulation, leading to broad physiological and pathological consequences. Although drug-induced disturbances are increasingly documented, they remain under-recognized in clinical practice and drug labeling. Methods: This disproportionality analysis used publicly available data from the FDA Adverse Event Reporting System (FAERS), covering reports from Q4 2004 to Q1 2025. After data cleaning and standardization, four disproportionality methods (ROR, PRR, MGPS, BCPNN) were applied to detect signals. A signal was considered positive only if all method thresholds were met (ROR: n ≥ 3, lower 95% CI > 1; PRR: χ² ≥ 4, lower 95% CI > 1; MGPS: EBGM05 > 2; BCPNN: IC025 > 0). A descriptive analysis of clinical characteristics and a case-by-case assessment were also performed. Results: Among 22,775,812 reports, 204,236 were related to glucose metabolism disorders and involved 1,827 drugs. A total of 128 drugs showed positive signals. The most frequent classes were anti-diabetic drugs (38%), antineoplastic agents (9.3%), renin-angiotensin system drugs (8.6%), and systemic corticosteroids (4.7%). Notably, several drugs, including basiliximab, enfortumab vedotin, and mercaptopurine, lack explicit warnings regarding glucose metabolism disorders. Conclusion: This study identifies potential safety signals that require further clinical validation. These findings emphasize the need for improved monitoring and timely updates to drug labeling, particularly for high-risk populations. Disproportionality analysis is hypothesis-generating and should be interpreted with caution.