Real-world pharmacovigilance study of drug-induced diabetes insipidus from the FAERS database.

OBJECTIVE

This study aims to identify potential drugs associated with diabetes insipidus (DI) and track its epidemiological characteristics using the FDA Adverse Event Reporting System (FAERS) database.

METHODS

A retrospective pharmacovigilance analysis was conducted on FAERS data from Q1 2004 to Q4 2024. Disproportionality analyses were performed using the reporting odds ratio and the Bayesian confidence propagation neural network (BCPNN).

RESULTS

A total of 2,189 cases of DI were recorded in FAERS, with a median age of 47.0 years (interquartile range (IQR) 27.0-60.0). Disproportionality analysis identified 71 drugs with positive signals, in which nervous system agents (22 drugs, 31.0%), antineoplastic agents (15 drugs, 21.1%), and systemic anti-infectives (14 drugs, 19.7%) constituted the top three drug classes. Lithium (n = 114, information component at the 95% lower credibility interval (IC025) = 6.12) and dexmedetomidine (n = 105, IC025 = 6.79) were identified as the most frequently reported drugs and showed the strongest association with DI. Several drugs, such as aripiprazole, letrozole, tigecycline, and dapagliflozin, were found to have unexpected potential associations with DI.

CONCLUSION

This study provides a comprehensive overview of drug-induced DI based on real-world data. It highlights the importance of monitoring patients for DI when using certain medications, particularly high-risk nervous system drugs and antineoplastic agents.