Drug-Induced Hyponatremia Surveillance: A disproportionality analysis based on FAERs database

Abstract

Objective: Mining the risk signals of drug-induced hyponatremia by the United States Food and Drug Administration adverse event reporting system (FAERS) database, to provide reference for clinical safe medication.

Methodology: Adverse drug events related to drug induced hyponatremia were analyzed by disproportionality analysis using the FAERS data between 2004 to 2023 were downloaded (https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html).

Results: A total of 1,306 drugs with identifiable risk signals were associated with Hyponatremia. Five drugs demonstrated the highest cases counts: furosemide (n=1,560), hydrochlorothiazide (n=1049), sertraline (n=899), omeprazole(n=864), citalopram (n=738). The pharmacovigilance analysis identified five substances exhibiting the strongest association signals: indapamide (ROR=91.46, 95% CI 83.38-100.32), hydrochlorothiazide (ROR=46.79, 95% CI 43.96-49.81), desmopressin (ROR=34.08, 95% CI 31.49-36.89), oxcarbazepine (ROR=24.47, 95% CI 22.72-26.37), and furosemide (ROR=24.11, 95% CI 22.91-25.37). Nivolumab (36.92%), bortezomib (30.58%), and zoledronic (29.36%) exhibited the highest proportional occurrence of target adverse events involving fatal or life-threatening outcomes. Additionally, clinical information about Drug-induced hyponatremia is absent from the Summary of Product Characteristics of 10 drugs in our study.

Conclusions: We provide a list of drugs with risk signals for Hyponatremia. In clinical practice, it is helpful to identify the culprit drug early, and prevent it from further aggravation into a serious condition.