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

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.

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).

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.

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.