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Drug-Induced Hyponatremia Surveillance: A disproportionality analysis based on FAERs database
Xin Xi1, Zhanfeng Bai2, Songqing Liu3
1Xin Xi Pharmacy Department, The Third Affiliated Hospital of, Chongqing Medical University, Chongqing, China.
Pakistan Journal of Medical Sciences
|June 8, 2026
Summary
This study identified 1,306 drugs linked to hyponatremia using FDA adverse event data. It highlights specific medications like furosemide and hydrochlorothiazide with significant risk signals for safer clinical practice.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Clinical Pharmacology
Background:
- Drug-induced hyponatremia is a significant adverse drug event.
- Identifying risk signals is crucial for patient safety.
- The United States Food and Drug Administration Adverse Event Reporting System (FAERS) database is a valuable resource for pharmacovigilance.
Purpose of the Study:
- To mine risk signals of drug-induced hyponatremia from the FAERS database.
- To provide a reference for safe medication practices.
- To identify drugs with the strongest association signals for hyponatremia.
Main Methods:
- Disproportionality analysis was performed on FAERS data from 2004 to 2023.
- Risk signals for hyponatremia were identified and quantified.
- Drugs were ranked by case counts and association signals (ROR).
Main Results:
- 1,306 drugs were associated with hyponatremia risk signals.
- Furosemide, hydrochlorothiazide, sertraline, omeprazole, and citalopram had the highest case counts.
- Indapamide, hydrochlorothiazide, desmopressin, oxcarbazepine, and furosemide showed the strongest association signals.
Conclusions:
- A comprehensive list of drugs with hyponatremia risk signals was generated.
- Early identification of culprit drugs is essential for preventing severe outcomes.
- Clinical information regarding drug-induced hyponatremia was found to be missing for some drugs.
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