- Academic Editor
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Background: The widely used Renin-angiotensin-aldosterone system
inhibitor (RASI) may increase the risk of hyperkalemia and acute kidney injury
(AKI). We aimed to analyze the RASI-related AKI or hyperkalemia reported in the
Food and Drug Administration’s Adverse Event Reporting System (FAERS) database
to optimize patients’ treatment and provide a reference for a clinically safe
and rational prescription. Methods: We obtained data in FAERS recorded
from January 2004 to December 2020. Disproportionality analysis
and Bayesian analysis were used in data mining to screen the suspected AKI or
hyperkalemia after RASI. The time to onset, hospitalization, and prognosis of
RASI-associated AKI or hyperkalemia were also investigated. Results: We
identified 11,301 RASI-related adverse events (AEs) of hyperkalemia and AKI in
the FAERS database; 4997 were due to Angiotensin-converting enzyme inhibitors (ACEIs),
5658 were due to angiotensin receptor blockers (ARBs), and 646 were
due to the combination of ACEI and ARB. AKI was more commonly reported in
patients with ARB (78.42%) than ACEI users (57.27%). Hyperkalemia cases were
reported more in ACEI users (28.70%) than ARB users (14.14%). The median time
to onset of RAS-associated AKI was 135.0 (17.0–620.0) days. RASI-associated
hyperkalemia occurred relatively later in ACEI users, with a median onset time of
261.0 (43.0–1097.7) days, compared with that of 200.5 (52.0–636.0) days in ARB
users (p