Fig 1.
Pathway of the renin-angiotensin system (RAS) and the intervention mechanism of aliskiren.
In the RAS pathway, aliskiren directly inhibits renin, blocking the conversion of angiotensinogen to angiotensin I (marked with a cross symbol), which leads to reduced angiotensin II production and ultimately lowers blood pressure. ACE, angiotensin-converting enzyme.
Fig 2.
Flowchart illustrating the adverse events analysis process for aliskiren using the FAERS database.
Table 1.
Clinical characteristics and essential demographic of AE reports related to aliskiren from the FAERS database (Q4 2023–Q4 2024).
Table 2.
Clinical Characteristics of adverse events for aliskiren in the VigiAccess database.
Fig 3.
Annual distribution and trends of aliskiren adverse event reports.
Table 3.
Signal strength of aliskiren related adverse events across system organ classes (SOCs) in the FDA Adverse Event Reporting System database.
Table 4.
Signal strength of aliskiren related AEs across 28 SOCs in the VigiAccess database.
Fig 4.
Proportion and frequency of adverse events by system organ class for aliskiren.
Table 5.
Top 30 most frequent AEs for aliskiren at the preferred term (PT) level in FAERS and VigiAccess databases.
Table 6.
Top 30 AEs with the highest signal intensity at the preferred term (PT) level in FAERS and VigiAccess databases.
Fig 5.
Time to onset of adverse events induced by aliskiren.
Distribution of adverse event onset time intervals (days) among study reports, presented as both the number of cases and corresponding percentage of total cases for each interval.
Fig 6.
Cumulative incidence of adverse events related to aliskiren, highlighting the early risk period.
Distribution of time to adverse event onset (days) for the aliskiren, with a median time to event of 62.00 days and an interquartile range (IQR) of 7.00-282.00 days.