To evaluate the post-marketing safety profiles of spironolactone, eplerenone, and finerenone using real-world data from the FAERS database.
Approach:
Key Findings:
Spironolactone had the most extensive safety profile with unique adverse events including congenital malformations, acute pulmonary edema, severe cutaneous reactions, and antiandrogenic effects.
Eplerenone showed a concentrated safety profile with serious cardiac incidents and renal/hepatic failure.
Finerenone exhibited a specific profile limited to renal and metabolic areas.
Hyperkalemia was a consistent moderate-priority signal across all three agents.
Numerous high-signal, unlabeled adverse events were recognized.
Interpretation:
The results highlight the need for individualized safety surveillance and independent verification in additional pharmacovigilance databases.
Limitations:
The study relies on post-marketing data which may not capture all adverse events.
Findings are hypothesis-generating and require independent verification in additional pharmacovigilance databases.
Conclusion:
Further research is necessary to establish reliable drug reference standards based on these findings.
