Real-world pharmacovigilance study of FDA adverse event reporting system events for finerenone
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View abstract on PubMed
Summary
This summary is machine-generated.This study identified new adverse event signals for finerenone, including kidney function changes and electrolyte imbalances. These findings aid in monitoring finerenone
Area Of Science
- Pharmacovigilance
- Drug Safety
- Clinical Pharmacology
Background
- Finerenone is a medication used for certain kidney and heart conditions.
- Understanding its adverse event profile is crucial for safe clinical use.
Purpose Of The Study
- To perform signal mining of adverse events associated with finerenone.
- To evaluate the drug's safety profile using real-world data.
- To provide a reference for safe finerenone administration in healthcare settings.
Main Methods
- Utilized the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.
- Analyzed data from Q3 2021 to Q4 2023.
- Employed signal mining techniques and Medical Dictionary for Regulatory Activities (MedDRA) coding.
Main Results
- Identified 905 adverse event reports where finerenone was the primary suspected drug.
- Common adverse events with positive signals included decreased glomerular filtration rate, hyperkalemia, increased blood creatinine, and dizziness.
- Adverse events were concentrated in metabolism/nutrition and renal/urinary systems.
Conclusions
- Identified significant novel adverse event signals for finerenone.
- Findings support enhanced clinical monitoring and risk identification for finerenone therapy.
- Contributes to the safe and effective use of finerenone.
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