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Temsirolimus safety evaluation: real-world adverse event analysis from the FDA adverse event reporting system
Lifeng Dan1, Zhenyu Liu1, Zecang Zhao1
1Department of Urology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, People's Republic of China.
Naunyn-Schmiedeberg'S Archives of Pharmacology
|March 30, 2026
Summary
This study analyzed the FDA Adverse Event Reporting System (FAERS) database to characterize temsirolimus safety. New adverse reactions like dehydration and pleural effusion were identified, enhancing patient safety monitoring.
Area of Science:
- Pharmacovigilance and drug safety research.
- Oncology and cancer therapeutics.
- Real-world data analysis in healthcare.
Background:
- Temsirolimus, a mTOR inhibitor, treats renal carcinoma and lymphomas.
- Its real-world safety profile requires further characterization.
- Understanding adverse events is crucial for clinical decision-making.
Purpose of the Study:
- To identify and characterize adverse reactions associated with temsirolimus using real-world data.
- To compare identified adverse events with existing drug labels.
- To discover new potential adverse reactions not previously documented.
Main Methods:
- Analysis of 2,929 temsirolimus-related adverse event reports from the FAERS database (Q2 2007-Q2 2024).
- Application of disproportionality analyses including ROR, PRR, BCPNN, and EBGM.
- Comparison of significant positive signals against the established drug label.
Main Results:
- Identified 128 preferred terms (PTs) across 17 organ systems associated with temsirolimus.
- Confirmed known adverse reactions like liver injury, hyperglycemia, and infections.
- Discovered new potential adverse events: dehydration, pleural effusion, cardiac failure, and ascites.
Conclusions:
- The study successfully identified new potential adverse events for temsirolimus.
- Findings enhance pharmacovigilance efforts and safety monitoring for temsirolimus.
- Insights support optimized clinical application and risk management strategies.
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