Safety profile of letrozole in the real world: a disproportionality analysis of FAERS database and systematic review of case reports.
Chunsu Liang, Yizhou Zhang, Pengjiao An et al.
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From the abstract
Letrozole is an aromatase inhibitor for breast cancer. Most of the safety data of letrozole came from clinical trials, while real-world information is insufficient.
Reported results
The analysis of FAERS (2004 Q1-2023 Q4) identified 1,165 ADR signals from 29,631 cases, with general disorders, gastrointestinal, and musculoskeletal connective tissue disorders being the most frequent system organ classes (SOCs). Fatigue (3,431 cases), nausea (2,421), diarrhea (1,943), arthralgia (1,756), and alopecia (1,640) were the top reported signals.
Authors' conclusions
Clinicians need to pay attention to rhabdomyolysis when letrozole combined with catecholaminergic agents. Patient education on urine output monitoring is essential due to potential kidney injury. Bone marrow suppression and reproductive toxicity risks require clinical attention.