Undocumented Safety Signals of Imatinib: Pharmacovigilance Insights from the FDA Adverse Event Reporting System (FAERS) and Implications for Clinical Practice

Aims To evaluate the safety profile of Imatinib using the FAERS database, identifying both documented and undocumented adverse events. Methods FAERS data Q1 2004 to Q1 2024 were analyzed via disproportionality analysis (ROR, PRR, BCPNN, EBGM) to quantify drug-AE associations. Results A total of 56,364 patients (170,659 AE occurrences) were included. Imatinib exhibited expected AEs (e.g., nausea, diarrhea) consistent with labels, alongside novel signals such as pubertal failure (ROR = 452.74), large intestine fibroma (ROR = 431.18), ototoxicity, and pregnancy complications. Severe outcomes comprised 84.24% of reports (34.44% death), with 38.08% of AEs occurring > 360 days post-treatment. Malignant neoplasm progression showed strong association (ROR = 8.33). Conclusions The study reveals undocumented safety risks of Imatinib, highlighting the need for long-term monitoring of rare and insidious toxicities. Limitations of spontaneous reporting systems were acknowledged.