Real-world disproportionality analysis of trabectedin using the United States food and drug administration adverse event reporting system.

Trabectedin has been approved for treating adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who have previously received anthracycline. However, the long-term safety of trabectedin in a large-sample population remains unknown. We used a real-world pharmacovigilance database to assess adverse events (AEs) related to trabectedin. A disproportionality analysis was performed to evaluate the relationship between trabectedin and AEs. Data between January 2015 and March 2024 were collected from the United States Food and Drug Administration Adverse Event Reporting System (FAERS), an international pharmacovigilance database, to analyze the characteristics and onset time of trabectedin-related AEs. During the studied period, the FAERS database recorded 14,931,458 AE reports, of which 1,748 were related to trabectedin. Approximately 137 trabectedin-related AE signals were identified in 17 system organ classes. The most common AEs listed on the trabectedin label were neutropenia, anemia, thrombocytopenia, and hepatobiliary disorders. We identified twenty-four new and unexpected significant off-label AEs, including atrial flutter, supraventricular tachycardia, increased troponin, venous thromboembolism, hyponatremia, hypokalemia, hypocalcemia, and hypophosphatemia. The median onset time of trabectedin-related AEs was 18.5 (interquartile range, 5-55.25) days. The findings confirmed expected trabectedin-related AEs and identified new AEs.