A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for niraparib

Niraparib was approved for the treatment of platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube and primary peritoneal cancer. The authors retrospectively investigated niraparib-related adverse events (AEs) through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS). Four algorithms were employed to quantify the signals of niraparib associated AEs, using data from the FAERS between 2017 and 2021. MYSQL 8.0, Navicat Premium 15, Microsoft EXCEL 2019 and the GraphPad Prism 8 were used to conduct statistical analysis. There are 7,238,157 reports collected from the FAERS database, of which 11,701 reports listed niraparib as the ‘primary suspected (PS)’ drug. A total of 97 significant disproportionality PTs conforming to the four algorithms were simultaneously retained. Unexpected significant AEs such as neuropathy peripheral, photosensitivity reaction, gastrooesophageal reflux disease might also occur. The median onset time of niraparib-associated AEs was 18 days (interquartile range [IQR] 4–66 days), and most of the cases occurred within the first months after niraparib initiation. The study found niraparib-associated AEs and might provide important support for clinical monitoring and risk identification of niraparib.