Pharmacovigilance study of Rucaparib based on the FDA Adverse Event Reporting System(FAERS)

Abstract Rucaparib was approved for the treatment of ovarian and prostate cancers. The aim of the study was to assess rucaparib-related adverse events (AEs) through data mining using the US Food and Drug Administration Adverse Event Reporting System (FAERS).We analyzed adverse event (AE) reports in the FAERS between 2016 Q4 and 2022 Q2. Disproportionality analyses were performed during data mining to quantify the signals of rucaparib-related AEs. Of 13,638,847 reports collected from the FAERS database, 7436 reports of rucaparib related AEs were identified . A total of 95 preferred terms (PTs) with significant disproportionality in 11 system organ classes (SOCs) were retained. Unexpected significant AEs, such as small intestinal obstruction, intestinal mass, intestinal obstruction, decreased glomerular filtration rate, have been also reported. The median time-to-onset of rucaparib-associated AEs was 32 days (interquartile range [IQR], 15–88 days). Time-to-onset of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) were 525 and 522.5 days, for photosensitivity reaction and sunburn, time-to-onset were 44 and 62 days, and for neuropathy peripheral and taste disorder, time-to-onset were 49.5 and 60.5 days. Our study identified potential new AE signals that might provide important support for clinical monitoring of rucaparib, supporting its rational use in clinical practice.