Adverse reactions of Niraparib

In clinical trials, the most common adverse reactions to revumenib (incidence ≥ 20%) included laboratory abnormalities, specifically: hyperphosphatemia, hemorrhage, nausea, infection of unknown pathogen, increased aspartate aminotransferase, increased alanine aminotransferase, increased creatinine, musculoskeletal pain, febrile neutropenia, prolonged QT interval on electrocardiogram, hypokalemia, increased intact parathyroid hormone, increased alkaline phosphatase, diarrhea, bacterial infection, hypertriglyceridemia, differentiation syndrome, fatigue, edema, viral infection, hypophosphatemia, decreased appetite, and constipation.

The incidence of serious adverse reactions was as high as 76%. The most common serious adverse reactions (≥ 10%) included: infection (29%), febrile neutropenia (20%), bacterial infection (15%), differentiation syndrome (13%), and hemorrhage (11%). Adverse reactions leading to treatment interruption, dose reduction, and permanent discontinuation have also been reported.

FDA，2025.10