Adverse reactions of Revumenib

Among patients treated with revumenib, 9 cases (4%) of fatal adverse reactions occurred, including 4 cases of sudden death, 2 cases of differentiation syndrome, 2 cases of hemorrhage, and 1 case of cardiac arrest.

Serious adverse reactions were reported in 184 patients (76%). The most common serious adverse reactions (≥10%) were infection (29%), febrile neutropenia (20%), bacterial infection (15%), differentiation syndrome (13%), and hemorrhage (11%).

The most common adverse reactions (≥20%) (including laboratory abnormalities) were: hyperphosphatemia (51%), hemorrhage (48%), nausea (48%), infection of unknown pathogen (46%), increased aspartate aminotransferase (44%), increased alanine aminotransferase (40%), increased creatinine (38%), musculoskeletal pain (37%), febrile neutropenia (37%), prolonged QT interval on electrocardiogram (36%), hypokalemia (34%), increased intact parathyroid hormone (34%), increased alkaline phosphatase (33%), diarrhea (29%), bacterial infection (27%), hypertriglyceridemia (27%), hypophosphatemia (25%), differentiation syndrome (25%), fatigue (24%), edema (24%), viral infection (23%), decreased appetite (20%), and constipation (20%).

FDA，2025.10