The real-world safety of ruxolitinib in graft-versus-host disease treatment: a pharmacovigilance study based on the FDA adverse event reporting system.

The analysis identified adverse event (adverse event) signals across 26 system organ classes, with common adverse event reports including infections and infestations (e.g., pneumonia, cytomegalovirus), blood and lymphatic system disorders (e.g., thrombocytopenia, anemia), and gastrointestinal disorders (e.g., diarrhea).

Subgroup analysis revealed higher frequencies of hematologic adverse event reports such as cytopenia and thrombocytopenia in acute graft-versus-host disease, and more undefined disorders in chronic graft-versus-host disease; designated medical event analysis highlighted significant renal (e.g., acute kidney injury) and hematologic reporting signals.