Haemorrhage-related adverse events associated with nintedanib: a pharmacovigilance study based on the FAERS database | Synapse
February 14, 2026
Haemorrhage-related adverse events associated with nintedanib: a pharmacovigilance study based on the FAERS database
Key Points
The study aims to investigate the incidence of haemorrhage-related adverse events (HrAE) linked to nintedanib using the FAERS database.
Analysis of data from the FAERS database regarding nintedanib and HrAE.
Focus on gastrointestinal bleeding incidents.
Comparison of HrAE incidence in patients over 65 years.
Gastrointestinal bleeding is the most frequently reported HrAE for nintedanib.
Older patients (over 65 years) show a higher likelihood of experiencing HrAE.
Life-threatening and fatal adverse events are more commonly reported in older patients.
Abstract
Gastrointestinal bleeding is the most commonly reported HrAE associated with nintedanib. Patients over 65 years were more likely to experience HrAE, especially in life-threatening and death AE reports.