Haemorrhage-related adverse events associated with nintedanib: a pharmacovigilance study based on the FAERS database
Authors' conclusion
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.
Study context
- Population
- FAERS reports of adverse events (AE) with nintedanib as primary suspect drug, Q4 2014 to Q3 20243,929 AE reports
- Participants
- 3,018 participants
- Exposure
- Haemorrhage-related adverse event (HrAE) vs non-HrAE reports with nintedanib as primary suspect drug
- Outcome
- Characteristics and positive signals of haemorrhage-related AE (HrAE) associated with nintedanib
Methodological detailsFAERS database, disproportionality analysis, multivariate analysis, multiplicative and additive drug-drug interaction (DDI) model, sensitivity analysis
- FAERS database
- Disproportionality analysis
- Multivariate analysis
- Multiplicative and additive DDI model
- Sensitivity analysis
Main finding
As reported in the abstract
Factors associated with HrAE (vs non-HrAE)
Odds ratio (95% CI)P value
Age ≥65 years
1.675(1.376–2.040)
P ≤ 0.001Lower daily dose
1.001(1.000–1.002)
P = 0.014ROR
- Antiplatelet co-administration
- 6.02 (95% CI 4.76–7.62)
- Anticoagulant co-administration
- 4.57 (95% CI 3.85–5.42)
- Prednisone co-administration
- 1.63 (95% CI 1.15–2.31)
Observational data: associations, not effects.
Further findings
Sensitivity analysis: life-threatening or fatal AE reports
| OR (95% CI) | P value | ||
|---|---|---|---|
| Age ≥65 years | 1.623 (1.088–2.420) | P = 0.018 | |
| TTO >90 days | 2.266 (1.744–2.944) | P ≤ 0.001 | |
| 0.20.5125Odds ratio (log scale) |
Sensitivity analysis: AE reports by physician or pharmacist
| OR (95% CI) | P value | ||
|---|---|---|---|
| Male | 1.004 (1.004–1.007) | P = 0.004 | |
| 0.512Odds ratio (log scale) |
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Haemorrhage-related adverse events associated with nintedanib: a pharmacovigilance study based on the FAERS database. Clin Exp Rheumatol. Published 29 October 2025. doi:10.
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