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Causality: well established
Causality assessment · Causality: well established
Imatinib and Fluid retention / oedema: is the FAERS signal real?
A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.
Imatinib ↔ Fluid retention / oedema
n=287 co-reports · PRR 28.5 · ROR 29.0
Imatinib commonly causes fluid retention and periorbital or generalised oedema, occasionally with pleural effusion or severe weight gain; 287 co-reports give PRR 28.5. The label lists fluid retention and advises monitoring and dose adjustment.
Regulatory basis: imatinib (Gleevec) prescribing information — fluid retention/oedema; monitoring and dose adjustment.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Weeks of therapy |
| Strength | met | PRR 28.5 with 287 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Fairly specific to imatinib |
| Biological gradient | met | Dose-related |
| Plausibility | met | Plausible kinase-inhibition mechanism |
| Coherence | met | Fits imatinib fluid retention |
| Experiment | n/a | Often coded in trials |
| Analogy | met | Analogous to other TKI oedema |
This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for imatinib captured fluid retention / oedema as a tracked adverse event in a usable structure. Fluid retention is coded in trials but confounded by disease-related oedema and other therapies.