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Causality: well established
Causality assessment · Causality: well established
Vancomycin and DRESS (eosinophilia and systemic symptoms): 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.
Vancomycin ↔ DRESS (eosinophilia and systemic symptoms)
n=2,386 co-reports · PRR 37.5 · ROR 39.1
Vancomycin is a recognised cause of DRESS (drug reaction with eosinophilia and systemic symptoms), a delayed multi-organ hypersensitivity syndrome; 2,386 co-reports give PRR 37.5. Management is prompt withdrawal and corticosteroid support.
Regulatory basis: vancomycin prescribing information and case literature — DRESS/hypersensitivity syndrome.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | 2-8 weeks after start |
| Strength | met | PRR 37.5 with 2,386 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Associated with HLA alleles |
| Biological gradient | not established | Not clearly dose-related |
| Plausibility | met | Immune-mediated mechanism |
| Coherence | met | Fits vancomycin hypersensitivity |
| Experiment | n/a | Too rare for trial detection |
| Analogy | met | Analogous to other antibiotic DRESS |
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 vancomycin captured dress (eosinophilia and systemic symptoms) as a tracked adverse event in a usable structure. A rare delayed hypersensitivity syndrome is not detectable in randomised trials.