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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Cetuximab and Rash: 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.
Cetuximab ↔ Rash
n=2,273 co-reports · PRR 3.5 · ROR 3.7
Cetuximab, an EGFR inhibitor, characteristically causes an acneiform rash that reflects target engagement and can be dose-limiting and socially distressing; 2,273 co-reports give PRR 3.5. The label advises management with topical therapy and dose adjustment.
Regulatory basis: cetuximab (Erbitux) prescribing information — acneiform rash; management guidance.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | First weeks of therapy |
| Strength | met | PRR 3.5 with 2,273 co-reports |
| Consistency | met | Consistent across cohorts |
| Specificity | met | Fairly specific to EGFR inhibitors |
| Biological gradient | met | Dose-related |
| Plausibility | met | Known EGFR skin mechanism |
| Coherence | met | Fits cetuximab's on-target effect |
| Experiment | n/a | Often coded in trials |
| Analogy | met | Analogous to other EGFR-inhibitor rash |
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.
✓ Trial evidence found — Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (NCT02741570)
| Adverse event | Nivolumab + Ipilimumab (n=468) · EXTREME Regimen (n=441) | |
|---|---|---|
| Rash | 1/468 | 0/441 |
Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →