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Causality: well established
Causality assessment · Causality: well established
Erlotinib and Interstitial lung disease: 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.
Erlotinib ↔ Interstitial lung disease
n=95 co-reports · PRR 4.3 · ROR 4.3
Erlotinib can cause interstitial lung disease-like events, an uncommon but potentially fatal pulmonary toxicity; 95 co-reports give PRR 4.3. The label warns of this risk and advises prompt interruption of treatment for new respiratory symptoms.
Regulatory basis: erlotinib (Tarceva) prescribing information — interstitial lung disease warning.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Weeks of therapy |
| Strength | met | PRR 4.3 with 95 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Fairly specific to EGFR inhibitors |
| Biological gradient | not established | Not clearly dose-related |
| Plausibility | met | Plausible pulmonary toxicity mechanism |
| Coherence | met | Fits erlotinib ILD |
| Experiment | n/a | Too rare for trial detection |
| Analogy | met | Analogous to gefitinib ILD |
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 erlotinib captured interstitial lung disease as a tracked adverse event in a usable structure. An uncommon pulmonary toxicity is not reliably captured in randomised oncology trials.