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Causality: well established
Causality assessment · Causality: well established
Leflunomide 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.
Leflunomide ↔ Interstitial lung disease
n=1,346 co-reports · PRR 5.7 · ROR 5.8
Leflunomide can cause interstitial lung disease/pneumonitis, an uncommon but potentially fatal complication that has been reported early and late in therapy; 1,346 co-reports give PRR 5.7. The label warns of this risk and advises prompt withdrawal if pulmonary symptoms emerge.
Regulatory basis: leflunomide (Arava) prescribing information — interstitial lung disease/pneumonitis warning.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Early or late in therapy |
| Strength | met | PRR 5.7 with 1,346 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | not established | ILD also occurs in rheumatoid disease |
| Biological gradient | not established | Not clearly dose-related |
| Plausibility | met | Plausible immune-mediated mechanism |
| Coherence | met | Fits leflunomide pulmonary toxicity |
| Experiment | n/a | Under-coded in trials |
| Analogy | met | Analogous to methotrexate lung toxicity |
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 — An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies (NCT00720798)
| Adverse event | Tocilizumab (n=2067) |
|---|---|
| Interstitial lung disease | 5/2067 |
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 →