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Causality: well established
Causality assessment · Causality: well established
Sirolimus 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.
Sirolimus ↔ Interstitial lung disease
n=92 co-reports · PRR 3.0 · ROR 3.0
Sirolimus (mTOR inhibitor) can cause non-infectious interstitial pneumonitis and lung disease, a potentially serious complication; 92 co-reports give PRR 3.0. The label lists interstitial lung disease and advises investigation of new respiratory symptoms.
Regulatory basis: sirolimus prescribing information — interstitial lung disease/pneumonitis warning.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Weeks to months |
| Strength | met | PRR 3.0 with 92 co-reports |
| Consistency | met | Reproduced across reports |
| Specificity | met | Fairly specific to mTOR inhibitors |
| Biological gradient | not established | Not clearly dose-related |
| Plausibility | met | Plausible immune-mediated mechanism |
| Coherence | met | Fits sirolimus pulmonary toxicity |
| Experiment | n/a | Too rare for trial detection |
| Analogy | met | Analogous to everolimus pneumonitis |
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 — Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM) (NCT01950819)
| Adverse event | Everolimus Plus@Reduced CNI (n=1014) · MPA Plus Standard@CNI (n=1012) | |
|---|---|---|
| Interstitial lung disease | 1/1014 | 0/1012 |
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 →