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Causality: well established
Causality assessment · Causality: well established
Penicillamine and Proteinuria: 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.
Penicillamine ↔ Proteinuria
n=65 co-reports · PRR 78.6 · ROR 84.5
Penicillamine, a chelator used in Wilson's disease and rheumatoid arthritis, can cause immune-complex membranous nephropathy presenting as proteinuria; 65 co-reports give a very high PRR of 78.6. The label advises baseline and periodic urinalysis, and the drug is withdrawn if proteinuria develops.
Regulatory basis: penicillamine prescribing information — proteinuria/nephropathy; periodic urinalysis monitoring.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Weeks to months |
| Strength | met | PRR 78.6, an extreme signal |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Fairly specific to penicillamine |
| Biological gradient | not established | Not clearly dose-related |
| Plausibility | met | Known immune-complex mechanism |
| Coherence | met | Fits penicillamine's renal toxicity |
| Experiment | n/a | Too rare for trial capture |
| Analogy | met | Analogous to gold-salt and captopril proteinuria |
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 penicillamine captured proteinuria as a tracked adverse event in a usable structure. Proteinuria from immune-complex nephropathy develops slowly and is rarely a coded trial endpoint.