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Causality: well established
Causality assessment · Causality: well established
Colchicine and Rhabdomyolysis: 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.
Colchicine ↔ Rhabdomyolysis
n=519 co-reports · PRR 10.1 · ROR 10.3
Colchicine can cause myopathy and rhabdomyolysis, particularly with concomitant statins or in renal impairment where it accumulates; 519 co-reports give PRR 10.1. The label warns of neuromuscular toxicity and advises caution with interacting drugs.
Regulatory basis: colchicine prescribing information — myopathy/rhabdomyolysis, especially with statins or renal impairment.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Days to weeks |
| Strength | met | PRR 10.1 with 519 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | not established | Rhabdomyolysis has many causes |
| Biological gradient | met | Dose/exposure-related |
| Plausibility | met | Known microtubule mechanism in muscle |
| Coherence | met | Fits the colchicine-statin interaction |
| Experiment | n/a | Not a routine trial endpoint |
| Analogy | met | Analogous to statin-associated myopathy |
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 colchicine captured rhabdomyolysis as a tracked adverse event in a usable structure. Randomised trials did not combine colchicine with statins at scale or code rhabdomyolysis.