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Causality: well established
Causality assessment · Causality: well established
Doxorubicin and Cardiotoxicity: 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.
Doxorubicin ↔ Cardiotoxicity
n=1,221 co-reports · PRR 37.7 · ROR 38.2
Doxorubicin carries a boxed warning for cardiotoxicity: cumulative-dose-related cardiomyopathy and heart failure, with risk rising above threshold doses; 1,221 co-reports give PRR 37.7. The label advises cardiac monitoring and cumulative-dose limits.
Regulatory basis: doxorubicin prescribing information — boxed warning for cardiotoxicity; cumulative-dose limits and cardiac monitoring.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Months, cumulative |
| Strength | met | PRR 37.7 with 1,221 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Fairly specific to anthracyclines |
| Biological gradient | met | Strong cumulative-dose relation |
| Plausibility | met | Known free-radical mechanism |
| Coherence | met | Fits anthracycline cardiomyopathy |
| Experiment | n/a | Often monitored in trials |
| Analogy | met | Analogous to other anthracycline cardiotoxicity |
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 doxorubicin captured cardiotoxicity as a tracked adverse event in a usable structure. Cardiac toxicity is monitored, but confounded by radiotherapy and other cardiotoxic agents.