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Causality: well established
Causality assessment · Causality: well established
Itraconazole and Heart failure: 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.
Itraconazole ↔ Heart failure
n=153 co-reports · PRR 3.4 · ROR 3.5
Itraconazole carries a labelled warning of negative inotropic effects and heart failure, particularly in patients with underlying ventricular dysfunction, and the FDA has advised caution and dose limits. The effect reflects the drug's ability to depress cardiac contractility, and it resolves on withdrawal in most cases. The 153 co-reports (PRR 3.4) are modest because heart failure is uncommon with itraconazole and the drug is used for narrower indications than fluconazole.
Regulatory basis: FDA/itraconazole prescribing information (heart failure warning; caution in ventricular dysfunction).
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Heart failure develops during therapy and often improves after withdrawal |
| Strength | partial | PRR 3 on a modest co-report count |
| Consistency | met | Supported by post-marketing reports and the labelled warning |
| Specificity | met | A recognised itraconazole effect, tied to negative inotropy |
| Biological gradient | partial | More likely at higher doses and in patients with existing cardiac impairment |
| Plausibility | met | Direct negative inotropic action on the myocardium is the proposed mechanism |
| Coherence | met | Coheres with the labelled caution in heart failure and dose limits |
| Experiment | partial | Dechallenge (withdrawal) usually improves symptoms; no randomized trial |
| Analogy | met | Analogous to cardiac depression by other negative-inotropic drugs |
This page's own qualitative read, not an automated/citation-gated assessment.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for itraconazole captured heart failure; the effect is uncommon, identified through post-marketing reports and the labelled warning rather than a trial AE table.