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Causality: well established
Causality assessment · Causality: well established
Ketoconazole and Hepatotoxicity: 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.
Ketoconazole ↔ Hepatotoxicity
n=64 co-reports · PRR 3.5 · ROR 3.5
Oral ketoconazole can cause serious hepatotoxicity and has been largely restricted to specific indications because of it; 64 co-reports give PRR 3.5. The label requires baseline and periodic liver tests and prompt withdrawal at the first sign of injury.
Regulatory basis: ketoconazole prescribing information — severe hepatotoxicity; liver-function monitoring and restricted use.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Weeks to months |
| Strength | met | PRR 3.5 with 64 co-reports |
| Consistency | met | Reproduced across reports |
| Specificity | not established | Hepatotoxicity has many causes |
| Biological gradient | not established | Not clearly dose-related |
| Plausibility | met | Plausible hepatocellular injury |
| Coherence | met | Fits azole-associated hepatotoxicity |
| Experiment | n/a | Not a routine trial endpoint |
| Analogy | met | Analogous to other antifungal hepatotoxins |
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 ketoconazole captured hepatotoxicity as a tracked adverse event in a usable structure. Trials were small and not designed to detect idiosyncratic hepatic injury.