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Causality: well established
Causality assessment · Causality: well established
Mitotane and Adrenal Insufficiency: 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.
Mitotane ↔ Adrenal Insufficiency
n=132 co-reports · PRR 131.2 · ROR 141.6
Mitotane is an adrenal cytotoxic agent for adrenocortical carcinoma. Adrenal insufficiency is the expected pharmacodynamic outcome: mitotane destroys the zona fasciculata and reticularis of the adrenal cortex. 564 co-reports (PRR 160.8) reflect the drug’s narrow therapeutic index and intended cytotoxic effect. The label carries a boxed warning for adrenal toxicity.
Boxed warning: mitotane label (adrenal toxicity). FDA PI.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 160.8 with 564 co-reports |
| Consistency | met | Reproduced across adrenal cytotoxics |
| Specificity | partial | Specific to adrenal tissue |
| Biological gradient | met | Correlates with cumulative dose |
| Plausibility | met | Known adrenal cytotoxic mechanism |
| Coherence | met | Coherent with pharmacology |
| Experiment | met | RCTs confirm |
| Analogy | met | Unique to this drug class |
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 Mitotane captured adrenal insufficiency as a tracked adverse event in a usable structure. Adrenal insufficiency is the expected therapeutic mechanism; trials track it as both effect and toxicity.