Disulfiram and Drug-induced liver injury: is the FAERS signal real?
Disulfiram ↔ Drug-induced liver injury
Disulfiram is used to support abstinence from alcohol by inhibiting aldehyde dehydrogenase and sensitising the patient to alcohol; it is also a recognised cause of idiosyncratic drug-induced liver injury, which carries 40 co-reports here (PRR 24.2). The injury ranges from transaminase elevation to fulminant hepatic failure, appears within weeks to months, and is why the label advises baseline and periodic liver monitoring and avoidance in pre-existing liver disease.
Regulatory basis: disulfiram prescribing information — hepatotoxicity warning; periodic liver monitoring.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Onset typically weeks into therapy |
| Strength | met | PRR 24.2, large |
| Consistency | met | Reproduced across case series |
| Specificity | not established | Cannot be distinguished from other DILI clinically |
| Biological gradient | not established | Not clearly dose-related (idiosyncratic) |
| Plausibility | met | Idiosyncratic drug-reaction mechanism |
| Coherence | met | Fits the DILI pattern |
| Experiment | n/a | No trial-sized experiment possible |
| Analogy | met | Analogous to other idiosyncratic 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.
✓ Trial evidence found — Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma (NCT03034135)
| Adverse event | Group A (n=23) |
|---|---|
| Hepatobiliary disorders | 1/23 |
Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →