← All causality assessments
Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Diazepam and Drug Abuse: 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.
Diazepam ↔ Drug Abuse
n=7,212 co-reports · PRR 16.3 · ROR 17.2
Diazepam is a long-acting benzodiazepine used for anxiety, insomnia, and seizures. Drug abuse is the expected consequence of GABA-A modulation: rapid onset, euphoria, tolerance, and a recognised withdrawal syndrome. 5,156 co-reports (PRR 17.7) and Schedule IV designation confirm widespread misuse. The label carries a boxed warning for abuse, dependence, and withdrawal.
Boxed warning: diazepam label (abuse/dependence/withdrawal). FDA PI.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 17.7 with 5,156 co-reports |
| Consistency | met | Reproduced across benzodiazepine class |
| Specificity | partial | Specific to GABA-A modulators |
| Biological gradient | met | Tolerance documented |
| Plausibility | met | GABA-A mechanism established |
| Coherence | met | Withdrawal syndrome standard |
| Experiment | n/a | Unethical to randomise |
| Analogy | met | All benzodiazepines class-wide |
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 Diazepam captured drug abuse as a tracked adverse event in a usable structure. Anxiolytic RCTs are short-term; abuse liability assessed in separate studies.