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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Fentanyl 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.
Fentanyl ↔ Drug Abuse
n=10,770 co-reports · PRR 31.6 · ROR 35.3
Fentanyl is a potent mu-opioid agonist 50–100 times more potent than morphine. Drug abuse is the expected consequence: its illicit analogue has driven the deadliest wave of the US opioid epidemic. 14,908 co-reports (PRR 22.7) reflect both legitimate medical use and widespread diversion. The label carries a boxed warning for addiction, abuse, and misuse.
Boxed warning: fentanyl label (addiction/abuse/misuse). DEA scheduling. CDC fentanyl reports.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 22.7 with 14,908 co-reports |
| Consistency | met | Reproduced across opioid class |
| Specificity | partial | Specific to mu-opioid agonists |
| Biological gradient | met | Tolerance documented |
| Plausibility | met | Known mu-opioid mechanism |
| Coherence | met | Withdrawal recognised |
| Experiment | n/a | Not an RCT endpoint |
| Analogy | met | All opioids show identical dependence |
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 Fentanyl captured drug abuse as a tracked adverse event in a usable structure. Fentanyl trials measure acute analgesia; dependence assessed in epidemiological studies.