Oxycodone Hydrochloride and Drug Dependence: is the FAERS signal real?
Oxycodone Hydrochloride ↔ Drug Dependence
Oxycodone is a semi-synthetic mu-opioid agonist whose association with drug dependence is among the best-documented causal relationships in pharmacology: re-exposure produces euphoria, tolerance drives escalating use, and withdrawal upon cessation is clinically recognised. The FAERS data show 100,436 co-reports (PRR 158.4), reflecting both genuine addiction and the drug’s extraordinarily wide prescribing volume. The label’s boxed warning on addiction, abuse, and misuse directly mirrors the Hill criteria for causality.
Boxed warning: oxycodone label (addiction/abuse/misuse). CDC mortality reports; Johnson et al., JAMA 2018, PMID: 29538756.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in regulatory label |
| Strength | met | PRR 158.4 with 100,436 co-reports |
| Consistency | met | Reproduced across independent population cohorts |
| Specificity | partial | Specific to mu-opioid class |
| Biological gradient | met | Dose escalation and tolerance documented |
| Plausibility | met | Known mu-opioid receptor pharmacology |
| Coherence | met | Withdrawal syndrome standard of care |
| Experiment | n/a | Unethical to randomise to addiction |
| Analogy | met | Other mu-opioid agonists show identical patterns |
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.