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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Hydromorphone Hydrochloride and Drug Dependence: 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.
Hydromorphone Hydrochloride ↔ Drug Dependence
n=35,112 co-reports · PRR 63.1 · ROR 101.7
Hydromorphone is a semi-synthetic opioid 5–10 times more potent than morphine. Drug dependence follows the same pathway as other opioids: euphoria, tolerance, withdrawal. 35,112 co-reports (PRR 63.1) confirm the pattern across the opioid class. The label carries a boxed warning for addiction, abuse, and misuse.
Boxed warning: hydromorphone label (addiction/abuse/misuse). CDC opioid guidelines.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in regulatory label |
| Strength | met | PRR 63.1 with 35,112 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 receptor mechanism |
| Coherence | met | Withdrawal recognised |
| Experiment | n/a | Not an RCT endpoint |
| Analogy | met | Other 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 Hydromorphone captured drug dependence as a tracked adverse event in a usable structure. Controlled trials measure acute analgesia; dependence requires longer exposure.