Causality assessment · Causality: well established

Hydromorphone and Drug dependence: is the FAERS signal real?

n=35,112 co-reports · PRR 63.1 · ROR 101.7

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.

Causality: well established

Hydromorphone ↔ Drug dependence

n=35,112 co-reports · PRR 63.1 · ROR 101.7

Hydromorphone is a potent mu-opioid agonist; tolerance, physical dependence, and addiction are intrinsic to chronic opioid exposure, and drug dependence carries 35,112 co-reports here (PRR 63.1). The risk is amplified with high doses, long duration, and pre-existing substance-use disorder, which is why opioid-prescribing guidelines emphasise cautious initiation and tapering.

Regulatory basis: hydromorphone prescribing information — dependence/abuse; opioid class boxed warning.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Dependence develops with chronic use
Strength	met	PRR 63.1, very large
Consistency	met	Universally reproduced
Specificity	met	Shared across all mu-opioids
Biological gradient	met	Rises with dose and duration
Plausibility	met	Mu-opioid-receptor adaptation
Coherence	met	Fits the mechanism exactly
Experiment	met	Long-term studies support it
Analogy	met	Direct class analogy to other opioids

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 — Single-arm Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration (NCT01709747)

Adverse event	Hydromorphone Hydrochloride (n=364)
Drug Withdrawal Syndrome	1/364

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 →