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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Hydrocodone Bitartrate And Acetaminophen 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.
Hydrocodone Bitartrate And Acetaminophen ↔ Drug Dependence
n=33,295 co-reports · PRR 96.4 · ROR 236.1
Hydrocodone/acetaminophen is one of the most widely prescribed opioid analgesics in the US. Drug dependence is class-wide for mu-opioid agonists; the product carries a boxed warning on addiction, abuse, and misuse. 34,513 co-reports (PRR 86.8) reflect real dependence and the enormous exposed population.
Boxed warning: hydrocodone/APAP label (addiction/abuse/misuse). CDC opioid reports; Lancet 2015, PMID: 26101189.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 86.8 with 34,513 co-reports |
| Consistency | met | Reproduced across opioid class |
| Specificity | partial | Specific to mu-opioid agonists |
| Biological gradient | met | Tolerance documented |
| Plausibility | met | Known mechanism |
| Coherence | met | Withdrawal recognised |
| Experiment | n/a | Not an RCT endpoint |
| Analogy | met | Analogous 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.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for Hydrocodone captured drug dependence as a tracked adverse event in a usable structure. Short-term analgesia trials do not capture dependence endpoints.