OpenPV Signal Explorer
FAERS disproportionality dashboard
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Causality assessment · Causality: well established

Oxycodone and Drug dependence / withdrawal syndrome: is the FAERS signal real?

Drug dependence: n=100,436 · PRR 158.4 · ROR 295.3
Oxycodone side-effect profileAll assessmentsSee in the full list
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

Oxycodone ↔ Drug dependence / withdrawal syndrome

Drug dependence: n=100,436 · PRR 158.4 · ROR 295.3 Drug withdrawal syndrome: n=36,964 · PRR 69.3

Reporting over time (stimulated-reporting check)

2004: 650 reports (17.09% of the drug's reports)2005: 694 reports (21.96% of the drug's reports)2006: 176 reports (10.82% of the drug's reports)2007: 659 reports (26.27% of the drug's reports)2008: 154 reports (9.45% of the drug's reports)2009: 94 reports (5.54% of the drug's reports)2010: 95 reports (3.25% of the drug's reports)2011: 112 reports (4.06% of the drug's reports)2012: 62 reports (2.06% of the drug's reports)2013: 88 reports (3.12% of the drug's reports)2014: 137 reports (3.75% of the drug's reports)2015: 170 reports (3.36% of the drug's reports)2016: 280 reports (4.52% of the drug's reports)2017: 275 reports (3.68% of the drug's reports)2018: 1,231 reports (4.34% of the drug's reports)2019: 415 reports (6.94% of the drug's reports)2020: 16,989 reports (66.42% of the drug's reports)2021: 46,526 reports (86.13% of the drug's reports)2022: 29,807 reports (85.43% of the drug's reports)2023: 1,034 reports (17.07% of the drug's reports)2024: 277 reports (5.59% of the drug's reports)2025: 382 reports (7.18% of the drug's reports)05081114172023

Reporting spiked in 2004, 2005, 2007, 2020, 2021, 2022, 2023 — 76% of all 100,307 reports arrived in two years (2021–2022). A burst like this usually follows a regulatory communication, media coverage or litigation advertising rather than a change in the drug's effect; it inflates disproportionality for those years.

Bars: reports per year as a share of all FAERS reports for this drug, 2004–2025; amber = spike year (>3× the median share, ≥50 reports). Source: openFDA count=receivedate, retrieved 2026-10-09.

The largest report volume of any pair on this page, and the least scientifically contested: oxycodone is a full mu-opioid receptor agonist, and physical dependence and withdrawal on cessation are expected, dose- and duration-related pharmacological effects of that mechanism, not an idiosyncratic reaction. This pair is included less because it is surprising and more because its sheer scale in this dataset (over 100,000 co-reports) is itself a public-health data point, central to the opioid-crisis regulatory response, including REMS requirements for opioid analgesics and prescribing-guideline changes from CDC.

Regulatory basis: opioid analgesic REMS program; CDC clinical practice guideline for prescribing opioids.

Bradford Hill viewpointStatusNote
Temporality (necessary)metDependence develops over the course of exposure, before withdrawal is observed on cessation
StrengthmetPRR 158
ConsistencymetReplicated across every opioid in the class
SpecificitypartialOpioid class effect, not specific to oxycodone
Biological gradientmetTextbook dose/duration dependence
PlausibilitymetMu-opioid receptor mechanism, among the best-characterized in pharmacology
CoherencemetFits the entire opioid pharmacology literature
ExperimentmetReduced prescribing volume demonstrably reduces new dependence at the population level
AnalogymetDirect analogy across the entire opioid class

This page's own qualitative read, not an automated/citation-gated assessment.

✗ No ClinicalTrials.gov results-posting trial in the top 15 search hits for oxycodone tracked dependence or withdrawal syndrome as a formal adverse-event term. Most registered oxycodone trials are short-duration analgesia studies not designed or powered to capture dependence, which develops over sustained use — the evidence base for this pairing is epidemiological and clinical (prescribing-pattern and REMS data), not trial AE tables.