OpenPV Signal Explorer
FAERS disproportionality dashboard
← All causality assessments
Causality assessment · Causality: well established

Alprazolam (benzodiazepines) and Drug dependence / abuse: is the FAERS signal real?

n=11,121 co-reports · PRR 15.6 · ROR 16.4
Alprazolam (benzodiazepines) 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

Alprazolam (benzodiazepines) ↔ Drug dependence / abuse

n=11,121 co-reports · PRR 15.6 · ROR 16.4

Reporting over time (stimulated-reporting check)

2004: 88 reports (2.89% of the drug's reports)2005: 95 reports (2.64% of the drug's reports)2006: 67 reports (1.93% of the drug's reports)2007: 73 reports (2.23% of the drug's reports)2008: 52 reports (1.28% of the drug's reports)2009: 37 reports (0.75% of the drug's reports)2010: 56 reports (0.72% of the drug's reports)2011: 69 reports (0.88% of the drug's reports)2012: 68 reports (0.69% of the drug's reports)2013: 92 reports (0.96% of the drug's reports)2014: 66 reports (0.64% of the drug's reports)2015: 101 reports (0.71% of the drug's reports)2016: 157 reports (1.08% of the drug's reports)2017: 93 reports (0.69% of the drug's reports)2018: 313 reports (2.10% of the drug's reports)2019: 328 reports (2.12% of the drug's reports)2020: 936 reports (6.41% of the drug's reports)2021: 635 reports (6.04% of the drug's reports)2022: 281 reports (2.91% of the drug's reports)2023: 120 reports (1.36% of the drug's reports)2024: 126 reports (1.48% of the drug's reports)2025: 204 reports (2.43% of the drug's reports)05081114172023

Reporting spiked in 2020, 2021 — 39% of all 4,057 reports arrived in two years (2020–2021). 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.

Alprazolam is a short-acting, high-potency benzodiazepine, and physical dependence with withdrawal on cessation is an expected, dose- and duration-related effect of the benzodiazepine class — the drug's own pharmacology, not an idiosyncratic reaction. In September 2020 the FDA updated the Boxed Warning for the entire class to address risks of abuse, addiction, physical dependence, and withdrawal. The high report count reflects both how widely these drugs are prescribed and how reliably dependence develops with sustained use.

Regulatory basis: FDA Drug Safety Communication, 23 September 2020 — Boxed Warning updated for the benzodiazepine class (abuse, addiction, physical dependence, withdrawal).

Bradford Hill viewpointStatusNote
Temporality (necessary)metDependence develops over the course of exposure, before withdrawal is seen on cessation
StrengthmetPRR 16, on a very large report base
ConsistencymetReproduced across the whole benzodiazepine class and decades of use
SpecificitypartialA class effect; potency and half-life differ between agents
Biological gradientmetRisk rises with dose, duration, and shorter half-life (more inter-dose withdrawal)
PlausibilitymetDirect consequence of GABA-A receptor modulation
CoherencemetCoheres with the known dependence liability of the class
ExperimentmetWithdrawal on discontinuation is itself the natural dechallenge
AnalogymetShared with other CNS depressants (alcohol, barbiturates)

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

✗ Searched, nothing relevant found. Dependence is a slow, behavioral outcome rarely captured as a discrete adverse-event term in short benzodiazepine trials; it is the class Boxed Warning, not trial AE tables, that records it.