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FAERS disproportionality dashboard
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Causality assessment · Contested: small, real but modest effect

Atorvastatin (statins) and Type 2 diabetes mellitus: is the FAERS signal real?

n=11,260 co-reports · PRR 42.4 · ROR 44.4
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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.
Contested: small, real but modest effect

Atorvastatin (statins) ↔ Type 2 diabetes mellitus

n=11,260 co-reports · PRR 42.4 · ROR 44.4

Reporting over time (stimulated-reporting check)

2004: 0 reports (0.00% of the drug's reports)2005: 0 reports (0.00% of the drug's reports)2006: 2 reports (0.02% of the drug's reports)2007: 12 reports (0.17% of the drug's reports)2008: 16 reports (0.25% of the drug's reports)2009: 219 reports (2.98% of the drug's reports)2010: 226 reports (1.55% of the drug's reports)2011: 133 reports (1.15% of the drug's reports)2012: 86 reports (0.62% of the drug's reports)2013: 355 reports (3.35% of the drug's reports)2014: 4,974 reports (32.41% of the drug's reports)2015: 2,630 reports (17.14% of the drug's reports)2016: 1,612 reports (10.95% of the drug's reports)2017: 512 reports (4.02% of the drug's reports)2018: 132 reports (1.03% of the drug's reports)2019: 108 reports (0.82% of the drug's reports)2020: 66 reports (0.54% of the drug's reports)2021: 43 reports (0.41% of the drug's reports)2022: 39 reports (0.37% of the drug's reports)2023: 36 reports (0.38% of the drug's reports)2024: 21 reports (0.21% of the drug's reports)2025: 30 reports (0.27% of the drug's reports)05081114172023

Reporting spiked in 2009, 2013, 2014, 2015, 2016, 2017 — 68% of all 11,252 reports arrived in two years (2014–2015). 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.

Pooled randomized-trial data found a small but statistically significant increase in new-onset diabetes among statin recipients (Sattar et al., Lancet 2010, PMID 20167359), and in 2012 the FDA added a warning about increases in blood glucose and HbA1c. The effect is real but modest, appears dose-related, and is generally judged to be outweighed by statins' cardiovascular benefit; whether it reflects a true diabetogenic action or the unmasking of already-predisposed patients remains debated. The very high FAERS PRR here overstates the clinical magnitude — statin users are heavily monitored, so even a modest true effect inflates further in spontaneous reporting.

Sattar N, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010;375(9716):735-742 (PMID 20167359). FDA prescribing-information change on glucose/HbA1c (2012).

Bradford Hill viewpointStatusNote
Temporality (necessary)partialNew diabetes appears after starting the statin, but latency is long and variable
StrengthpartialPRR 42 in FAERS, but only a small absolute effect in randomized trials
ConsistencymetReproduced across many statin trials in the pooled analysis
Specificitynot establishedDiabetes is common and multifactorial; statins affect many pathways
Biological gradientpartialThe effect tracks with statin intensity/dose in several analyses
PlausibilitypartialProposed mechanisms include effects on insulin sensitivity and glucose transport
CoherencepartialFits the modest glucose-raising seen with the class, without implying large harm
ExperimentmetRandomized trials are the strongest evidence here — the effect is real, just small
AnalogypartialOther drugs with metabolic effects can modestly shift glucose

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

✗ Searched; the trial that surfaced was not evidence either way. A real-world atorvastatin cohort (NCT02565615) recorded type 2 diabetes as a serious event in a single patient (1/3,080 at 20 mg) — far too small and short to detect a modest, long-latency metabolic effect. The relevant evidence is the pooled long-term randomized trials, not a trial AE table.