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Causality assessment · Expected pharmacological effect

Insulin glargine and Hypoglycaemia (blood glucose decreased): is the FAERS signal real?

n=10,511 co-reports · PRR 23.6 · ROR 24.7
Insulin glargine 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.
Expected pharmacological effect

Insulin glargine ↔ Hypoglycaemia (blood glucose decreased)

n=10,511 co-reports · PRR 23.6 · ROR 24.7

Reporting over time (stimulated-reporting check)

2004: 90 reports (8.70% of the drug's reports)2005: 152 reports (8.43% of the drug's reports)2006: 184 reports (5.63% of the drug's reports)2007: 244 reports (7.34% of the drug's reports)2008: 241 reports (8.17% of the drug's reports)2009: 220 reports (5.62% of the drug's reports)2010: 216 reports (4.00% of the drug's reports)2011: 271 reports (4.32% of the drug's reports)2012: 268 reports (4.79% of the drug's reports)2013: 409 reports (5.02% of the drug's reports)2014: 447 reports (3.69% of the drug's reports)2015: 628 reports (3.21% of the drug's reports)2016: 512 reports (3.34% of the drug's reports)2017: 496 reports (3.33% of the drug's reports)2018: 833 reports (3.87% of the drug's reports)2019: 571 reports (2.98% of the drug's reports)2020: 506 reports (2.97% of the drug's reports)2021: 377 reports (2.43% of the drug's reports)2022: 314 reports (2.17% of the drug's reports)2023: 319 reports (2.49% of the drug's reports)2024: 246 reports (1.71% of the drug's reports)2025: 249 reports (1.38% of the drug's reports)05081114172023

No reporting spike: the pair's share of the drug's reports is fairly stable over time (busiest two years hold 18% of 7,793 reports), so stimulated reporting is unlikely to explain the signal.

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.

Insulin glargine is a long-acting basal insulin, and hypoglycaemia is its defining and most important adverse effect — a direct, dose-related consequence of the drug's own mechanism, not an idiosyncratic reaction. Every insulin product carries this risk, and it is the principal safety concern in insulin therapy, requiring careful titration and glucose monitoring. It is the textbook expected pharmacological effect: the drug's intended action (lowering glucose) can overshoot.

Regulatory basis: insulin glargine prescribing information (hypoglycemia listed as the most common adverse reaction and among the most important risks).

Bradford Hill viewpointStatusNote
Temporality (necessary)metHypoglycaemia follows insulin action, within its duration of effect
StrengthmetPRR 24, on a very large insulin-treated population
ConsistencymetUniversal across insulins and settings
SpecificitypartialA class effect of all insulins and secretagogues
Biological gradientmetClose dose–effect relationship; the core of insulin titration
PlausibilitymetDirect consequence of exogenous insulin's glucose-lowering action
CoherencemetCoheres with the entire insulin pharmacotherapy literature
ExperimentmetDose reduction and glucose/glucagon correction reverse it — a clean on/off
AnalogymetShared by every insulin formulation and by insulin secretagogues

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

Not searched in ClinicalTrials.gov for this entry. Hypoglycaemia is insulin's defining labeled effect and is measured as the primary safety endpoint in essentially every insulin trial; a disproportionality signal adds little to what those trials already quantify directly.