Insulin Glargine Safety Profile & Adverse Events

Safety Profile Overview

Long-acting basal insulin analog for type 1 and type 2 diabetes. Most prescribed insulin worldwide. Hypoglycemia and injection site reactions are monitored.

Generic Name

insulin glargine

Brand Names

Lantus, Basaglar, Toujeo

Therapeutic Class

Long-Acting Insulin

Manufacturer

Sanofi

What Pharma Signal Tracks for Insulin Glargine

Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Insulin Glargine, including serious outcomes, hospitalizations, and deaths.
FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Insulin Glargine products.
Label Changes — Boxed warning additions, new contraindications, dosing modifications, and safety-related labeling supplements.
Risk Score — Composite risk score (0–100) combining adverse event rates, recall history, and label severity with explainable breakdown.
Pharmacovigilance Signals — Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR) analysis detecting disproportionate adverse reactions.
Trend Analysis — Monthly time series with anomaly detection for emerging safety signals.

Data Disclaimer: Pharma Signal aggregates data from the FDA Adverse Event Reporting System (FAERS) and other public regulatory sources. FAERS reports do not establish causation. Report counts may reflect prescription volume rather than relative safety. Always consult healthcare professionals for medical decisions.

Get Insulin Glargine Safety Data via API

One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Insulin Glargine.

curl "https://api.pharma-signal.com/drug/safety/insulin-glargine" \
  -H "X-API-Key: your_key"

# Returns risk score, adverse event counts,
# serious/death rates, recalls, and signals

Try the API API Reference

Related Safety Intelligence

Pharma Signal provides comparative analysis across therapeutic classes. Compare Insulin Glargine against other Long-Acting Insulin drugs, or explore the full manufacturer portfolio for Sanofi.

Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
Therapeutic class benchmarking — See how Insulin Glargine ranks within Long-Acting Insulin on serious event rates.
Company portfolio risk — View all drugs from Sanofi with aggregate risk exposure.
AI analyst briefs — Get a natural-language safety assessment combining all data sources.