Metformin Safety Profile & Adverse Events

Safety Profile Overview

First-line treatment for type 2 diabetes and one of the most prescribed drugs worldwide. Key safety concern is lactic acidosis in renal impairment.

Generic Name

metformin hydrochloride

Brand Names

Glucophage, Glucophage XR, Fortamet, Riomet

Therapeutic Class

Biguanide

Manufacturer

Various

What Pharma Signal Tracks for Metformin

Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Metformin, including serious outcomes, hospitalizations, and deaths.
FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Metformin 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 Metformin Safety Data via API

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

curl "https://api.pharma-signal.com/drug/safety/metformin" \
  -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 Metformin against other Biguanide drugs, or explore the full manufacturer portfolio for Various.

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