Sotagliflozin Safety Profile & Adverse Events

Safety Profile Overview

Dual SGLT1/SGLT2 inhibitor for heart failure. First in class to inhibit both transporters, providing cardiac and glycemic benefits.

Generic Name

sotagliflozin

Brand Names

Inpefa

Therapeutic Class

SGLT1/SGLT2 Inhibitor

Manufacturer

Lexicon

What Pharma Signal Tracks for Sotagliflozin

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

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

curl "https://api.pharma-signal.com/drug/safety/sotagliflozin" \
  -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 Sotagliflozin against other SGLT1/SGLT2 Inhibitor drugs, or explore the full manufacturer portfolio for Lexicon.

Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
Therapeutic class benchmarking — See how Sotagliflozin ranks within SGLT1/SGLT2 Inhibitor on serious event rates.
Company portfolio risk — View all drugs from Lexicon with aggregate risk exposure.
AI analyst briefs — Get a natural-language safety assessment combining all data sources.