Entresto Safety Profile & Adverse Events

Safety Profile Overview

First-in-class angiotensin receptor-neprilysin inhibitor for heart failure. Reduced death and hospitalization versus enalapril in the PARADIGM-HF trial.

Generic Name

sacubitril/valsartan

Brand Names

Entresto

Therapeutic Class

ARNI

Manufacturer

Novartis

What Pharma Signal Tracks for Entresto

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

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

curl "https://api.pharma-signal.com/drug/safety/entresto" \
  -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 Entresto against other ARNI drugs, or explore the full manufacturer portfolio for Novartis.

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