Praluent Safety Profile & Adverse Events

Safety Profile Overview

PCSK9 inhibitor for high-risk cardiovascular patients with inadequate LDL control. Monitored for injection site reactions.

Generic Name

alirocumab

Brand Names

Praluent

Therapeutic Class

PCSK9 Inhibitor

Manufacturer

Regeneron/Sanofi

What Pharma Signal Tracks for Praluent

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

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

curl "https://api.pharma-signal.com/drug/safety/praluent" \
  -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 Praluent against other PCSK9 Inhibitor drugs, or explore the full manufacturer portfolio for Regeneron/Sanofi.

Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
Therapeutic class benchmarking — See how Praluent ranks within PCSK9 Inhibitor on serious event rates.
Company portfolio risk — View all drugs from Regeneron/Sanofi with aggregate risk exposure.
AI analyst briefs — Get a natural-language safety assessment combining all data sources.