Leqembi Safety Profile & Adverse Events

Safety Profile Overview

Anti-amyloid antibody granted full FDA approval for early Alzheimer's. ARIA monitoring required. Represents a new era in AD treatment.

Generic Name

lecanemab

Brand Names

Leqembi

Therapeutic Class

Anti-Amyloid Antibody

Manufacturer

Eisai/Biogen

What Pharma Signal Tracks for Leqembi

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

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

curl "https://api.pharma-signal.com/drug/safety/leqembi" \
  -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 Leqembi against other Anti-Amyloid Antibody drugs, or explore the full manufacturer portfolio for Eisai/Biogen.

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