Safety Profile Overview
Controversial anti-amyloid antibody for Alzheimer's disease. Accelerated approval was highly debated. ARIA (amyloid-related imaging abnormalities) is the key safety concern.
Generic Name
aducanumab
Brand Names
Aduhelm
Therapeutic Class
Anti-Amyloid Antibody
Manufacturer
Biogen
What Pharma Signal Tracks for Aduhelm
- Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Aduhelm, including serious outcomes, hospitalizations, and deaths.
- FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Aduhelm 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 Aduhelm Safety Data via API
One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Aduhelm.
curl "https://api.pharma-signal.com/drug/safety/aduhelm" \ -H "X-API-Key: your_key" # Returns risk score, adverse event counts, # serious/death rates, recalls, and signals
Related Safety Intelligence
Pharma Signal provides comparative analysis across therapeutic classes. Compare Aduhelm against other Anti-Amyloid Antibody drugs, or explore the full manufacturer portfolio for Biogen.
- Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
- Therapeutic class benchmarking — See how Aduhelm ranks within Anti-Amyloid Antibody on serious event rates.
- Company portfolio risk — View all drugs from Biogen with aggregate risk exposure.
- AI analyst briefs — Get a natural-language safety assessment combining all data sources.