Zolgensma Safety Profile & Adverse Events

Safety Profile Overview

AAV9-based gene therapy for spinal muscular atrophy. One of the most expensive single-dose treatments. Monitored for hepatotoxicity and thrombotic microangiopathy.

Generic Name

onasemnogene abeparvovec

Brand Names

Zolgensma

Therapeutic Class

Gene Therapy

Manufacturer

Novartis

What Pharma Signal Tracks for Zolgensma

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

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

curl "https://api.pharma-signal.com/drug/safety/zolgensma" \
  -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 Zolgensma against other Gene Therapy 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 Zolgensma ranks within Gene Therapy 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.