Xolair Safety Profile & Adverse Events

Safety Profile Overview

Anti-IgE antibody for moderate-severe allergic asthma, chronic urticaria, nasal polyps, and food allergy. Boxed warning for anaphylaxis.

Generic Name

omalizumab

Brand Names

Xolair

Therapeutic Class

Anti-IgE Monoclonal Antibody

Manufacturer

Roche/Genentech

What Pharma Signal Tracks for Xolair

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

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

curl "https://api.pharma-signal.com/drug/safety/xolair" \
  -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 Xolair against other Anti-IgE Monoclonal Antibody drugs, or explore the full manufacturer portfolio for Roche/Genentech.

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