Tagrisso Safety Profile & Adverse Events

Safety Profile Overview

Third-generation EGFR TKI for non-small cell lung cancer. Monitored for cardiac effects including QTc prolongation and cardiomyopathy.

Generic Name

osimertinib

Brand Names

Tagrisso

Therapeutic Class

EGFR Tyrosine Kinase Inhibitor

Manufacturer

AstraZeneca

What Pharma Signal Tracks for Tagrisso

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

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

curl "https://api.pharma-signal.com/drug/safety/tagrisso" \
  -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 Tagrisso against other EGFR Tyrosine Kinase Inhibitor drugs, or explore the full manufacturer portfolio for AstraZeneca.

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