Enhertu Safety Profile & Adverse Events

Safety Profile Overview

HER2-directed antibody-drug conjugate with breakthrough results across multiple tumor types. Boxed warning for interstitial lung disease.

Generic Name

trastuzumab deruxtecan

Brand Names

Enhertu

Therapeutic Class

Antibody-Drug Conjugate

Manufacturer

Daiichi Sankyo/AstraZeneca

What Pharma Signal Tracks for Enhertu

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

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

curl "https://api.pharma-signal.com/drug/safety/enhertu" \
  -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 Enhertu against other Antibody-Drug Conjugate drugs, or explore the full manufacturer portfolio for Daiichi Sankyo/AstraZeneca.

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