Keytruda Safety Profile & Adverse Events

Safety Profile Overview

Anti-PD-1 checkpoint inhibitor approved for multiple cancer types. The world's top-selling drug by revenue. FDA monitors for immune-mediated adverse reactions across all organ systems.

Generic Name

pembrolizumab

Brand Names

Keytruda

Therapeutic Class

PD-1 Inhibitor

Manufacturer

Merck

What Pharma Signal Tracks for Keytruda

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

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

curl "https://api.pharma-signal.com/drug/safety/keytruda" \
  -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 Keytruda against other PD-1 Inhibitor drugs, or explore the full manufacturer portfolio for Merck.

Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
Therapeutic class benchmarking — See how Keytruda ranks within PD-1 Inhibitor on serious event rates.
Company portfolio risk — View all drugs from Merck with aggregate risk exposure.
AI analyst briefs — Get a natural-language safety assessment combining all data sources.