Xtandi Safety Profile & Adverse Events

Safety Profile Overview

Androgen receptor inhibitor for metastatic and non-metastatic castration-resistant prostate cancer. Monitored for seizures and falls.

Generic Name

enzalutamide

Brand Names

Xtandi

Therapeutic Class

Androgen Receptor Inhibitor

Manufacturer

Pfizer/Astellas

What Pharma Signal Tracks for Xtandi

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

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

curl "https://api.pharma-signal.com/drug/safety/xtandi" \
  -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 Xtandi against other Androgen Receptor Inhibitor drugs, or explore the full manufacturer portfolio for Pfizer/Astellas.

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