Trelegy Safety Profile & Adverse Events

Safety Profile Overview

First once-daily single-inhaler triple therapy for COPD and asthma. Demonstrated mortality reduction in COPD trials.

Generic Name

fluticasone/umeclidinium/vilanterol

Brand Names

Trelegy Ellipta

Therapeutic Class

ICS/LAMA/LABA Triple Therapy

Manufacturer

GSK

What Pharma Signal Tracks for Trelegy

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

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

curl "https://api.pharma-signal.com/drug/safety/trelegy" \
  -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 Trelegy against other ICS/LAMA/LABA Triple Therapy drugs, or explore the full manufacturer portfolio for GSK.

Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
Therapeutic class benchmarking — See how Trelegy ranks within ICS/LAMA/LABA Triple Therapy on serious event rates.
Company portfolio risk — View all drugs from GSK with aggregate risk exposure.
AI analyst briefs — Get a natural-language safety assessment combining all data sources.