Orkambi Safety Profile & Adverse Events

Safety Profile Overview

First CFTR modulator combination for F508del homozygous CF patients. Monitored for hepatic effects and respiratory events at treatment initiation.

Generic Name

lumacaftor/ivacaftor

Brand Names

Orkambi

Therapeutic Class

CFTR Modulator

Manufacturer

Vertex

What Pharma Signal Tracks for Orkambi

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

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

curl "https://api.pharma-signal.com/drug/safety/orkambi" \
  -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 Orkambi against other CFTR Modulator drugs, or explore the full manufacturer portfolio for Vertex.

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