Safety Profile Overview
Triple CFTR modulator combination for cystic fibrosis. Transformed CF treatment for approximately 90% of patients. Monitored for hepatotoxicity and cataracts.
Generic Name
elexacaftor/tezacaftor/ivacaftor
Brand Names
Trikafta
Therapeutic Class
CFTR Modulator
Manufacturer
Vertex
What Pharma Signal Tracks for Trikafta
- Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Trikafta, including serious outcomes, hospitalizations, and deaths.
- FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Trikafta 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 Trikafta Safety Data via API
One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Trikafta.
curl "https://api.pharma-signal.com/drug/safety/trikafta" \ -H "X-API-Key: your_key" # Returns risk score, adverse event counts, # serious/death rates, recalls, and signals
Related Safety Intelligence
Pharma Signal provides comparative analysis across therapeutic classes. Compare Trikafta 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 Trikafta 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.