Safety Profile Overview
CDK4/6 inhibitor for HR+/HER2- breast cancer with demonstrated overall survival benefit. Key safety concern is QTc prolongation.
Generic Name
ribociclib
Brand Names
Kisqali
Therapeutic Class
CDK4/6 Inhibitor
Manufacturer
Novartis
What Pharma Signal Tracks for Kisqali
- Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Kisqali, including serious outcomes, hospitalizations, and deaths.
- FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Kisqali 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 Kisqali Safety Data via API
One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Kisqali.
curl "https://api.pharma-signal.com/drug/safety/kisqali" \ -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 Kisqali against other CDK4/6 Inhibitor drugs, or explore the full manufacturer portfolio for Novartis.
- Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
- Therapeutic class benchmarking — See how Kisqali ranks within CDK4/6 Inhibitor on serious event rates.
- Company portfolio risk — View all drugs from Novartis with aggregate risk exposure.
- AI analyst briefs — Get a natural-language safety assessment combining all data sources.