Safety Profile Overview
Second-generation BTK inhibitor for CLL/SLL and MCL. Designed with improved selectivity versus first-generation BTK inhibitors.
Generic Name
acalabrutinib
Brand Names
Calquence
Therapeutic Class
BTK Inhibitor
Manufacturer
AstraZeneca
What Pharma Signal Tracks for Calquence
- Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Calquence, including serious outcomes, hospitalizations, and deaths.
- FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Calquence 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 Calquence Safety Data via API
One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Calquence.
curl "https://api.pharma-signal.com/drug/safety/calquence" \ -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 Calquence against other BTK Inhibitor drugs, or explore the full manufacturer portfolio for AstraZeneca.
- Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
- Therapeutic class benchmarking — See how Calquence ranks within BTK Inhibitor on serious event rates.
- Company portfolio risk — View all drugs from AstraZeneca with aggregate risk exposure.
- AI analyst briefs — Get a natural-language safety assessment combining all data sources.