Safety Profile Overview
Anti-CD38 antibody for multiple myeloma. Infusion-related reactions are the primary safety concern.
Generic Name
daratumumab
Brand Names
Darzalex, Darzalex Faspro
Therapeutic Class
Anti-CD38 Monoclonal Antibody
Manufacturer
Janssen
What Pharma Signal Tracks for Darzalex
- Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Darzalex, including serious outcomes, hospitalizations, and deaths.
- FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Darzalex 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 Darzalex Safety Data via API
One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Darzalex.
curl "https://api.pharma-signal.com/drug/safety/darzalex" \ -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 Darzalex against other Anti-CD38 Monoclonal Antibody drugs, or explore the full manufacturer portfolio for Janssen.
- Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
- Therapeutic class benchmarking — See how Darzalex ranks within Anti-CD38 Monoclonal Antibody on serious event rates.
- Company portfolio risk — View all drugs from Janssen with aggregate risk exposure.
- AI analyst briefs — Get a natural-language safety assessment combining all data sources.