Safety Profile Overview
Ancient anti-inflammatory for gout flares and pericarditis. Narrow therapeutic index with significant drug interactions. GI toxicity is dose-limiting.
Generic Name
colchicine
Brand Names
Colcrys, Mitigare
Therapeutic Class
Anti-Inflammatory
Manufacturer
Takeda
What Pharma Signal Tracks for Colchicine
- Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Colchicine, including serious outcomes, hospitalizations, and deaths.
- FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Colchicine 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 Colchicine Safety Data via API
One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Colchicine.
curl "https://api.pharma-signal.com/drug/safety/colchicine" \ -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 Colchicine against other Anti-Inflammatory drugs, or explore the full manufacturer portfolio for Takeda.
- Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
- Therapeutic class benchmarking — See how Colchicine ranks within Anti-Inflammatory on serious event rates.
- Company portfolio risk — View all drugs from Takeda with aggregate risk exposure.
- AI analyst briefs — Get a natural-language safety assessment combining all data sources.