Pradaxa Safety Profile & Adverse Events

Safety Profile Overview

Direct thrombin inhibitor for stroke prevention and VTE. Has a specific reversal agent (idarucizumab). Monitored for GI bleeding.

Generic Name

dabigatran etexilate

Brand Names

Pradaxa

Therapeutic Class

Direct Thrombin Inhibitor

Manufacturer

Boehringer Ingelheim

What Pharma Signal Tracks for Pradaxa

Adverse Events (FAERS) — All FDA Adverse Event Reporting System reports mentioning Pradaxa, including serious outcomes, hospitalizations, and deaths.
FDA Recalls — Class I, II, and III recalls, market withdrawals, and safety alerts related to Pradaxa 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 Pradaxa Safety Data via API

One API call returns adverse events, risk scores, recalls, and pharmacovigilance signals for Pradaxa.

curl "https://api.pharma-signal.com/drug/safety/pradaxa" \
  -H "X-API-Key: your_key"

# Returns risk score, adverse event counts,
# serious/death rates, recalls, and signals

Try the API API Reference

Related Safety Intelligence

Pharma Signal provides comparative analysis across therapeutic classes. Compare Pradaxa against other Direct Thrombin Inhibitor drugs, or explore the full manufacturer portfolio for Boehringer Ingelheim.

Head-to-head comparison — Compare up to 5 drugs side by side on all safety metrics.
Therapeutic class benchmarking — See how Pradaxa ranks within Direct Thrombin Inhibitor on serious event rates.
Company portfolio risk — View all drugs from Boehringer Ingelheim with aggregate risk exposure.
AI analyst briefs — Get a natural-language safety assessment combining all data sources.