Aspirin Safety Profile & Adverse Events

Safety Profile Overview

One of the oldest and most studied drugs. Used for pain, fever, inflammation, and cardiovascular prevention. GI bleeding and Reye's syndrome are key safety concerns.

Generic Name

aspirin

Brand Names

Bayer Aspirin, Ecotrin, Bufferin

Therapeutic Class

NSAID / Antiplatelet

Manufacturer

Bayer

What Pharma Signal Tracks for Aspirin

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

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

curl "https://api.pharma-signal.com/drug/safety/aspirin" \
  -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 Aspirin against other NSAID / Antiplatelet drugs, or explore the full manufacturer portfolio for Bayer.

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