Acetaminophen Safety Profile & Adverse Events

Safety Profile Overview

The most widely used OTC analgesic. Hepatotoxicity from overdose is the leading cause of acute liver failure in the US. FDA max dose guidance at 3g/day.

Generic Name

acetaminophen

Brand Names

Tylenol

Therapeutic Class

Analgesic / Antipyretic

Manufacturer

Johnson & Johnson

What Pharma Signal Tracks for Acetaminophen

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

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

curl "https://api.pharma-signal.com/drug/safety/acetaminophen" \
  -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 Acetaminophen against other Analgesic / Antipyretic drugs, or explore the full manufacturer portfolio for Johnson & Johnson.

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