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TYLENOL® Safety Profile

TYLENOL® is an appropriate analgesic choice for many patients

Closeup of two TYLENOL® Extra Strength Caplets with acetaminophen – Use product only as directed.

TYLENOL® has an outstanding safety profile when used as directed. Studies have shown:

  • No evidence of acetaminophen toxicity at therapeutic doses for patients with stable chronic liver disease1

  • No evidence of liver dysfunction in a clinical trial with alcoholic patients2

  • Dose up to 4000 mg/day safely at a healthcare professional’s discretion for a wide range of patients*

Use of Acetaminophen in Patients with Liver Disease

ALT relative to upper limit of reference range (ULRR) in patients with hepatic impairment
No statistically significant change from baseline.
Acetaminophen 4000 mg/day is well tolerated1

Graph of ALT relative to ULRR in patients with hepatic impairment taking acetaminophen 4000 mg/day.

Study Design

  • 10-day, open-label, parallel-group, in-clinic study

  • 12 subjects with moderate hepatic impairment

  • 13 healthy match-controlled adult subjects

  • Day 1: acetaminophen 1000 mg; Days 1 to 3: washout period; Days 4 to 8: acetaminophen 1000 mg every 6 hours

  • Measures: acetaminophen and metabolites in blood samples and pooled urine samples

Use of Acetaminophen in Patients Who Consume Alcohol

Serum ALT measures in alcoholic patients treated with acetaminophen 4000 mg/day for 5 days—no statistically significant difference compared with placebo on any single day of the study2

Graph of serum ALT measures in alcoholic patients treated with acetaminophen 4000 mg/day for 5 days.

Study Design

  • Randomized, double-blind, placebo-controlled study

  • 142 adult subjects who abuse alcohol

  • Groups: acetaminophen 4000 mg/day or placebo

  • 5 days

  • Measures: serum alanine transaminase (ALT) and aspartate aminotransferase (AST), total bilirubin, et al

Acetaminophen Label Liver Warnings

All TYLENOL® product labels have the following liver warnings:

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours

  • with other drugs containing acetaminophen

  • 3 or more alcoholic drinks every day while using this product

References

1. Gelotte C, Temple AR, Zimmerman BA, Slattery JT. Acetaminophen biotransformation at single and repeat maximum doses is similar between adults with and without chronic liver disease. Poster presented at: 58th Annual Meeting of the American Association for the Study of Liver Disease; November 2007; Boston, MA.
2. Dart RC, Green JL, Kuffner EK, Heard K, Sproule B, Brands B. The effects of paracetamol (acetaminophen) on hepatic tests in patients who chronically abuse alcohol—a randomized study. Ailment Pharmacol Ther. 2010;32(3):478-486.

*The efficacy and safety of TYLENOL® at 4000 mg/day are well established.