TYLENOL® Safety Profile

When used as directed, TYLENOL® is an appropriate choice for many patients.

TYLENOL® can be dosed at 4000 mg per day safely for a wide range of patients3

The hepatic safety of labeled doses of acetaminophen has been demonstrated in clinical studies. In studies, there was no evidence of acetaminophen toxicity at therapeutic doses for patients with liver disease of varying severity and etiology.1,2,4-6  In alcoholic patients treated for up to 5 days, there was no statistically significant difference in alanine aminotransferase (ALT) values compared to patients receiving placebo.2

Use of acetaminophen in patients with liver disease

ALT relative to Upper Limit of Reference Range (ULRR)—no statistically significant change from baseline.1

Considerations in hepatic-impaired patients

Acetaminophen (4000 mg/day) was well tolerated in subjects with hepatic impairment, showing no significant changes from baseline in ALT levels in a pharmacokinetic study.1

Data from 5 prospective studies in adults with liver disease of varying severity and etiology show no evidence of acetaminophen toxicity at therapeutic doses.1,2,4-6

Use of acetaminophen in patients with liver disease

 

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 to placebo.2

Acetaminophen and alcohol use

Studies in recently abstinent alcoholic patients demonstrated that patients treated with acetaminophen 4000 mg/day for up to 5 days had no statistically significant difference in ALT values compared to patients receiving placebo.2

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

Ask a doctor before use if you have liver disease.

Acetaminophen and Alcohol Use with Placebo Graph

 

Safety and efficacy graph

Acetaminophen 1000 mg and 650 mg are effective for postoperative dental pain7

Read about efficacy
Educate patients on dosing

Help patients read and follow labels

TYLENOL® is safe and effective when used as directed.

View product dosing

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. Green JL, Kuffner EK, Bogdan GM, Dart RC. Hepatic function in alcoholics throughout 5 days of maximal therapeutic dosing of acetaminophen (APAP). Clin Toxicol. 2005;43:683. 3. Data on file. Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. Fort Washington, PA; 2017. 4. Benson GD. Acetaminophen in chronic liver disease. Clin Pharmacol Ther. 1983;33(1):95-101. 5. Andreasen PB, Hutters L. Paracetamol (acetaminophen) clearance in patients with cirrhosis of the liver. Acta Med Scand Suppl. 1979;624:99-105. 6. Dargere S, Collet T, Crampon D, et al. Lack of toxicity of acetaminophen in patients with chronic hepatitis C: a randomized controlled trial. Gastroenterology. 2000;118(4, suppl 2);A947. 7. Qi DS, May LG, Zimmerman B, et al. A randomized, double-blind, placebo-controlled study of acetaminophen 1000 mg versus acetaminophen 650 mg for the treatment of postsurgical dental pain. Clin Ther. 2012;34(12):2247-2258.