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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

EXTRA STRENGTH TYLENOL: 36 Adverse Event Reports & Safety Profile

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36
Total FAERS Reports
9 (25.0%)
Deaths Reported
26
Hospitalizations
36
As Primary/Secondary Suspect
4
Life-Threatening

First Report: 19930207 · Latest Report: 20120427

What Are the Most Common EXTRA STRENGTH TYLENOL Side Effects?

#1 Most Reported
Acute hepatic failure
27 reports (75.0%)
#2 Most Reported
Overdose
13 reports (36.1%)
#3 Most Reported
Toxicity to various agents
12 reports (33.3%)

All EXTRA STRENGTH TYLENOL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Acute hepatic failure 27 75.0% 5 21
Overdose 13 36.1% 3 11
Toxicity to various agents 12 33.3% 6 9
Hepatic failure 7 19.4% 4 5
Renal failure acute 7 19.4% 2 7
Accidental overdose 6 16.7% 0 6
Coagulopathy 5 13.9% 1 4
Respiratory failure 5 13.9% 2 4

Who Reports EXTRA STRENGTH TYLENOL Side Effects? Age & Gender Data

Average age: 48.4 years. Most reports from: US. View detailed demographics →

Is EXTRA STRENGTH TYLENOL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 3 0 2
2010 4 0 4
2011 15 4 13
2012 3 0 1

View full timeline →

What Is EXTRA STRENGTH TYLENOL Used For?

IndicationReports
Pain 14
Headache 7
Pyrexia 5

Official FDA Label for EXTRA STRENGTH TYLENOL

Official prescribing information from the FDA-approved drug label.