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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.

ACETAMINOPHEN\ASPIRIN: 48 Adverse Event Reports & Safety Profile

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48
Total FAERS Reports
13 (27.1%)
Deaths Reported
25
Hospitalizations
48
As Primary/Secondary Suspect
2
Life-Threatening
1
Disabilities

First Report: 2010 · Latest Report: 20220101

What Are the Most Common ACETAMINOPHEN\ASPIRIN Side Effects?

#1 Most Reported
Nsaid exacerbated respiratory disease
8 reports (16.7%)
#2 Most Reported
Drug hypersensitivity
7 reports (14.6%)
#3 Most Reported
Completed suicide
7 reports (14.6%)

All ACETAMINOPHEN\ASPIRIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Nsaid exacerbated respiratory disease 8 16.7% 0 8
Asthma 7 14.6% 0 7
Completed suicide 7 14.6% 7 3
Drug hypersensitivity 7 14.6% 0 6
Chronic rhinosinusitis with nasal polyps 6 12.5% 0 6
Obstructive airways disorder 6 12.5% 0 6
Toxicity to various agents 6 12.5% 3 3
Dyspnoea 5 10.4% 0 5
Therapeutic response unexpected 5 10.4% 0 0

Who Reports ACETAMINOPHEN\ASPIRIN Side Effects? Age & Gender Data

Gender: 82.4% female, 17.6% male. Average age: 45.3 years. Most reports from: US. View detailed demographics →

Is ACETAMINOPHEN\ASPIRIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2010 2 1 0
2011 2 0 1
2012 1 0 0
2014 4 2 2
2015 2 1 2
2017 4 4 2
2018 1 1 1
2020 7 0 7
2021 2 1 0
2022 1 1 0

View full timeline →

What Is ACETAMINOPHEN\ASPIRIN Used For?

IndicationReports
Product used for unknown indication 14
Headache 10
Back pain 6
Migraine 6

Official FDA Label for ACETAMINOPHEN\ASPIRIN

Official prescribing information from the FDA-approved drug label.