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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\NAPROXEN: 23 Adverse Event Reports & Safety Profile

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23
Total FAERS Reports
11 (47.8%)
Deaths Reported
11
Hospitalizations
23
As Primary/Secondary Suspect
11
Life-Threatening
11
Disabilities

First Report: 20150701 · Latest Report: 20190610

What Are the Most Common ACETAMINOPHEN\NAPROXEN Side Effects?

#1 Most Reported
Off label use
19 reports (82.6%)
#2 Most Reported
Drug ineffective
18 reports (78.3%)
#3 Most Reported
Synovitis
17 reports (73.9%)

All ACETAMINOPHEN\NAPROXEN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 19 82.6% 10 10
Drug ineffective 18 78.3% 9 9
Contraindicated product administered 17 73.9% 9 9
Pain 17 73.9% 9 9
Rheumatoid arthritis 17 73.9% 9 9
Swelling 17 73.9% 9 9
Synovitis 17 73.9% 9 9
Condition aggravated 16 69.6% 8 8
Rash 16 69.6% 8 8
Arthralgia 15 65.2% 6 6
Drug intolerance 14 60.9% 6 6
Hepatic enzyme increased 14 60.9% 6 6
Asthenia 12 52.2% 4 4
Gastrooesophageal reflux disease 11 47.8% 3 3
Mobility decreased 11 47.8% 3 3
Muscle spasms 11 47.8% 3 3
Pneumonia 11 47.8% 3 3
Therapeutic response decreased 11 47.8% 2 2
Blood cholesterol increased 10 43.5% 2 2
Infusion related reaction 10 43.5% 10 10

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

Gender: 95.0% female, 5.0% male. Average age: 48.2 years. Most reports from: CA. View detailed demographics →

Is ACETAMINOPHEN\NAPROXEN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2015 1 0 0
2019 1 0 0

View full timeline →

What Is ACETAMINOPHEN\NAPROXEN Used For?

IndicationReports
Rheumatoid arthritis 16

Official FDA Label for ACETAMINOPHEN\NAPROXEN

Official prescribing information from the FDA-approved drug label.