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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\CAFFEINE\CARISOPRODOL\DICLOFENAC: 36 Adverse Event Reports & Safety Profile

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36
Total FAERS Reports
1 (2.8%)
Deaths Reported
14
Hospitalizations
36
As Primary/Secondary Suspect
4
Life-Threatening
3
Disabilities

First Report: 20060830 · Latest Report: 20230223

What Are the Most Common ACETAMINOPHEN\CAFFEINE\CARISOPRODOL\DICLOFENAC Side Effects?

#1 Most Reported
Pain
11 reports (30.6%)
#2 Most Reported
Headache
9 reports (25.0%)
#3 Most Reported
Foetal exposure during pregnancy
9 reports (25.0%)

All ACETAMINOPHEN\CAFFEINE\CARISOPRODOL\DICLOFENAC Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pain 11 30.6% 1 5
Arthralgia 9 25.0% 1 3
Congenital anomaly 9 25.0% 0 0
Foetal exposure during pregnancy 9 25.0% 1 1
Headache 9 25.0% 1 3
Drug ineffective 8 22.2% 1 2
Maternal exposure during pregnancy 8 22.2% 0 0
Fatigue 7 19.4% 1 5
Dyspnoea 6 16.7% 1 4
Spinal pain 6 16.7% 0 2
Abdominal pain upper 5 13.9% 0 2
Arthropathy 5 13.9% 1 3
Blood cholesterol increased 5 13.9% 1 2
Cough 5 13.9% 0 3
Hypertension 5 13.9% 1 3
Pruritus 5 13.9% 1 4
Swelling 5 13.9% 1 3
Weight increased 5 13.9% 0 1

Who Reports ACETAMINOPHEN\CAFFEINE\CARISOPRODOL\DICLOFENAC Side Effects? Age & Gender Data

Gender: 80.0% female, 20.0% male. Average age: 48.5 years. Most reports from: BR. View detailed demographics →

Is ACETAMINOPHEN\CAFFEINE\CARISOPRODOL\DICLOFENAC Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 1 0 0
2009 2 0 0
2010 2 0 2
2013 1 0 0
2014 1 0 1
2015 5 0 3
2016 3 0 3
2017 1 0 1
2018 1 0 0
2019 2 0 0
2020 1 0 1
2021 1 0 1
2022 1 0 1
2023 1 0 0

View full timeline →

What Is ACETAMINOPHEN\CAFFEINE\CARISOPRODOL\DICLOFENAC Used For?

IndicationReports
Product used for unknown indication 21
Exposure during pregnancy 8

Official FDA Label for ACETAMINOPHEN\CAFFEINE\CARISOPRODOL\DICLOFENAC

Official prescribing information from the FDA-approved drug label.