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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\CODEINE: 354 Adverse Event Reports & Safety Profile

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354
Total FAERS Reports
110 (31.1%)
Deaths Reported
160
Hospitalizations
354
As Primary/Secondary Suspect
105
Life-Threatening
99
Disabilities

Active Ingredient: ACETAMINOPHEN\CAFFEINE\CODEINE PHOSPHATE ·

First Report: 1990 · Latest Report: 20240830

What Are the Most Common ACETAMINOPHEN\CAFFEINE\CODEINE Side Effects?

#1 Most Reported
Fatigue
107 reports (30.2%)
#2 Most Reported
Dyspnoea
97 reports (27.4%)
#3 Most Reported
Arthralgia
96 reports (27.1%)

All ACETAMINOPHEN\CAFFEINE\CODEINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fatigue 107 30.2% 59 68
Dyspnoea 97 27.4% 63 71
Arthralgia 96 27.1% 57 76
Infusion related reaction 90 25.4% 56 70
Dizziness 87 24.6% 53 65
Nausea 85 24.0% 50 70
Rheumatoid arthritis 85 24.0% 54 69
Duodenal ulcer perforation 84 23.7% 69 70
Hypersensitivity 84 23.7% 60 63
Pruritus 82 23.2% 51 52
Anxiety 81 22.9% 54 56
Gastrointestinal disorder 80 22.6% 59 66
Pain 80 22.6% 42 56
Abdominal discomfort 79 22.3% 59 62
Arthropathy 79 22.3% 59 64
Depression 79 22.3% 56 57
Folliculitis 79 22.3% 64 65
Hand deformity 79 22.3% 61 62
Hepatic enzyme increased 79 22.3% 60 61
Nasopharyngitis 79 22.3% 50 59

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

Gender: 74.1% female, 25.9% male. Average age: 52.2 years. Most reports from: CA. View detailed demographics →

Is ACETAMINOPHEN\CAFFEINE\CODEINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 2 0 2
2013 1 0 1
2014 2 0 1
2015 3 0 1
2016 3 0 3
2017 5 0 4
2018 5 0 0
2019 7 0 2
2020 2 0 2
2021 10 0 7
2022 2 0 0
2023 5 0 5
2024 4 0 0

View full timeline →

What Is ACETAMINOPHEN\CAFFEINE\CODEINE Used For?

IndicationReports
Product used for unknown indication 217
Pain 29
Rheumatoid arthritis 20
Crohn's disease 11
Pruritus 11
Headache 8
Pain in extremity 5
Rotator cuff syndrome 5
Tendonitis 5

ACETAMINOPHEN\CAFFEINE\CODEINE vs Alternatives: Which Is Safer?

ACETAMINOPHEN\CAFFEINE\CODEINE vs ACETAMINOPHEN\CAFFEINE\DIHYDROCODEINE ACETAMINOPHEN\CAFFEINE\CODEINE vs ACETAMINOPHEN\CAFFEINE\OPIUM ACETAMINOPHEN\CAFFEINE\CODEINE vs ACETAMINOPHEN\CAFFEINE\PROPYPHENAZONE ACETAMINOPHEN\CAFFEINE\CODEINE vs ACETAMINOPHEN\CAFFEINE\PYRILAMINE ACETAMINOPHEN\CAFFEINE\CODEINE vs ACETAMINOPHEN\CHLORPHENIRAMINE ACETAMINOPHEN\CAFFEINE\CODEINE vs ACETAMINOPHEN\CHLORPHENIRAMINE\DEXTROMETHORPHAN HYDROBROMIDE ACETAMINOPHEN\CAFFEINE\CODEINE vs ACETAMINOPHEN\CHLORPHENIRAMINE\DEXTROMETHORPHAN HYDROBROMIDE\PHENYLEPHRINE OR ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE\PHENYLEPHRINE OR HOMEOPATHICS ACETAMINOPHEN\CAFFEINE\CODEINE vs ACETAMINOPHEN\CHLORPHENIRAMINE\DEXTROMETHORPHAN\PHENYLEPHRINE ACETAMINOPHEN\CAFFEINE\CODEINE vs ACETAMINOPHEN\CODEINE ACETAMINOPHEN\CAFFEINE\CODEINE vs ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE

Official FDA Label for ACETAMINOPHEN\CAFFEINE\CODEINE

Official prescribing information from the FDA-approved drug label.