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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\OPIUM: 570 Adverse Event Reports & Safety Profile

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570
Total FAERS Reports
36 (6.3%)
Deaths Reported
421
Hospitalizations
570
As Primary/Secondary Suspect
59
Life-Threatening
12
Disabilities

First Report: 1977 · Latest Report: 20250721

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

#1 Most Reported
Fall
58 reports (10.2%)
#2 Most Reported
Somnolence
55 reports (9.6%)
#3 Most Reported
Hypotension
45 reports (7.9%)

All ACETAMINOPHEN\CAFFEINE\OPIUM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fall 58 10.2% 0 57
Somnolence 55 9.7% 5 47
Hypotension 45 7.9% 0 38
Acute kidney injury 38 6.7% 4 30
Intentional overdose 35 6.1% 0 28
Vomiting 35 6.1% 0 23
Confusional state 34 6.0% 0 33
Poisoning deliberate 32 5.6% 2 24
Toxicity to various agents 32 5.6% 0 22
Cholestasis 30 5.3% 0 24
Coma 29 5.1% 0 18
Bradycardia 24 4.2% 0 16
Nausea 24 4.2% 0 20
Pancreatitis acute 24 4.2% 3 23
Hepatocellular injury 23 4.0% 0 18
Drug use disorder 22 3.9% 0 4
Pneumonia aspiration 22 3.9% 5 17
Rash maculo-papular 20 3.5% 0 20
Suicide attempt 20 3.5% 0 18
Eosinophilia 17 3.0% 0 17

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

Gender: 66.7% female, 33.3% male. Average age: 60.1 years. Most reports from: FR. View detailed demographics →

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

YearReportsDeathsHosp.
2004 1 0 1
2006 1 0 1
2010 3 0 2
2012 3 0 2
2013 6 4 6
2014 45 0 35
2015 34 1 33
2016 51 0 42
2017 62 7 50
2018 68 4 58
2019 63 0 48
2020 30 2 20
2021 26 0 24
2022 44 13 33
2023 37 3 21
2024 16 2 4
2025 13 0 1

View full timeline →

What Is ACETAMINOPHEN\CAFFEINE\OPIUM Used For?

IndicationReports
Product used for unknown indication 171
Pain 156
Back pain 27
Toxicity to various agents 14
Arthralgia 13
Toothache 11
Intentional overdose 10
Neck pain 10
Poisoning deliberate 10
Analgesic therapy 8

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

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

Official FDA Label for ACETAMINOPHEN\CAFFEINE\OPIUM

Official prescribing information from the FDA-approved drug label.