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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\CAFFEINE\CODEINE: 22 Adverse Event Reports & Safety Profile

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22
Total FAERS Reports
2 (9.1%)
Deaths Reported
16
Hospitalizations
22
As Primary/Secondary Suspect
3
Life-Threatening

Active Ingredient: ACETAMINOPHEN\ASPIRIN\CAFFEINE\CODEINE PHOSPHATE ·

First Report: 20210101 · Latest Report: 20250122

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

#1 Most Reported
Pain
8 reports (36.4%)
#2 Most Reported
Toxicity to various agents
7 reports (31.8%)
#3 Most Reported
Balance disorder
7 reports (31.8%)

All ACETAMINOPHEN\ASPIRIN\CAFFEINE\CODEINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pain 8 36.4% 0 8
Balance disorder 7 31.8% 0 7
Toxicity to various agents 7 31.8% 1 6
Blood calcium decreased 6 27.3% 0 6
Cognitive disorder 6 27.3% 0 6
Constipation 6 27.3% 0 6
Creatinine renal clearance decreased 6 27.3% 0 6
Depressed level of consciousness 6 27.3% 0 6
Fall 6 27.3% 0 6
Hypotension 6 27.3% 0 6
Mobility decreased 6 27.3% 0 6
Orthostatic hypotension 6 27.3% 0 6
Sedation 6 27.3% 0 6
Sedation complication 6 27.3% 0 6

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

Gender: 79.2% female, 20.8% male. Average age: 56.7 years. Most reports from: CA. View detailed demographics →

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

YearReportsDeathsHosp.
2021 1 1 1
2025 1 0 1

View full timeline →

What Is ACETAMINOPHEN\ASPIRIN\CAFFEINE\CODEINE Used For?

IndicationReports
Product used for unknown indication 9
Headache 6

Official FDA Label for ACETAMINOPHEN\ASPIRIN\CAFFEINE\CODEINE

Official prescribing information from the FDA-approved drug label.