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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.

ASPIRIN\CAFFEINE: 245 Adverse Event Reports & Safety Profile

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245
Total FAERS Reports
16 (6.5%)
Deaths Reported
123
Hospitalizations
245
As Primary/Secondary Suspect
47
Life-Threatening
6
Disabilities

First Report: 1999 · Latest Report: 20250405

What Are the Most Common ASPIRIN\CAFFEINE Side Effects?

#1 Most Reported
Toxicity to various agents
42 reports (17.1%)
#2 Most Reported
Hypotension
39 reports (15.9%)
#3 Most Reported
Pain
36 reports (14.7%)

All ASPIRIN\CAFFEINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Toxicity to various agents 42 17.1% 4 41
Hypotension 39 15.9% 0 38
Pain 36 14.7% 0 32
Constipation 35 14.3% 0 35
Fall 35 14.3% 0 33
Depressed level of consciousness 34 13.9% 0 34
Balance disorder 32 13.1% 0 31
Cognitive disorder 32 13.1% 0 31
Blood calcium decreased 31 12.7% 0 31
Creatinine renal clearance decreased 31 12.7% 0 31
Mobility decreased 31 12.7% 0 31
Orthostatic hypotension 31 12.7% 0 31
Sedation 31 12.7% 0 31
Sedation complication 31 12.7% 0 31
Incorrect product administration duration 22 9.0% 0 8
Overdose 20 8.2% 1 12
Drug dependence 19 7.8% 0 3
Intentional overdose 18 7.4% 2 14
Vomiting 18 7.4% 0 14
Drug ineffective 17 6.9% 0 6

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

Gender: 63.9% female, 36.1% male. Average age: 57.1 years. Most reports from: US. View detailed demographics →

Is ASPIRIN\CAFFEINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 1
2008 1 0 0
2011 2 0 1
2012 2 1 1
2013 3 0 1
2014 15 2 11
2015 9 0 7
2016 3 0 2
2017 6 0 5
2018 3 0 2
2019 6 0 4
2020 4 0 3
2021 1 0 0
2022 2 0 0
2023 4 0 4
2024 2 0 2
2025 1 0 1

View full timeline →

What Is ASPIRIN\CAFFEINE Used For?

IndicationReports
Product used for unknown indication 79
Headache 27
Pain 19
Back pain 10
Migraine 9
Allogenic stem cell transplantation 5
Arthritis 5

ASPIRIN\CAFFEINE vs Alternatives: Which Is Safer?

ASPIRIN\CAFFEINE vs ASPIRIN\CARISOPRODOL ASPIRIN\CAFFEINE vs ASPIRIN\CARISOPRODOL\CODEINE ASPIRIN\CAFFEINE vs ASPIRIN\CLOPIDOGREL ASPIRIN\CAFFEINE vs ASPIRIN\CLOPIDOGREL BISULFATE ASPIRIN\CAFFEINE vs ASPIRIN\DIPYRIDAMOLE ASPIRIN\CAFFEINE vs ASPIRIN\LANSOPRAZOLE ASPIRIN\CAFFEINE vs ASPIRIN\MAGNESIUM ASPIRIN\CAFFEINE vs ASPIRIN\OXYCODONE ASPIRIN\CAFFEINE vs ASPIRIN\OXYCODONE\OXYCODONE TEREPHTHALATE ASPIRIN\CAFFEINE vs ASUNAPREVIR

Official FDA Label for ASPIRIN\CAFFEINE

Official prescribing information from the FDA-approved drug label.