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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: 748 Adverse Event Reports & Safety Profile

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748
Total FAERS Reports
53 (7.1%)
Deaths Reported
412
Hospitalizations
748
As Primary/Secondary Suspect
111
Life-Threatening
52
Disabilities

First Report: 1979 · Latest Report: 20250522

What Are the Most Common ACETAMINOPHEN\CAFFEINE Side Effects?

#1 Most Reported
Pain
333 reports (44.5%)
#2 Most Reported
Hypotension
279 reports (37.3%)
#3 Most Reported
Mobility decreased
274 reports (36.6%)

All ACETAMINOPHEN\CAFFEINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pain 333 44.5% 8 279
Hypotension 279 37.3% 0 268
Mobility decreased 274 36.6% 10 268
Fall 272 36.4% 0 265
Balance disorder 266 35.6% 0 260
Cognitive disorder 266 35.6% 0 260
Constipation 265 35.4% 0 257
Depressed level of consciousness 265 35.4% 0 259
Blood calcium decreased 262 35.0% 0 256
Orthostatic hypotension 262 35.0% 0 256
Sedation 262 35.0% 0 255
Creatinine renal clearance decreased 261 34.9% 0 255
Sedation complication 256 34.2% 0 253
Toxicity to various agents 231 30.9% 12 220
Drug interaction 114 15.2% 0 44
Product use in unapproved indication 105 14.0% 3 49
Drug ineffective 88 11.8% 7 29
Dyspnoea 85 11.4% 7 69
Off label use 81 10.8% 6 62
Vomiting 80 10.7% 10 27

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

Gender: 96.3% female, 3.7% male. Average age: 72.6 years. Most reports from: CA. View detailed demographics →

Is ACETAMINOPHEN\CAFFEINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 2 0 0
2008 1 0 1
2010 4 0 1
2011 1 0 0
2012 2 0 2
2013 2 0 0
2014 11 2 5
2015 11 0 8
2016 6 0 4
2017 7 1 1
2018 3 0 0
2019 11 0 4
2020 6 0 2
2021 15 0 9
2022 8 1 1
2023 16 6 5
2024 16 0 6
2025 3 0 2

View full timeline →

What Is ACETAMINOPHEN\CAFFEINE Used For?

IndicationReports
Product used for unknown indication 255
Pain 252
Angina pectoris 110
Cerebrovascular accident 98
Coronary artery disease 97
Hypertension 97
Chronic obstructive pulmonary disease 84
Chest pain 80
Headache 68
Pyrexia 66

ACETAMINOPHEN\CAFFEINE vs Alternatives: Which Is Safer?

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

Official FDA Label for ACETAMINOPHEN\CAFFEINE

Official prescribing information from the FDA-approved drug label.