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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\BUTALBITAL\CAFFEINE: 1,160 Adverse Event Reports & Safety Profile

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1,160
Total FAERS Reports
307 (26.5%)
Deaths Reported
264
Hospitalizations
1,160
As Primary/Secondary Suspect
18
Life-Threatening
14
Disabilities

First Report: 1972 · Latest Report: 20250721

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

#1 Most Reported
Drug ineffective
208 reports (17.9%)
#2 Most Reported
Completed suicide
189 reports (16.3%)
#3 Most Reported
Toxicity to various agents
158 reports (13.6%)

All ACETAMINOPHEN\BUTALBITAL\CAFFEINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 208 17.9% 0 12
Completed suicide 189 16.3% 189 33
Toxicity to various agents 158 13.6% 123 50
Overdose 78 6.7% 22 52
Headache 73 6.3% 2 13
Nausea 56 4.8% 1 21
Metabolic acidosis 49 4.2% 17 32
Migraine 45 3.9% 1 9
Dizziness 40 3.5% 0 7
Foetal exposure during pregnancy 40 3.5% 2 16
Feeling abnormal 38 3.3% 0 6
Maternal exposure during pregnancy 38 3.3% 1 16
Vomiting 38 3.3% 3 18
Drug dependence 37 3.2% 8 14
Cardio-respiratory arrest 31 2.7% 31 4
Drug hypersensitivity 31 2.7% 0 1
Pain 31 2.7% 0 9
Depressed level of consciousness 29 2.5% 22 5
Coma 25 2.2% 21 4
Hepatotoxicity 25 2.2% 22 3

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

Gender: 79.1% female, 20.9% male. Average age: 50.5 years. Most reports from: US. View detailed demographics →

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

YearReportsDeathsHosp.
2004 2 1 1
2005 1 1 1
2006 2 1 0
2007 1 0 0
2008 1 0 0
2009 2 0 0
2010 1 0 1
2011 3 1 1
2012 3 2 0
2013 18 8 3
2014 28 7 4
2015 46 15 9
2016 87 44 20
2017 61 40 4
2018 23 5 2
2019 17 4 2
2020 21 1 2
2021 12 0 2
2022 31 13 8
2023 40 2 10
2024 20 0 9
2025 23 2 5

View full timeline →

What Is ACETAMINOPHEN\BUTALBITAL\CAFFEINE Used For?

IndicationReports
Product used for unknown indication 472
Migraine 246
Headache 132
Pain 36
Suicide attempt 16
Tension headache 14
Pyrexia 10
Completed suicide 7
Migraine prophylaxis 7
Back pain 6

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

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

Official FDA Label for ACETAMINOPHEN\BUTALBITAL\CAFFEINE

Official prescribing information from the FDA-approved drug label.