Skip to content
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\CODEINE: 1,253 Adverse Event Reports & Safety Profile

Grow Your Own Natural Pharmacy at Home

Medicinal Garden Kit — 10 healing herbs, 4,818 seeds + step-by-step guide.

Get the Kit
1,253
Total FAERS Reports
237 (18.9%)
Deaths Reported
32
Hospitalizations
1,253
As Primary/Secondary Suspect
11
Life-Threatening
8
Disabilities

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

First Report: 19930101 · Latest Report: 20221101

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

#1 Most Reported
Dependence
1,081 reports (86.3%)
#2 Most Reported
Overdose
563 reports (44.9%)
#3 Most Reported
Death
174 reports (13.9%)

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

Side Effect Reports % of Total Deaths Hosp.
Dependence 1,081 86.3% 160 6
Overdose 563 44.9% 132 4
Death 174 13.9% 174 0
Depression 65 5.2% 12 7
Ill-defined disorder 61 4.9% 10 3
Anxiety 48 3.8% 8 4
Withdrawal syndrome 44 3.5% 1 1
Completed suicide 43 3.4% 42 14
Maternal exposure during pregnancy 25 2.0% 3 2
Amnesia 22 1.8% 4 5
Drug ineffective 21 1.7% 1 1
Pain 21 1.7% 4 4
Post-traumatic stress disorder 21 1.7% 1 1
Product prescribing issue 19 1.5% 3 0
Disability 18 1.4% 2 2
Headache 17 1.4% 5 4
Foetal exposure during pregnancy 16 1.3% 0 2
Toxicity to various agents 15 1.2% 12 4
Vomiting 15 1.2% 4 4
Constipation 14 1.1% 3 0

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

Gender: 56.8% female, 43.2% male. Average age: 48.0 years. Most reports from: US. View detailed demographics →

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

YearReportsDeathsHosp.
2000 2 0 1
2003 2 2 1
2009 1 0 1
2011 1 0 0
2013 2 1 0
2014 3 1 0
2015 2 0 0
2016 12 10 3
2017 3 1 0
2018 7 7 3
2019 3 1 0
2022 1 0 0

View full timeline →

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

IndicationReports
Product used for unknown indication 154
Pain 16
Migraine 13
Headache 12

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

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

Official FDA Label for ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE

Official prescribing information from the FDA-approved drug label.