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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\DIHYDROCODEINE: 1,436 Adverse Event Reports & Safety Profile

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1,436
Total FAERS Reports
229 (15.9%)
Deaths Reported
132
Hospitalizations
1,436
As Primary/Secondary Suspect
14
Life-Threatening
284
Disabilities

Active Ingredient: ACETAMINOPHEN\CAFFEINE\DIHYDROCODEINE BITARTRATE ·

First Report: 1990 · Latest Report: 20201015

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

#1 Most Reported
Drug dependence
1,249 reports (87.0%)
#2 Most Reported
Overdose
544 reports (37.9%)
#3 Most Reported
Pain
414 reports (28.8%)

All ACETAMINOPHEN\CAFFEINE\DIHYDROCODEINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug dependence 1,249 87.0% 176 115
Overdose 544 37.9% 129 69
Pain 414 28.8% 18 45
Emotional distress 401 27.9% 20 26
Learning disability 227 15.8% 11 10
Drug withdrawal syndrome 219 15.3% 12 21
Drug withdrawal syndrome neonatal 217 15.1% 7 1
Developmental delay 214 14.9% 6 5
Foetal exposure during pregnancy 193 13.4% 3 1
Anxiety 185 12.9% 12 26
Disability 121 8.4% 3 5
Depression 119 8.3% 14 30
Cardiac disorder 111 7.7% 15 10
Death 95 6.6% 95 7
Drug abuse 90 6.3% 27 31
Maternal exposure during pregnancy 82 5.7% 3 5
Injury 73 5.1% 10 12
Mental disorder 66 4.6% 6 11
Congenital anomaly 48 3.3% 4 3
Spina bifida 45 3.1% 4 1

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

Gender: 45.3% female, 54.7% male. Average age: 41.6 years. Most reports from: US. View detailed demographics →

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

YearReportsDeathsHosp.
2000 2 0 1
2001 3 2 0
2002 1 0 0
2003 6 4 1
2005 7 4 2
2006 4 3 1
2007 5 4 2
2008 7 3 2
2009 5 3 2
2010 5 3 1
2011 7 3 2
2012 7 5 4
2013 11 10 2
2014 7 4 1
2015 10 6 1
2016 11 7 4
2017 13 9 4
2018 13 9 3
2019 12 11 1
2020 7 6 1

View full timeline →

What Is ACETAMINOPHEN\CAFFEINE\DIHYDROCODEINE Used For?

IndicationReports
Product used for unknown indication 1,259
Pain 81
Back pain 14
Injury 8
Back injury 7
Foetal exposure during pregnancy 6

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

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

Official FDA Label for ACETAMINOPHEN\CAFFEINE\DIHYDROCODEINE

Official prescribing information from the FDA-approved drug label.