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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\CODEINE: 15,186 Adverse Event Reports & Safety Profile

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15,186
Total FAERS Reports
3,387 (22.3%)
Deaths Reported
4,926
Hospitalizations
15,186
As Primary/Secondary Suspect
2,013
Life-Threatening
1,858
Disabilities

Active Ingredient: ACETAMINOPHEN\CODEINE PHOSPHATE ·

First Report: 1979 · Latest Report: 20250903

What Are the Most Common ACETAMINOPHEN\CODEINE Side Effects?

#1 Most Reported
Dependence
3,857 reports (25.4%)
#2 Most Reported
Overdose
2,600 reports (17.1%)
#3 Most Reported
Pain
1,712 reports (11.3%)

All ACETAMINOPHEN\CODEINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dependence 3,857 25.4% 507 42
Overdose 2,600 17.1% 669 339
Pain 1,712 11.3% 675 872
Off label use 1,309 8.6% 668 904
Drug ineffective 1,300 8.6% 500 673
Nausea 1,291 8.5% 496 805
Drug dependence 1,273 8.4% 80 149
Fatigue 1,240 8.2% 656 770
Vomiting 1,224 8.1% 626 883
Depression 1,153 7.6% 670 626
Dizziness 1,108 7.3% 537 551
Headache 1,083 7.1% 602 730
Rash 1,077 7.1% 693 770
Confusional state 1,032 6.8% 754 809
Diarrhoea 994 6.6% 631 678
Abdominal pain upper 992 6.5% 658 663
Maternal exposure during pregnancy 987 6.5% 547 538
Drug hypersensitivity 986 6.5% 598 540
Malaise 984 6.5% 442 656
Arthralgia 912 6.0% 662 677

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

Gender: 65.6% female, 34.4% male. Average age: 50.7 years. Most reports from: US. View detailed demographics →

Is ACETAMINOPHEN\CODEINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 11 0 5
2001 3 0 3
2002 19 13 12
2003 11 2 4
2004 15 1 9
2005 17 1 6
2006 5 0 2
2007 27 1 15
2008 14 3 6
2009 34 4 25
2010 20 4 8
2011 45 5 29
2012 76 25 24
2013 67 7 35
2014 271 22 111
2015 427 87 186
2016 392 80 176
2017 409 61 222
2018 703 87 391
2019 360 42 168
2020 433 103 266
2021 276 15 147
2022 172 9 90
2023 215 38 113
2024 183 3 111
2025 71 0 40

View full timeline →

What Is ACETAMINOPHEN\CODEINE Used For?

IndicationReports
Product used for unknown indication 6,494
Pain 1,195
Rheumatoid arthritis 411
Back pain 386
Arthralgia 150
Analgesic therapy 139
Headache 136
Pruritus 129
Migraine 107
Toxicity to various agents 100

ACETAMINOPHEN\CODEINE vs Alternatives: Which Is Safer?

ACETAMINOPHEN\CODEINE vs ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE ACETAMINOPHEN\CODEINE vs ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE ACETAMINOPHEN\CODEINE vs ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE\PHENYLEPHRINE ACETAMINOPHEN\CODEINE vs ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\GUAIFENESIN\PHENYLEPHRINE ACETAMINOPHEN\CODEINE vs ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\PHENYLEPHRINE ACETAMINOPHEN\CODEINE vs ACETAMINOPHEN\DIHYDROCODEINE ACETAMINOPHEN\CODEINE vs ACETAMINOPHEN\DIPHENHYDRAMINE ACETAMINOPHEN\CODEINE vs ACETAMINOPHEN\HYDROCODONE ACETAMINOPHEN\CODEINE vs ACETAMINOPHEN/HYDROCODONE ACETAMINOPHEN\CODEINE vs ACETAMINOPHEN\IBUPROFEN

Official FDA Label for ACETAMINOPHEN\CODEINE

Official prescribing information from the FDA-approved drug label.