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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\OXYCODONE: 99,551 Adverse Event Reports & Safety Profile

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99,551
Total FAERS Reports
31,342 (31.5%)
Deaths Reported
7,703
Hospitalizations
99,551
As Primary/Secondary Suspect
1,471
Life-Threatening
7,254
Disabilities

Active Ingredient: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE ·

First Report: 1900 · Latest Report: 20250830

What Are the Most Common ACETAMINOPHEN\OXYCODONE Side Effects?

#1 Most Reported
Drug dependence
34,821 reports (35.0%)
#2 Most Reported
Overdose
29,876 reports (30.0%)
#3 Most Reported
Dependence
26,147 reports (26.3%)

All ACETAMINOPHEN\OXYCODONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug dependence 34,821 35.0% 4,882 2,609
Overdose 29,876 30.0% 11,176 1,614
Dependence 26,147 26.3% 2,699 151
Death 17,849 17.9% 17,832 482
Pain 11,524 11.6% 1,066 1,523
Toxicity to various agents 10,568 10.6% 8,957 1,746
Ill-defined disorder 9,780 9.8% 867 764
Emotional distress 8,559 8.6% 383 387
Drug withdrawal syndrome neonatal 5,767 5.8% 104 475
Foetal exposure during pregnancy 5,042 5.1% 115 480
Anxiety 4,599 4.6% 666 800
Drug withdrawal syndrome 4,417 4.4% 280 529
Drug abuse 4,389 4.4% 1,904 933
Withdrawal syndrome 4,046 4.1% 239 171
Depression 4,035 4.1% 762 890
Drug ineffective 3,752 3.8% 414 702
Developmental delay 3,271 3.3% 77 280
Maternal exposure during pregnancy 2,739 2.8% 451 631
Learning disability 2,618 2.6% 66 171
Fatigue 2,525 2.5% 734 991

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

Gender: 47.0% female, 53.0% male. Average age: 49.1 years. Most reports from: US. View detailed demographics →

Is ACETAMINOPHEN\OXYCODONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 283 221 21
2001 241 198 25
2002 301 233 42
2003 337 258 43
2004 459 370 50
2005 503 419 53
2006 554 465 56
2007 810 713 49
2008 977 803 77
2009 1,112 944 108
2010 1,632 1,400 120
2011 1,545 1,348 72
2012 1,787 1,599 101
2013 2,021 1,695 96
2014 2,443 1,919 196
2015 3,035 2,443 177
2016 3,006 2,405 182
2017 1,055 575 148
2018 620 259 112
2019 607 320 116
2020 386 196 78
2021 251 107 36
2022 159 41 31
2023 194 62 34
2024 113 3 12
2025 43 1 3

View full timeline →

What Is ACETAMINOPHEN\OXYCODONE Used For?

IndicationReports
Product used for unknown indication 40,255
Pain 27,508
Back pain 904
Pain management 353
Migraine 319
Rheumatoid arthritis 241
Injury 228
Arthralgia 212
Back injury 210
Analgesic therapy 165

ACETAMINOPHEN\OXYCODONE vs Alternatives: Which Is Safer?

ACETAMINOPHEN\OXYCODONE vs ACETAMINOPHEN\OXYCODONE\OXYCODONE ACETAMINOPHEN\OXYCODONE vs ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE ACETAMINOPHEN\OXYCODONE vs ACETAMINOPHEN\PROPOXYPHENE ACETAMINOPHEN\OXYCODONE vs ACETAMINOPHEN\PSEUDOEPHEDRINE ACETAMINOPHEN\OXYCODONE vs ACETAMINOPHEN\TRAMADOL ACETAMINOPHEN\OXYCODONE vs ACETAZOLAMIDE ACETAMINOPHEN\OXYCODONE vs ACETYLCYSTEINE ACETAMINOPHEN\OXYCODONE vs ACETYLLEUCINE ACETAMINOPHEN\OXYCODONE vs ACETYLLEUCINE, L- ACETAMINOPHEN\OXYCODONE vs ACETYLSALICYLIC ACID

Official FDA Label for ACETAMINOPHEN\OXYCODONE

Official prescribing information from the FDA-approved drug label.