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\HYDROCODONE: 108,921 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
108,921
Total FAERS Reports
31,727 (29.1%)
Deaths Reported
6,901
Hospitalizations
108,921
As Primary/Secondary Suspect
405
Life-Threatening
7,808
Disabilities

Active Ingredient: ACETAMINOPHEN\HYDROCODONE BITARTRATE ·

First Report: 10160229 · Latest Report: 20250923

What Are the Most Common ACETAMINOPHEN\HYDROCODONE Side Effects?

#1 Most Reported
Drug dependence
41,789 reports (38.4%)
#2 Most Reported
Overdose
30,936 reports (28.4%)
#3 Most Reported
Dependence
28,841 reports (26.5%)

All ACETAMINOPHEN\HYDROCODONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug dependence 41,789 38.4% 5,014 2,812
Overdose 30,936 28.4% 9,570 1,709
Dependence 28,841 26.5% 2,026 133
Death 16,341 15.0% 16,332 528
Pain 14,958 13.7% 497 845
Emotional distress 13,878 12.7% 430 412
Toxicity to various agents 10,343 9.5% 9,710 1,007
Drug withdrawal syndrome 8,378 7.7% 373 538
Ill-defined disorder 6,159 5.7% 226 26
Drug withdrawal syndrome neonatal 5,340 4.9% 104 474
Foetal exposure during pregnancy 5,085 4.7% 109 483
Drug abuse 4,675 4.3% 2,364 919
Anxiety 4,343 4.0% 209 450
Depression 3,699 3.4% 325 596
Developmental delay 3,443 3.2% 74 279
Completed suicide 3,366 3.1% 3,360 777
Learning disability 2,799 2.6% 73 175
Withdrawal syndrome 2,636 2.4% 158 191
Drug ineffective 2,552 2.3% 31 183
Disability 2,066 1.9% 99 232

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

Gender: 46.5% female, 53.5% male. Average age: 51.3 years. Most reports from: US. View detailed demographics →

Is ACETAMINOPHEN\HYDROCODONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 295 222 30
2001 247 195 30
2002 311 238 48
2003 352 263 51
2004 465 371 55
2005 525 418 61
2006 577 470 55
2007 853 731 61
2008 986 806 83
2009 1,144 960 121
2010 1,660 1,411 127
2011 1,547 1,353 74
2012 1,880 1,633 131
2013 2,211 1,852 119
2014 2,575 1,909 308
2015 3,216 2,446 233
2016 3,027 2,232 258
2017 1,292 738 187
2018 848 412 175
2019 781 394 160
2020 623 335 118
2021 387 194 56
2022 354 194 50
2023 336 203 44
2024 105 4 23
2025 45 2 11

View full timeline →

What Is ACETAMINOPHEN\HYDROCODONE Used For?

IndicationReports
Product used for unknown indication 47,000
Pain 26,494
Back pain 1,288
Pain management 360
Arthralgia 324
Injury 246
Back injury 230
Suicide attempt 230
Procedural pain 186
Neck pain 173

ACETAMINOPHEN\HYDROCODONE vs Alternatives: Which Is Safer?

ACETAMINOPHEN\HYDROCODONE vs ACETAMINOPHEN/HYDROCODONE ACETAMINOPHEN\HYDROCODONE vs ACETAMINOPHEN\IBUPROFEN ACETAMINOPHEN\HYDROCODONE vs ACETAMINOPHEN\METHOCARBAMOL ACETAMINOPHEN\HYDROCODONE vs ACETAMINOPHEN\OPIUM ACETAMINOPHEN\HYDROCODONE vs ACETAMINOPHEN\OXYCODONE ACETAMINOPHEN\HYDROCODONE vs ACETAMINOPHEN\OXYCODONE\OXYCODONE ACETAMINOPHEN\HYDROCODONE vs ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE ACETAMINOPHEN\HYDROCODONE vs ACETAMINOPHEN\PROPOXYPHENE ACETAMINOPHEN\HYDROCODONE vs ACETAMINOPHEN\PSEUDOEPHEDRINE ACETAMINOPHEN\HYDROCODONE vs ACETAMINOPHEN\TRAMADOL

Official FDA Label for ACETAMINOPHEN\HYDROCODONE

Official prescribing information from the FDA-approved drug label.