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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.

HYDROCODONE\IBUPROFEN: 3,870 Adverse Event Reports & Safety Profile

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3,870
Total FAERS Reports
695 (18.0%)
Deaths Reported
50
Hospitalizations
3,870
As Primary/Secondary Suspect
9
Life-Threatening
26
Disabilities

Active Ingredient: HYDROCODONE BITARTRATE\IBUPROFEN ·

First Report: 19790101 · Latest Report: 20220615

What Are the Most Common HYDROCODONE\IBUPROFEN Side Effects?

#1 Most Reported
Dependence
3,304 reports (85.4%)
#2 Most Reported
Overdose
1,717 reports (44.4%)
#3 Most Reported
Death
634 reports (16.4%)

All HYDROCODONE\IBUPROFEN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dependence 3,304 85.4% 527 15
Overdose 1,717 44.4% 450 12
Death 634 16.4% 634 2
Depression 179 4.6% 15 6
Ill-defined disorder 177 4.6% 18 1
Withdrawal syndrome 168 4.3% 8 4
Drug dependence 130 3.4% 25 18
Anxiety 111 2.9% 7 6
Foetal exposure during pregnancy 71 1.8% 4 5
Pain 68 1.8% 5 4
Drug withdrawal syndrome neonatal 60 1.6% 4 5
Amnesia 45 1.2% 1 1
Product prescribing issue 44 1.1% 7 2
Drug ineffective 42 1.1% 0 1
Constipation 39 1.0% 6 0
Nausea 38 1.0% 2 0
Post-traumatic stress disorder 38 1.0% 2 1
Emotional distress 37 1.0% 3 5
Drug abuse 36 0.9% 13 6
Cardiac disorder 35 0.9% 3 1

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

Gender: 40.9% female, 59.1% male. Average age: 54.0 years. Most reports from: US. View detailed demographics →

Is HYDROCODONE\IBUPROFEN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2001 1 1 0
2002 1 0 1
2003 3 1 0
2005 2 1 0
2006 2 0 0
2007 3 1 0
2008 3 0 0
2009 1 0 1
2010 4 2 0
2011 3 1 0
2012 3 1 0
2013 8 6 3
2014 15 5 5
2015 9 1 2
2016 9 2 0
2017 11 3 1
2018 1 1 1
2019 8 2 1
2020 2 0 1
2021 5 2 0
2022 1 0 0

View full timeline →

What Is HYDROCODONE\IBUPROFEN Used For?

IndicationReports
Product used for unknown indication 423
Pain 82
Back pain 15

HYDROCODONE\IBUPROFEN vs Alternatives: Which Is Safer?

HYDROCODONE\IBUPROFEN vs HYDROCODONE+PARACETAMOL HYDROCODONE\IBUPROFEN vs HYDROCORTISONE HYDROCODONE\IBUPROFEN vs HYDROCORTISONE PROBUTATE HYDROCODONE\IBUPROFEN vs HYDROCORTISONE\HYDROCORTISONE HYDROCODONE\IBUPROFEN vs HYDROCORTISONE\NEOMYCIN\POLYMYXIN B HYDROCODONE\IBUPROFEN vs HYDROCORTISONE\PRAMOXINE HYDROCODONE\IBUPROFEN vs HYDROGEN PEROXIDE HYDROCODONE\IBUPROFEN vs HYDROMORPHONE HYDROCODONE\IBUPROFEN vs HYDROQUINONE HYDROCODONE\IBUPROFEN vs HYDROXOCOBALAMIN

Official FDA Label for HYDROCODONE\IBUPROFEN

Official prescribing information from the FDA-approved drug label.