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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.

NALOXONE\OXYCODONE: 1,592 Adverse Event Reports & Safety Profile

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1,592
Total FAERS Reports
275 (17.3%)
Deaths Reported
790
Hospitalizations
1,592
As Primary/Secondary Suspect
132
Life-Threatening
31
Disabilities

Active Ingredient: NALOXONE HYDROCHLORIDE\OXYCODONE HYDROCHLORIDE ·

First Report: 20060101 · Latest Report: 20250517

What Are the Most Common NALOXONE\OXYCODONE Side Effects?

#1 Most Reported
Nausea
167 reports (10.5%)
#2 Most Reported
Overdose
158 reports (9.9%)
#3 Most Reported
Death
152 reports (9.5%)

All NALOXONE\OXYCODONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Nausea 167 10.5% 21 100
Overdose 158 9.9% 128 22
Death 152 9.6% 152 2
Toxicity to various agents 113 7.1% 26 77
Vomiting 100 6.3% 13 66
Constipation 91 5.7% 17 48
Dizziness 84 5.3% 2 53
Drug abuse 84 5.3% 4 32
Pain 83 5.2% 9 39
Somnolence 82 5.2% 12 36
Sopor 81 5.1% 0 67
Fall 78 4.9% 1 65
Dyspnoea 77 4.8% 18 58
Confusional state 76 4.8% 19 55
Diarrhoea 76 4.8% 12 40
Drug dependence 76 4.8% 5 12
Headache 76 4.8% 5 20
Decreased appetite 71 4.5% 11 40
Asthenia 64 4.0% 16 46
Fatigue 61 3.8% 1 23

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

Gender: 59.7% female, 40.3% male. Average age: 64.9 years. Most reports from: DE. View detailed demographics →

Is NALOXONE\OXYCODONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 11 0 10
2010 2 0 2
2011 5 1 4
2012 44 42 1
2013 62 26 13
2014 89 4 48
2015 113 17 77
2016 139 29 78
2017 176 11 69
2018 100 13 64
2019 64 12 53
2020 55 16 32
2021 32 0 24
2022 34 6 21
2023 45 0 18
2024 32 0 23
2025 18 0 12

View full timeline →

What Is NALOXONE\OXYCODONE Used For?

IndicationReports
Product used for unknown indication 538
Pain 522
Back pain 59
Arthralgia 45
Analgesic therapy 43
Cancer pain 32
Neuralgia 31
Bone pain 25
Drug abuse 16
Restless legs syndrome 15

NALOXONE\OXYCODONE vs Alternatives: Which Is Safer?

NALOXONE\OXYCODONE vs NALOXONE\TILIDINE NALOXONE\OXYCODONE vs NALTREXONE NALOXONE\OXYCODONE vs NAPHAZOLINE\PHENIRAMINE NALOXONE\OXYCODONE vs NAPROXEN NALOXONE\OXYCODONE vs NAPROXEN\NAPROXEN NALOXONE\OXYCODONE vs NAPROXEN\PSEUDOEPHEDRINE NALOXONE\OXYCODONE vs NAPROXEN\SUMATRIPTAN NALOXONE\OXYCODONE vs NARATRIPTAN NALOXONE\OXYCODONE vs NASONEX NALOXONE\OXYCODONE vs NATALIZUMAB

Official FDA Label for NALOXONE\OXYCODONE

Official prescribing information from the FDA-approved drug label.