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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.

BUPRENORPHINE\NALOXONE: 21,631 Adverse Event Reports & Safety Profile

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21,631
Total FAERS Reports
1,119 (5.2%)
Deaths Reported
2,872
Hospitalizations
21,631
As Primary/Secondary Suspect
446
Life-Threatening
1,372
Disabilities

Active Ingredient: BUPRENORPHINE HYDROCHLORIDE\NALOXONE HYDROCHLORIDE ·

First Report: 19701121 · Latest Report: 20250919

What Are the Most Common BUPRENORPHINE\NALOXONE Side Effects?

#1 Most Reported
Drug dependence
4,755 reports (22.0%)
#2 Most Reported
Drug withdrawal syndrome
3,167 reports (14.6%)
#3 Most Reported
Pain
2,472 reports (11.4%)

All BUPRENORPHINE\NALOXONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug dependence 4,755 22.0% 253 483
Drug withdrawal syndrome 3,167 14.6% 41 519
Pain 2,472 11.4% 29 209
Off label use 1,946 9.0% 18 179
Nausea 1,899 8.8% 11 164
Overdose 1,749 8.1% 365 326
Emotional distress 1,696 7.8% 20 58
Vomiting 1,370 6.3% 17 185
Foetal exposure during pregnancy 1,309 6.1% 20 297
Anxiety 1,307 6.0% 27 201
Drug abuse 1,180 5.5% 214 383
Drug withdrawal syndrome neonatal 1,165 5.4% 13 251
Headache 1,108 5.1% 1 86
Intentional underdose 1,037 4.8% 13 162
Product use issue 1,004 4.6% 18 137
Wrong technique in product usage process 890 4.1% 1 163
Feeling abnormal 863 4.0% 2 59
Drug ineffective 855 4.0% 3 78
Maternal exposure during pregnancy 852 3.9% 6 86
Substance abuse 798 3.7% 43 142

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

Gender: 49.1% female, 50.9% male. Average age: 40.3 years. Most reports from: US. View detailed demographics →

Is BUPRENORPHINE\NALOXONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 11 0 2
2001 6 0 1
2002 14 0 4
2003 15 3 8
2004 14 2 4
2005 23 1 8
2006 28 1 8
2007 38 0 11
2008 59 4 15
2009 72 9 16
2010 117 7 32
2011 153 8 31
2012 275 15 62
2013 663 36 112
2014 1,053 55 170
2015 911 55 120
2016 924 60 116
2017 1,062 63 143
2018 908 38 118
2019 757 43 93
2020 587 62 66
2021 378 16 40
2022 383 15 24
2023 297 17 47
2024 152 3 21
2025 77 0 7

View full timeline →

What Is BUPRENORPHINE\NALOXONE Used For?

IndicationReports
Product used for unknown indication 8,523
Drug dependence 6,931
Drug use disorder 1,817
Pain 1,711
Drug withdrawal syndrome 219
Dependence 198
Pain management 159
Back pain 155
Drug abuse 150
Drug withdrawal maintenance therapy 114

BUPRENORPHINE\NALOXONE vs Alternatives: Which Is Safer?

BUPRENORPHINE\NALOXONE vs BUPROPION BUPRENORPHINE\NALOXONE vs BUPROPION HYDROBROMIDE BUPRENORPHINE\NALOXONE vs BUPROPION\DEXTROMETHORPHAN HYDROBROMIDE BUPRENORPHINE\NALOXONE vs BUPROPION\NALTREXONE BUPRENORPHINE\NALOXONE vs BUROSUMAB BUPRENORPHINE\NALOXONE vs BUROSUMAB-TWZA BUPRENORPHINE\NALOXONE vs BUSPIRONE BUPRENORPHINE\NALOXONE vs BUSULFAN BUPRENORPHINE\NALOXONE vs BUSULFEX BUPRENORPHINE\NALOXONE vs BUTALBITAL

Official FDA Label for BUPRENORPHINE\NALOXONE

Official prescribing information from the FDA-approved drug label.