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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.

SUBOXONE: 615 Adverse Event Reports & Safety Profile

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615
Total FAERS Reports
31 (5.0%)
Deaths Reported
261
Hospitalizations
615
As Primary/Secondary Suspect
12
Life-Threatening
12
Disabilities

First Report: 2001 · Latest Report: 20140526

What Are the Most Common SUBOXONE Side Effects?

#1 Most Reported
Foetal exposure during pregnancy
118 reports (19.2%)
#2 Most Reported
Wrong technique in drug usage process
107 reports (17.4%)
#3 Most Reported
Drug withdrawal syndrome
92 reports (15.0%)

All SUBOXONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Foetal exposure during pregnancy 118 19.2% 0 77
Wrong technique in drug usage process 107 17.4% 2 44
Drug withdrawal syndrome 92 15.0% 0 42
Drug withdrawal syndrome neonatal 89 14.5% 0 65
Maternal exposure during pregnancy 66 10.7% 0 18
Substance abuse 61 9.9% 5 23
Vomiting 52 8.5% 0 21
Nausea 49 8.0% 0 18
Exposure during breast feeding 41 6.7% 0 26
Dyspnoea 37 6.0% 0 14
Off label use 37 6.0% 0 22
Anxiety 36 5.9% 0 20
Pain 36 5.9% 0 16
Drug abuse 35 5.7% 2 10
Intentional underdose 33 5.4% 0 13
Convulsion 31 5.0% 0 7
Headache 31 5.0% 0 6
Hypersensitivity 30 4.9% 0 10
Depression 28 4.6% 0 14
Feeling abnormal 28 4.6% 0 10

Who Reports SUBOXONE Side Effects? Age & Gender Data

Average age: 39.2 years. Most reports from: US. View detailed demographics →

Is SUBOXONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 2 0 0
2003 2 0 0
2004 6 0 1
2005 5 0 4
2006 6 0 4
2007 15 0 12
2008 18 0 14
2009 16 1 9
2010 29 2 14
2011 38 1 16
2012 73 2 35
2013 129 5 55
2014 71 4 25

View full timeline →

What Is SUBOXONE Used For?

IndicationReports
Drug dependence 371
Product used for unknown indication 191
Pain 28
Accidental exposure to product by child 5

SUBOXONE vs Alternatives: Which Is Safer?

SUBOXONE vs SUBUTEX SUBOXONE vs SUCCINYLCHOLINE SUBOXONE vs SUCRALFATE SUBOXONE vs SUCROFERRIC OXYHYDROXIDE SUBOXONE vs SUCROSE SUBOXONE vs SUFENTANIL SUBOXONE vs SUGAMMADEX SUBOXONE vs SULBACTAM SUBOXONE vs SULFACETAMIDE SUBOXONE vs SULFADIAZINE

Official FDA Label for SUBOXONE

Official prescribing information from the FDA-approved drug label.