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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.

SUBUTEX: 256 Adverse Event Reports & Safety Profile

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256
Total FAERS Reports
7 (2.7%)
Deaths Reported
139
Hospitalizations
256
As Primary/Secondary Suspect
6
Life-Threatening
4
Disabilities

First Report: 2001 · Latest Report: 20140507

What Are the Most Common SUBUTEX Side Effects?

#1 Most Reported
Foetal exposure during pregnancy
111 reports (43.4%)
#2 Most Reported
Drug withdrawal syndrome neonatal
98 reports (38.3%)
#3 Most Reported
Maternal exposure during pregnancy
52 reports (20.3%)

All SUBUTEX Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Foetal exposure during pregnancy 111 43.4% 1 71
Drug withdrawal syndrome neonatal 98 38.3% 1 72
Maternal exposure during pregnancy 52 20.3% 0 25
Drug abuse 35 13.7% 2 20
Exposure during breast feeding 32 12.5% 0 18
Substance abuse 29 11.3% 2 11
Drug withdrawal syndrome 20 7.8% 0 9
Wrong technique in drug usage process 16 6.3% 0 8
Vomiting 15 5.9% 0 7
Nausea 14 5.5% 0 5
Exposure during pregnancy 13 5.1% 0 7
Intentional product misuse 13 5.1% 1 10
Intentional drug misuse 12 4.7% 0 10
Premature baby 12 4.7% 0 5
Diarrhoea 11 4.3% 0 4
Premature delivery 11 4.3% 0 3
Hospitalisation 10 3.9% 0 8
Depression 9 3.5% 0 2
Drug diversion 9 3.5% 0 8
Drug dependence 8 3.1% 0 3

Who Reports SUBUTEX Side Effects? Age & Gender Data

Average age: 32.9 years. Most reports from: US. View detailed demographics →

Is SUBUTEX Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2003 1 0 0
2004 6 0 3
2005 5 0 4
2006 5 0 5
2007 17 0 14
2008 16 0 13
2009 3 0 2
2010 8 1 4
2011 16 0 9
2012 44 5 19
2013 38 0 16
2014 18 0 9

View full timeline →

What Is SUBUTEX Used For?

IndicationReports
Drug dependence 149
Product used for unknown indication 87

SUBUTEX vs Alternatives: Which Is Safer?

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

Official FDA Label for SUBUTEX

Official prescribing information from the FDA-approved drug label.