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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.

FENTANYL SYSTEM: 438 Adverse Event Reports & Safety Profile

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438
Total FAERS Reports
83 (18.9%)
Deaths Reported
26
Hospitalizations
438
As Primary/Secondary Suspect
5
Life-Threatening
4
Disabilities

First Report: 20010116 · Latest Report: 20140622

What Are the Most Common FENTANYL SYSTEM Side Effects?

#1 Most Reported
Pain
79 reports (18.0%)
#2 Most Reported
Wrong technique in drug usage process
62 reports (14.2%)
#3 Most Reported
Drug effect decreased
60 reports (13.7%)

All FENTANYL SYSTEM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pain 79 18.0% 0 2
Wrong technique in drug usage process 62 14.2% 0 4
Drug effect decreased 60 13.7% 0 3
Drug ineffective 58 13.2% 0 4
Drug withdrawal syndrome 40 9.1% 0 1
Toxicity to various agents 39 8.9% 37 3
Intentional drug misuse 35 8.0% 31 4
Drug abuse 31 7.1% 30 2
Hyperhidrosis 31 7.1% 0 0
Application site pruritus 28 6.4% 0 0
Nausea 28 6.4% 0 0
Death 25 5.7% 25 1
Application site erythema 22 5.0% 0 0
Dizziness 21 4.8% 0 1
Incorrect drug administration duration 21 4.8% 0 0
Overdose 20 4.6% 12 2
Headache 18 4.1% 0 1
Product quality issue 18 4.1% 0 3
Feeling abnormal 17 3.9% 0 1
Application site pain 16 3.7% 0 0

Who Reports FENTANYL SYSTEM Side Effects? Age & Gender Data

Average age: 55.4 years. Most reports from: US. View detailed demographics →

Is FENTANYL SYSTEM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 1
2002 1 0 0
2005 1 0 1
2006 4 0 0
2007 3 0 0
2008 5 0 1
2009 5 1 0
2010 5 1 0
2011 7 0 1
2012 23 1 4
2013 212 0 4
2014 33 3 4

View full timeline →

What Is FENTANYL SYSTEM Used For?

IndicationReports
Pain 175
Product used for unknown indication 89
Back pain 75
Cancer pain 16
Arthralgia 14
Fibromyalgia 11
Neck pain 8
Pain in extremity 7
Headache 5

FENTANYL SYSTEM vs Alternatives: Which Is Safer?

FENTANYL SYSTEM vs FENTANYL\FENTANYL FENTANYL SYSTEM vs FENTORA FENTANYL SYSTEM vs FERRIC ANHYDROUS FENTANYL SYSTEM vs FERRIC CARBOXYMALTOSE FENTANYL SYSTEM vs FERRIC DERISOMALTOSE FENTANYL SYSTEM vs FERRIC HYDROXIDE FENTANYL SYSTEM vs FERRIC MALTOL FENTANYL SYSTEM vs FERRIC OXYHYDROXIDE FENTANYL SYSTEM vs FERROUS FENTANYL SYSTEM vs FERROUS ANHYDROUS

Official FDA Label for FENTANYL SYSTEM

Official prescribing information from the FDA-approved drug label.