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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.

ENBREL: 17,910 Adverse Event Reports & Safety Profile

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17,910
Total FAERS Reports
312 (1.7%)
Deaths Reported
1,784
Hospitalizations
17,910
As Primary/Secondary Suspect
82
Life-Threatening
92
Disabilities

First Report: 1992 · Latest Report: 20140625

What Are the Most Common ENBREL Side Effects?

#1 Most Reported
Injection site pain
2,386 reports (13.3%)
#2 Most Reported
Arthralgia
2,102 reports (11.7%)
#3 Most Reported
Injection site erythema
1,879 reports (10.5%)

All ENBREL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Injection site pain 2,386 13.3% 0 83
Arthralgia 2,102 11.7% 4 261
Injection site erythema 1,879 10.5% 2 41
Pain in extremity 1,381 7.7% 1 156
Pain 1,240 6.9% 5 154
Injection site swelling 1,121 6.3% 2 26
Psoriasis 1,100 6.1% 1 93
Injection site pruritus 1,026 5.7% 0 20
Injection site reaction 933 5.2% 1 30
Drug ineffective 925 5.2% 5 77
Injection site bruising 854 4.8% 0 25
Headache 790 4.4% 1 53
Fatigue 782 4.4% 1 70
Nasopharyngitis 777 4.3% 2 48
Joint swelling 696 3.9% 1 101
Cough 610 3.4% 1 45
Local swelling 586 3.3% 1 57
Musculoskeletal stiffness 580 3.2% 1 44
Back pain 555 3.1% 0 94
Injection site warmth 544 3.0% 0 7

Who Reports ENBREL Side Effects? Age & Gender Data

Average age: 53.4 years. Most reports from: US. View detailed demographics →

Is ENBREL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 25 0 10
2001 12 0 6
2002 19 0 8
2003 36 2 8
2004 42 0 7
2005 54 0 10
2006 55 0 14
2007 63 3 23
2008 86 0 25
2009 134 3 36
2010 189 2 49
2011 314 4 72
2012 781 14 138
2013 6,477 72 535
2014 4,737 89 438

View full timeline →

What Is ENBREL Used For?

IndicationReports
Rheumatoid arthritis 9,897
Psoriasis 2,992
Psoriatic arthropathy 2,729
Product used for unknown indication 1,738
Ankylosing spondylitis 1,032
Juvenile idiopathic arthritis 268
Arthritis 72
Osteoarthritis 26
Pustular psoriasis 16
Arthritis reactive 15

ENBREL vs Alternatives: Which Is Safer?

ENBREL vs ENCORAFENIB ENBREL vs ENDOXAN ENBREL vs ENDOXAN BAXTER ENBREL vs ENDOXAN , POUDRE POUR ENBREL vs ENFORTUMAB VEDOTIN ENBREL vs ENFORTUMAB VEDOTIN-EJFV ENBREL vs ENFORTUMAB VEDOTIN\ENFORTUMAB VEDOTIN-EJFV ENBREL vs ENFUVIRTIDE ENBREL vs ENOXAPARIN ENBREL vs ENOXAPARIN - WINTHROP

Official FDA Label for ENBREL

Official prescribing information from the FDA-approved drug label.