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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.

HUMIRA: 39,756 Adverse Event Reports & Safety Profile

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39,756
Total FAERS Reports
526 (1.3%)
Deaths Reported
3,568
Hospitalizations
39,756
As Primary/Secondary Suspect
136
Life-Threatening
149
Disabilities

First Report: 1997 · Latest Report: 20141101

What Are the Most Common HUMIRA Side Effects?

#1 Most Reported
Injection site pain
6,005 reports (15.1%)
#2 Most Reported
Drug ineffective
3,506 reports (8.8%)
#3 Most Reported
Arthralgia
2,204 reports (5.5%)

All HUMIRA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Injection site pain 6,005 15.1% 0 105
Drug ineffective 3,506 8.8% 11 223
Arthralgia 2,204 5.5% 4 215
Pain 2,045 5.1% 7 211
Fatigue 1,868 4.7% 4 126
Psoriasis 1,857 4.7% 4 119
Injection site erythema 1,654 4.2% 0 21
Injection site bruising 1,623 4.1% 0 25
Headache 1,582 4.0% 7 114
Nasopharyngitis 1,552 3.9% 2 55
Nausea 1,412 3.6% 4 179
Incorrect dose administered 1,377 3.5% 1 39
Diarrhoea 1,374 3.5% 10 247
Injection site haemorrhage 1,304 3.3% 0 28
Device malfunction 1,212 3.1% 0 20
Crohn's disease 1,154 2.9% 10 399
Rash 1,091 2.7% 5 54
Injection site pruritus 1,077 2.7% 0 19
Drug dose omission 1,047 2.6% 1 69
Pyrexia 1,030 2.6% 23 290

Who Reports HUMIRA Side Effects? Age & Gender Data

Average age: 47.9 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →

Is HUMIRA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 4 0 1
2001 2 0 2
2002 5 0 1
2003 25 0 3
2004 29 0 3
2005 41 0 3
2006 70 0 12
2007 100 3 8
2008 156 2 22
2009 249 2 47
2010 438 12 77
2011 802 40 138
2012 4,011 40 410
2013 20,981 126 1,476
2014 1,393 130 772

View full timeline →

What Is HUMIRA Used For?

IndicationReports
Rheumatoid arthritis 11,051
Crohn's disease 10,174
Psoriasis 6,346
Psoriatic arthropathy 4,070
Product used for unknown indication 3,953
Colitis ulcerative 2,707
Ankylosing spondylitis 1,548
Juvenile idiopathic arthritis 295
Maternal exposure timing unspecified 110
Arthritis 108

HUMIRA vs Alternatives: Which Is Safer?

HUMIRA vs HUMIRA PEN HUMIRA vs HYALURONATE HUMIRA vs HYALURONIC ACID HUMIRA vs HYALURONIC ACID\LIDOCAINE HUMIRA vs HYALURONIDASE HUMIRA vs HYALURONIDASE-OCSQ\OCRELIZUMAB HUMIRA vs HYALURONIDASE \RITUXIMAB HUMIRA vs HYALURONIDASE-ZZXF\PERTUZUMAB\TRASTUZUMAB HUMIRA vs HYDRALAZINE HUMIRA vs HYDRALAZINE\ISOSORBIDE DINITRATE

Official FDA Label for HUMIRA

Official prescribing information from the FDA-approved drug label.