HUMIRA PEN: 258 Adverse Event Reports & Safety Profile
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258
Total FAERS Reports
4 (1.6%)
Deaths Reported
54
Hospitalizations
258
As Primary/Secondary Suspect
2
Life-Threatening
2
Disabilities
First Report: 2001 · Latest Report: 20140610
What Are the Most Common HUMIRA PEN Side Effects?
#1 Most Reported
Injection site pain
38 reports (14.7%)
#2 Most Reported
Drug ineffective
28 reports (10.9%)
#3 Most Reported
Arthralgia
28 reports (10.9%)
All HUMIRA PEN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Injection site pain | 38 | 14.7% | 0 | 3 |
| Arthralgia | 28 | 10.9% | 0 | 5 |
| Drug ineffective | 28 | 10.9% | 0 | 5 |
| Pain | 19 | 7.4% | 0 | 6 |
| Headache | 18 | 7.0% | 0 | 2 |
| Nasopharyngitis | 18 | 7.0% | 0 | 2 |
| Psoriasis | 16 | 6.2% | 0 | 1 |
| Fatigue | 15 | 5.8% | 1 | 3 |
| Incorrect dose administered | 15 | 5.8% | 0 | 4 |
| Nausea | 15 | 5.8% | 0 | 5 |
| Cough | 14 | 5.4% | 0 | 3 |
| Diarrhoea | 14 | 5.4% | 0 | 8 |
| Abdominal pain | 13 | 5.0% | 0 | 7 |
| Crohn's disease | 13 | 5.0% | 0 | 7 |
| Injection site bruising | 13 | 5.0% | 0 | 0 |
| Pain in extremity | 11 | 4.3% | 0 | 1 |
| Pneumonia | 11 | 4.3% | 1 | 7 |
| Pruritus | 11 | 4.3% | 0 | 3 |
| Rash | 11 | 4.3% | 0 | 1 |
| Rheumatoid arthritis | 11 | 4.3% | 0 | 5 |
Who Reports HUMIRA PEN Side Effects? Age & Gender Data
Average age: 49.4 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →
Is HUMIRA PEN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 0 |
| 2007 | 7 | 0 | 2 |
| 2008 | 3 | 0 | 0 |
| 2009 | 13 | 0 | 3 |
| 2010 | 15 | 0 | 2 |
| 2011 | 50 | 1 | 17 |
| 2012 | 85 | 1 | 18 |
| 2013 | 29 | 1 | 8 |
| 2014 | 17 | 0 | 2 |
What Is HUMIRA PEN Used For?
| Indication | Reports |
|---|---|
| Rheumatoid arthritis | 92 |
| Crohn's disease | 70 |
| Psoriasis | 46 |
| Psoriatic arthropathy | 30 |
| Ankylosing spondylitis | 10 |
| Colitis ulcerative | 9 |
| Product used for unknown indication | 5 |
HUMIRA PEN vs Alternatives: Which Is Safer?
HUMIRA PEN vs HYALURONATE
HUMIRA PEN vs HYALURONIC ACID
HUMIRA PEN vs HYALURONIC ACID\LIDOCAINE
HUMIRA PEN vs HYALURONIDASE
HUMIRA PEN vs HYALURONIDASE-OCSQ\OCRELIZUMAB
HUMIRA PEN vs HYALURONIDASE \RITUXIMAB
HUMIRA PEN vs HYALURONIDASE-ZZXF\PERTUZUMAB\TRASTUZUMAB
HUMIRA PEN vs HYDRALAZINE
HUMIRA PEN vs HYDRALAZINE\ISOSORBIDE DINITRATE
HUMIRA PEN vs HYDROCHLOROTHIAZIDE
Official FDA Label for HUMIRA PEN
Official prescribing information from the FDA-approved drug label.