ACTEMRA: 603 Adverse Event Reports & Safety Profile
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603
Total FAERS Reports
47 (7.8%)
Deaths Reported
248
Hospitalizations
603
As Primary/Secondary Suspect
31
Life-Threatening
22
Disabilities
First Report: 200801 · Latest Report: 20140619
What Are the Most Common ACTEMRA Side Effects?
#1 Most Reported
Arthralgia
74 reports (12.3%)
#2 Most Reported
Pain
59 reports (9.8%)
#3 Most Reported
Drug ineffective
54 reports (9.0%)
All ACTEMRA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Arthralgia | 74 | 12.3% | 3 | 36 |
| Pain | 59 | 9.8% | 3 | 31 |
| Drug ineffective | 54 | 9.0% | 1 | 20 |
| Fatigue | 49 | 8.1% | 0 | 21 |
| Dyspnoea | 42 | 7.0% | 4 | 19 |
| Rheumatoid arthritis | 39 | 6.5% | 1 | 18 |
| Pain in extremity | 36 | 6.0% | 1 | 17 |
| Headache | 34 | 5.6% | 1 | 13 |
| Nausea | 34 | 5.6% | 2 | 15 |
| Weight increased | 34 | 5.6% | 0 | 17 |
| Fall | 32 | 5.3% | 4 | 16 |
| Joint swelling | 32 | 5.3% | 2 | 11 |
| Pneumonia | 32 | 5.3% | 4 | 25 |
| Diarrhoea | 30 | 5.0% | 2 | 17 |
| Nasopharyngitis | 30 | 5.0% | 2 | 14 |
| Blood pressure increased | 29 | 4.8% | 1 | 13 |
| Cough | 28 | 4.6% | 2 | 13 |
| Rash | 27 | 4.5% | 1 | 14 |
| Vomiting | 27 | 4.5% | 2 | 14 |
| Malaise | 26 | 4.3% | 0 | 17 |
Who Reports ACTEMRA Side Effects? Age & Gender Data
Average age: 56.0 years. Most reports from: CA. View detailed demographics →
Is ACTEMRA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 4 | 1 | 3 |
| 2009 | 2 | 0 | 2 |
| 2010 | 7 | 0 | 2 |
| 2011 | 17 | 1 | 10 |
| 2012 | 55 | 5 | 31 |
| 2013 | 192 | 18 | 87 |
| 2014 | 127 | 8 | 54 |
What Is ACTEMRA Used For?
| Indication | Reports |
|---|---|
| Rheumatoid arthritis | 483 |
| Product used for unknown indication | 62 |
| Juvenile idiopathic arthritis | 27 |
| Still's disease adult onset | 5 |
ACTEMRA vs Alternatives: Which Is Safer?
ACTEMRA vs ACTIQ
ACTEMRA vs ACTIVATED CHARCOAL
ACTEMRA vs ACTONEL
ACTEMRA vs ACYCLOVIR
ACTEMRA vs AD26.COV2.S
ACTEMRA vs ADAGRASIB
ACTEMRA vs ADALIMUMAB
ACTEMRA vs ADALIMUMAB-AACF
ACTEMRA vs ADALIMUMAB-AATY
ACTEMRA vs ADALIMUMAB-ADAZ
Official FDA Label for ACTEMRA
Official prescribing information from the FDA-approved drug label.