ARAVA: 191 Adverse Event Reports & Safety Profile
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191
Total FAERS Reports
9 (4.7%)
Deaths Reported
61
Hospitalizations
191
As Primary/Secondary Suspect
14
Life-Threatening
7
Disabilities
First Report: 20060110 · Latest Report: 20140530
What Are the Most Common ARAVA Side Effects?
#1 Most Reported
Exposure during pregnancy
33 reports (17.3%)
#2 Most Reported
Arthralgia
18 reports (9.4%)
#3 Most Reported
Diarrhoea
13 reports (6.8%)
All ARAVA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Exposure during pregnancy | 33 | 17.3% | 0 | 1 |
| Arthralgia | 18 | 9.4% | 0 | 5 |
| Diarrhoea | 13 | 6.8% | 0 | 7 |
| Fatigue | 10 | 5.2% | 0 | 3 |
| Hepatic enzyme increased | 10 | 5.2% | 0 | 5 |
| Pyrexia | 10 | 5.2% | 0 | 6 |
| Pain | 9 | 4.7% | 0 | 3 |
| Back pain | 8 | 4.2% | 0 | 3 |
| Cough | 8 | 4.2% | 0 | 3 |
| Drug ineffective | 8 | 4.2% | 0 | 0 |
| Dyspnoea | 8 | 4.2% | 0 | 5 |
| Alopecia | 7 | 3.7% | 0 | 2 |
| Drug hypersensitivity | 7 | 3.7% | 0 | 0 |
| Rash | 7 | 3.7% | 1 | 4 |
| Upper respiratory tract infection | 7 | 3.7% | 0 | 0 |
| Arthropathy | 6 | 3.1% | 0 | 2 |
| Headache | 6 | 3.1% | 0 | 2 |
| Infection | 6 | 3.1% | 1 | 2 |
| Injection site bruising | 6 | 3.1% | 0 | 0 |
| Nausea | 6 | 3.1% | 1 | 4 |
Who Reports ARAVA Side Effects? Age & Gender Data
Average age: 54.9 years. Most reports from: US. View detailed demographics →
Is ARAVA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 1 | 0 | 1 |
| 2008 | 1 | 0 | 0 |
| 2009 | 2 | 0 | 2 |
| 2010 | 6 | 1 | 4 |
| 2011 | 4 | 0 | 1 |
| 2012 | 26 | 1 | 5 |
| 2013 | 54 | 4 | 20 |
| 2014 | 39 | 3 | 20 |
What Is ARAVA Used For?
| Indication | Reports |
|---|---|
| Rheumatoid arthritis | 72 |
| Product used for unknown indication | 67 |
| Psoriatic arthropathy | 10 |
ARAVA vs Alternatives: Which Is Safer?
ARAVA vs AREDIA
ARAVA vs ARFORMOTEROL
ARAVA vs ARGATROBAN
ARAVA vs ARGININE
ARAVA vs ARGININE\LYSINE
ARAVA vs ARIMIDEX
ARAVA vs ARIPIPRAZOLE
ARAVA vs ARIPIPRAZOLE LAUROXIL
ARAVA vs ARIXTRA
ARAVA vs ARMODAFINIL
Official FDA Label for ARAVA
Official prescribing information from the FDA-approved drug label.