SAVELLA: 55 Adverse Event Reports & Safety Profile
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55
Total FAERS Reports
1 (1.8%)
Deaths Reported
6
Hospitalizations
55
As Primary/Secondary Suspect
3
Life-Threatening
4
Disabilities
First Report: 2007 · Latest Report: 20140620
What Are the Most Common SAVELLA Side Effects?
#1 Most Reported
Drug hypersensitivity
8 reports (14.5%)
#2 Most Reported
Pain
7 reports (12.7%)
#3 Most Reported
Headache
7 reports (12.7%)
All SAVELLA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug hypersensitivity | 8 | 14.6% | 0 | 0 |
| Drug ineffective | 7 | 12.7% | 0 | 0 |
| Headache | 7 | 12.7% | 0 | 0 |
| Pain | 7 | 12.7% | 0 | 0 |
| Palpitations | 6 | 10.9% | 0 | 1 |
| Dizziness | 5 | 9.1% | 0 | 0 |
| Feeling abnormal | 5 | 9.1% | 0 | 0 |
| Nausea | 5 | 9.1% | 0 | 2 |
| Vomiting | 5 | 9.1% | 0 | 2 |
Who Reports SAVELLA Side Effects? Age & Gender Data
Average age: 52.7 years. Most reports from: US. View detailed demographics →
Is SAVELLA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2007 | 1 | 0 | 0 |
| 2010 | 2 | 0 | 1 |
| 2011 | 2 | 0 | 0 |
| 2012 | 6 | 1 | 1 |
| 2013 | 13 | 0 | 2 |
| 2014 | 13 | 0 | 2 |
What Is SAVELLA Used For?
| Indication | Reports |
|---|---|
| Fibromyalgia | 29 |
| Pain | 5 |
Official FDA Label for SAVELLA
Official prescribing information from the FDA-approved drug label.