ULTRAM: 88 Adverse Event Reports & Safety Profile
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88
Total FAERS Reports
3 (3.4%)
Deaths Reported
10
Hospitalizations
88
As Primary/Secondary Suspect
7
Life-Threatening
First Report: 2002 · Latest Report: 20140317
What Are the Most Common ULTRAM Side Effects?
#1 Most Reported
Drug hypersensitivity
48 reports (54.5%)
#2 Most Reported
Pain
5 reports (5.7%)
#3 Most Reported
Malaise
5 reports (5.7%)
All ULTRAM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug hypersensitivity | 48 | 54.6% | 0 | 0 |
| Back pain | 5 | 5.7% | 0 | 0 |
| Drug ineffective | 5 | 5.7% | 0 | 0 |
| Drug interaction | 5 | 5.7% | 0 | 1 |
| Malaise | 5 | 5.7% | 0 | 2 |
| Pain | 5 | 5.7% | 0 | 1 |
Who Reports ULTRAM Side Effects? Age & Gender Data
Average age: 58.8 years. Most reports from: US. View detailed demographics →
Is ULTRAM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2002 | 1 | 0 | 0 |
| 2006 | 1 | 0 | 0 |
| 2008 | 1 | 0 | 0 |
| 2011 | 2 | 0 | 0 |
| 2012 | 8 | 0 | 2 |
| 2013 | 5 | 1 | 2 |
| 2014 | 4 | 0 | 2 |
What Is ULTRAM Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 11 |
| Pain | 6 |
Official FDA Label for ULTRAM
Official prescribing information from the FDA-approved drug label.