GABLOFEN: 57 Adverse Event Reports & Safety Profile
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57
Total FAERS Reports
8 (14.0%)
Deaths Reported
27
Hospitalizations
57
As Primary/Secondary Suspect
2
Life-Threatening
First Report: 20120924 · Latest Report: 20140512
What Are the Most Common GABLOFEN Side Effects?
#1 Most Reported
Muscle spasticity
10 reports (17.5%)
#2 Most Reported
Implant site erosion
7 reports (12.3%)
#3 Most Reported
Drug withdrawal syndrome
7 reports (12.3%)
All GABLOFEN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Muscle spasticity | 10 | 17.5% | 0 | 4 |
| Drug withdrawal syndrome | 7 | 12.3% | 0 | 4 |
| Implant site erosion | 7 | 12.3% | 0 | 3 |
| Cerebrospinal fluid leakage | 5 | 8.8% | 0 | 4 |
| Implant site infection | 5 | 8.8% | 0 | 3 |
| Pruritus | 5 | 8.8% | 0 | 3 |
Who Reports GABLOFEN Side Effects? Age & Gender Data
Average age: 36.8 years. Most reports from: US. View detailed demographics →
Is GABLOFEN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 2 | 0 | 0 |
| 2013 | 11 | 1 | 7 |
| 2014 | 14 | 3 | 9 |
What Is GABLOFEN Used For?
| Indication | Reports |
|---|---|
| Muscle spasticity | 45 |
Official FDA Label for GABLOFEN
Official prescribing information from the FDA-approved drug label.