GLIADEL: 35 Adverse Event Reports & Safety Profile
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35
Total FAERS Reports
3 (8.6%)
Deaths Reported
20
Hospitalizations
35
As Primary/Secondary Suspect
3
Life-Threatening
First Report: 20130218 · Latest Report: 20140420
What Are the Most Common GLIADEL Side Effects?
#1 Most Reported
Brain oedema
21 reports (60.0%)
#2 Most Reported
Hemiplegia
7 reports (20.0%)
#3 Most Reported
Condition aggravated
7 reports (20.0%)
All GLIADEL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Brain oedema | 21 | 60.0% | 3 | 12 |
| Aphasia | 7 | 20.0% | 1 | 0 |
| Condition aggravated | 7 | 20.0% | 0 | 5 |
| Hemiplegia | 7 | 20.0% | 1 | 5 |
| Convulsion | 6 | 17.1% | 0 | 4 |
Who Reports GLIADEL Side Effects? Age & Gender Data
Average age: 53.9 years. Most reports from: JP. View detailed demographics →
Is GLIADEL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 23 | 3 | 18 |
| 2014 | 6 | 0 | 1 |
What Is GLIADEL Used For?
| Indication | Reports |
|---|---|
| Malignant glioma | 28 |
Official FDA Label for GLIADEL
Official prescribing information from the FDA-approved drug label.