TEMODAL: 83 Adverse Event Reports & Safety Profile
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83
Total FAERS Reports
24 (28.9%)
Deaths Reported
41
Hospitalizations
83
As Primary/Secondary Suspect
10
Life-Threatening
2
Disabilities
First Report: 20100205 · Latest Report: 20140604
What Are the Most Common TEMODAL Side Effects?
#1 Most Reported
Thrombocytopenia
6 reports (7.2%)
#2 Most Reported
Disease progression
6 reports (7.2%)
#3 Most Reported
Brain oedema
6 reports (7.2%)
All TEMODAL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Bone marrow failure | 6 | 7.2% | 4 | 3 |
| Brain oedema | 6 | 7.2% | 0 | 2 |
| Disease progression | 6 | 7.2% | 5 | 3 |
| Thrombocytopenia | 6 | 7.2% | 2 | 5 |
| Pancytopenia | 5 | 6.0% | 2 | 3 |
| Platelet count decreased | 5 | 6.0% | 2 | 3 |
| Pneumonia | 5 | 6.0% | 3 | 3 |
| Pyrexia | 5 | 6.0% | 1 | 3 |
Who Reports TEMODAL Side Effects? Age & Gender Data
Average age: 50.9 years. Most reports from: JP. View detailed demographics →
Is TEMODAL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 2 | 2 | 2 |
| 2011 | 1 | 1 | 1 |
| 2012 | 4 | 3 | 2 |
| 2013 | 18 | 6 | 12 |
| 2014 | 32 | 7 | 17 |
What Is TEMODAL Used For?
| Indication | Reports |
|---|---|
| Glioblastoma | 20 |
| Glioblastoma multiforme | 18 |
| Anaplastic astrocytoma | 7 |
| Malignant glioma | 5 |
Official FDA Label for TEMODAL
Official prescribing information from the FDA-approved drug label.