FLUDARA: 38 Adverse Event Reports & Safety Profile
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38
Total FAERS Reports
3 (7.9%)
Deaths Reported
18
Hospitalizations
38
As Primary/Secondary Suspect
5
Life-Threatening
3
Disabilities
First Report: 20081023 · Latest Report: 20140604
What Are the Most Common FLUDARA Side Effects?
#1 Most Reported
Febrile neutropenia
11 reports (28.9%)
#2 Most Reported
Pyrexia
5 reports (13.2%)
#3 Most Reported
Drug reaction with eosinophilia and systemic symptoms
4 reports (10.5%)
All FLUDARA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Febrile neutropenia | 11 | 29.0% | 1 | 6 |
| Pyrexia | 5 | 13.2% | 0 | 3 |
Who Reports FLUDARA Side Effects? Age & Gender Data
Average age: 51.5 years. Most reports from: US. View detailed demographics →
Is FLUDARA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 1 | 0 | 1 |
| 2009 | 1 | 0 | 1 |
| 2010 | 1 | 0 | 0 |
| 2011 | 4 | 1 | 1 |
| 2012 | 8 | 1 | 5 |
| 2013 | 15 | 0 | 8 |
| 2014 | 4 | 1 | 2 |
What Is FLUDARA Used For?
| Indication | Reports |
|---|---|
| Chronic lymphocytic leukaemia | 21 |
| Bone marrow conditioning regimen | 7 |
Official FDA Label for FLUDARA
Official prescribing information from the FDA-approved drug label.