HALAVEN: 77 Adverse Event Reports & Safety Profile
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77
Total FAERS Reports
11 (14.3%)
Deaths Reported
46
Hospitalizations
77
As Primary/Secondary Suspect
8
Life-Threatening
5
Disabilities
First Report: 2009 · Latest Report: 20140611
What Are the Most Common HALAVEN Side Effects?
#1 Most Reported
Neutropenia
11 reports (14.3%)
#2 Most Reported
Interstitial lung disease
8 reports (10.4%)
#3 Most Reported
Febrile neutropenia
8 reports (10.4%)
All HALAVEN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Neutropenia | 11 | 14.3% | 0 | 7 |
| Febrile neutropenia | 8 | 10.4% | 1 | 7 |
| Interstitial lung disease | 8 | 10.4% | 4 | 7 |
| Anaemia | 7 | 9.1% | 0 | 5 |
| Stomatitis | 7 | 9.1% | 2 | 4 |
| Cardiac failure | 6 | 7.8% | 0 | 5 |
| Malignant neoplasm progression | 5 | 6.5% | 1 | 3 |
| Rectal haemorrhage | 5 | 6.5% | 0 | 4 |
Who Reports HALAVEN Side Effects? Age & Gender Data
Average age: 58.7 years. Most reports from: JP. View detailed demographics →
Is HALAVEN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 1 | 0 | 0 |
| 2011 | 2 | 1 | 2 |
| 2012 | 9 | 2 | 5 |
| 2013 | 31 | 1 | 24 |
| 2014 | 23 | 5 | 13 |
What Is HALAVEN Used For?
| Indication | Reports |
|---|---|
| Breast cancer recurrent | 24 |
| Breast cancer metastatic | 18 |
| Breast cancer | 16 |
| Product used for unknown indication | 10 |
Official FDA Label for HALAVEN
Official prescribing information from the FDA-approved drug label.