FEMARA: 90 Adverse Event Reports & Safety Profile
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90
Total FAERS Reports
12 (13.3%)
Deaths Reported
16
Hospitalizations
90
As Primary/Secondary Suspect
1
Life-Threatening
5
Disabilities
First Report: 20031028 · Latest Report: 20140604
What Are the Most Common FEMARA Side Effects?
#1 Most Reported
Malignant neoplasm progression
16 reports (17.8%)
#2 Most Reported
Breast cancer metastatic
9 reports (10.0%)
#3 Most Reported
Nausea
7 reports (7.8%)
All FEMARA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Malignant neoplasm progression | 16 | 17.8% | 5 | 2 |
| Breast cancer metastatic | 9 | 10.0% | 4 | 1 |
| Fatigue | 7 | 7.8% | 2 | 0 |
| Nausea | 7 | 7.8% | 1 | 0 |
| Breast cancer recurrent | 6 | 6.7% | 2 | 0 |
| Diarrhoea | 6 | 6.7% | 1 | 2 |
| Disease progression | 6 | 6.7% | 1 | 0 |
| Arthralgia | 5 | 5.6% | 1 | 0 |
| Bone pain | 5 | 5.6% | 1 | 0 |
| Breast cancer | 5 | 5.6% | 1 | 1 |
| Headache | 5 | 5.6% | 1 | 0 |
| Metastases to lymph nodes | 5 | 5.6% | 2 | 1 |
| Metastases to spine | 5 | 5.6% | 2 | 1 |
| Pain | 5 | 5.6% | 2 | 0 |
| Pyrexia | 5 | 5.6% | 1 | 2 |
Who Reports FEMARA Side Effects? Age & Gender Data
Average age: 62.0 years. Most reports from: JP. View detailed demographics →
Is FEMARA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 1 | 0 |
| 2007 | 1 | 0 | 0 |
| 2008 | 2 | 0 | 1 |
| 2009 | 1 | 1 | 0 |
| 2010 | 5 | 5 | 0 |
| 2011 | 3 | 0 | 0 |
| 2012 | 5 | 1 | 1 |
| 2013 | 21 | 2 | 8 |
| 2014 | 12 | 0 | 3 |
What Is FEMARA Used For?
| Indication | Reports |
|---|---|
| Breast cancer | 34 |
| Breast cancer metastatic | 13 |
| Product used for unknown indication | 6 |
Official FDA Label for FEMARA
Official prescribing information from the FDA-approved drug label.