XGEVA: 1,042 Adverse Event Reports & Safety Profile
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1,042
Total FAERS Reports
350 (33.6%)
Deaths Reported
365
Hospitalizations
1,042
As Primary/Secondary Suspect
12
Life-Threatening
10
Disabilities
First Report: 2001 · Latest Report: 20140624
What Are the Most Common XGEVA Side Effects?
#1 Most Reported
Death
309 reports (29.7%)
#2 Most Reported
Osteonecrosis of jaw
159 reports (15.3%)
#3 Most Reported
Investigation
115 reports (11.0%)
All XGEVA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 309 | 29.7% | 309 | 24 |
| Osteonecrosis of jaw | 159 | 15.3% | 5 | 14 |
| Investigation | 115 | 11.0% | 11 | 115 |
| Hospitalisation | 77 | 7.4% | 4 | 77 |
| Hypocalcaemia | 48 | 4.6% | 7 | 34 |
| Metastases to bone | 30 | 2.9% | 3 | 2 |
| Pain | 28 | 2.7% | 2 | 9 |
| Pain in extremity | 17 | 1.6% | 1 | 5 |
| Dyspnoea | 16 | 1.5% | 5 | 9 |
| Disease progression | 15 | 1.4% | 6 | 4 |
| Terminal state | 14 | 1.3% | 0 | 2 |
| Back pain | 13 | 1.3% | 0 | 2 |
| Fatigue | 13 | 1.3% | 1 | 4 |
| Hypoaesthesia | 13 | 1.3% | 5 | 6 |
| Malaise | 13 | 1.3% | 2 | 6 |
| Nausea | 13 | 1.3% | 7 | 7 |
| Neoplasm malignant | 13 | 1.3% | 4 | 2 |
| Pain in jaw | 12 | 1.2% | 0 | 1 |
| Arthralgia | 11 | 1.1% | 0 | 0 |
| Malignant neoplasm progression | 11 | 1.1% | 6 | 2 |
Who Reports XGEVA Side Effects? Age & Gender Data
Average age: 66.9 years. Most reports from: NL. View detailed demographics →
Is XGEVA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 0 |
| 2008 | 2 | 0 | 2 |
| 2011 | 3 | 2 | 0 |
| 2012 | 104 | 46 | 50 |
| 2013 | 243 | 74 | 124 |
| 2014 | 269 | 123 | 89 |
What Is XGEVA Used For?
| Indication | Reports |
|---|---|
| Metastases to bone | 412 |
| Prophylaxis | 385 |
| Product used for unknown indication | 349 |
| Prostate cancer | 32 |
| Prostate cancer metastatic | 25 |
| Breast cancer metastatic | 24 |
| Breast cancer | 23 |
| Bone disorder | 7 |
| Osteoporosis | 6 |
| Neoplasm malignant | 5 |
XGEVA vs Alternatives: Which Is Safer?
XGEVA vs XIPAMIDE
XGEVA vs XOLAIR
XGEVA vs XTANDI
XGEVA vs XYLAZINE
XGEVA vs XYLOMETAZOLINE
XGEVA vs XYREM
XGEVA vs XYREM , /ML
XGEVA vs YASMIN
XGEVA vs YAZ
XGEVA vs YERVOY
Official FDA Label for XGEVA
Official prescribing information from the FDA-approved drug label.