XTANDI: 1,393 Adverse Event Reports & Safety Profile
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1,393
Total FAERS Reports
389 (27.9%)
Deaths Reported
194
Hospitalizations
1,393
As Primary/Secondary Suspect
8
Life-Threatening
10
Disabilities
First Report: 201006 · Latest Report: 20140623
What Are the Most Common XTANDI Side Effects?
#1 Most Reported
Malignant neoplasm progression
235 reports (16.9%)
#2 Most Reported
Death
234 reports (16.8%)
#3 Most Reported
Fatigue
162 reports (11.6%)
All XTANDI Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Malignant neoplasm progression | 235 | 16.9% | 110 | 34 |
| Death | 234 | 16.8% | 234 | 13 |
| Fatigue | 162 | 11.6% | 19 | 18 |
| Drug ineffective | 158 | 11.3% | 7 | 11 |
| Prostatic specific antigen increased | 94 | 6.8% | 5 | 7 |
| Nausea | 69 | 5.0% | 5 | 13 |
| Asthenia | 62 | 4.5% | 5 | 13 |
| Decreased appetite | 56 | 4.0% | 12 | 8 |
| Dizziness | 52 | 3.7% | 2 | 6 |
| Diarrhoea | 51 | 3.7% | 3 | 12 |
| Back pain | 41 | 2.9% | 6 | 10 |
| Malaise | 41 | 2.9% | 4 | 9 |
| Arthralgia | 36 | 2.6% | 5 | 5 |
| Investigation | 31 | 2.2% | 6 | 31 |
| Dyspnoea | 30 | 2.2% | 2 | 13 |
| Headache | 30 | 2.2% | 2 | 7 |
| Insomnia | 29 | 2.1% | 4 | 0 |
| Oedema peripheral | 27 | 1.9% | 4 | 9 |
| Weight decreased | 27 | 1.9% | 7 | 8 |
| Confusional state | 26 | 1.9% | 3 | 6 |
Who Reports XTANDI Side Effects? Age & Gender Data
Average age: 75.0 years. Most reports from: US. View detailed demographics →
Is XTANDI Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 2 | 2 | 0 |
| 2011 | 1 | 1 | 0 |
| 2012 | 10 | 1 | 1 |
| 2013 | 265 | 90 | 56 |
| 2014 | 475 | 157 | 66 |
What Is XTANDI Used For?
| Indication | Reports |
|---|---|
| Prostate cancer | 787 |
| Product used for unknown indication | 384 |
| Prostate cancer metastatic | 135 |
| Neoplasm malignant | 23 |
| Hormone-refractory prostate cancer | 8 |
| Bone cancer | 6 |
| Neoplasm prostate | 6 |
| Ill-defined disorder | 5 |
XTANDI vs Alternatives: Which Is Safer?
XTANDI vs XYLAZINE
XTANDI vs XYLOMETAZOLINE
XTANDI vs XYREM
XTANDI vs XYREM , /ML
XTANDI vs YASMIN
XTANDI vs YAZ
XTANDI vs YERVOY
XTANDI vs YTTRIUM Y-90
XTANDI vs ZAFIRLUKAST
XTANDI vs ZALCITABINE
Official FDA Label for XTANDI
Official prescribing information from the FDA-approved drug label.