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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

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

YearReportsDeathsHosp.
2010 2 2 0
2011 1 1 0
2012 10 1 1
2013 265 90 56
2014 475 157 66

View full timeline →

What Is XTANDI Used For?

IndicationReports
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.