ZYTIGA: 432 Adverse Event Reports & Safety Profile
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432
Total FAERS Reports
118 (27.3%)
Deaths Reported
145
Hospitalizations
432
As Primary/Secondary Suspect
19
Life-Threatening
7
Disabilities
First Report: 2011 · Latest Report: 20140618
What Are the Most Common ZYTIGA Side Effects?
#1 Most Reported
Death
73 reports (16.9%)
#2 Most Reported
Disease progression
31 reports (7.2%)
#3 Most Reported
Prostatic specific antigen increased
27 reports (6.3%)
All ZYTIGA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 73 | 16.9% | 73 | 8 |
| Disease progression | 31 | 7.2% | 23 | 4 |
| Prostatic specific antigen increased | 27 | 6.3% | 8 | 6 |
| Blood alkaline phosphatase increased | 19 | 4.4% | 12 | 2 |
| Drug ineffective | 19 | 4.4% | 3 | 2 |
| Asthenia | 17 | 3.9% | 4 | 9 |
| Fatigue | 17 | 3.9% | 3 | 8 |
| Anaemia | 15 | 3.5% | 2 | 10 |
| Haemoglobin decreased | 12 | 2.8% | 11 | 0 |
| Pain | 12 | 2.8% | 3 | 7 |
| Prostate cancer | 12 | 2.8% | 9 | 4 |
| Urinary tract infection | 12 | 2.8% | 3 | 7 |
| Atrial fibrillation | 11 | 2.6% | 3 | 6 |
| Hypokalaemia | 11 | 2.6% | 3 | 8 |
| Pneumonia | 11 | 2.6% | 3 | 9 |
| Vomiting | 11 | 2.6% | 1 | 6 |
| Decreased appetite | 10 | 2.3% | 4 | 3 |
| Drug dose omission | 10 | 2.3% | 2 | 7 |
| Myocardial infarction | 9 | 2.1% | 3 | 5 |
| Off label use | 9 | 2.1% | 2 | 4 |
Who Reports ZYTIGA Side Effects? Age & Gender Data
Average age: 73.9 years. Most reports from: US. View detailed demographics →
Is ZYTIGA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 3 | 1 | 1 |
| 2012 | 5 | 1 | 3 |
| 2013 | 78 | 23 | 37 |
| 2014 | 147 | 19 | 59 |
What Is ZYTIGA Used For?
| Indication | Reports |
|---|---|
| Prostate cancer | 219 |
| Product used for unknown indication | 99 |
| Prostate cancer metastatic | 68 |
| Neoplasm malignant | 7 |
ZYTIGA vs Alternatives: Which Is Safer?
ZYTIGA vs ZYVOX
ZYTIGA vs 5-FLUOROURACIL
ZYTIGA vs 5-FU
ZYTIGA vs 6-ACETYLMORPHINE
ZYTIGA vs ABACAVIR
ZYTIGA vs ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE
ZYTIGA vs ABACAVIR\LAMIVUDINE
ZYTIGA vs ABACAVIR\LAMIVUDINE\ZIDOVUDINE
ZYTIGA vs ABALOPARATIDE
ZYTIGA vs ABATACEPT
Official FDA Label for ZYTIGA
Official prescribing information from the FDA-approved drug label.