ZOLADEX: 153 Adverse Event Reports & Safety Profile
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153
Total FAERS Reports
60 (39.2%)
Deaths Reported
18
Hospitalizations
153
As Primary/Secondary Suspect
8
Life-Threatening
7
Disabilities
First Report: 20010516 · Latest Report: 20140518
What Are the Most Common ZOLADEX Side Effects?
#1 Most Reported
Death
55 reports (35.9%)
#2 Most Reported
Malignant neoplasm progression
28 reports (18.3%)
#3 Most Reported
Hot flush
17 reports (11.1%)
All ZOLADEX Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 55 | 36.0% | 55 | 2 |
| Malignant neoplasm progression | 28 | 18.3% | 4 | 2 |
| Hot flush | 17 | 11.1% | 1 | 3 |
| Interstitial lung disease | 9 | 5.9% | 1 | 3 |
| Fatigue | 6 | 3.9% | 0 | 0 |
| Therapy cessation | 6 | 3.9% | 1 | 1 |
| Asthenia | 5 | 3.3% | 2 | 2 |
| Breast cancer female | 5 | 3.3% | 0 | 0 |
| Dizziness | 5 | 3.3% | 0 | 2 |
| Off label use | 5 | 3.3% | 0 | 1 |
Who Reports ZOLADEX Side Effects? Age & Gender Data
Average age: 69.9 years. Most reports from: AU. View detailed demographics →
Is ZOLADEX Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 1 | 0 |
| 2007 | 3 | 0 | 0 |
| 2008 | 3 | 1 | 0 |
| 2010 | 2 | 1 | 0 |
| 2011 | 3 | 0 | 1 |
| 2012 | 6 | 2 | 1 |
| 2013 | 32 | 11 | 8 |
| 2014 | 40 | 20 | 4 |
What Is ZOLADEX Used For?
| Indication | Reports |
|---|---|
| Prostate cancer | 89 |
| Breast cancer | 6 |
ZOLADEX vs Alternatives: Which Is Safer?
ZOLADEX vs ZOLBETUXIMAB
ZOLADEX vs ZOLBETUXIMAB-CLZB
ZOLADEX vs ZOLEDRONIC ACID
ZOLADEX vs ZOLMITRIPTAN
ZOLADEX vs ZOLOFT
ZOLADEX vs ZOLPIDEM
ZOLADEX vs ZOLPIDEM\ZOLPIDEM
ZOLADEX vs ZOMETA
ZOLADEX vs ZONISAMIDE
ZOLADEX vs ZOPICLONE
Official FDA Label for ZOLADEX
Official prescribing information from the FDA-approved drug label.