ZOLEDRONATE: 54 Adverse Event Reports & Safety Profile
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54
Total FAERS Reports
7 (13.0%)
Deaths Reported
25
Hospitalizations
54
As Primary/Secondary Suspect
4
Life-Threatening
4
Disabilities
First Report: 20001020 · Latest Report: 20230215
What Are the Most Common ZOLEDRONATE Side Effects?
#1 Most Reported
Osteonecrosis of jaw
14 reports (25.9%)
#2 Most Reported
Malignant neoplasm progression
11 reports (20.4%)
#3 Most Reported
Pyrexia
7 reports (13.0%)
All ZOLEDRONATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Osteonecrosis of jaw | 14 | 25.9% | 2 | 7 |
| Malignant neoplasm progression | 11 | 20.4% | 6 | 3 |
| Pyrexia | 7 | 13.0% | 1 | 6 |
| Metastases to bone | 6 | 11.1% | 2 | 1 |
| Death | 5 | 9.3% | 5 | 1 |
| Hypocalcaemia | 5 | 9.3% | 0 | 4 |
| Malaise | 5 | 9.3% | 1 | 3 |
Who Reports ZOLEDRONATE Side Effects? Age & Gender Data
Gender: 50.0% female, 50.0% male. Average age: 58.4 years. Most reports from: JP. View detailed demographics →
Is ZOLEDRONATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 1 | 0 | 1 |
| 2004 | 1 | 0 | 1 |
| 2005 | 1 | 0 | 1 |
| 2006 | 2 | 0 | 0 |
| 2007 | 3 | 0 | 2 |
| 2010 | 2 | 2 | 1 |
| 2011 | 2 | 0 | 0 |
| 2012 | 3 | 1 | 1 |
| 2013 | 9 | 0 | 7 |
| 2014 | 5 | 0 | 3 |
| 2015 | 1 | 0 | 0 |
| 2023 | 1 | 0 | 0 |
What Is ZOLEDRONATE Used For?
| Indication | Reports |
|---|---|
| Metastases to bone | 13 |
| Osteoporosis | 8 |
Official FDA Label for ZOLEDRONATE
Official prescribing information from the FDA-approved drug label.