ACLASTA/ZOLEDRONATE: 82 Adverse Event Reports & Safety Profile
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82
Total FAERS Reports
5 (6.1%)
Deaths Reported
28
Hospitalizations
82
As Primary/Secondary Suspect
2
Life-Threatening
2
Disabilities
First Report: 20090606 · Latest Report: 20140404
What Are the Most Common ACLASTA/ZOLEDRONATE Side Effects?
#1 Most Reported
Fall
18 reports (22.0%)
#2 Most Reported
Spinal fracture
16 reports (19.5%)
#3 Most Reported
Forearm fracture
8 reports (9.8%)
All ACLASTA/ZOLEDRONATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Fall | 18 | 22.0% | 2 | 7 |
| Spinal fracture | 16 | 19.5% | 0 | 0 |
| Forearm fracture | 8 | 9.8% | 0 | 0 |
| Back pain | 6 | 7.3% | 0 | 4 |
| Femur fracture | 6 | 7.3% | 0 | 2 |
| Rib fracture | 6 | 7.3% | 0 | 1 |
| Osteoarthritis | 5 | 6.1% | 0 | 2 |
Who Reports ACLASTA/ZOLEDRONATE Side Effects? Age & Gender Data
Average age: 76.3 years. Most reports from: FR. View detailed demographics →
Is ACLASTA/ZOLEDRONATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 1 | 1 | 1 |
| 2010 | 3 | 2 | 2 |
| 2011 | 4 | 0 | 3 |
| 2012 | 23 | 1 | 12 |
| 2013 | 14 | 0 | 6 |
| 2014 | 4 | 0 | 2 |
What Is ACLASTA/ZOLEDRONATE Used For?
| Indication | Reports |
|---|---|
| Osteoporosis | 64 |
| Osteoporotic fracture | 9 |
Official FDA Label for ACLASTA/ZOLEDRONATE
Official prescribing information from the FDA-approved drug label.