BONIVA: 131 Adverse Event Reports & Safety Profile
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131
Total FAERS Reports
8 (6.1%)
Deaths Reported
84
Hospitalizations
131
As Primary/Secondary Suspect
1
Life-Threatening
27
Disabilities
First Report: 1995 · Latest Report: 201405
What Are the Most Common BONIVA Side Effects?
#1 Most Reported
Femur fracture
61 reports (46.6%)
#2 Most Reported
Low turnover osteopathy
38 reports (29.0%)
#3 Most Reported
Intramedullary rod insertion
31 reports (23.7%)
All BONIVA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Femur fracture | 61 | 46.6% | 0 | 54 |
| Low turnover osteopathy | 38 | 29.0% | 0 | 33 |
| Arthralgia | 31 | 23.7% | 0 | 27 |
| Fall | 31 | 23.7% | 1 | 31 |
| Intramedullary rod insertion | 31 | 23.7% | 0 | 31 |
| Pain | 30 | 22.9% | 0 | 22 |
| Osteoarthritis | 26 | 19.9% | 0 | 26 |
| Hypertension | 21 | 16.0% | 0 | 20 |
| Pain in extremity | 19 | 14.5% | 0 | 17 |
| Stress fracture | 19 | 14.5% | 0 | 15 |
| Arthritis | 17 | 13.0% | 0 | 16 |
| Back pain | 17 | 13.0% | 0 | 15 |
| Anxiety | 15 | 11.5% | 0 | 12 |
| Bone disorder | 15 | 11.5% | 0 | 10 |
| Nausea | 15 | 11.5% | 1 | 10 |
| Depression | 14 | 10.7% | 0 | 12 |
| Spinal osteoarthritis | 14 | 10.7% | 0 | 14 |
| Urinary tract infection | 14 | 10.7% | 1 | 13 |
| Anaemia | 13 | 9.9% | 0 | 13 |
| Fatigue | 13 | 9.9% | 0 | 11 |
Who Reports BONIVA Side Effects? Age & Gender Data
Average age: 69.2 years. Most reports from: US. View detailed demographics →
Is BONIVA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 3 | 0 | 3 |
| 2001 | 5 | 0 | 5 |
| 2002 | 3 | 0 | 3 |
| 2003 | 2 | 0 | 2 |
| 2004 | 3 | 0 | 3 |
| 2006 | 5 | 0 | 5 |
| 2007 | 3 | 0 | 2 |
| 2008 | 4 | 0 | 3 |
| 2009 | 5 | 0 | 5 |
| 2010 | 8 | 0 | 8 |
| 2011 | 13 | 1 | 8 |
| 2012 | 8 | 1 | 3 |
| 2013 | 8 | 0 | 4 |
| 2014 | 9 | 0 | 6 |
What Is BONIVA Used For?
| Indication | Reports |
|---|---|
| Osteoporosis | 71 |
| Osteopenia | 26 |
| Product used for unknown indication | 12 |
| Senile osteoporosis | 10 |
| Osteoporosis prophylaxis | 9 |
BONIVA vs Alternatives: Which Is Safer?
BONIVA vs BONVIVA
BONIVA vs BORAGE OIL
BONIVA vs BORIC ACID
BONIVA vs BORTEZOMIB
BONIVA vs BOSENTAN
BONIVA vs BOSENTAN\BOSENTAN
BONIVA vs BOSUTINIB
BONIVA vs BOTOX
BONIVA vs BOTOX COSMETIC
BONIVA vs BOTULINUM TOXIN NOS
Official FDA Label for BONIVA
Official prescribing information from the FDA-approved drug label.