STRONTIUM RANELATE: 64 Adverse Event Reports & Safety Profile
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64
Total FAERS Reports
4 (6.3%)
Deaths Reported
38
Hospitalizations
64
As Primary/Secondary Suspect
4
Life-Threatening
5
Disabilities
First Report: 200603 · Latest Report: 20160229
What Are the Most Common STRONTIUM RANELATE Side Effects?
#1 Most Reported
Drug reaction with eosinophilia and systemic symptoms
14 reports (21.9%)
#2 Most Reported
Tibia fracture
11 reports (17.2%)
#3 Most Reported
Osteonecrosis of jaw
10 reports (15.6%)
All STRONTIUM RANELATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug reaction with eosinophilia and systemic symptoms | 14 | 21.9% | 3 | 14 |
| Tibia fracture | 11 | 17.2% | 0 | 11 |
| Ischaemic stroke | 10 | 15.6% | 0 | 4 |
| Metaphyseal corner fracture | 10 | 15.6% | 0 | 10 |
| Osteonecrosis of jaw | 10 | 15.6% | 0 | 3 |
| Atypical fracture | 8 | 12.5% | 0 | 8 |
| Arrhythmia | 7 | 10.9% | 0 | 0 |
| Fracture | 7 | 10.9% | 0 | 1 |
| Toxic skin eruption | 7 | 10.9% | 0 | 1 |
| Atrial fibrillation | 6 | 9.4% | 0 | 0 |
| Cardiac failure | 6 | 9.4% | 0 | 0 |
| Femur fracture | 6 | 9.4% | 0 | 0 |
| Fracture nonunion | 6 | 9.4% | 0 | 0 |
| Hip fracture | 6 | 9.4% | 0 | 0 |
| Hypertension | 6 | 9.4% | 0 | 6 |
| Myalgia | 6 | 9.4% | 0 | 6 |
| Myocardial infarction | 6 | 9.4% | 0 | 0 |
| Osteomyelitis | 6 | 9.4% | 0 | 0 |
| Cholestasis | 5 | 7.8% | 0 | 5 |
| General physical health deterioration | 5 | 7.8% | 0 | 5 |
Who Reports STRONTIUM RANELATE Side Effects? Age & Gender Data
Gender: 100.0% female, 0.0% male. Average age: 69.7 years. Most reports from: FR. View detailed demographics →
Is STRONTIUM RANELATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 1 | 0 | 1 |
| 2007 | 6 | 2 | 5 |
| 2008 | 5 | 0 | 5 |
| 2010 | 1 | 0 | 0 |
| 2012 | 9 | 0 | 1 |
| 2013 | 1 | 0 | 1 |
| 2014 | 13 | 0 | 12 |
| 2015 | 1 | 0 | 1 |
| 2016 | 5 | 0 | 4 |
What Is STRONTIUM RANELATE Used For?
| Indication | Reports |
|---|---|
| Osteoporosis | 40 |
| Product used for unknown indication | 18 |
Official FDA Label for STRONTIUM RANELATE
Official prescribing information from the FDA-approved drug label.