ETIDRONATE: 95 Adverse Event Reports & Safety Profile
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95
Total FAERS Reports
3 (3.2%)
Deaths Reported
30
Hospitalizations
95
As Primary/Secondary Suspect
13
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Yes
Generic Available
Active Ingredient: ETIDRONATE DISODIUM · FDA Application: 017831 ·
First Report: 19960122 · Latest Report: 20221101
What Are the Most Common ETIDRONATE Side Effects?
#1 Most Reported
Femur fracture
22 reports (23.2%)
#2 Most Reported
Atypical femur fracture
22 reports (23.2%)
#3 Most Reported
Osteonecrosis of jaw
19 reports (20.0%)
All ETIDRONATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Atypical femur fracture | 22 | 23.2% | 0 | 9 |
| Femur fracture | 22 | 23.2% | 2 | 14 |
| Arthralgia | 19 | 20.0% | 2 | 4 |
| Osteonecrosis of jaw | 19 | 20.0% | 0 | 2 |
| Pain | 17 | 17.9% | 0 | 3 |
| Hypertension | 16 | 16.8% | 2 | 2 |
| Inflammation | 16 | 16.8% | 0 | 2 |
| Rheumatoid arthritis | 15 | 15.8% | 0 | 1 |
| Tooth abscess | 15 | 15.8% | 0 | 0 |
| Cough | 14 | 14.7% | 0 | 0 |
| Lip blister | 14 | 14.7% | 0 | 0 |
| Musculoskeletal stiffness | 14 | 14.7% | 0 | 0 |
| Nasopharyngitis | 14 | 14.7% | 0 | 0 |
| Therapeutic response decreased | 14 | 14.7% | 0 | 0 |
| Transaminases increased | 14 | 14.7% | 0 | 0 |
| Weight decreased | 14 | 14.7% | 0 | 0 |
| Hepatic steatosis | 10 | 10.5% | 0 | 1 |
| Blood pressure increased | 9 | 9.5% | 0 | 0 |
| Blood pressure systolic increased | 9 | 9.5% | 0 | 0 |
| Fall | 9 | 9.5% | 0 | 9 |
Who Reports ETIDRONATE Side Effects? Age & Gender Data
Gender: 74.7% female, 25.3% male. Average age: 67.7 years. Most reports from: US. View detailed demographics →
Is ETIDRONATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2002 | 4 | 2 | 4 |
| 2003 | 1 | 0 | 0 |
| 2005 | 4 | 0 | 2 |
| 2006 | 5 | 0 | 5 |
| 2008 | 4 | 0 | 3 |
| 2010 | 1 | 0 | 0 |
| 2014 | 2 | 0 | 2 |
| 2015 | 2 | 0 | 1 |
| 2016 | 2 | 0 | 1 |
| 2017 | 4 | 0 | 0 |
| 2018 | 3 | 0 | 3 |
| 2022 | 1 | 0 | 0 |
What Is ETIDRONATE Used For?
| Indication | Reports |
|---|---|
| Osteoporosis | 31 |
| Product used for unknown indication | 24 |
Official FDA Label for ETIDRONATE
Official prescribing information from the FDA-approved drug label.