VALDOXAN: 39 Adverse Event Reports & Safety Profile
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39
Total FAERS Reports
9 (23.1%)
Deaths Reported
22
Hospitalizations
39
As Primary/Secondary Suspect
3
Life-Threatening
First Report: 20111030 · Latest Report: 20140209
What Are the Most Common VALDOXAN Side Effects?
#1 Most Reported
Fall
11 reports (28.2%)
#2 Most Reported
Speech disorder
9 reports (23.1%)
#3 Most Reported
Sedation
9 reports (23.1%)
All VALDOXAN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Fall | 11 | 28.2% | 1 | 11 |
| Eating disorder | 9 | 23.1% | 0 | 9 |
| Movement disorder | 9 | 23.1% | 0 | 9 |
| Salivary hypersecretion | 9 | 23.1% | 0 | 9 |
| Sedation | 9 | 23.1% | 0 | 9 |
| Speech disorder | 9 | 23.1% | 0 | 9 |
| Blood creatine phosphokinase increased | 6 | 15.4% | 0 | 0 |
Who Reports VALDOXAN Side Effects? Age & Gender Data
Average age: 58.2 years. Most reports from: DE. View detailed demographics →
Is VALDOXAN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 10 | 1 | 10 |
| 2012 | 7 | 0 | 1 |
| 2013 | 10 | 3 | 8 |
| 2014 | 7 | 3 | 2 |
What Is VALDOXAN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 16 |
| Depression | 7 |
Official FDA Label for VALDOXAN
Official prescribing information from the FDA-approved drug label.