GALVUS: 39 Adverse Event Reports & Safety Profile
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39
Total FAERS Reports
6 (15.4%)
Deaths Reported
20
Hospitalizations
39
As Primary/Secondary Suspect
9
Life-Threatening
1
Disabilities
First Report: 2008 · Latest Report: 20140310
What Are the Most Common GALVUS Side Effects?
#1 Most Reported
Renal failure acute
11 reports (28.2%)
#2 Most Reported
Blood creatine phosphokinase increased
9 reports (23.1%)
#3 Most Reported
Weight increased
3 reports (7.7%)
All GALVUS Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Renal failure acute | 11 | 28.2% | 0 | 10 |
| Blood creatine phosphokinase increased | 9 | 23.1% | 0 | 9 |
Who Reports GALVUS Side Effects? Age & Gender Data
Average age: 74.0 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →
Is GALVUS Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 1 | 0 | 0 |
| 2011 | 1 | 1 | 1 |
| 2012 | 2 | 1 | 1 |
| 2013 | 11 | 3 | 5 |
| 2014 | 10 | 0 | 10 |
What Is GALVUS Used For?
| Indication | Reports |
|---|---|
| Diabetes mellitus | 17 |
| Type 2 diabetes mellitus | 12 |
Official FDA Label for GALVUS
Official prescribing information from the FDA-approved drug label.