NOVONORM: 23 Adverse Event Reports & Safety Profile
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23
Total FAERS Reports
6 (26.1%)
Deaths Reported
20
Hospitalizations
23
As Primary/Secondary Suspect
2
Life-Threatening
1
Disabilities
First Report: 201104 · Latest Report: 20140528
What Are the Most Common NOVONORM Side Effects?
#1 Most Reported
Hypoglycaemia
7 reports (30.4%)
#2 Most Reported
Hepatitis
4 reports (17.4%)
#3 Most Reported
Hepatic encephalopathy
4 reports (17.4%)
All NOVONORM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Hypoglycaemia | 7 | 30.4% | 1 | 6 |
Who Reports NOVONORM Side Effects? Age & Gender Data
Average age: 76.6 years. Most reports from: FR. View detailed demographics →
Is NOVONORM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 1 | 1 |
| 2012 | 2 | 0 | 2 |
| 2013 | 12 | 5 | 11 |
| 2014 | 8 | 0 | 6 |
What Is NOVONORM Used For?
| Indication | Reports |
|---|---|
| Type 2 diabetes mellitus | 10 |
| Diabetes mellitus | 6 |
Official FDA Label for NOVONORM
Official prescribing information from the FDA-approved drug label.