NOVALGIN: 19 Adverse Event Reports & Safety Profile
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19
Total FAERS Reports
2 (10.5%)
Deaths Reported
9
Hospitalizations
19
As Primary/Secondary Suspect
1
Life-Threatening
First Report: 2008 · Latest Report: 20140509
What Are the Most Common NOVALGIN Side Effects?
#1 Most Reported
Pulmonary artery stenosis congenital
6 reports (31.6%)
#2 Most Reported
Neonatal respiratory distress syndrome
6 reports (31.6%)
#3 Most Reported
Macrocephaly
6 reports (31.6%)
All NOVALGIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Atrial septal defect | 6 | 31.6% | 0 | 1 |
| Macrocephaly | 6 | 31.6% | 0 | 1 |
| Neonatal respiratory distress syndrome | 6 | 31.6% | 0 | 1 |
| Pulmonary artery stenosis congenital | 6 | 31.6% | 0 | 1 |
| Agranulocytosis | 5 | 26.3% | 2 | 3 |
Who Reports NOVALGIN Side Effects? Age & Gender Data
Average age: 39.1 years. Most reports from: DE. View detailed demographics →
Is NOVALGIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 5 | 0 | 1 |
| 2013 | 5 | 0 | 5 |
| 2014 | 6 | 1 | 3 |
What Is NOVALGIN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 5 |
Official FDA Label for NOVALGIN
Official prescribing information from the FDA-approved drug label.