NIAPRAZINE: 23 Adverse Event Reports & Safety Profile
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23
Total FAERS Reports
1 (4.3%)
Deaths Reported
5
Hospitalizations
23
As Primary/Secondary Suspect
4
Life-Threatening
First Report: 2010 · Latest Report: 20250525
What Are the Most Common NIAPRAZINE Side Effects?
#1 Most Reported
Agitation
15 reports (65.2%)
#2 Most Reported
Paradoxical drug reaction
13 reports (56.5%)
#3 Most Reported
Off label use
13 reports (56.5%)
All NIAPRAZINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Agitation | 15 | 65.2% | 0 | 2 |
| Irritability | 13 | 56.5% | 0 | 1 |
| Off label use | 13 | 56.5% | 1 | 1 |
| Paradoxical drug reaction | 13 | 56.5% | 0 | 1 |
| Sleep disorder | 12 | 52.2% | 0 | 1 |
| Confusional arousal | 11 | 47.8% | 0 | 1 |
| Fatigue | 11 | 47.8% | 0 | 1 |
| Quality of life decreased | 11 | 47.8% | 0 | 1 |
| Drug ineffective | 10 | 43.5% | 0 | 1 |
Who Reports NIAPRAZINE Side Effects? Age & Gender Data
Gender: 80.8% female, 19.2% male. Average age: 10.4 years. Most reports from: IT. View detailed demographics →
Is NIAPRAZINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 1 | 0 | 1 |
| 2025 | 3 | 0 | 3 |
What Is NIAPRAZINE Used For?
| Indication | Reports |
|---|---|
| Sleep disorder | 12 |
Official FDA Label for NIAPRAZINE
Official prescribing information from the FDA-approved drug label.