ELONTRIL: 21 Adverse Event Reports & Safety Profile
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21
Total FAERS Reports
0
Deaths Reported
5
Hospitalizations
21
As Primary/Secondary Suspect
1
Life-Threatening
First Report: 20090813 · Latest Report: 201404
What Are the Most Common ELONTRIL Side Effects?
#1 Most Reported
Neonatal respiratory distress syndrome
9 reports (42.9%)
#2 Most Reported
Feeding disorder neonatal
9 reports (42.9%)
#3 Most Reported
Atrial septal defect
9 reports (42.9%)
All ELONTRIL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Atrial septal defect | 9 | 42.9% | 0 | 3 |
| Feeding disorder neonatal | 9 | 42.9% | 0 | 3 |
| Neonatal respiratory distress syndrome | 9 | 42.9% | 0 | 3 |
| Convulsion | 7 | 33.3% | 0 | 1 |
| Drug withdrawal syndrome neonatal | 7 | 33.3% | 0 | 1 |
| Neonatal asphyxia | 7 | 33.3% | 0 | 1 |
| Patent ductus arteriosus | 7 | 33.3% | 0 | 1 |
| Persistent foetal circulation | 6 | 28.6% | 0 | 0 |
Who Reports ELONTRIL Side Effects? Age & Gender Data
Average age: 26.1 years. Most reports from: DE. View detailed demographics →
Is ELONTRIL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 2 | 0 | 2 |
| 2012 | 2 | 0 | 0 |
| 2013 | 11 | 0 | 1 |
| 2014 | 2 | 0 | 0 |
What Is ELONTRIL Used For?
| Indication | Reports |
|---|---|
| Depression | 14 |
| Product used for unknown indication | 5 |
Official FDA Label for ELONTRIL
Official prescribing information from the FDA-approved drug label.