ORFIRIL: 18 Adverse Event Reports & Safety Profile
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18
Total FAERS Reports
4 (22.2%)
Deaths Reported
5
Hospitalizations
18
As Primary/Secondary Suspect
3
Life-Threatening
1
Disabilities
First Report: 20111025 · Latest Report: 20140124
What Are the Most Common ORFIRIL Side Effects?
#1 Most Reported
Neonatal respiratory distress syndrome
8 reports (44.4%)
#2 Most Reported
Microphthalmos
8 reports (44.4%)
#3 Most Reported
Hypotonia neonatal
8 reports (44.4%)
All ORFIRIL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Agitation neonatal | 8 | 44.4% | 0 | 1 |
| Atrial septal defect | 8 | 44.4% | 0 | 1 |
| Cardiac septal hypertrophy | 8 | 44.4% | 0 | 1 |
| Dysmorphism | 8 | 44.4% | 0 | 1 |
| Hypoglycaemia neonatal | 8 | 44.4% | 0 | 1 |
| Hypotonia neonatal | 8 | 44.4% | 0 | 1 |
| Microphthalmos | 8 | 44.4% | 0 | 1 |
| Neonatal respiratory distress syndrome | 8 | 44.4% | 0 | 1 |
| Foetal exposure during pregnancy | 5 | 27.8% | 0 | 1 |
| Foetal macrosomia | 5 | 27.8% | 0 | 1 |
Who Reports ORFIRIL Side Effects? Age & Gender Data
Average age: 21.8 years. Most reports from: DE. View detailed demographics →
Is ORFIRIL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 1 | 1 |
| 2012 | 2 | 2 | 0 |
| 2013 | 8 | 0 | 1 |
| 2014 | 3 | 0 | 3 |
What Is ORFIRIL Used For?
| Indication | Reports |
|---|---|
| Epilepsy | 9 |
| Product used for unknown indication | 5 |
Official FDA Label for ORFIRIL
Official prescribing information from the FDA-approved drug label.