PORACTANT ALFA for Off label use: Side Effects & Safety Data
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There are 20 adverse event reports in the FDA FAERS database where PORACTANT ALFA was used for Off label use.
Most Reported Side Effects for PORACTANT ALFA
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Neonatal hypoxia | 118 | 20.9% | 6 | 7 |
| Off label use | 71 | 12.6% | 17 | 14 |
| Ill-defined disorder | 48 | 8.5% | 41 | 0 |
| Bradycardia neonatal | 45 | 8.0% | 6 | 5 |
| Pulmonary haemorrhage | 38 | 6.7% | 27 | 3 |
| Drug ineffective | 34 | 6.0% | 11 | 12 |
| Endotracheal intubation complication | 32 | 5.7% | 4 | 2 |
| Product complaint | 31 | 5.5% | 5 | 9 |
| Infantile apnoea | 30 | 5.3% | 1 | 1 |
| Pulmonary haemorrhage neonatal | 27 | 4.8% | 12 | 5 |
| Product administration error | 26 | 4.6% | 1 | 0 |
| Neonatal respiratory failure | 25 | 4.4% | 21 | 4 |
| Pneumothorax | 21 | 3.7% | 8 | 2 |
| Cyanosis neonatal | 20 | 3.6% | 0 | 0 |
| Product quality issue | 20 | 3.6% | 4 | 0 |
Other Indications for PORACTANT ALFA
Neonatal respiratory distress syndrome (412)
Product used for unknown indication (99)
Respiratory distress (8)
Acute respiratory distress syndrome (5)
Premature baby (5)
Respiratory failure (5)
Other Drugs Used for Off label use
LENALIDOMIDE (5,767)
ECULIZUMAB (3,550)
CERTOLIZUMAB PEGOL (2,256)
ABOBOTULINUMTOXINA (2,170)
LEVETIRACETAM (2,161)
APREMILAST (1,995)
PROPRANOLOL (1,576)
CETIRIZINE (1,416)
HUMAN IMMUNOGLOBULIN G (1,129)
THALIDOMIDE (1,033)