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Side Effects


The most common adverse reactions associated with Infasurf dosing procedures in the controlled trials were cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), and reintubation (3%). These events were generally transient and not associated with serious complications or death. The incidence of common complications of prematurity and RDS in the four controlled Infasurf trials are presented in Table 3. Prophylaxis and treatment study results for each surfactant are combined.

Table 3 : Common Complications of Prematurity and RDS in Controlled Trials

Complication Infasurf
(N=1001) %
Exosurf Neonatal®
(N=978) %
(N=553) %
(N=566) %
Apnea 61 61 76 76
Patent ductus arteriosus 47 48 45 48
Intracranial hemorrhage 29 31 36 36
  Severe intracranial hemorrhagea 12 10 9 7
IVH and PVL b 7 3 5 5
Sepsis 20 22 28 27
Pulmonary air leaks 12 22 15 15
  Pulmonary interstitial emphysema 7 17 10 10
Pulmonary hemorrhage 7 7 7 6
Necrotizing enterocolitis 5 5 17 18
a Grade III and IV by the method of Papile.
b Patients with both intraventricular hemorrhage and periventricular leukomalacia.

Follow-Up Evaluations

Two-year follow-up data of neurodevelopmental outcomes in 415 infants enrolled in 5 centers that participated in the Infasurf vs. Exosurf Neonatal® controlled trials demonstrated significant developmental delays in equal percentages of Infasurf and Exosurf Neonatal® patients.

Read the Infasurf (calfactant) Side Effects Center for a complete guide to possible side effects


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This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 7/12/2016

Side Effects

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