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Survanta (Beractant) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Survanta (Beractant) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (10)
Death (8)

Reports by Reaction Type

Pulmonary Haemorrhage (5)Death (3)Drug Ineffective (1)Pneumomediastinum (1)Overdose (1)Medication Error (1)Hypoxia (1)Oxygen Saturation Decreased (1)Neonatal Respiratory Distress Syndrome (1)

Possible Survanta side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-09

Patient:

Reactions: Overdose, Medication Error, Hypoxia

Drug(s) suspected as cause:
Survanta



Possible Survanta side effects in female

Reported by a physician from Chile on 2012-02-22

Patient: female, weighing 1.4 kg (3.1 pounds)

Reactions: Neonatal Respiratory Distress Syndrome, Drug Ineffective, Pneumomediastinum

Drug(s) suspected as cause:
Survanta

Other drugs received by patient: Amikacin; Ampicillin; Caffeine; Caffeine



Possible Survanta side effects in

Reported by a physician from Iran (Islamic Republic OF) on 2012-01-24

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Survanta



Possible Survanta side effects in male

Reported by a physician from Iran (Islamic Republic OF) on 2012-01-24

Patient: male, weighing 1.1 kg (2.4 pounds)

Reactions: Pulmonary Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Survanta



Possible Survanta side effects in

Reported by a physician from Iran (Islamic Republic OF) on 2012-01-24

Patient:

Reactions: Pulmonary Haemorrhage, Oxygen Saturation Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Survanta



Possible Survanta side effects in

Reported by a physician from Iran (Islamic Republic OF) on 2012-01-24

Patient:

Reactions: Pulmonary Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Survanta



Possible Survanta side effects in female

Reported by a physician from Iran (Islamic Republic OF) on 2012-01-24

Patient: female, weighing 0.9 kg (2.0 pounds)

Reactions: Pulmonary Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Survanta



Possible Survanta side effects in male

Reported by a physician from Iran (Islamic Republic OF) on 2012-01-24

Patient: male, weighing 1.2 kg (2.8 pounds)

Reactions: Pulmonary Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Survanta



Possible Survanta side effects in

Reported by a physician from Iran (Islamic Republic OF) on 2012-01-09

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Survanta



Possible Survanta side effects in

Reported by a consumer/non-health professional from Iran (Islamic Republic OF) on 2012-01-09

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Survanta

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