This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Curosurf (Poractant Alfa) 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 (16)
Death (5)
Life Threatening Events (2)
Reports by Reaction Type
C-Reactive Protein Increased (4),
Pulmonary Haemorrhage (4),
Drug Ineffective (3),
Oxygen Saturation Decreased (3),
Shock (3),
Disseminated Intravascular Coagulation (2),
Expired Drug Administered (2),
Pallor (2),
Thrombocytopenia (2),
Product Quality Issue (2),
Dyspnoea (2),
Interleukin Level Increased (2)
Possible Curosurf side effects in
Reported by a physician from Mexico on 2012-07-13
Patient:
Reactions: Product Quality Issue, Drug Ineffective
Drug(s) suspected as cause:
Curosurf
Possible Curosurf side effects in
Reported by a physician from Germany on 2012-07-11
Patient:
Reactions: Pulmonary Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Curosurf
Possible Curosurf side effects in
Reported by a physician from Mexico on 2012-06-27
Patient:
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Curosurf
Possible Curosurf side effects in
Reported by a physician from Mexico on 2012-06-07
Patient:
Reactions: Product Quality Issue, Drug Ineffective
Drug(s) suspected as cause:
Curosurf
Possible Curosurf side effects in male
Reported by a individual with unspecified qualification from United States on 2012-05-01
Patient: male, weighing 0.8 kg (1.8 pounds)
Reactions: Pulmonary Interstitial Emphysema Syndrome
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Curosurf
Possible Curosurf side effects in male
Reported by a health professional (non-physician/pharmacist) from Finland on 2012-04-18
Patient: male
Reactions: Drug Administered AT Inappropriate Site, Pulmonary Haemorrhage, Swelling, Injection Site Swelling, Fluid Retention
Drug(s) suspected as cause:
Numeta G13e
Start date: 2012-02-20
Curosurf
Other drugs received by patient: Tomycin; Penicillin G
Possible Curosurf side effects in
Reported by a physician from India on 2012-01-05
Patient:
Reactions: Expired Drug Administered
Adverse event resulted in: death
Drug(s) suspected as cause:
Curosurf
Possible Curosurf side effects in female
Reported by a physician from China on 2012-01-04
Patient: female
Reactions: Dyspnoea, Pallor, Oxygen Saturation Decreased, Shock
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Curosurf
Dosage: daily dose 120 milligrams;unknown
Indication: Neonatal Respiratory Distress Syndrome Prophylaxis
Start date: 2011-11-07
End date: 2011-11-07
Curosurf
Dosage: daily dose 120 milligrams;unknown
Indication: Oxygen Saturation Abnormal
Start date: 2011-11-07
End date: 2011-11-07
Other drugs received by patient: Mezlocillin (Mezlocillin); Etamsilate (Etamsilate); Cefotiam (Cefotiam); Oxygen (Oxygen); Ambroxol (Ambroxol)
Possible Curosurf side effects in male
Reported by a physician from China on 2012-01-04
Patient: male
Reactions: Peripheral Coldness, Dyspnoea, Rales, Erythema, Pallor, Poor Peripheral Circulation, Sepsis, Oxygen Saturation Decreased, Shock, Infantile Apnoeic Attack
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Curosurf
Other drugs received by patient: Etamsilate (Etamsilate); Cefotiam (Cefotiam); Mezlocillin (Mezlocillin); Ambroxol (Ambroxol)
Possible Curosurf side effects in male
Reported by a physician from China on 2012-01-04
Patient: male
Reactions: LOW Birth Weight Baby, Anaemia Neonatal, Neonatal Respiratory Distress Syndrome, Metabolic Acidosis, Neonatal Pneumonia, Disseminated Intravascular Coagulation, Hyperglycaemia, Jaundice Neonatal, Pulmonary Haemorrhage, Cardio-Respiratory Arrest, Hypocalcaemia, Shock
Adverse event resulted in: death
Drug(s) suspected as cause:
Piperacillin W / Sulbactam Sodium (NO Pref. Name)
Dosage: daily dose 0.18 grams;twice a day
Indication: Pneumonia
Start date: 2011-09-19
End date: 2011-09-23
Curosurf
Dosage: daily dose 240 milligrams;daily
Indication: Neonatal Respiratory Distress Syndrome
Start date: 2011-09-19
End date: 2011-09-20
Other drugs received by patient: Haemocoagulase (Haemocoagulase); Etamsilate (Etamsilate); Phenobarbital TAB; Cefodizime (Cefodizime)
Possible Curosurf side effects in male
Reported by a physician from China on 2012-01-04
Patient: male
Reactions: Pulmonary Haemorrhage, Disseminated Intravascular Coagulation
Drug(s) suspected as cause:
Curosurf
Other drugs received by patient: Haemocoagulase (Haemocoagulase); Cefotiam (Cefotiam); Furbencillin Sodium (NO Pref. Name); Antiinfectives (Antiinfectives); Vitamin K NOS (Vitamin K Nos)
Possible Curosurf side effects in
Reported by a physician from India on 2011-12-16
Patient:
Reactions: Incorrect Route of Drug Administration, Expired Drug Administered
Adverse event resulted in: death
Drug(s) suspected as cause:
Curosurf
Possible Curosurf side effects in male
Reported by a physician from Germany on 2011-11-03
Patient: male
Reactions: Conjunctivitis, Interleukin Level Increased, Hyperbilirubinaemia Neonatal, C-Reactive Protein Increased, Bradycardia, Apnoea, Thrombocytopenia, Oxygen Saturation Decreased, Leukopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Curosurf
Other drugs received by patient: Ecolicin; Solutions FOR Parenteral Nutrition; Caffeine Citrate
Possible Curosurf side effects in female
Reported by a physician from Germany on 2011-11-03
Patient: female
Reactions: C-Reactive Protein Increased, Respiratory Failure
Drug(s) suspected as cause:
Curosurf
Other drugs received by patient: Valproic Acid; Ampicillin; Cefotaxime Sodium
Possible Curosurf side effects in male
Reported by a physician from Germany on 2011-10-11
Patient: male
Reactions: C-Reactive Protein Increased, Thrombocytopenia, Interleukin Level Increased, Leukopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Curosurf
Other drugs received by patient: Solutions FOR Parenteral Nutrition
Possible Curosurf side effects in female
Reported by a physician from Germany on 2011-10-11
Patient: female
Reactions: C-Reactive Protein Increased
Drug(s) suspected as cause:
Curosurf
Other drugs received by patient: Cefotaxime; Ampicillin Sodium
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