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Prostin VR Pediatric (Alprostadil) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Central Nervous System

Apnea has been reported in about 12% of the neonates treated. (See WARNING box.) Other common adverse reactions reported have been fever in about 14% of the patients treated and seizures in about 4%. The following reactions have been reported in less than 1% of the patients: cerebral bleeding, hyperextension of the neck, hyperirritability, hypothermia, jitteriness, lethargy, and stiffness.

Cardiovascular System

The most common adverse reactions reported have been flushing in about 10% of patients (more common after intraarterial dosing), bradycardia in about 7%, hypotension in about 4%, tachycardia in about 3%, cardiac arrest in about 1%, and edema in about 1%. The following reactions have been reported in less than 1% of the patients: congestive heart failure, hyperemia, second degree heart block, shock, spasm of the right ventricle infundibulum, supraventricular tachycardia, and ventricular fibrillation.

Respiratory System

The following reactions have been reported in less than 1% of the patients: bradypnea, bronchial wheezing, hypercapnia, respiratory depression, respiratory distress, and tachypnea.

Gastrointestinal System

See WARNINGS

The most common adverse reaction reported has been diarrhea in about 2% of the patients. The following reactions have been reported in less than 1% of the patients: gastric regurgitation, and hyperbilirubinemia.

Hematologic System

The most common hematologic event reported has been disseminated intravascular coagulation in about 1% of the patients. The following events have been reported in less than 1% of the patients: anemia, bleeding, and thrombocytopenia.

Excretory System

Anuria and hematuria have been reported in less than 1% of the patients.

Skeletal System

Cortical proliferation of the long bones has been reported. See PRECAUTIONS.

Miscellaneous

Sepsis has been reported in about 2% of the patients. Peritonitis has been reported in less than 1% of the patients. Hypokalemia has been reported in about 1%, and hypoglycemia and hyperkalemia have been reported in less than 1% of the patients.



REPORTS OF SUSPECTED PROSTIN VR PEDIATRIC SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Prostin VR Pediatric. The information is not vetted and should not be considered as verified clinical evidence.

Possible Prostin VR Pediatric side effects / adverse reactions in female

Reported by a consumer/non-health professional from Venezuela on 2011-10-31

Patient: female

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Prostin VR Pediatric



See index of all Prostin VR Pediatric side effect reports >>

Drug label data at the top of this Page last updated: 2006-04-20

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