Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
WARNINGS See WARNING box.
NOTE : Alprostadil injection must be diluted before it is administered.
See dilution instructions in DOSAGE AND ADMINISTRATION section.
The administration of alprostadil injection to neonates may result in gastric outlet obstruction secondary to antral hyperplasia.
This effect appears to be related to duration of therapy and cumulative dose of the drug.
Like all medications, Alprostadil can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: