Prostin VR Pediatric Side Effects

Generic Name: alprostadil

Please note - some side effects for Prostin VR Pediatric may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Prostin VR Pediatric Side Effects - for the Professional

Prostin VR Pediatric

Central Nervous System

Apnea has been reported in about 12% of the neonates treated. 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.

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Side Effects by Body System - for Healthcare Professionals

Local

Local side effects have included penile pain (37%), prolonged erection (4%), penile fibrosis (3%), injection site hematoma (3%), penis disorder (3%), injection site ecchymosis (2%), penile rash (1%), penile edema (1%), balanitis, injection site hemorrhage, injection site inflammation, injection site itching, injection site swelling and edema, urethral bleeding, penile warmth, numbness, yeast infection, irritation, sensitivity, phimosis, pruritus, erythema, venous leak, painful erection, and abnormal ejaculation. Postmarketing experience has included reports of needle breakage.

Cardiovascular

Hemodynamic changes manifested as hypotension and increases in pulse rate were generally observed at doses above 20 mcg and 30 mcg respectively, and appeared to be dose-dependent. These changes were usually reported as clinically unimportant, and only three patients discontinued treatment because of symptomatic hypotension.

Cardiovascular side effects have included hypertension (2%), hypotension, vasodilation, peripheral vascular disorder, supraventricular extrasystoles, vasovagal reactions, and increases in pulse rate.

Nervous system

Nervous system side effects have included headache (2%), dizziness (1%), hypesthesia, and non-generalized weakness.

Musculoskeletal

Musculoskeletal side effects have included back pain (1%) and leg cramps.

Respiratory

Respiratory side effects have included upper respiratory infection (4%), flu syndrome (2%), sinusitis (2%), nasal congestion (1%), and cough (1%).

Genitourinary

Genitourinary side effects have included prostatic disorder (2%), testicular pain, scrotal disorder, scrotal edema, hematuria, testicular disorder, impaired urination, urinary frequency, urinary urgency, and pelvic pain.

Ocular

Ocular side effects have included mydriasis.

Gastrointestinal

Gastrointestinal side effects have rarely included nausea and dry mouth.

Other

Other side effects have included localized pain (2%), trauma (2%), diaphoresis, rash, non-application site pruritus, skin neoplasm, and increased serum creatinine.

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