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Prostin VR Pediatric Side Effects

Generic Name: alprostadil

Note: This page contains side effects data for the generic drug alprostadil. It is possible that some of the dosage forms included below may not apply to the brand name Prostin VR Pediatric.

It is possible that some side effects of Prostin VR Pediatric may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to alprostadil: intracavernosal kit, intracavernosal powder for solution, intracavernosal solution

As well as its needed effects, alprostadil (the active ingredient contained in Prostin VR Pediatric) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking alprostadil, check with your doctor immediately:

  • Curving of penis with pain during erection
  • erection continuing for 4 to 6 hours
  • erection continuing longer than 6 hours with severe and continuing pain of the penis
  • swelling in or pain of the testes

Some alprostadil side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Bleeding and pain at the injection site (short-term)
  • painful erection
  • Bruising or clotted blood in the penis at the injection site, usually caused by an incorrect injection

For Healthcare Professionals

Applies to alprostadil: compounding powder, injectable kit, injectable powder for injection, injectable solution, transurethral suppository


The most common side effects were penile pain, local bleeding, fever, urethral pain, urethral burning, apnea, and flushing.[Ref]


Very common (10% or more): Penile pain (up to 36%), urethral pain (13%), urethral burning (12%)
Common (1% to 10%): Prolonged erection greater than 4 hours, penile angulation, penile fibrosis, cavernous body fibrosis, Peyronie's disease, penis disorder, prostate disorder, testicular pain, urethral bleeding/spotting and other minor urethral abrasions, vaginal burning/itching
Uncommon (0.1% to 1%): Priapism, scrotal erythema, dysuria, hematuria, pollakiuria, micturition urgency, urethral hemorrhage, balanitis, phimosis, ejaculation disorder, scrotal disorder, scrotal pain, testicular swelling, testicular edema, scrotal edema, spermatocele, testicular disorder, testicular mass, penile hemosiderin deposits, swelling of the preputium or the glans, perineal pain, painful erection
Rare (less than 0.1%): Urinary tract infection
Frequency not reported: Anuria, abnormal ejaculation, penile deviations, penile warmth, urinary frequency/urinary urgency/impaired urination[Ref]


Very common (10% or more): Flushing (10.1%)
Common (1% to 10%): Bradycardia, hypotension, tachycardia, cardiac arrest, edema, hematoma, hypertension, myocardial infarction, abnormal ECG
Uncommon (0.1% to 1%): Vascular fragility, supraventricular extrasystoles, vein disorder, vasodilatation, peripheral vascular disorder, peripheral edema, swelling of the leg veins
Frequency not reported: Congestive heart failure, hyperemia, second degree heart block, shock, spasm of the right ventricle infundibulum, supraventricular tachycardia, ventricular fibrillation, rapid pulse, pneumopericardium, ventricular hypertrophy, tachyphylaxis, ductus arteriosus histological changes, venous leak, cardiac arrhythmias, postural hypotension, changes in blood pressure, vagal shock, vasovagal reactions, myocardial ischemia[Ref]


Very common (10% or more): Local bleeding (15%)
Common (1% to 10%): Injection site hematoma, injection site burning, sensation of tension in the penis, injection site pain
Uncommon (0.1% to 1%): Injection site hemorrhage, injection site edema, injection site inflammation, injection site mass, injection site pruritus, injection site swelling and reddening, injection site irritation, injection site anesthesia, injection site warmth
Frequency not reported: Localized pain[Ref]


Very common (10% or more): Apnea (12%)
Common (1% to 10%): Upper respiratory tract infection, sinusitis, rhinitis
Frequency not reported: Bradypnea, bronchial wheezing, hypercapnia, respiratory depression, respiratory distress, tachypnea, hypoplastic lungs, pneumothorax[Ref]


Very common (10% or more): Fever (14%)
Common (1% to 10%): Sepsis, influenza-like symptoms, pain, accidental injury
Uncommon (0.1% to 1%): Asthenia
Rare (less than 0.1%): Vertigo
Frequency not reported: Hypothermia, jitteriness, non-generalized weakness[Ref]


Common (1% to 10%): Back pain, leg pain, pelvic pain, muscle spasms
Uncommon (0.1% to 1%): Exostosis
Frequency not reported: Hyperextension of the neck, stiffness, cortical proliferation of the long bones, microcephaly, leg cramps[Ref]


Common (1% to 10%): Hypokalemia, hypertriglyceridemia, hypercholesterolemia, hyperglycemia
Frequency not reported: Hypoglycemia, hyperkalemia[Ref]

Nervous system

Common (1% to 10%): Seizures, headache, dizziness
Uncommon (0.1% to 1%): Syncope, hypoesthesia, hyperesthesia, presyncope
Frequency not reported: Cerebral bleeding, lethargy, numbness, collapse, amnesia, cerebrovascular accident[Ref]


Common (1% to 10%): Ecchymosis, erythema, skin disorder
Uncommon (0.1% to 1%): Rash, pruritus, hyperhidrosis
Rare (less than 0.1%): Urticaria
Frequency not reported: Diaphoresis, sensitivity, irritation, non-application site pruritus[Ref]


Common (1% to 10%): Diarrhea, inguinal hernia
Uncommon (0.1% to 1%): Obstruction gastric, gastric mucosal hypertrophy, nausea, dry mouth
Frequency not reported: Gastric regurgitation, peritonitis[Ref]


Common (1% to 10%): Infection
Uncommon (0.1% to 1%): Fungal infection, common cold
Rare (less than 0.1%): Anaphylactic/anaphylactoid reactions[Ref]


Common (1% to 10%): Disseminated intravascular coagulation
Uncommon (0.1% to 1%): Blood creatinine increased
Very rare (less than 0.01%): Thrombocytopenia
Frequency not reported: Anemia, bleeding, hypochromic anemia[Ref]


Common (1% to 10%): Abnormal vision
Uncommon (0.1% to 1%): Mydriasis[Ref]


Frequency not reported: Hyperbilirubinemia, biliary atresia[Ref]


Frequency not reported: Polycystic kidneys, renal failure[Ref]


Frequency not reported: Hyperirritability[Ref]


1. "Product Information. Muse (alprostadil)" Vivus Inc, Menlo Park, CA.

2. "Product Information. Edex (alprostadil)." Schwarz Pharma, Mequon, WI.

3. "Product Information. Caverjet Sterile Powder (alprostadil)" Pharmacia and Upjohn, Kalamazoo, MI.

4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

5. "Product Information. Prostin VR Pediatric Sterile Solution (alprostadil)" Pharmacia and Upjohn, Kalamazoo, MI.

6. Cerner Multum, Inc. "Australian Product Information." O 0

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