Prostin VR Pediatric Side Effects

Generic name: alprostadil

Medically reviewed by Drugs.com. Last updated on Sep 15, 2024.

Note: This document provides detailed information about Prostin VR Pediatric Side Effects associated with alprostadil. Some dosage forms listed on this page may not apply specifically to the brand name Prostin VR Pediatric.

Applies to alprostadil: intracavernosal powder for solution.

Other dosage forms:

• intravenous solution
• urethral suppository

Other side effects

Some side effects of alprostadil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• bleeding and pain at the injection site (short-term)
• painful erection

Rare side effects

• bruising or clotted blood in the penis at the injection site, usually caused by an incorrect injection

Serious side effects

Along with its needed effects, alprostadil (the active ingredient contained in Prostin VR Pediatric) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking alprostadil:

Rare side effects

• 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

For healthcare professionals

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

General adverse events

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

Genitourinary

• 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]

Cardiovascular

• 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]

Local

• 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]

Respiratory

• 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]

Other

• 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]

Musculoskeletal

• 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]

Metabolic

• 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]

Dermatologic

• 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]

Gastrointestinal

• 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]

Immunologic

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

Hematologic

• 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]

Ocular

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

Hepatic

• Frequency not reported: Hyperbilirubinemia, biliary atresia^[Ref]

Renal

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

Psychiatric

• Frequency not reported: Hyperirritability^[Ref]

Further information

Prostin VR Pediatric side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer