Prostin VR Pediatric Side Effects
Generic name: alprostadil
Medically reviewed by Drugs.com. Last updated on Mar 11, 2024.
Note: This document contains side effect information about alprostadil. Some dosage forms listed on this page may not apply to the brand name Prostin VR Pediatric.
Applies to alprostadil: urethral suppository. Other dosage forms:
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:
More common
- Burning sensation in the urethra
- pain in the penis or urethra
Less common
- Bleeding and pain in the testes
- blurred vision
- confusion
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- pain in the testes
- sweating
- unusual tiredness or weakness
Rare
- Fainting
Get emergency help immediately if any of the following symptoms of overdose occur while taking alprostadil:
Symptoms of overdose
- Painful or prolonged erection of the penis
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:
Less common
- Back pain
- chills
- cough
- diarrhea
- fever
- general feeling of discomfort or illness
- headache
- joint pain
- loss of appetite
- muscle aches and pains
- nausea
- runny nose
- shivering
- sneezing
- sore throat
- stuffy nose
- sweating
- swelling of the legs
- trouble sleeping
- vomiting
For Healthcare Professionals
Applies to alprostadil: compounding powder, injectable kit, injectable powder for injection, injectable solution, transurethral suppository.
General
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]
More about Prostin VR Pediatric (alprostadil)
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- Drug class: impotence agents
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Patient resources
Other brands
Professional resources
Other brands
Caverject, Muse, Edex, Caverject Impulse
Related treatment guides
References
1. Product Information. Edex (alprostadil). Schwarz Pharma. 2001;PROD.
2. Product Information. Caverject (alprostadil). Pharmacia and Upjohn. PROD.
3. Product Information. Muse (alprostadil). Vivus Inc. 2001;PROD.
4. Product Information. Prostin VR Pediatric (alprostadil). Pharmacia and Upjohn.
5. Cerner Multum, Inc. UK Summary of Product Characteristics.
6. Cerner Multum, Inc. Australian Product Information.
Further information
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.