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Note: This document contains side effect information about alprostadil. Some of the dosage forms listed on this page may not apply to the brand name Edex.
For the ConsumerApplies to alprostadil: intracavernosal powder for solution, intracavernosal solution
Other dosage forms:
Along with its needed effects, alprostadil (the active ingredient contained in Edex) 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
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
Rare
For Healthcare Professionals
Applies to alprostadil: compounding powder, injectable kit, injectable powder for injection, injectable solution, transurethral suppository
GeneralThe most common side effects were penile pain, local bleeding, fever, urethral pain, urethral burning, apnea, and flushing.
GenitourinaryVery 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
CardiovascularVery 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
LocalVery 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
RespiratoryVery 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
OtherVery 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
MusculoskeletalCommon (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
MetabolicCommon (1% to 10%): Hypokalemia, hypertriglyceridemia, hypercholesterolemia, hyperglycemia
Frequency not reported: Hypoglycemia, hyperkalemia
Nervous systemCommon (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
DermatologicCommon (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
GastrointestinalCommon (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
ImmunologicCommon (1% to 10%): Infection
Uncommon (0.1% to 1%): Fungal infection, common cold
Rare (less than 0.1%): Anaphylactic/anaphylactoid reactions
HematologicCommon (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
OcularCommon (1% to 10%): Abnormal vision
Uncommon (0.1% to 1%): Mydriasis
HepaticFrequency not reported: Hyperbilirubinemia, biliary atresia
RenalFrequency not reported: Polycystic kidneys, renal failure
PsychiatricFrequency not reported: Hyperirritability
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/3/2022.
Source: Drugs.com Edex (www.drugs.com/cdi/edex.html).
August 16, 2021
May 17, 2022
May 17, 2022
May 17, 2022
May 17, 2022
May 16, 2022