Edex Refill Side Effects

Generic name: alprostadil

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

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

Applies to alprostadil: intravenous solution.

Other dosage forms:

• intracavernosal powder for solution
• urethral suppository

Important warnings This medicine can cause some serious health issues

Intravenous route (solution)

Apnea, which generally occurs during the first hour of infusion and most often in neonates weighing less than 2 kg at birth, develops in approximately 10% to 12% of neonates with congenital heart defects treated with Prostin VR Pediatric® IV solution.

Monitor respiratory status throughout treatment and use only where ventilatory assistance is immediately available.

Serious side effects of Edex Refill

Along with its needed effects, alprostadil (the active ingredient contained in Edex Refill) 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 or nurse immediately if any of the following side effects occur while taking alprostadil:

More common side effects

• bluish lips or skin
• chest pain or discomfort
• feeling of warmth
• fever
• lightheadedness, dizziness, or fainting
• not breathing
• redness of the face, neck, arms, and occasionally, upper chest
• slow or irregular heartbeat
• unusual tiredness

Less common side effects

• blood in the urine or stools
• bruising
• confusion
• convulsions
• coughing or vomiting blood
• decreased urine
• dry mouth
• fast, pounding, or irregular heartbeat or pulse
• increased thirst
• loss of appetite
• mood changes
• no blood pressure or pulse
• persistent bleeding or oozing from puncture sites, mouth, or nose
• rash
• seizures
• unconsciousness
• vomiting

Rare side effects

• abdominal or stomach pain
• anxiety
• black, tarry stools
• bleeding gums
• clumsiness
• cold clammy skin
• difficult or troubled breathing
• dilated neck veins
• fainting
• low body temperature
• neck is bent backward
• pale or blue lips, fingernails, or skin
• pale skin
• pinpoint red spots on the skin
• restlessness
• shivering or chills
• slow to respond
• sweating
• swelling of the face, fingers, feet, or lower legs
• unusual bleeding or bruising
• unusual drowsiness, dullness, tiredness, weakness, or sleepiness
• unusually irritable
• weak or feeble pulse
• yellow eyes or skin

Other side effects of Edex Refill

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 side effects

• diarrhea

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

Edex Refill 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