Edex Refill Side Effects
Generic name: alprostadil
Medically reviewed by Drugs.com. Last updated on Nov 12, 2020.
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 Refill.
For the Consumer
Applies to alprostadil: intracavernosal powder for solution, intracavernosal solution
Other dosage forms:
Side effects requiring immediate medical attention
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 immediately if any of the following side effects occur while taking alprostadil:
- 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
Side effects not requiring immediate medical attention
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:
- 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
Very common (10% or more): Flushing (10.1%)
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
Very common (10% or more): Fever (14%)
Uncommon (0.1% to 1%): Asthenia
Rare (less than 0.1%): Vertigo
Frequency not reported: Hypothermia, jitteriness, non-generalized weakness[Ref]
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
Common (1% to 10%): Seizures, headache, dizziness
Uncommon (0.1% to 1%): Syncope, hypoesthesia, hyperesthesia, presyncope
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
Common (1% to 10%): Abnormal vision
Uncommon (0.1% to 1%): Mydriasis[Ref]
Frequency not reported: Polycystic kidneys, renal failure[Ref]
Frequency not reported: Hyperirritability[Ref]
1. "Product Information. Edex (alprostadil)." Schwarz Pharma, Mequon, WI.
2. "Product Information. Muse (alprostadil)" Vivus Inc, Menlo Park, CA.
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
More about Edex Refill (alprostadil)
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Some side effects may not be reported. You may report them to the FDA.