Edex Refill Side Effects
Generic name: alprostadil
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.
Some side effects of Edex Refill may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to alprostadil: kit, powder for solution, solution, suppository
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:Rare
- 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
- pelvic pain
- flu-like symptoms
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
- Bleeding at place of injection, short-term
- mild bleeding or spotting from urethra (suppository only)
- pain at place of injection
- painful erection
- stinging of urethra (suppository only)
Female partners may experience itching or stinging of vagina when you first begin using the alprostadil suppository. These side effects may not be caused from the medicine but may result if female partner has not had frequent or recent sexual intercourse.
- Bruising or clotted blood in penis at place of injection, usually caused by an incorrect injection
For Healthcare Professionals
Applies to alprostadil: compounding powder, injectable kit, injectable powder for injection, injectable solution, transurethral suppository
Local side effects have included penile pain (37%), prolonged erection (4%), penile fibrosis (3%), injection site hematoma (3%), penis disorder (3%), injection site ecchymosis (2%), penile rash (1%), penile edema (1%), balanitis, injection site hemorrhage, injection site inflammation, injection site itching, injection site swelling and edema, urethral bleeding, penile warmth, numbness, yeast infection, irritation, sensitivity, phimosis, pruritus, erythema, venous leak, painful erection, and abnormal ejaculation. Postmarketing experience has included reports of needle breakage.
Hemodynamic changes manifested as hypotension and increases in pulse rate were generally observed at doses above 20 mcg and 30 mcg respectively, and appeared to be dose-dependent. These changes were usually reported as clinically unimportant, and only three patients discontinued treatment because of symptomatic hypotension.
Cardiovascular side effects have included hypertension (2%), hypotension, vasodilation, peripheral vascular disorder, supraventricular extrasystoles, vasovagal reactions, and increases in pulse rate.
Nervous system side effects have included headache (2%), dizziness (1%), hypesthesia, and non-generalized weakness.
Musculoskeletal side effects have included back pain (1%) and leg cramps.
Respiratory side effects have included upper respiratory infection (4%), flu syndrome (2%), sinusitis (2%), nasal congestion (1%), and cough (1%).
Genitourinary side effects have included prostatic disorder (2%), testicular pain, scrotal disorder, scrotal edema, hematuria, testicular disorder, impaired urination, urinary frequency, urinary urgency, and pelvic pain.
Ocular side effects have included mydriasis.
Gastrointestinal side effects have rarely included nausea and dry mouth.
Other side effects have included localized pain (2%), trauma (2%), diaphoresis, rash, non-application site pruritus, skin neoplasm, and increased serum creatinine.
More Edex Refill resources
- Edex Refill injectable and transurethral Concise Consumer Information (Cerner Multum)
- Alprostadil Prescribing Information (FDA)
- alprostadil MedFacts Consumer Leaflet (Wolters Kluwer)
- Alprostadil Monograph (AHFS DI)
- alprostadil Intraurethral, Intravenous, Intracavernosal Advanced Consumer (Micromedex) - Includes Dosage Information
- Caverject Prescribing Information (FDA)
- Edex MedFacts Consumer Leaflet (Wolters Kluwer)
- Muse suppository MedFacts Consumer Leaflet (Wolters Kluwer)
- Muse Prescribing Information (FDA)
- Prostin VR Pediatric Prescribing Information (FDA)
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