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: injectable kit, injectable powder for injection, transurethral suppository
Get emergency medical help if you have any of these signs of an allergic reaction while taking alprostadil (the active ingredient contained in Edex Refill) hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using alprostadil and call your doctor at once if you have a serious side effect such as:
feeling light-headed, fainting;
trouble urinating, blood in your urine;
bleeding, bruising, or swelling where you injected the medication;
a painful erection that lasts 4 hours or longer;
severe pain or irritation of your penis or urethra; or
redness, lumps, tenderness, unusual shape or curving of the erect penis.
Less serious side effects of alprostadil may include:
unusual discharge from your penis; or
mild pain in your penis, urethra, or testicles;
a rash on the skin of your penis;
itching, warmth, or numbness of your penis;
cough, stuffy nose, cold symptoms, flu symptoms.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
Your sexual partner may also have side effects such as burning, itching, or irritation of the body areas that come into contact with your penis.
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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