Edex Refill Side Effects
Generic Name: alprostadil
Note: This page contains information about the side effects of alprostadil. Some of the dosage forms included on this document may not apply to the brand name Edex Refill.
Not all side effects for Edex Refill may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to alprostadil: kit, powder for solution, solution, suppository
In addition to its needed effects, some unwanted effects may be caused by alprostadil (the active ingredient contained in Edex Refill). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when 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 of the side effects that can occur with alprostadil may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional: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.
Postmarketing reports: Device malfunction/failure
More about Edex Refill (alprostadil)
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