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Edex 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.

Not all side effects for Edex 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). 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

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 and pain at the injection site (short-term)
  • painful erection
Rare
  • 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

General

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]

References

1. "Product Information. Muse (alprostadil)" Vivus Inc, Menlo Park, CA.

2. "Product Information. Edex (alprostadil)." Schwarz Pharma, Mequon, WI.

3. "Product Information. Caverjet Sterile Powder (alprostadil)" Pharmacia and Upjohn, Kalamazoo, MI.

4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

5. Cerner Multum, Inc. "Australian Product Information." O 0

6. "Product Information. Prostin VR Pediatric Sterile Solution (alprostadil)" Pharmacia and Upjohn, Kalamazoo, MI.

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