Edex Refill Side Effects

Generic name: alprostadil

Medically reviewed by Drugs.com. Last updated on Mar 8, 2025.

Note: This document provides detailed information about Edex Refill Side Effects associated with alprostadil. Some dosage forms listed on this page may not apply specifically to the brand name Edex Refill.

Applies to alprostadil: urethral suppository.

Other dosage forms:

• intracavernosal powder for solution
• intravenous solution

Precautions

Do not use alprostadil (the active ingredient contained in Edex Refill) suppositories if you have a penile implant unless advised by doctor.

Use a condom when having sexual intercourse with a pregnant female while using this medicine. Although harm to the fetus is unlikely, using a condom will protect the fetus from exposure to this medicine. If a woman can become pregnant, use of contraceptive methods is recommended because the effects of this medicine on early pregnancy are not known.

This medicine may make you dizzy or lightheaded. Do not drive or do anything that could be dangerous until you know how this medicine affects you.

If too much is used, the erection lasts too long and does not reverse when it should. This condition is called priapism. If the erection is not reversed, the blood supply to the penis may be cut off and permanent damage may occur.

Contact your doctor immediately if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of priapism and must be treated right away to prevent permanent damage.

This medicine will not prevent pregnancy or protect you or your partner from diseases such as syphilis, herpes, or HIV. Use a latex condom during sex for protection.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Edex Refill

Along with its needed effects, alprostadil 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:

Get emergency help immediately if any of the following symptoms of overdose occur while taking alprostadil:

Symptoms of overdose

• painful or prolonged erection of the penis

Other side effects of Edex Refill

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:

See also:

For healthcare professionals

Applies to alprostadil: compounding powder, injectable kit, injectable powder for injection, injectable solution, transurethral suppository.

General adverse events

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]

Further information

Edex Refill side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer