Alprostadil Side Effects

Brand Names: Muse, Edex, Prostin VR Pediatric, Caverject

Please note - some side effects for Alprostadil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Alprostadil - for the Consumer

Alprostadil

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Alprostadil:

Mild bleeding at the injection site; mild genital pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal ejaculation; bleeding from the tip of the penis; bloody urine or change in the amount of urine; chest pain; curving of the erect penis; dizziness; fainting; fast or irregular heartbeat; new or worsening genital pain; painful or prolonged erection; redness, lumps, swelling, tenderness, inflammation, numbness, strange sensation, or discoloration of the penis; severe or persistent bleeding or bruising at the injection site; severe or persistent pain, swelling, or redness at the injection site; swelling of the leg veins; white patches or discharge from the penis.

Alprostadil Suppository

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Alprostadil Suppository:

Dizziness; burning, bleeding, or spotting of the urethra; flu symptoms; groin pain; pain; penile pain; runny nose; testicular pain.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; fast pulse; leg pain; prolonged, painful erections; redness, lumps, swelling, tenderness, or curving of the erect penis; swelling of the leg veins.

Side Effects by Body System

Local

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.

Cardiovascular

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

Nervous system side effects have included headache (2%), dizziness (1%), hypesthesia, and non-generalized weakness.

Musculoskeletal

Musculoskeletal side effects have included back pain (1%) and leg cramps.

Respiratory

Respiratory side effects have included upper respiratory infection (4%), flu syndrome (2%), sinusitis (2%), nasal congestion (1%), and cough (1%).

Genitourinary

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

Ocular side effects have included mydriasis.

Gastrointestinal

Gastrointestinal side effects have rarely included nausea and dry mouth.

Other

Other side effects have included localized pain (2%), trauma (2%), diaphoresis, rash, non-application site pruritus, skin neoplasm, and increased serum creatinine.

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