Muse Side Effects
Generic Name: alprostadil
Please note - some side effects for Muse may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Muse - for the Consumer
Muse 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 Muse Suppository:
Seek medical attention right away if any of these SEVERE side effects occur when using Muse 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.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopMuse Side Effects - for the Professional
Muse
In-Clinic Titration:
In the 2 largest double-blind, parallel, placebo-controlled trials, 1511 patients received Muse at least 1 time in the clinic setting. The most frequently reported drug-related side effects during in-clinic titration included pain in the penis (36%), urethra (13%), or testes (5%). These discomforts were most commonly reported as mild and transient, but about 7% of patients withdrew at this stage because of adverse events. Urethral bleeding/spotting and other minor abrasions to the urethra were reported in approximately 3% of patients. Symptomatic lowering of blood pressure (hypotension) occurred in 3% of patients; in addition, some lowering of blood pressure may occur without symptoms. Dizziness was reported in 4% of patients. Syncope (fainting) was reported by 0.4% of patients..
Home Treatment:
996 patients (66% of those who began titration) were studied during the home treatment portion of 2 Phase III placebo-controlled studies. Fewer than 2% of patients discontinued from these studies primarily because of adverse events. The following table summarizes the frequency of adverse events reported by patients using Muse or placebo.
| Muse | Placebo | Muse | Placebo | ||
| Event | n = 486 | n = 511 | Event | n = 486 | n = 511 |
| UROGENITAL SYSTEM | BODY AS A WHOLE | ||||
| Penile Pain | 32% | 3% | Flu Symptoms | 4% | 2% |
| Urethral Burning | 12% | 4% | Headache | 3% | 2% |
| Minor Urethral Bleeding/ | 5% | 1% | Pain | 3% | 1% |
| Spotting | Accidental Injury | 3% | 2% | ||
| Testicular Pain | 5% | 1% | Back Pain | 2% | 1% |
| NERVOUS SYSTEM | Pelvic Pain | 2% | <1% | ||
| Dizziness | 2% | <1% | RESPIRATORY | ||
| Rhinitis | 2% | <1% | |||
| Infection | 3% | 2% |
Other drug-related side effects observed during in-clinic titration and home treatment include swelling of leg veins, leg pain, perineal pain, and rapid pulse, each occurring in <2% of patients.
Female Partner Adverse Events: The most common drug-related adverse event reported by female partners during placebo-controlled clinical studies was vaginal burning/itching, reported by 5.8% of partners of patients on active vs. 0.8% of partners of patients on placebo. It is unknown whether this adverse event experienced by female partners was a result of the medication or a result of resuming sexual intercourse, which occurred much more frequently in partners of patients on active medication.
To report suspected adverse reactions, contact Meda Pharmaceuticals Inc. at 1-888-345-6873 or contact FDA at 1-800-FDA-1088, fax 1-800-FDA-0178 or online at www.fda.gov/medwatch/report.htm.
TopSide Effects by Body System - for Healthcare Professionals
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.
TopMore Muse resources
- Muse Advanced Consumer (Micromedex) - Includes Dosage Information
- Muse injectable and transurethral Concise Consumer Information (Cerner Multum)
- Muse Suppository MedFacts Consumer Leaflet (Wolters Kluwer)
- Muse Prescribing Information (FDA)
- Alprostadil Prescribing Information (FDA)
- Alprostadil Monograph (AHFS DI)
- Alprostadil MedFacts Consumer Leaflet (Wolters Kluwer)
- Caverject Prescribing Information (FDA)
- Edex MedFacts Consumer Leaflet (Wolters Kluwer)
- Prostin VR Pediatric Prescribing Information (FDA)
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