Muse
- Generic Name: alprostadil urethral suppository
- Brand Name: Muse
- Drug Class: Prostaglandins, Genitourinary
Muse (Alprostadil Urethral Suppository) side effects drug center
Muse Side Effects Center
What Is Muse?
Muse (alprostadil) is a single-use, medicated transurethral system for the delivery of alprostadil, a vasodilator, to the male urethra indicated for the treatment of erectile dysfunction.
What Are Side Effects of Muse?
Common side effects of Muse include:
- pain in the penile pain,
- urethral burning,
- testicular pain,
- urethral bleeding/spotting,
- low blood pressure (hypotension),
- dizziness, or
- fainting
Female partners of men using Muse may experience vaginal burning or itching.
Dosage for Muse
Muse is a transurethral delivery system available in 4 dosage strengths: 125 mcg, 250 mcg, 500 mcg, and 1000 mcg. Muse should be administered as needed to achieve an erection. The onset of effect is within 5–10 minutes after administration. The duration of effect is approximately 30–60 minutes, which varies by patient.
What Drugs, Substances, or Supplements Interact with Muse?
Muse may interact with antihypertensive medications. Tell your doctor all medications and supplements you use.
Muse During Pregnancy or Breastfeeding
Muse is not indicated for use in newborns, children, or women and is unlikely to be used by women who are pregnant or breastfeeding.
Additional Information
Our Muse (alprostadil) Urethral Suppository Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Muse Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using alprostadil and call your doctor at once if you have:
- a light-headed feeling, like you might pass out;
- bleeding after an injection;
- a painful erection that lasts 4 hours or longer;
- new or worsening pain in your penis; or
- redness, swelling, tenderness, lumps, unusual shape or curving of the erect penis.
Common side effects may include:
- mild pain in your penis, urethra, or testicles;
- redness of the penis; or
- warmth or burning in your urethra.
Your sex partner may have side effects such as burning, itching, or irritation of body areas that come into contact with your penis.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Muse (Alprostadil Urethral Suppository)
Muse Professional Information
SIDE EFFECTS
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. (See WARNINGS).
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.
Adverse Events Reported by ≥2% of Patients
Treated with MUSE, and More Common than on Placebo, at Home in Phase III
Placebo-Controlled Clinical Studies for up to 3 Months
| Event | MUSE n = 486 |
Placebo n = 511 |
| UROGENITAL SYSTEM | ||
| Penile Pain | 32% | 3% |
| Urethral Burning | 12% | 4% |
| Minor Urethral Bleeding/ Spotting | 5% | 1% |
| Testicular Pain | 5% | 1% |
| NERVOUS SYSTEM | ||
| Dizziness | 2% | <1% |
| BODY AS A WHOLE | ||
| Flu Symptoms | 4% | 2% |
| Headache | 3% | 2% |
| Pain | 3% | 1% |
| Accidental Injury | 3% | 2% |
| Back Pain | 2% | 1% |
| Pelvic Pain | 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.
Read the entire FDA prescribing information for Muse (Alprostadil Urethral Suppository)
&Copy; Muse Patient Information is supplied by Cerner Multum, Inc. and Muse Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.