DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Muse (Alprostadil) - Side Effects and Adverse Reactions



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
MUSE Placebo MUSE Placebo
Event n = 486 n = 511 Event n = 486 n = 511
     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.


Below is a sample of reports where side effects / adverse reactions may be related to Muse. The information is not vetted and should not be considered as verified clinical evidence.

Possible Muse side effects / adverse reactions in 76 year old male

Reported by a individual with unspecified qualification on 2012-06-26

Patient: 76 year old male

Reactions: Malaise, Overdose, Penile Pain, Drug Ineffective, Bladder Pain, Urethral Pain, Pubic Pain

Suspect drug(s):

Possible Muse side effects / adverse reactions in 76 year old male

Reported by a consumer/non-health professional on 2012-06-29

Patient: 76 year old male

Reactions: Overdose, Drug Ineffective, Penile Pain, Bone Pain, Bladder Pain, Urethral Pain, Pubic Pain

Suspect drug(s):

See index of all Muse side effect reports >>

Drug label data at the top of this Page last updated: 2013-08-08

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017