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
|
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.
|
REPORTS OF SUSPECTED MUSE SIDE EFFECTS / ADVERSE REACTIONS
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):
Muse
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):
Muse
|