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Safety

Oxytrol® For Women has a well-established safety and tolerability profile[10,11]


In a 12-week, double-blind, randomized, placebo-controlled study[10]

  • Incidence of dry mouth with transdermal oxybutynin 3.9 mg/day was comparable with placebo group (9.6% vs 8.3%, respectively)[10]

In the pivotal clinical trials

  • Anticholinergic adverse events were similar to placebo as reflected in the table below[10,11]


OXY-TDS, oxybutynin transdermal system. PBO, placebo patch.

  • Consumers may have itching, rash, or redness where patch was applied. More than 70% of patients in 1 clinical trial reported no application site reactions with transdermal oxybutynin 3.9 mg/day,[11] and the reported site reactions in both pivotal trials were mostly mild or moderate[10,11]


Oxytrol® For Women Drug Facts label warns that sleepiness, dizziness, and blurry vision may occur. Do not drive or operate machinery until you know how the patch affects you. Drinking alcohol may increase sleepiness.

  • Study was a multicenter, prospective, open-label, randomized trial in a community-dwelling population of adults ≥18 years of age who had been given a diagnosis of OAB (N=2878). Subjects could be treatment naïve, or previously or currently treated with OAB therapy. Treatment duration was up to 6 months, with 1 transdermal oxybutynin 3.9 mg/day patch applied twice weekly. All study participants were provided with study drug. Sites were randomized to distribute enhanced patient education materials or standard product information.[11]
  • §The sum of these individual application-site reactions does not equal the percentage of participants who had any application-site reaction (14.0%) because participants could have had more than one type of reaction.[11]
  • Study Descriptions
    2 phase 3 pivotal clinical trials were conducted. The following is a description of 2 trials:
  • * Study 1 was a randomized, double-blind study of transdermal oxybutynin vs active and placebo controls conducted in 361 patients. The 12-week, double-blind treatment included transdermal oxybutynin 3.9 mg/day, an active comparator, and placebo. The majority of patients were Caucasian (95%) and female (93%) with a mean age of 64 years (range, 18 to 89 years). Entry criteria required that all patients have urge or mixed incontinence (with a predominance of urge) and had achieved a beneficial response from the anticholinergic treatment they were using at the time of study entry. There was a washout period prior to the study. The patient's medical history and a urinary diary during the treatment-free baseline period confirmed the diagnosis of urge incontinence. Throughout the study, patients were instructed to continue nonpharmacologic treatment measures (eg, pelvic floor exercise, timed voiding, or other behavioral techniques) consistent with standard practices.[10]
  • Study 2 was a randomized, double-blind, placebo-controlled, parallel group study of 3 dose levels of transdermal oxybutynin conducted in 520 patients.[10] The 12-week, double-blind treatment included transdermal oxybutynin 3.9 mg/day or matching placebo. The majority of patients were Caucasian (91%) and female (92%) with a mean age of 61 years (range, 20 to 88 years). Entry criteria required that patients have urge or mixed incontinence (with a predominance of urge), urge incontinence episodes of ≥10 per week, and ≥8 micturitions per day. The patient's medical history and a urinary diary during the treatment-free baseline period confirmed the diagnosis of urge incontinence. Approximately 22% of patients treated with transdermal oxybutynin 3.9 mg/day had no prior anticholinergic treatment. There was a washout period prior to the study. Throughout the study, patients were instructed to continue nonpharmacologic treatment measures (eg, pelvic floor exercise, timed voiding, or other behavioral techniques) consistent with standard practices.[11]