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Anturol Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Anturol (oxybutynin) is indicated for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Anturol is not available in a generic form. Reported side effects include dry mouth and itching at the site of application.
The recommended dosage is three pumps of Anturol (84 mg/day) applied once daily to clean, dry, intact skin on the abdomen, or upper arms/shoulders, or thighs. Application sites may be rotated to reduce the potential for local site reactions. The drug is only used topically on skin. Serious side effects may include gastric and urinary retention; patients with narrow angle glaucoma or myasthenia gravis may have their symptoms increased. Women should tell their doctors if they are pregnant or planning to become pregnant. It is not known if Anturol will harm unborn babies. Women should also tell their doctors in they are breastfeeding or planning to breastfeed. It is not known if Anturol passes into breast milk. Safety and effectiveness of Anturol in pediatric patients is not known.
Our Anturol Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Anturol FDA Prescribing Information: Side Effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
The safety of ANTUROL was evaluated in 626 patients (210 randomized to ANTUROL 56 mg/day, 214 randomized to ANTUROL 84 mg/day and 202 randomized to placebo) during a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study. A subset of these 626 patients (N = 77) participated in the 24-week open-label safety extension that followed the placebo-controlled study. Of the 77 patients in the safety extension, 24 were randomized to placebo gel during the double-blind, placebo-controlled 12-week study. In the combined double-blind, placebo-controlled study and the open-label safety extension, a total of 441 patients were exposed to at least one dose of ANTUROL. 364 patients received at least 12 weeks of ANTUROL treatment and 66 patients received an additional 24 weeks of ANTUROL treatment during the open-label safety extension. The study population primarily consisted of women (87%) of Caucasian descent (87%) with an average age of 59 years who had overactive bladder with urge urinary incontinence.
Table 1 lists adverse reactions (ARs), regardless of causality, that were reported in the randomized, double-blind, placebo-controlled 12-week study at an incidence greater than placebo and in greater than 3% of patients treated with ANTUROL.
Overall, 672 ARs were experienced by 51.9% of patients. Majority of the ARs were mild to moderate in intensity. The AR most commonly reported was dry mouth which was experienced by a greater proportion of patients in the oxybutynin group than the placebo group (26 patients [12.1%] in the oxybutynin 84 mg group, 10 patients [5.0%] in the placebo group). Application site erythema was the next most commonly reported AR (8 patients [3.7%] in the oxybutynin 84 mg group and 2 patients [1.0%] in the placebo group). Other commonly reported ARs experienced by more patients in the oxybutynin groups compared with placebo were application site rash (7 patients [3.3%] in the oxybutynin 84 mg group and 1 patient [0.5%] in the placebo group); application site pruritus (6 patients [2.8%] in the oxybutynin 84 mg group and 1 patient [0.5%] in the placebo group). The overall rate of application site adverse reactions of any kind was 14.2% in patients receiving ANTUROL as compared to 3.7% in patients receiving placebo. Other cholinergic AEs < 2% in occurrence include dry eyes and blurred vision.
There were no deaths during the study. There were no clinically meaningful changes in vital signs, laboratory values, or ECG examinations over the course of the study.
Table 1: Commonly Reported Adverse Reactions that were reported
In greater than 3% of patients treated with ANTUROL and at an incidence greater
|Preferred Term1||Treatment Group|
|n (%)||n (%)|
|Dry mouth||26 (12.1)||10 (5.0)|
|Application site erythema||8 (3.7)||2 (1.0)|
|Application site rash||7 (3.3)||1 (0.5)|
|1 Each patient is counted only once within each treatment, body system and preferred term. All percentages are based on number of patients in the ITT population within each treatment group as denominator.|
During the 24-week open-label safety extension, the most commonly reported ARs were urinary tract infection and nasopharyngitis reported in 4 patients each (5.2%), followed by conjunctivitis and application site erythema (both occurred in 3 patients [3.9%]). One patient prematurely discontinued due to the application site erythema and pruritus (both considered to be of mild severity).
Read the entire FDA prescribing information for Anturol (Oxybutynin)
Additional Anturol Information
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