Oxytrol Side Effects

Generic Name: oxybutynin

Please note - some side effects for Oxytrol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Oxytrol - for the Consumer

Oxytrol System

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Oxytrol System:

Blurred vision; constipation; diarrhea; dizziness; drowsiness; dry eyes, nose, skin, or mouth; headache; indigestion; nausea; minor redness, itching, or irritation at patch application site; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficult or painful urination; fast or irregular heartbeat; fever; hallucinations; pain, burning, blistering, or oozing at the application site; seizures; swelling of the hands, ankles, or feet; vision problems.

Oxytrol Side Effects - for the Professional

Oxytrol

The safety of Oxytrol was evaluated in a total of 417 patients who participated in two Phase 3 clinical efficacy and safety studies and an open-label extension. Additional safety information was collected in Phase 1 and Phase 2 trials. In the two pivotal studies, a total of 246 patients received Oxytrol during the 12-week treatment periods. A total of 411 patients entered the open-label extension and of those, 65 patients and 52 patients received Oxytrol for at least 24 weeks and at least 36 weeks, respectively.

No deaths were reported during treatment. No serious adverse events related to treatment were reported.

Adverse events reported in the pivotal trials are summarized in Tables 4 and 5 below.

Other adverse events reported by > 1% of Oxytrol-treated patients, and judged by the investigator to be possibly, probably or definitely related to treatment include: abdominal pain, nausea, flatulence, fatigue, somnolence, headache, flushing, rash, application site burning and back pain.

Most treatment-related adverse events were described as mild or moderate in intensity. Severe application site reactions were reported by 6.4% of Oxytrol-treated patients in Study 1 and by 5.0% of Oxytrol-treated patients in Study 2.

Treatment-related adverse events that resulted in discontinuation were reported by 11.2% of Oxytrol-treated patients in Study 1 and 10.7% of Oxytrol-treated patients in Study 2. Most of these were secondary to application site reaction. In the two pivotal studies, no patient discontinued Oxytrol treatment due to dry mouth.

In the open-label extension, the most common treatment-related adverse events were: application site pruritus, application site erythema and dry mouth.

Side Effects by Body System

General

General side effects have included abdominal pain (6.5%), accidental injury, back pain, and flu syndrome.

Nervous system

Nervous system side effects including dizziness (15.6%), somnolence (12.6%), headache (6%), confusion (2% to less than 5%), insomnia (2% to less than 5%), nervousness (2% to less than 5%), convulsions (2% to less than 5%), heat stroke, paralysis, coma, and CNS excitation have been reported.

Gastrointestinal

Reports of moderate to severe dry mouth was significantly lower in the group of people taking oxybutynin extended-release form in a study, at the same daily dose, comparing it to oxybutynin immediate-release. The reported incidence of dry mouth with the extended-release formulation is lower with the use of lower daily doses.

Dry mouth has been mentioned as the primary reason given by patients for discontinuation of therapy.

Gastrointestinal side effects have been reported the most frequently. These have included dry mouth (71.4%), constipation (12.6%), nausea (10.1%), dyspepsia (7%), diarrhea (5%), flatulence (2% to less than 5%), decreased GI motility (2% to less than 5%), and gastroesophageal reflux. At least one case of vomiting has been reported in a clinical study.

Cardiovascular

Cardiovascular side effects including palpitations, peripheral edema, tachycardia, and vasodilation have been reported in 2% to less than 5% of patients. Oxybutynin can aggravate symptoms of hypertension, coronary insufficiency, congestive heart failure, and cardiac arrhythmias. Hypotension has also been reported.

Dermatologic

Dermatologic side effects including decreased sweating, dry skin, and rash have been reported in 2% to less than 5% of patients. Pruritus 16.8 % (n=125), application site vesicles, macules, burning, rash, and erythema have been reported in patients treated with the oxybutynin transdermal system.

Genitourinary

Genitourinary side effects have included impaired urination (10.6%), urinary tract infections (10.6%), increased post void retention (5%), urinary retention (2% to less than 5%), impotence (2% to less than 5%), dysuria, urinary hesitancy, cystitis, and aggravation of symptoms of prostatic hypertrophy.

Endocrine

Endocrine side effects including suppression of lactation (2% to less than 5%) have been reported during worldwide postmarketing experience.

Metabolic

Metabolic side effects have included dehydration and aggravation of hyperthyroidism symptoms.

Ocular

Ocular side effects have included blurred vision (9%), cycloplegia (2% to less than 5%), and dry eyes (2% to less than 5%), mydriasis (2% to less than 5%), acute angle closure glaucoma, amblyopia, and decreased lacrimation.

Respiratory

Respiratory side effects have been reported rarely. Rhinitis has been reported in approximately 6% of patients during extended release oxybutynin therapy. Upper respiratory tract infections, cough, sinusitis, bronchitis, pharyngitis, and respiratory failure have been reported.

Musculoskeletal

Musculoskeletal side effects have included arthritis and asthenia.

Psychiatric

Psychiatric side effects including hallucinations (2% to less than 5%) have been reported during worldwide postmarketing experience. Cognitive and mental status changes in elderly patients receiving oxybutynin have been reported.

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