Gelnique Side Effects

Generic Name: oxybutynin,oxybutynin chloride

Please note - some side effects for Gelnique may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Gelnique - for the Consumer

Gelnique Gel

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 Gelnique Gel:

Blurred vision; constipation; dizziness; drowsiness; dry mouth; headache; mild redness, irritation, or itching at the application site.

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); blisters, rash, pain, or loss of feeling at the application site; confusion; difficult or painful urination; fast or irregular heartbeat; fever; hallucinations; mental or mood changes (eg, agitation); seizures; severe or persistent redness, irritation, or itching at the application site; swelling of the hands, ankles, or feet; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Gelnique Side Effects - for the Professional

Gelnique

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.

Clinical Studies Experience

The safety of Gelnique was evaluated in 789 patients (389 randomized to Gelnique 1 g and 400 randomized to placebo) during a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study. A subset of these 789 patients (N = 216) participated in the 14-week open-label safety extension that followed the placebo-controlled study. Of 216 patients in the safety extension, 107 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 496 patients were exposed to at least one dose of Gelnique. Four hundred thirty-one (431) patients received at least 12 weeks of Gelnique treatment and 85 patients received 26 weeks of Gelnique treatment. The study population primarily consisted of Caucasian women (approximately 90%) with an average age of 59 years who had overactive bladder with urge urinary incontinence.

Table 1 lists adverse reactions that were reported in the randomized, double-blind, placebo-controlled 12-week study in greater than 2% of patients treated with Gelnique and at an incidence greater than placebo.

Other common adverse reactions that were reported in ≥ 1% of Gelnique-treated patients were headache (1.5%), constipation (1.3%), and pruritus (1.3%). Application site pruritus (2.1%) and application site dermatitis (1.8%) were the most commonly reported application site reactions. A majority of adverse reactions were described as mild or moderate in intensity, except for two patients reporting severe headache.

The most common adverse reaction leading to drug discontinuation was application site reaction (0.8% with Gelnique versus 0.3% with placebo).

The most common adverse reactions reported during the 14-week open-label extension study were application site reactions (6.0%) and dry mouth (1.9%). The most common reason for premature discontinuation was application site reactions (9 patients or 4.2%). Two of these 9 patients experienced application site reactions of severe intensity (dermatitis, urticaria, and erythema).

Side Effects by Body System - for Healthcare Professionals

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. Memory impairment has been reported postmarketing.

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 vasodilatation 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. QT interval prolongation has been reported postmarketing.

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.

Other

Other side effects including asthenia, taste perversion, and dry nasal and sinus mucous membranes have been reported in 2% to less than 5% of patients. Flushing and fever have also been reported.

Hypersensitivity

Hypersensitivity side effects have included angioedema requiring emergency medical treatment and/or hospitalization.

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