Oxytrol for Women Side Effects

Generic name: oxybutynin

Note: This document contains side effect information about oxybutynin. Some of the dosage forms listed on this page may not apply to the brand name Oxytrol for Women.

Some side effects of Oxytrol for Women may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to oxybutynin: oral syrup, oral tablet, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking oxybutynin (the active ingredient contained in Oxytrol for Women) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using oxybutynin and call your doctor at once if you have a serious side effect such as:

• hot, dry skin and extreme thirst;

• severe stomach pain or constipation;

• blurred vision, eye pain, or seeing halos around lights;

• pain or burning when you urinate; or

• urinating less than usual or not at all.

Less serious side effects of oxybutynin may include:

• dry mouth;

• dry eyes, blurred vision;

• mild constipation;

• diarrhea;

• nausea, mild stomach pain or upset;

• dizziness, drowsiness, weakness;

• headache;

• sleep problems; or

• runny nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to oxybutynin: oral syrup, oral tablet, oral tablet extended release, transdermal film extended release, transdermal gel

Nervous system

Very common (10% or more): Dizziness, somnolence
Common (1% to 10%): Headache, confusion, insomnia, nervousness, convulsions, dysgeusia
Frequency not reported: Heat stroke, paralysis, coma, CNS excitation

Gastrointestinal

Reports of moderate to severe dry mouth was significantly lower in the group of people taking oxybutynin (the active ingredient contained in Oxytrol for Women) 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.

Very common (10% or more): Dry mouth, constipation, nausea
Common (1% to 10%): Dyspepsia, diarrhea, flatulence, vomiting, decreased GI motility, loose stools, aptyalism, eructation, tongue coated, gastroesophageal reflux, abdominal pain, taste perversion
Uncommon (0.1% to 1%): Dysphagia, frequent bowel movements
Frequency not reported: Taste perversion

Cardiovascular

Common (1% to 10%): Palpitations, peripheral edema, tachycardia, vasodilation, hypertension, chest pain
Uncommon (0.1% to 1%): Hot flush
Rare (less than 0.1%): Chest discomfort
Frequency not reported: Hypotension
Postmarketing reports: QT interval prolongation, arrhythmia, flushing

Dermatologic

Very common (10% or more): Pruritis with transdermal system
Common (1% to 10%): Decreased sweating, dry skin, rash, pruritus
Frequency not reported: Application site vesicles, macules, burning, rash, and erythema with transdermal system.

Genitourinary

Very common (10% or more): Impaired urination, urinary tract infections
Common (1% to 10%): Increased post void retention, urinary retention, impotence, urinary hesitancy, dysuria, pollakiuria
Frequency not reported: Dysuria, cystitis, aggravation of symptoms of prostatic hypertrophy

Endocrine

Postmarketing reports: Suppression of lactation

Metabolic

Uncommon (0.1% to 1%): Anorexia, fluid retention, increased blood glucose
Frequency not reported: Dehydration, aggravation of hyperthyroidism symptoms

Ocular

Very common (10% or more): Blurred vision
Common (1% to 10%): Cycloplegia, dry eyes, mydriasis, keratoconjunctivitis sicca, eye irritation
Frequency not reported: Acute angle closure glaucoma, amblyopia, decreased lacrimation
Postmarketing reports: Glaucoma

Respiratory

Common (1% to 10%): Rhinitis, bronchitis, nasal dryness, oropharyngeal pain, cough, dry throat, sinus/nasal congestion, hoarseness, asthma, dry nasal and sinus mucous membranes
Uncommon (0.1% to 1%): Dysphonia
Frequency not reported: Upper respiratory tract infections, sinusitis, bronchitis, pharyngitis, respiratory failure

Musculoskeletal

Common (1% to 10%): Asthenia, back pain, arthralgia, pain in extremity, flank pain
Frequency not reported: Arthritis

Psychiatric

Common (1% to 10%): Depression, nervousness, insomnia, confusional state
Frequency not reported: Cognitive and mental status changes in elderly patients
Postmarketing reports: Hallucinations, psychotic disorder, agitation, memory impairment

Other

Common (1% to 10%): Fatigue, fungal infection
Uncommon (0.1% to 1%): Thirst
Frequency not reported: Accidental injury, flu syndrome, flushing, fever
Postmarketing reports: Falls

Hypersensitivity

Frequency not reported: Angioedema with airway obstruction, urticaria, and face edema and rare anaphylactic reactions

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