Oxybutynin Side Effects

Brand Names: Ditropan, Oxytrol, Gelnique, Ditropan XL

Please note - some side effects for Oxybutynin 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 Oxybutynin - for the Consumer

Oxybutynin

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 Oxybutynin:

Blurred vision; constipation; diarrhea; dizziness; drowsiness; dry eyes, nose, skin, or mouth; headache; indigestion; nausea; stomach pain; taste changes; trouble sleeping.

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; mental or mood changes (eg, agitation); seizures; swelling of the hands, ankles, or feet; vision problems.

Oxybutynin Extended-Release Tablets

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 Oxybutynin Extended-Release Tablets:

Blurred vision; constipation; diarrhea; dizziness; drowsiness; dry eyes, nose, skin, or mouth; headache; indigestion; nausea; runny nose; stomach pain or upset; trouble sleeping; weakness.

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; mental or mood changes (eg, agitation); seizures; swelling of the hands, ankles, or feet; vision problems.

Oxybutynin 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 Oxybutynin 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 breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); 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.

Oxybutynin Syrup

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 Oxybutynin Syrup:

Blurred vision; constipation; diarrhea; dizziness; drowsiness; dry eyes, nose, skin, or mouth; headache; indigestion; nausea; stomach pain; taste changes; trouble sleeping.

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; mental or mood changes (eg, agitation); seizures; swelling of the hands, ankles, or feet; vision problems.

Oxybutynin 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 Oxybutynin 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.

Oxybutynin Side Effects - for the Professional

Oxybutynin

The safety and efficacy of Oxybutynin chloride was evaluated in a total of 199 patients in three clinical trials. These participants were treated with Oxybutynin chloride 5-20 mg/day for up to 6 weeks. Table 3 shows the incidence of adverse events judged by investigators to be at least possibly related to treatment and reported by at least 5% of patients.

The most common adverse events reported by patients receiving Oxybutynin chloride 5-20 mg/day were the expected side effects of anticholinergic agents. The incidence of dry mouth was dose-related.

In addition, the following adverse events were reported by 1 to <5% of patients using Oxybutynin chloride (5-20 mg/day) in all studies. Infections and Infestations: nasopharyngitis, upper respiratory tract infection, bronchitis, cystitis, fungal infection; Metabolism and Nutrition Disorders: fluid retention; Psychiatric Disorders: confusional state; Nervous System Disorders: dysgeusia, sinus headache; Eye Disorders: keratoconjunctivitis sicca, eye irritation; Cardiac Disorders: palpications, sinus arrhythmia; Vascular Disorders: flushing; Respiratory, Thoracic and Mediastinal Disorders: nasal dryness, cough, pharyngolaryngeal pain, dry throat, sinus congestion, hoarsness, asthma, nasal congestion; Gastrointestinal Disorders: diarrhea, abdominal pain, loose stools, flatulence, vomiting, abdominal pain upper, dysphagia, aptyalism, eructation, tongue coated; Skin and Subcutaneous Tissue Disorders: dry skin, puritis; Musculoskeletal and Connective Tissue Disorders: back pain, arthralgia, pain in extremity, flank pain; Renal and Urinary Disorders: dysuria, pollakiuria; General Disorders and Administration Site Conditions: fatigue, edema peripheral, asthenia, pain, thirst, edema; Investigations: blood pressure increased, blood glucose increased, blood pressure decreased; Injury, Poisoning, and Procedural Complications: fall.

Postmarketing Surveillance

Because postmarketing adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following additional adverse events have been reported from worldwide postmarketing experience with Oxybutynin chloride: Psychiatric Disorders: psychotic disorder, agitation, hallucination, memory impairment; Nervous System Disorders: convulsions; Eye disorders: cycloplegia, mydriasis; Cardiac Disorders: tachycardia, QT interval prolongation; Gastrointestinal Disorders: decreased gastrointestinal motility; Skin and Subcutaneous Tissue Disorders: rash, decreased sweating; Renal and Urinary Disorders: impotence; Reproductive system and breast disorders: Supression of lactation.

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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