Oxybutynin Side Effects

Brand Names: Ditropan, Ditropan XL, Gelnique, Oxytrol

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Oxybutynin:

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Oxybutynin Extended-Release Tablets:

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Oxybutynin Gel:

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Oxybutynin Syrup:

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Oxybutynin System:

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.

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Oxybutynin Side Effects - for the Professional

Oxybutynin

Following administration of Oxybutynin chloride, the symptoms that can be associated with the use of other anticholinergic drugs may occur:

Cardiovascular: Palpitations, tachycardia, vasodilatation.

Dermatologic: Decreased sweating, rash.

Gastrointestinal/Genitourinary: Constipation, decreased gastrointestinal motility, dry mouth, nausea, urinary hesitance and retention.

Nervous System: Asthenia, dizziness, drowsiness, hallucinations, insomnia, restlessness.

Ophthalmic: Amblyopia, cycloplegia, decreased lacrimation, mydriasis.

Other: Impotence, suppression of lactation.

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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. 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.

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