Ditropan XL Side Effects

Generic Name: oxybutynin,oxybutynin chloride

Please note - some side effects for Ditropan XL 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 Ditropan XL - for the Consumer

Ditropan XL 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 Ditropan XL 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 swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); 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.

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.

Ditropan XL Side Effects - for the Professional

Ditropan XL

Adverse Events with Ditropan XL®

The safety and efficacy of Ditropan XL® (oxybutynin chloride) were evaluated in a total of 580 participants who received Ditropan XL® in 4 clinical trials (429 patients) and four pharmacokinetic studies (151 healthy volunteers). The 429 patients were treated with 5–30 mg/day for up to 4.5 months. Three of the 4 clinical trials allowed dose adjustments based on efficacy and adverse events and one was a fixed-dose escalation design. Safety information is provided for 429 patients from these three controlled clinical studies and one open-label study in the first column of Table 3 below.

Adverse events from two additional fixed-dose, active-controlled, 12-week treatment duration, postmarketing studies, in which 576 patients were treated with Ditropan XL® 10 mg/day, are also listed in Table 3 (second column). The adverse events are reported regardless of causality.

The most common adverse events reported by the 429 patients receiving 5–30 mg/day Ditropan XL® were the expected side effects of anticholinergic agents. The incidence of dry mouth was dose-related.

The discontinuation rate for all adverse events was 6.8% in the 429 patients from the 4 studies of efficacy and safety who received 5–30 mg/day. The most frequent adverse event causing early discontinuation of study medication was nausea (1.9%), while discontinuation due to dry mouth was 1.2%.

In addition, the following adverse events were reported by ≥ 1 to < 5% of all patients who received Ditropan XL® in the 6 adjustable and fixed-dose efficacy and safety studies. Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, bronchitis, cystitis; Psychiatric disorders: insomnia, depression, nervousness, confusional state; Nervous System Disorders: dysgeusia;Cardiac disorders: palpitations;Vascular disorders: hypertension;Respiratory, thoracic and mediastinal disorders: nasal dryness, cough, pharyngolaryngeal pain, dry throat;Gastrointestinal Disorders: gastroesophageal reflux disease, abdominal pain, loose stools, flatulence, vomiting;Skin and subcutaneous tissue disorders: dry skin, pruritis;Musculoskeletal and connective tissue disorders: back pain, arthralgia, pain in extremity;Renal and urinary disorders: urinary retention, urinary hesitation, dysuria; General disorders and administration site conditions: fatigue, edema peripheral, asthenia, chest pain; Investigations: blood pressure increased.

Postmarketing Surveillance

Because postmarketing reactions 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 drug reactions have been reported from worldwide postmarketing experience with Ditropan XL®:Psychiatric Disorders: psychotic disorder, agitation, hallucinations, memory impairment; Nervous System Disorders: convulsions;Cardiac Disorders: arrhythmia, tachycardia, QT interval prolongation;Vascular Disorders: flushing;Skin and Subcutaneous Tissue Disorders: rash;Renal and Urinary Disorders: impotence;General Disorders and Administration Site Conditions: hypersensitivity reactions, including angioedema with airway obstruction, urticaria, and face edema; rare anaphylactic reactions requiring hospitalization for emergency treatment;Injury, poisoning and procedural complications: fall.

Additional adverse events reported with some other oxybutynin chloride formulations include: cycloplegia, mydriasis, and suppression of lactation.

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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