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Ditropan XL

Last reviewed on RxList: 9/12/2016
Ditropan XL Side Effects Center

Last reviewed on RxList 9/12/2016

Ditropan XL (oxybutynin chloride) is an antispasmodic and anticholinergic agent used to treat symptoms of overactive bladder, such as frequent or urgent urination, incontinence (urine leakage), and increased night-time urination. Ditropan XL is available in generic form. Common side effects of Ditropan XL include:

Tell your doctor if you experience serious side effects of Ditropan XL including decreased sexual activity, difficulty urinating, fast/pounding heartbeat, signs of kidney infection (such as burning/painful/frequent urination, lower back pain, fever), mental/mood changes (such as confusion), swelling of arms/legs/ankles/feet, vision problems (including eye pain), seizures, or stomach/intestinal blockage (such as persistent nausea/vomiting, prolonged constipation).

The recommended starting dose of Ditropan XL 5 or 10 mg once/day for adults. For children 6 years and older, the starting dose is 5 mg once/day. Doses may be adjusted by your doctor. Some products that may adversely interact with Ditropan XL include other bladder or urinary medications, glycopyrrolate, flecainide, thioridazine, HIV /AIDS medicine, antibiotics, antifungal medications, atropine, benztropine, dimenhydrinate, methscopolamine, scopolamine, bronchodilators, irritable bowel medications, or antidepressants. Tell your doctor all medications you are taking. Ditropan XL should be used only when prescribed by your doctor during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Ditropan XL Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ditropan XL Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ditropan XL (Oxybutynin Chloride Extended Release Tablets)

Ditropan XL Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety and efficacy of DITROPAN XL® (5 to 30 mg/day) was evaluated in 774 adult subjects who participated in five double-blind, controlled clinical trials. In four of the five studies, Ditropan IR (5 to 20 mg/day in 199 subjects) was an active comparator. Adverse reactions reported by ≥ 1% of subjects are shown in Table 1.

Table 1: Adverse Drug Reactions Reported by ≥ 1% of DITROPAN XL® - treated Adult Subjects in Five Double-blind, Controlled Clinical Trials of DITROPAN XL®

System/Organ Class
Preferred Term
DITROPAN XL®� 5 to 30 mg/day
n = 774 %
Ditropan IR* 5 to 20 mg/day
n = 199 %
Psychiatric Disorders
  Insomnia 3.0 5.5
Nervous System Disorders
  Headache 7.5 8.0
  Somnolence 5.6 14.1
  Dizziness 5.0 16.6
  Dysgeusia 1.6 1.5
Eye Disorders
  Vision blurred 4.3 9.6
  Dry eye 3.1 2.5
Respiratory, Thoracic and Mediastinal Disorders
  Cough 1.9 3.0
  Oropharyngeal pain 1.9 1.5
  Dry throat 1.7 2.5
  Nasal dryness 1.7 4.5
Gastrointestinal Disorders
  Dry mouth 34.9 72.4
  Constipation 8.7 15.1
  Diarrhea 7.9 6.5
  Dyspepsia 4.5 6.0
  Nausea 4.5 11.6
  Abdominal pain 1.6 2.0
  Vomiting 1.3 1.5
  Flatulence 1.2 2.5
  Gastro-esophageal reflux disease 1.0 0.5
Skin and Subcutaneous Tissue Disorders
  Dry skin 1.8 2.5
  Pruritus 1.3 1.5
Renal and Urinary Disorders
  Dysuria 1.9 2.0
  Urinary hesitation 1.9 8.5
  Urinary retention 1.2 3.0
General Disorders and Administration Site Conditions
  Fatigue 2.6 3.0
Investigations
  Residual urine volume 2.3 3.5
*IR = immediate release
The bundled term residual urine volume consists of the preferred terms residual urine volume and residual urine volume increased.

The discontinuation rate due to adverse reactions was 4.4% with DITROPAN XL® compared to 0% with Ditropan IR. The most frequent adverse reaction causing discontinuation of study medication was dry mouth (0.7%).

The following adverse reactions were reported by <1% of DITROPAN XL® -treated patients and at a higher incidence than placebo in clinical trials: Metabolism and Nutrition Disorders: anorexia, fluid retention; Vascular disorders: hot flush; Respiratory, thoracic and mediastinal disorders: dysphonia; Gastrointestinal Disorders: dysphagia, frequent bowel movements; General disorders and administration site conditions: chest discomfort, thirst.

Postmarketing Experience

The following additional adverse reactions have been reported from worldwide postmarketing experience with DITROPAN XL® . 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.

Psychiatric Disorders: psychotic disorder, agitation, hallucinations, memory impairment; Nervous System Disorders: convulsions; Eye Disorders: glaucoma; 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; 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.

Read the entire FDA prescribing information for Ditropan XL (Oxybutynin Chloride Extended Release Tablets)

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