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Ditropan XL

"April 9, 2012 -- Drugs that treat incontinence caused by an overactive bladder offer modest benefits to some women, and they often come with significant side effects, a new review of research shows.

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Ditropan XL

Ditropan XL Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Ditropan XL (oxybutynin chloride) is used to treat symptoms of overactive bladder, such as frequent or urgent urination, incontinence (urine leakage), and increased night-time urination. Ditropan XL is in the antispasmodic and anticholinergic agent classes of drugs. This medication is available in generic form. Common side effects include dry mouth, drowsiness, headache, dizziness, nausea, vomiting, upset stomach, stomach pain, constipation, diarrhea, inability to urinate, blurred vision, dry eyes, unusual taste in mouth, dry/flushed skin, stuffy nose, and cough.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Ditropan XL in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using oxybutynin and call your doctor at once if you have any of these serious side effects:

  • hot, dry skin and extreme thirst;
  • severe stomach pain or constipation;
  • 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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Ditropan XL Overview - Patient Information: Side Effects

SIDE EFFECTS: Dry mouth, drowsiness, headache, dizziness, nausea, vomiting, upset stomach, stomach pain, constipation, diarrhea, blurred vision, dry eyes, unusual taste in mouth, dry/flushed skin, stuffy nose, and cough may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute. To relieve dry eyes, use artificial tears or other eye lubricants. Consult your pharmacist for further advice.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated, consult your pharmacist for help in choosing a laxative (e.g., stimulant-type with stool softener).

For certain products of this drug, an empty tablet shell may appear in your stool. This is harmless.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: 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).

Tell your doctor immediately if any of these rare but very serious side effects occur: seizures, stomach/intestinal blockage (such as persistent nausea/vomiting, prolonged constipation).

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Ditropan XL (Oxybutynin Chloride Extended Release Tablets)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Ditropan XL FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials

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® (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 reactions 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).

Table 3 : Incidence (%) of Adverse Reactions Reported by ≥ 5% of Patients Using DITROPAN XL® (530 mg/day) and % of Corresponding Adverse Reactions in Two Fixed-Dose (10 mg/day) Studies

Body System Adverse Reactions DITROPAN XL® 5-30 mg/day
(n=429)
DITROPAN XL® 10 mg/day
(n=576)
General headache 10 6
Digestive dry mouth 61 29
constipation 13 7
diarrhea 9 7
nausea 9 2
dyspepsia 7 5
Nervous somnolence 12 2
dizziness 6 4
Special senses blurred vision 8 1
dry eyes 6 3
Urogenital urinary tract infection 5 5

The most common adverse reactions 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 reactions 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 reactions causing early discontinuation of study medication was nausea (1.9%), while discontinuation due to dry mouth was 1.2%.

In addition, the following adverse reactions were reported by ≥ 1 to < 5% of all patients who received DITROPAN XL® in the 6 adjustable and fixed-dose efficacy and safety studies. Psychiatric disorders: depression, nervousness, insomnia, confusional state; Nervous System Disorders: dysgeusia; Cardiac disorders: palpitations; Vascular disorders: hypertension; Respiratory, thoracic and mediastinal disorders: nasal dryness, cough, oropharyngeal pain, dry throat; Gastrointestinal Disorders: gastroesophageal reflux disease, abdominal pain, flatulence, vomiting; Skin and subcutaneous tissue disorders: dry skin, pruritus; Renal and urinary disorders: urinary retention, urinary hesitation, dysuria; General disorders and administration site conditions: fatigue, edema peripheral, chest pain.

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 drug 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; 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.

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

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Ditropan XL - User Reviews

Ditropan XL User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Ditropan XL sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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