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Ditropan

"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.

The government-funded review compar"...

Ditropan

Ditropan Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Ditropan (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 is in the antispasmodic and anticholinergic agent classes of drugs. This medication is available in generic form. Common side effects include dry mouth, dizziness, drowsiness, blurred vision, dry eyes, nausea, vomiting, upset stomach, stomach pain, constipation, diarrhea, headache, unusual taste in mouth, dry/flushed skin, and weakness.

The usual adult dose of Ditropan is one 5-mg tablet 2-3 times a day. The maximum recommended adult dose is one 5-mg tablet four times a day. The usual pediatric dose is one 5-mg tablet two times a day. The maximum recommended pediatric dose is one 5-mg tablet three times a day. Doses may be adjusted by your doctor. Some products that may adversely interact with Ditropan include other bladder or urinary medications, glycopyrrolate, flecainide, mepenzolate, 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 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 (oxybutynin chloride) 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 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 (Oxybutynin Tablets) »

What is Patient Information Overview?

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

Ditropan Overview - Patient Information: Side Effects

SIDE EFFECTS: Dry mouth, dizziness, drowsiness, blurred vision, dry eyes, nausea, vomiting, upset stomach, stomach pain, constipation, diarrhea, headache, unusual taste in mouth, dry/flushed skin, and weakness 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).

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 (Oxybutynin Tablets)»

What is Prescribing information?

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

Ditropan FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The safety and efficacy of DITROPAN® (oxybutynin chloride) was evaluated in a total of 199 patients in three clinical trials. These participants were treated with DITROPAN 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.

Table 3 : Incidence (%) of Adverse Events Reported by ≥ 5% of Patients Using DITROPAN (5-20mg/day)

Body System Adverse Event DITROPAN
(5-20 mg/day)
(n=199)
Infections and Infestations Urinary tract infection 6.50%
Psychiatric Disorders Insomnia 5.50%
Nervousness 6.50%
Nervous System Disorders Dizziness 16.60%
Somnolence 14.00%
Headache 7.50%
Eye Disorders Blurred vision 9.60%
Gastrointestinal Disorders Dry mouth 71.40%
Constipation 15.10%
Nausea 11.60%
Dyspepsia 6.00%
Renal and Urinary Disorders Urinary Hesitation 8.50%
Urinary Retention 6.00%

The most common adverse events reported by patients receiving DITROPAN 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 DITROPAN (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: palpitations, sinus arrhythmia; Vascular Disorders: flushing; Respiratory, Thoracic and Mediastinal Disorders: nasal dryness, cough, pharyngolaryngeal pain, dry throat, sinus congestion, hoarseness, 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, pruritis; 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

DITROPAN: Psychiatric Disorders: psychotic disorder, agitation, hallucination, memory impairment; Nervous System Disorders: convulsions; Eye Disorders: cycloplegia, mydriasis, glaucoma; 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: Suppression of lactation; 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.

Read the entire FDA prescribing information for Ditropan (Oxybutynin Tablets) »

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Ditropan - User Reviews

Ditropan 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 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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