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Ditropan

Last reviewed on RxList: 1/24/2017
Ditropan Side Effects Center

Last reviewed on RxList 9/23/2016

Ditropan (oxybutynin chloride) is an antispasmodic and anticholinergic used to treat symptoms of overactive bladder, such as frequent or urgent urination, incontinence (urine leakage), and increased night-time urination. Ditropan is available in generic form. Common side effects of Ditropan 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,
  • weakness,
  • sleep problems, or
  • runny nose.

Tell your doctor if you experience serious side effects of Ditropan including:

  • decreased sexual activity,
  • difficulty urinating,
  • fast or 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 or intestinal blockage (such as persistent nausea or vomiting, or prolonged constipation).

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 breastfeeding.

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.

Ditropan 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 (Oxybutynin Tablets)

Ditropan Professional Information

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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