Ditropan XL
- Generic Name: oxybutynin chloride extended release tablets
- Brand Name: Ditropan XL
- Drug Class: Antispasmodic Agents, Urinary
Ditropan XL(Oxybutynin Chloride Extended Release Tablets) side effects drug center
What Is Ditropan XL?
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.
What Are Side Effects of Ditropan XL?
Common side effects of Ditropan XL include:
- dry mouth,
- drowsiness,
- headache,
- dizziness,
- weakness,
- nausea,
- vomiting,
- upset stomach,
- stomach pain,
- constipation,
- diarrhea,
- inability to urinate,
- blurred vision,
- dry eyes,
- unusual taste in mouth,
- dry/flushed skin,
- sleep problems,
- stuffy or runny nose, and
- cough.
Dosage for Ditropan XL
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.
What Drugs, Substances, or Supplements Interact with Ditropan XL?
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 During Pregnancy and Breastfeeding
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.
Additional Information
aOur Ditropan XL Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have 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:
- severe stomach pain or constipation;
- blurred vision, tunnel vision, eye pain, or seeing halos around lights;
- little or no urination;
- painful or difficult urination; or
- dehydration --dizziness, confusion, feeling very thirsty, less urination or sweating.
Common side effects may include:
- dizziness, drowsiness;
- headache;
- dry mouth; or
- diarrhea, constipation.
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)
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)
© Ditropan XL Patient Information is supplied by Cerner Multum, Inc. and Ditropan XL Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.