Ditropan
- Generic Name: oxybutynin tablets
- Brand Name: Ditropan
Ditropan (Oxybutynin Tablets) side effects drug center
What Is Ditropan?
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.
What Are Side Effects of Ditropan?
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).
Dosage for Ditropan?
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.
What Drugs, Substances, or Supplements Interact with Ditropan?
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 During Pregnancy and Breastfeeding
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.
Additional Information
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.
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; o
- dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.
Common side effects may include:
- dizziness, drowsiness;
- blurred vision;
- 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 (Oxybutynin 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.
Infections and Infestations: Urinary tract infection; Psychiatric Disorders: psychotic disorder, agitation, confusional state, hallucinations, memory impairment, abnormal behavior; Nervous System Disorders: convulsions; Eye Disorders: glaucoma; Respiratory, Thoracic and Mediastinal Disorders: nasal congestion; Cardiac Disorders: arrhythmia, tachycardia, palpitations, QT interval prolongation; Vascular Disorders: flushing, hypertension; 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. In one reported case, concomitant use of oxybutynin with carbamazepine and dantrolene was associated with adverse events of vomiting, drowsiness, confusion, unsteadiness, slurred speech and nystagmus, suggestive of carbamazepine toxicity.
Read the entire FDA prescribing information for Ditropan (Oxybutynin Tablets)
© Ditropan Patient Information is supplied by Cerner Multum, Inc. and Ditropan Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
