Oxybutynin Chloride Side Effects
Brand Names: Ditropan, Ditropan XL, Gelnique, Oxytrol
Please note - some side effects for Oxybutynin Chloride may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Oxybutynin Chloride Side Effects - for the Professional
Oxybutynin Chloride
Adverse Events with Oxybutynin Chloride Extended Release Tablets
The safety and efficacy of Oxybutynin Chloride Extended Release Tablets was evaluated in a total of 580 participants who received Oxybutynin Chloride Extended Release Tablets 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 events from two additional fixed-dose, active-controlled, 12-week treatment duration, postmarketing studies, in which 576 patients were treated with Oxybutynin Chloride Extended Release Tablets 10 mg/day, are also listed in Table 3 (second column). The adverse events are reported regardless of causality.
| Oxybutynin Chloride Extended Release Tablets | Oxybutynin Chloride Extended Release Tablets | ||
|---|---|---|---|
| Body System | Adverse Event | 5–30 mg/day (n=429) |
10 mg/day (n=576) |
| General | headache | 10 | 6 |
| asthenia | 7 | 3 | |
| pain | 7 | 4 | |
| Digestive | dry mouth | 61 | 29 |
| constipation | 13 | 7 | |
| diarrhea | 9 | 7 | |
| nausea | 9 | 2 | |
| dyspepsia | 7 | 5 | |
| Nervous | somnolence | 12 | 2 |
| dizziness | 6 | 4 | |
| Respiratory | rhinitis | 6 | 2 |
| Special senses | blurred vision | 8 | 1 |
| dry eyes | 6 | 3 | |
| Urogenital | urinary tract infection | 5 | 5 |
The most common adverse events reported by the 429 patients receiving 5–30 mg/day Oxybutynin Chloride Extended Release Tablets were the expected side effects of anticholinergic agents. The incidence of dry mouth was dose-related.
The discontinuation rate for all adverse events 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 event causing early discontinuation of study medication was nausea (1.9%), while discontinuation due to dry mouth was 1.2%.
In addition, the following adverse events were reported by ≥ 1 to < 5% of all patients who received Oxybutynin Chloride Extended Release Tablets in the 6 adjustable and fixed-dose efficacy and safety studies. Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, bronchitis, cystitis; Psychiatric disorders: insomnia, depression, nervousness, confusional state; Nervous System Disorders: dysgeusia; Cardiac disorders: palpitations; Vascular disorders: hypertension; Respiratory, thoracic and mediastinal disorders: nasal dryness, cough, pharyngolaryngeal pain, dry throat; Gastrointestinal Disorders: gastroesophageal reflux disease, abdominal pain, loose stools, flatulence, vomiting; Skin and subcutaneous tissue disorders: dry skin, pruritis; Musculoskeletal and connective tissue disorders: back pain, arthralgia, pain in extremity; Renal and urinary disorders: urinary retention, urinary hesitation, dysuria; General disorders and administration site conditions: fatigue, edema peripheral, asthenia, chest pain; Investigations: blood pressure increased.
Postmarketing Surveillance
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. The following additional adverse drug reactions have been reported from worldwide postmarketing experience with Oxybutynin Chloride Extended Release Tablets: Psychiatric Disorders: psychotic disorder, agitation, hallucinations, memory impairment; Nervous System Disorders: convulsions; 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.
Top- Oxybutynin Chloride Monograph (AHFS DI)
- Oxybutynin Prescribing Information (FDA)
- Ditropan Consumer Overview
- Ditropan Prescribing Information (FDA)
- Ditropan Advanced Consumer (Micromedex) - Includes Dosage Information
- Ditropan MedFacts Consumer Leaflet (Wolters Kluwer)
- Ditropan XL Prescribing Information (FDA)
- Ditropan XL Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)
- Gelnique Prescribing Information (FDA)
- Gelnique Gel MedFacts Consumer Leaflet (Wolters Kluwer)
- Gelnique Advanced Consumer (Micromedex) - Includes Dosage Information
- Gelnique Consumer Overview
- Oxytrol Prescribing Information (FDA)
- Oxytrol Consumer Overview
- Oxytrol System MedFacts Consumer Leaflet (Wolters Kluwer)
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
