ADVERSE REACTIONS
The safety and efficacy of oxybutynin chloride was evaluated in a total of 199 patients in three clinical trials. These participants were treated with oxybutynin chloride 5 to 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 Oxybutynin Chloride (5 to 20 mg/day)
|
Body System
|
Adverse Event
|
Oxybutynin Chloride (5 to 20 mg/day) (n=199)
|
|
|
Infections and Infestations |
Urinary tract infection |
6.5% |
Psychiatric Disorders |
Insomnia |
5.5% |
|
Nervousness |
6.5% |
Nervous System Disorders |
Dizziness |
16.6% |
|
Somnolence |
14.0% |
|
Headache |
7.5% |
Eye Disorders |
Blurred vision |
9.6% |
Gastrointestinal Disorders |
Dry mouth |
71.4% |
|
Constipation |
15.1% |
|
Nausea |
11.6% |
|
Dyspepsia |
6.0% |
Renal and Urinary Disorders |
Urinary Hesitation |
8.5% |
|
Urinary Retention |
6.0% |
The most common adverse events reported by patients receiving oxybutynin chloride 5 to 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 oxybutynin chloride (5 to 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 oxybutynin chloride: 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.
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REPORTS OF SUSPECTED OXYBUTYNIN SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Oxybutynin. The information is not vetted and should not be considered as verified clinical evidence.
Possible Oxybutynin side effects / adverse reactions in 73 year old male
Reported by a pharmacist from United States on 2011-10-06
Patient: 73 year old male weighing 115.0 kg (253.0 pounds)
Reactions: Dystonia, Hyponatraemia, Blood Creatinine Increased, Hypovolaemia
Adverse event resulted in: hospitalization
Suspect drug(s):
Oxybutynin
Other drugs received by patient: Glyburide; Allopurinol; Niaspan; Ciprofloxacin; Lisinopril and Hydrochlorothiazide; Actos; Lortab
Possible Oxybutynin side effects / adverse reactions in 73 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-06
Patient: 73 year old female
Reactions: Vomiting, Liver Function Test Abnormal
Adverse event resulted in: hospitalization
Suspect drug(s):
Oxybutynin
Other drugs received by patient: Aspirin; Metformin Hydrochloride; Ezetimibe; Simvastatin; Acetaminophen; Trimethoprim; Gliclazide; Irbesartan
Possible Oxybutynin side effects / adverse reactions in 82 year old female
Reported by a physician from Romania on 2011-10-18
Patient: 82 year old female weighing 45.0 kg (99.0 pounds)
Reactions: Femur Fracture, Dizziness
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Neupro
Indication: Parkinson's Disease
Start date: 2010-05-07
End date: 2010-06-28
Neupro
Start date: 2010-06-29
Rawel
Indication: Hypertension
Start date: 2009-05-25
Enalapril Maleate
Indication: Hypertension
Start date: 2009-05-25
Isicom
Indication: Parkinson's Disease
Start date: 1995-05-16
End date: 2011-03-07
Viregyt K
Indication: Parkinson's Disease
Start date: 2004-12-07
End date: 2010-05-07
Oxybutynin
Indication: Urinary Incontinence
Start date: 2009-06-11
Other drugs received by patient: Selegos
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