Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common (incidence ≥5%) adverse reactions were dry mouth, constipation, diarrhea, headache, somnolence, and dizziness.
(6) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc.
at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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 Oxybutynin chloride extended-release tablets (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, Oxybutynin chloride IR (5 to 20 mg/day in 199 subjects) was an active comparator.
Adverse reactions reported by ≥ 1% of subjects are shown in Table
Table 1: Adverse Drug Reactions Reported by ≥ 1% of Oxybutynin chloride extended-release tablets-treated Adult Subjects in Five Double-blind, Controlled Clinical Trials of Oxybutynin chloride extended-release tablets System/Organ Class Preferred Term Oxybutynin chloride extended-release tablets 5 to 30 mg/day n = 774 % Oxybutynin chloride IR IR = immediate release 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 The bundled term residual urine volume consists of the preferred terms residual urine volume and residual urine volume increased.
2.3 3.5 The discontinuation rate due to adverse reactions was 4.4% with Oxybutynin chloride extended-release tablets compared to 0% with Oxybutynin chloride IR.
The most frequent adverse reaction causing discontinuation of study medication was dry mouth (0.7% ).
5 WARNINGS AND PRECAUTIONS Angioedema: Angioedema has been reported with oxybutynin.
If symptoms of angioedema occur, discontinue Oxybutynin chloride extended-release tablets immediately and initiate appropriate therapy.
( 5.1 ) Central Nervous System (CNS) effects: CNS effects have been reported with oxybutynin.
If patient experiences anticholinergic CNS effects, consider dose adjustment or discontinuation of Oxybutynin chloride extended-release tablets.
( 5.2 ) Use with caution due to aggravation of symptoms: Pre-existing dementia in patients treated with cholinesterase inhibitors ( 5.2 ), Parkinson's disease ( 5.2 ), Myasthenia gravis ( 5.3 ), and Decreased gastrointestinal motility in patients with autonomic neuropathy.
Like all medications, Oxybutynin Chloride Extended Release can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: