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 Rising Pharmaceuticals, Inc. at 1-866-562-4597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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 immediate release tablets (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 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 1 Tablets 5 to 20 mg/day n = 199 % Psychiatric Disorders Insomnia 3.0
5.5 Nervous System Disorders Headache 7.5
1.5Eye Disorders
Vision blurred 4.3
2.5 Respiratory , Thoracic and Mediastinal Disorders Cough 1.9
3.0 Oropharyngeal pain 1.9
4.5Gastrointestinal Disorders
Dry mouth 34.9
2.5 Gastro-esophageal reflux disease 1.0
0.5Skin and Subcutaneous Tissue Disorders
Dry skin 1.8
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
3.0Investigations
Residual urine volume 2 2.3 3.5 1 IR=immediate release 2 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 oxybutynin chloride extended-release tablets compared to 0% with oxybutynin chloride immediate release tablets. The most frequent adverse reaction causing discontinuation of study medication was dry mouth (0.7%).
The following adverse reactions were reported by < 1% of oxybutynin chloride extended-release tablets-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.
6.2Postmarketing Experience
The following additional adverse reactions have been reported from worldwide postmarketing experience with oxybutynin chloride extended-release tablets. 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.
