Información de la droga para OXYBUTYNIN CHLORIDE SYRUP (OXYBUTYNIN CHLORIDE ORAL SOLUTION, USP 5 mg per 5 mL) (Qualitest Pharmaceuticals): ADVERSE REACTIONS

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  • The safety and efficacy of oxybutynin chloride was evaluated in a total of 199 patients in three clinical trials comparing oxybutynin chloride with oxybutynin chloride extended release tablets (see Table 3). These participants were treated with oxybutynin chloride 5–20 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 PatientsUsing Oxybutynin Chloride (5–20 mg/day)
    Body SystemAdverse EventOxybutynin Chloride(5–20 mg/day) (n=199)
    Infections and Infestations Urinary tract infection6.5%
    Psychiatric Disorders Insomnia5.5%
    Nervousness6.5%
    Nervous System Disorders Dizziness16.6%
    Somnolence14.0%
    Headache7.5%
    Eye Disorders Blurred vision9.6%
    Gastrointestinal Disorders Dry mouth71.4%
    Constipation15.1%
    Nausea11.6%
    Dyspepsia6.0%
    Renal and Urinary Disorders Urinary Hesitation8.5%
    Urinary Retention6.0%

    The most common adverse events reported by patients receiving oxybutynin chloride 5–20 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 (5–20 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 disorders, agitation, hallucinations;

    Nervous System Disorders: convulsions;

    Eye disorders: cycloplegia, mydriasis;

    Cardiac Disorders: tachycardia;

    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.

  • Drug Information Provided by National Library of Medicine (NLM).
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