Oxybutynin Oral Solution Side Effects

Please note - some side effects for Oxybutynin Oral Solution may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Oxybutynin Oral Solution Side Effects - for the Professional

Oxybutynin Oral Solution

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. 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 Patients Using Oxybutynin Chloride (5–20 mg/day)
Body System	Adverse Event	Oxybutynin Chloride (5–20 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 5–20 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 disorder, 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.

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