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Oxybutynin (Oxybutynin Chloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 Patients Using Oxybutynin Chloride (5-20 mg/day)
Body System Adverse Event Oxybutynin Chloride

(5-20 mg/day) (n=199)
Infections and InfestationsUrinary tract infection6.5%
Psychiatric DisordersInsomnia5.5%
Nervousness6.5%
Nervous System DisordersDizziness16.6%
Somnolence14.0%
Headache7.5%
Eye DisordersBlurred vision9.6%
Gastrointestinal DisordersDry mouth71.4%
Constipation15.1%
Nausea11.6%
Dyspepsia6.0%
Renal and Urinary DisordersUrinary 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: palpications, sinus arrhythmia; Vascular Disorders: flushing; Respiratory, Thoracic and Mediastinal Disorders: nasal dryness, cough, pharyngolaryngeal pain, dry throat, sinus congestion, hoarsness, 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, puritis; 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: Supression of lactation.



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



See index of all Oxybutynin side effect reports >>

Drug label data at the top of this Page last updated: 2008-04-08

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