Ditropan (Oxybutynin Chloride) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The safety and efficacy of DITROPAN^® (oxybutynin chloride) was evaluated in a total of 199 patients in three clinical trials comparing DITROPAN with DITROPAN XL (see Table 3). These participants were treated with DITROPAN 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 DITROPAN (5–20 mg/day)

Body System	Adverse Event	DITROPAN (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 DITROPAN 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 DITROPAN (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 DITROPAN: 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.

REPORTS OF SUSPECTED DITROPAN SIDE EFFECTS / ADVERSE REACTIONS

Possible Ditropan side effects / adverse reactions in 87 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-09

Patient: 87 year old female

Reactions: Confusional State, Urine Output Decreased, Dyskinesia, Lung Infection, Livedo Reticularis, Pyrexia, Culture Urine Positive, Tremor, Faecaloma, Escherichia Test Positive, Renal Failure, Incontinence, Areflexia, Pollakiuria, Dizziness, Memory Impairment

Adverse event resulted in: hospitalization

Suspect drug(s):
Ditropan
    Dosage: 5 mg, 2x/day
    Administration route: Oral

Neurontin
    Dosage: 600 mg, 3x/day
    Administration route: Oral
    End date: 2011-11-18

Other drugs received by patient: Aspirin; Levothyroxine Sodium; Simvastatin; Klipal Codeine; Acetaminophen; Micardis; Veinamitol

Possible Ditropan side effects / adverse reactions in 87 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-13

Patient: 87 year old female

Reactions: Confusional State, Urine Output Decreased, Lung Infection, Dyskinesia, Culture Urine Positive, Livedo Reticularis, Pyrexia, Faecaloma, Tremor, Renal Failure, Incontinence, Dizziness, Areflexia, Pollakiuria, Memory Impairment

Adverse event resulted in: hospitalization

Suspect drug(s):
Ditropan
    Dosage: 5 mg, 2x/day
    Administration route: Oral
    End date: 2011-11-20

Neurontin
    Dosage: 600 mg, 3x/day
    Administration route: Oral
    End date: 2011-11-18

Other drugs received by patient: Simvastatin; Veinamitol; Acetaminophen; Aspirin; Klipal Codeine; Levothyroxine Sodium; Micardis

Possible Ditropan side effects / adverse reactions in 90 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-14

Patient: 90 year old female

Reactions: Bradycardia, Fall

Adverse event resulted in: hospitalization

Suspect drug(s):
Prazosin HCL
    Administration route: Oral

Lasix
    Dosage: 120 mg, 1x/day
    Administration route: Oral

Cordarone
    Dosage: 0.5 df, 5 times/week

Ditropan
    Administration route: Oral

Noctran 10
    Dosage: 5 mg, 1x/day