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 SIDE EFFECTS / ADVERSE REACTIONS RELATED TO DITROPAN

Possible Ditropan side effects / adverse reactions in 4 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2007-07-05

Patient: 4 year old female weighing 25.9 kg (56.9 pounds)

Reactions: Agitation, Restlessness, DRY Mouth, Hallucination, Tremor

Suspect drug(s):
Ditropan

Other drugs received by patient: Benadryl