Ditropan (Oxybutynin Chloride) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Adverse Events with DITROPAN XL^®

The safety and efficacy of DITROPAN XL^® (oxybutynin chloride) were evaluated in a total of 580 participants who received DITROPAN XL^® in 4 clinical trials (429 patients) and four pharmacokinetic studies (151 healthy volunteers). The 429 patients were treated with 5–30 mg/day for up to 4.5 months. Three of the 4 clinical trials allowed dose adjustments based on efficacy and adverse events and one was a fixed-dose escalation design. Safety information is provided for 429 patients from these three controlled clinical studies and one open-label study in the first column of Table 3 below.

Adverse events from two additional fixed-dose, active-controlled, 12-week treatment duration, postmarketing studies, in which 576 patients were treated with DITROPAN XL^® 10 mg/day, are also listed in Table 3 (second column). The adverse events are reported regardless of causality.

Table 3 Incidence (%) of Adverse Events Reported by ≥ 5% of Patients Using DITROPAN XL^® (5–30 mg/day) and % of Corresponding Adverse Events in Two Fixed-Dose (10 mg/day) Studies

		DITROPAN XL®	DITROPAN XL®
Body System	Adverse Event	5–30 mg/day (n=429)	10 mg/day (n=576)
General	headache	10	6
	asthenia	7	3
	pain	7	4
Digestive	dry mouth	61	29
	constipation	13	7
	diarrhea	9	7
	nausea	9	2
	dyspepsia	7	5
Nervous	somnolence	12	2
	dizziness	6	4
Respiratory	rhinitis	6	2
Special senses	blurred vision	8	1
	dry eyes	6	3
Urogenital	urinary tract infection	5	5

The most common adverse events reported by the 429 patients receiving 5–30 mg/day DITROPAN XL^® were the expected side effects of anticholinergic agents. The incidence of dry mouth was dose-related.

The discontinuation rate for all adverse events was 6.8% in the 429 patients from the 4 studies of efficacy and safety who received 5–30 mg/day. The most frequent adverse event causing early discontinuation of study medication was nausea (1.9%), while discontinuation due to dry mouth was 1.2%.

In addition, the following adverse events were reported by ≥ 1 to < 5% of all patients who received DITROPAN XL^® in the 6 adjustable and fixed-dose efficacy and safety studies. Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, bronchitis, cystitis; Psychiatric disorders: insomnia, depression, nervousness, confusional state; Nervous System Disorders: dysgeusia; Cardiac disorders: palpitations; Vascular disorders: hypertension; Respiratory, thoracic and mediastinal disorders: nasal dryness, cough, pharyngolaryngeal pain, dry throat; Gastrointestinal Disorders: gastroesophageal reflux disease, abdominal pain, loose stools, flatulence, vomiting; Skin and subcutaneous tissue disorders: dry skin, pruritis; Musculoskeletal and connective tissue disorders: back pain, arthralgia, pain in extremity; Renal and urinary disorders: urinary retention, urinary hesitation, dysuria; General disorders and administration site conditions: fatigue, edema peripheral, asthenia, chest pain; Investigations: blood pressure increased.

Postmarketing Surveillance

Because postmarketing reactions 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 drug reactions have been reported from worldwide postmarketing experience with DITROPAN XL^®: Psychiatric Disorders: psychotic disorder, agitation, hallucinations, memory impairment; Nervous System Disorders: convulsions; Eye Disorders: glaucoma; Cardiac Disorders: arrhythmia, tachycardia, QT interval prolongation; Vascular Disorders: flushing; Skin and Subcutaneous Tissue Disorders: rash; Renal and Urinary Disorders: impotence; General Disorders and Administration Site Conditions: hypersensitivity reactions, including angioedema with airway obstruction, urticaria, and face edema; rare anaphylactic reactions requiring hospitalization for emergency treatment; Injury, poisoning and procedural complications: fall.

Additional adverse events reported with some other oxybutynin chloride formulations include: cycloplegia, mydriasis, and 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