Ditropan XL (Oxybutynin Chloride Extended Release) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Adverse Events with DITROPAN XL

The safety and efficacy of DITROPAN XL^® (oxybutynin chloride) was 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 (10mg/day) Studies

Body System	Adverse Event	DITROPAN XL 5-30 mg/day (n=429)	DITROPAN XL 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; Nervous System Disorders: convulsions; Cardiac Disorders: arrhythmia; tachycardia; Vascular Disorders: flushing; Skin and Subcutaneous Tissue Disorders: rash; Renal and Urinary Disorders: impotence; 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 XL SIDE EFFECTS / ADVERSE REACTIONS

Possible Ditropan XL side effects / adverse reactions in 61 year old female

Reported by a pharmacist from Canada on 2012-01-20

Patient: 61 year old female

Reactions: Ocular Retrobulbar Haemorrhage

Suspect drug(s):
Ditropan XL

Other drugs received by patient: Nonsteroidal Anti-Inflammatory Drug NOS