Tolterodine (Detrol®, Detrol® LA) Adverse Reactions
- anaphylactoid reactions
- angioedema
- anxiety
- blurred vision
- chest pain (unspecified)
- confusion
- constipation
- cough
- dizziness
- drowsiness
- dyspepsia
- dysuria
- fatigue
- flatulence
- flushing
- gastroesophageal reflux
- hallucinations
- headache
- hypertension
- infection
- nausea/vomiting
- palpitations
- paresthesias
- peripheral edema
- pruritus
- sinus tachycardia
- sinusitis
- urinary retention
- visual impairment
- weight gain
- xerophthalmia
- xerosis
- xerostomia
Tolterodine (Detrol®, Detrol® LA) Adverse Reactions
No differences in the safety profile of tolterodine were identified based on age, gender, race, or metabolism in clinical trials, including in the elderly.
Adverse events considered to be treatment-related (rates given vs. placebo) with immediate-release tolterodine were xerostomia (39.5% vs. 15.9%), dyspepsia (5.9% vs. 1.7%), headache (11% vs. 7.4%), constipation (6.5% vs. 4.5%), and xerophthalmia (3.8% vs. 1.7%). Common adverse effects reported with tolterodine extended-release capsules were dry mouth (23% vs. 7.7%), headache (6% vs. 4%), constipation (6% vs. 4%), and abdominal pain (4% vs. 2%). Dry mouth, constipation, and dry eyes are expected side effects of antimuscarinics. Xerostomia was the most frequently reported adverse event with doses of 4 mg/day in clinical studies; however, only 0.8% of patients discontinued treatment due to this side effect. According to comparative phase III trials, xerostomia occurs less often with tolterodine at doses <= 2 mg/day than with oxybutynin 5 mg/day. Roughly 8% of patients overall discontinue treatment; discontinuation rates are highest during the first 4 weeks. The most common adverse events leading to discontinuation are dizziness and headache. Dizziness was reported at a rate similar to placebo in controlled trials of the immediate-release product (8.6% vs. 9.1%), and was more frequent than placebo with the extended-release product (2% vs. 1%). Urinary retention or problems with micturition, while expected side effects that may occur with antimuscarinic treatment, occurred in 1.7% of patients on tolterodine vs. 2.8% on placebo.
Events reported in >= 1% of patients treated with tolterodine formulations at an incidence > 0.5% higher than in placebo are as follows: abdominal pain (7.6%), bronchitis (2.1%), chest pain (unspecified) (3.4%), fall (1.3%), fatigue (2%), flatulence (1.3%), fungal infection and other infection (2.1% and 1.1%, respectively), hypertension (1.5%), nausea/vomiting (1.7%), nervousness (anxiety) (1.1%), drowsiness (3%, reported as somnolence), sinusitis (2%), and xerosis (dry skin) (1.7%). Dysuria occurred in 1% of those patients receiving the extended-release tolterodine product. Visual impairment (e.g., blurred vision or accommodation abnormalities), occurred in 4.7% of patients and is an expected effect of antimuscarinic agents.
Adverse events reported in >= 1% of patients treated with tolterodine immediate-release but at an incidence <= 0.5% higher than with placebo and without regard to causality are as follows: cough (2.1%), nausea without vomiting (4.2%), paresthesias (1.1%), pruritus (1.3%), and weight gain (1.5%).
Adverse effects consistent with the actions of antimuscarinic agents and reported in < 1% of patients treated with tolterodine in controlled clinical studies were confusion, gastroesophageal reflux, and flushing of the skin. The following events have been reported in association with tolterodine use in clinical practice: anaphylactoid reactions, angioedema, hallucinations, palpitations, sinus tachycardia, and peripheral edema. ECG monitoring is recommended in the event of overdosage.
[ Last revised: 2/18/2004 5:18:00 PM ]
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