Detrusitol/Detrusitol SR Adverse Reactions

Detrusitol: Summary of the safety profile: Due to the pharmacological effect of tolterodine it may cause mild-to-moderate antimuscarinic effects, like dryness of the mouth, dyspepsia, and dry eyes.
Table 5 as follows reflects the data obtained with tolterodine in clinical trials and from post-marketing experience. The most commonly reported adverse reaction was dry mouth, which occurred in 35% of patients treated with tolterodine and in 10% of placebo treated patients. Headaches were also reported very commonly and occurred in 10.1% of patients treated with tolterodine and in 7.4% of placebo treated patients.
Tabulated list of adverse reactions: The adverse drug reactions listed in the table as follows are presented by System Organ Class (SOC) and frequency categories, defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table 5.)

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Cases of aggravation of symptoms of dementia (e.g. confusion, disorientation, delusion) have been reported after tolterodine therapy was initiated in patients taking cholinesterase inhibitors for the treatment of dementia.
Detrusitol SR: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Trials Experience: The efficacy and safety of DETRUSITOL SR Capsules was evaluated in 1073 patients (537 assigned to DETRUSITOL SR; 536 assigned to placebo) who were treated with 2, 4, 6, or 8 mg/day for up to 15 months. These included a total of 1012 patients (505 randomized to DETRUSITOL SR 4 mg once daily and 507 randomized to placebo) enrolled in a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study.
Adverse events were reported in 52% (n=263) of patients receiving DETRUSITOL SR and in 49% (n=247) of patients receiving placebo. The most common adverse events reported by patients receiving DETRUSITOL SR were dry mouth, headache, constipation, and abdominal pain. Dry mouth was the most frequently reported adverse event for patients treated with DETRUSITOL SR occurring in 23.4% of patients treated with DETRUSITOL SR and 7.7% of placebo-treated patients. Dry mouth, constipation, abnormal vision (accommodation abnormalities), urinary retention, and dry eyes are expected side effects of antimuscarinic agents. A serious adverse event was reported by 1.4% (n=7) of patients receiving DETRUSITOL SR and by 3.6% (n=18) of patients receiving placebo.
Table 6 lists the adverse events, regardless of causality, that were reported in the randomized, double-blind, placebo-controlled 12-week study at an incidence greater than placebo and in greater than or equal to 1% of patients treated with DETRUSITOL SR 4 mg once daily. (See Table 6.)

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The frequency of discontinuation due to adverse events was highest during the first 4 weeks of treatment. Similar percentages of patients treated with DETRUSITOL SR or placebo discontinued treatment due to adverse events. Dry mouth was the most common adverse event leading to treatment discontinuation among patients receiving DETRUSITOL SR [n=12 (2.4%) vs. placebo n=6 (1.2%)].
Post-marketing Experience: The following events have been reported in association with tolterodine use in worldwide post-marketing experience: General: anaphylaxis and angioedema;
Cardiovascular: tachycardia, palpitations, peripheral edema;
Gastrointestinal: diarrhea;
Central/Peripheral Nervous: confusion, disorientation, memory impairment, hallucinations.
Reports of aggravation of symptoms of dementia (e.g., confusion, disorientation, delusion) have been reported after tolterodine therapy was initiated in patients taking cholinesterase inhibitors for the treatment of dementia.
Because these spontaneously reported events are from the worldwide post-marketing experience, the frequency of events and the role of tolterodine in their causation cannot be reliably determined.