Detrusitol Adverse Reactions





Zuellig Pharma
Full Prescribing Info
Adverse Reactions
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 2 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 2.)

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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.
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