Detrusitol 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.)

Click on icon to see table/diagram/image

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.