Spiriva Adverse Reactions

Summary of the safety profile: Many of the listed undesirable effects can be assigned to the anticholinergic properties of SPIRIVA/SPIRIVA RESPIMAT.
Spiriva: Tabulated summary of adverse reactions: The frequencies assigned to the undesirable effects listed as follows are based on crude incidence rates of adverse drug reactions (i.e. events attributed to tiotropium) observed in the tiotropium group (9,647 patients) from 28 pooled placebo-controlled clinical trials with treatment periods ranging from four weeks to four years.
Frequency is 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), not known (cannot be estimated from the available data). (See Table 5.)

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Description of selected adverse reactions: In controlled clinical studies, the commonly observed undesirable effects were anticholinergic undesirable effects such as dry mouth which occurred in approximately 4% of patients. In 28 clinical trials, dry mouth led to discontinuation in 18 of 9,647 tiotropium treated patients (0.2 %).
Serious undesirable effects consistent with anticholinergic effects include glaucoma, constipation and intestinal obstruction including ileus paralytic as well as urinary retention.
Other special population: An increase in anticholinergic effects may occur with increasing age.
Spiriva Respimat: Many of the listed adverse effects can be assigned to the anticholinergic properties of SPIRIVA RESPIMAT.
Adverse drug reactions were identified from data obtained in clinical trials and spontaneous reporting during post approval use of the drug.
The clinical trial database for COPD includes 3,282 SPIRIVA RESPIMAT patients from 7 placebo-controlled clinical trials with treatment periods ranging between four weeks and one year, contributing 2,440 person years of exposure.
The clinical trial database for asthma includes 1,930 tiotropium treated patients from 12 placebo controlled trials with treatment period ranging between twelve weeks and one year, contributing 1,128 person years of exposure to tiotropium.
Frequency is 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), not known (cannot be estimated from the available data). (See Table 6.)

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Description of selected adverse effects: In controlled clinical studies of COPD, the commonly observed adverse effects were anticholinergic undesirable effects such as dry mouth which occurred in approximately 2.9% of patients. In asthma the incidence of dry mouth was 0.83%.
Serious adverse effects consistent with anticholinergic effects include glaucoma, constipation, intestinal obstruction (including paralytic ileus) and urinary retention.
An increase in anticholinergic effects may occur with increasing age.
Paedriatic population: The frequency, type, and severity of adverse reactions in the paediatric population are similar as in adults.