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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.
Metabolism and nutrition disorders: dehydration.
Nervous system disorders: dizziness, insomnia.
Eye disorders: glaucoma, intraocular pressure increased, vision blurred.
Cardiac disorders: atrial fibrillation, palpitations, supraventricular tachycardia, tachycardia.
Respiratory, thoracic and mediastinal disorders: cough, epistaxis, pharyngitis, dysphonia, bronchospasm, laryngitis, sinusitis.
Gastrointestinal disorders: dry mouth, usually mild; constipation, oropharyngaeal candidiasis, dysphagia, gastrooesophageal reflux disease, gingivitis, glossitis, stomatitis, intestinal obstruction incl. ileus paralytic.
Skin and subcutaneous tissue disorders, Immune system disorders: rash, pruritus, angioneurotic oedema, urticaria, skin infection and skin ulcer, dry skin, hypersensitivity (including immediate reactions).
Musculoskeletal and connective tissue disorders: joint swelling.
Renal and urinary disorders: urinary retention (usually in men with predisposing factors), dysuria, urinary tract infection.
Paedriatic population: The safety database includes 560 paediatric patients (296 patients aged 1 to 11 and 264 patients aged 12 to 17) from 5 placebo-controlled clinical trials with treatment periods ranging between 12 weeks to one year. The frequency, type, and severity of adverse reactions in the paediatric population are similar as in adults.
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