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 includes 9,647 tiotropium patients from 28 placebo-controlled clinical trials with treatment periods ranging between four weeks and four years, contributing 12,469 person years of exposure to Tiotropium.
Metabolism and nutrition disorders: Dehydration.
Nervous system disorders: Dizziness; Insomnia.
Eye disorders: Vision blurred; Glaucoma; Intraocular pressure increased.
Cardiac disorders: Atrial fibrillation; Supraventricular tachycardia; Tachycardia; Palpitations.
Respiratory, thoracic and mediastinal disorders: Cough; Dysphonia; Pharyngitis; Bronchospasm; Epistaxis; Laryngitis; Sinusitis.
Gastrointestinal disorders: Dry mouth, usually mild; Constipation; Gastroesophageal reflux disease; Oropharyngeal obstruction incl. ileus paralytic; Dysphagia; Gingivitis; Glossitis; Stomatitis; Intestinal obstruction incl. ileus paralytic.
Skin and subcutaneous tissue disorder, Immune system disorders: Rash; Angioedema; Hypersensitivity (including immediate reactions); Pruritus; Urticaria; Dry skin; Skin infection and skin ulcer.
Musculoskeletal and connective tissue disorders: Joint swelling.
Renal and urinary disorders: Urinary retention (usually in men with predisposing factors); Dysuria; Urinary tract infection.
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