Summary of the safety profile: Many of the listed undesirable effects can be assigned to the anticholinergic and beta-adrenergic properties of DUOVENT. As with all inhalation therapy DUOVENT may show symptoms of local irritation.
The most frequent side effects reported in clinical trials were cough, dry mouth, headache, tremor, pharyngitis, nausea, dizziness, dysphonia, tachycardia, palpitations, vomiting, blood pressure systolic increased and nervousness.
Summary of adverse reactions: The following adverse reactions have been reported during use of DUOVENT in clinical trials and during the post-marketing experience.
Immune system disorders: anaphylactic reaction, hypersensitivity.
Metabolism and nutritional disorders: hypokalemia.
Psychiatric disorders: nervousness, agitation, mental disorder.
Nervous system disorders: headache, tremor, dizziness.
Eye disorders: glaucoma, intraocular pressure increased, accommodation disorder, mydriasis, vision blurred, eye pain, corneal oedema, conjunctival hyperaemia, halo vision.
Cardiac disorders: tachycardia, heart rate increased, palpitations, arrhythmia, atrial fibrillation, supraventricular tachycardia, myocardial ischaemia.
Respiratory, thoracic and mediastinal disorders: cough, pharyngitis, dysphonia, bronchospasm, throat irritation, pharyngeal oedema, laryngospasm, bronchospasm paradoxical, dry throat.
Gastrointestinal disorders: vomiting, nausea, dry mouth, stomatitis, glossitis, gastrointestinal motility disorder, diarrhoea, constipation, oedema mouth.
Skin and subcutaneous tissue disorders: urticaria, rash, pruritus, angioedema, hyperhidrosis.
Musculoskeletal and connective tissue disorders: muscular weakness, muscle spasms; myalgia.
Renal and urinary disorders: urinary retention.
Investigations: blood pressure systolic increased, blood pressure diastolic decreased.