Summary of the safety profile: The most frequent side effects reported in clinical trials were headache, throat irritation, cough, dry mouth, gastro-intestinal motility disorders (including constipation, diarrhoea and vomiting), nausea, and dizziness.
List of adverse reactions: The following adverse reactions have been reported during use of ATROVENT in clinical trials and during the post-marketing experience.
Immune system disorders: hypersensitivity, anaphylactic reaction.
Nervous system disorders: headache, dizziness.
Eye disorders: vision blurred, mydriasis, intraocular pressure increased, glaucoma, eye pain, halo vision, conjunctival hyperaemia, corneal oedema, accommodation disorder.
Cardiac disorders: palpitations, supraventricular tachycardia, atrial fibrillation, heart rate increased.
Respiratory, thoracic and mediastinal disorders: throat irritation, cough, bronchospasm, bronchospasm paradoxical, laryngospasm, pharyngeal oedema, dry throat.
Gastrointestinal disorders: dry mouth, nausea, gastrointestinal motility disorder, diarrhoea, constipation, vomiting, stomatitis, oedema mouth.
Skin and subcutaneous tissue disorders: rash, pruritus, angioedema, urticaria.
Renal and urinary disorders: urinary retention.
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