Combivent Adverse Reactions

Summary of the safety profile: Many of the listed undesirable effects can be assigned to the anticholinergic and beta2-sympathomimetic properties of COMBIVENT. As with all inhalation therapy COMBIVENT may show symptoms of local irritation. Adverse drug reactions were identified from data obtained in clinical trials and pharmacovigilance during post approval use of the drug.
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.
The following adverse reactions have been reported during use of COMBIVENT in clinical trials and during the post-marketing experience.
Immune system disorders: Anaphylactic reaction, Hypersensitivity.
Metabolism and nutrition disorders: Hypokalaemia.
Psychiatric disorders: Nervousness, Mental disorder.
Nervous system disorders: Headache, Tremor Dizziness.
Eye disorders: Accommodation disorder, Corneal oedema, Glaucoma, Intraocular pressure increased, Mydriasis, Vision blurred, Eye pain, Conjunctival hyperaemia, Halo vision.
Cardiac disorders: Palpitations, Tachycardia, Arrhythmia, Atrial fibrillation, Supraventricular tachycardia, Myocardial ischaemia.
Respiratory, thoracic and mediastinal disorders: Cough, Dysphonia, Dry throat, Bronchospasm, Bronchospasm paradoxical, Laryngospasm, Pharyngeal oedema.
Gastrointestinal disorders: Dry mouth, Nausea, Throat irritation, Diarrhoea, Vomiting, Constipation, Gastrointestinal motility disorder, Mouth oedema, Stomatitis.
Skin and subcutaneous tissue disorders: Skin reactions such as: Rash, Pruritus, Urticaria, Angioedema, Hyperhidrosis.
Musculoskeletal and connective tissue disorders: Muscle spasms, Muscular weakness, Myalgia.
Renal and urinary disorders: Urinary retention.
General disorders and administration site conditions: Asthenia.
Investigations: Blood pressure diastolic decreased, Blood pressure systolic increased.