Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports. Very common and common events were generally determined from clinical trial data. Rare, very rare and unknown events were generally determined from spontaneous data.
Immune system disorders: Very rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.
Metabolism and nutrition disorders: Rare: Hypokalaemia. Potentially serious hypokalaemia may result from beta2 agonist therapy.
Nervous system disorders: Common: Tremor, headache. Very rare: Hyperactivity.
Cardiac disorders: Common: Tachycardia. Uncommon: Palpitations. Very rare: Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles). Unknown: Myocardial ischaemia.
Vascular disorders: Rare: Peripheral vasodilatation.
Respiratory, thoracic and mediastinal disorders: Very rare: Paradoxical bronchospasm.
As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator. It should be discontinued immediately, the patient assessed, and, if necessary, alternative therapy instituted.
Gastrointestinal disorders: Uncommon: Mouth and throat irritation.
Musculoskeletal and connective tissue disorders: Uncommon: Muscle cramps.