In clinical trials and post‑marketing experience, the most frequently reported adverse reactions were nasopharyngitis (7.9%) and headache (6.8%), both classified as common. Other common adverse reactions included urinary tract infection, sinusitis, tooth abscess, insomnia, anxiety, dizziness, tremor, cough, diarrhoea, nausea, dry mouth, myalgia, muscle spasms, increased blood creatine phosphokinase and combination of sore throat and runny nose (nasopharyngitis). Uncommon reactions included hypokalaemia, hyperglycaemia, agitation, dysgeusia, blurred vision, dysphonia, throat irritation, stomatitis, rash, pruritus, urinary retention and increased blood pressure. Cardiac events such as cardiac arrhythmias (including atrial fibrillation and paroxysmal tachycardia), tachycardia, QTc prolongation, palpitations and angina pectoris were reported as uncommon. Rare and more serious reactions included bronchospasm (including paradoxical bronchospasm) and hypersensitivity reactions, with angioedema and anaphylactic reaction reported with frequency not known. These serious hypersensitivity and bronchospasm events could necessitate discontinuation and urgent medical management.
Clinical Trial Type and Population
