Seretide Adverse Reactions

MDI: All of the adverse reactions associated with the individual components, salmeterol xinafoate and fluticasone propionate, are listed as follows. There are no additional adverse reactions attributed to the combination product when compared to the adverse event profiles of the individual components.
Adverse events are listed as follows by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000). The majority of frequencies were determined from pooled clinical trial data from 23 asthma and 7 COPD studies. Not all events were reported in clinical trials. For these events, the frequency was calculated based on spontaneous data.
Clinical Trial Data: Very common: Headache (see Precautions). Common: Candidiasis of mouth and throat, pneumonia (in COPD patients), hoarseness/dysphonia, muscle cramps, arthralgia; Uncommon: cutaneous hypersensitivity reactions, dyspnoea, cataract, hyperglycemia, anxiety, sleep disorders, tremor (see Precautions), palpitations (see Precautions), tachycardia, atrial fibrillation, throat irritation, contusions; Rare: Anaphylactic reactions, glaucoma, behavioural changes, including hyperactivity and irritability (predominantly in children), cardiac arrhythmias including supraventricular tachycardia and extrasystoles, angioedema (mainly facial and oropharyngeal oedema) and bronchospasm, Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, paradoxical bronchospasm (see Precautions), oesophageal candidiasis.