System Organ ClassAdverse EventFrequency
Infections & InfestationsCandidiasis of the mouth and throatVery Common
Immune System DisordersHypersensitivity reactions with the following manifestations:
Cutaneous hypersensitivity reactionsUncommon
Angioedema (mainly facial and oropharyngeal oedema)Very Rare
Respiratory symptoms (dyspnoea and/or bronchospasm)Very Rare
Anaphylactic reactionsVery Rare
Endocrine DisordersCushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataract, glaucomaVery Rare
Metabolism & Nutrition DisordersHyperglycaemia (see Flixotide SPC Section 4.4 ‘Special Warnings and Precautions for Use’)Very Rare
Gastrointestinal DisordersDyspepsiaVery Rare
Musculoskeletal & Connective Tissue DisordersArthralgiaVery Rare
Psychiatric DisordersAnxiety, sleep disorders, behavioural changes, including hyperactivity and irritability (predominantly in children)Very Rare
Respiratory, Thoracic & Mediastinal DisordersHoarseness/dysphoniaCommon
Paradoxical bronchospasmVery Rare
Skin & Subcutaneous Tissue DisordersContusionsCommon

From: Appendix 7, Protocol

Cover of Management of Asthma in School age Children On Therapy (MASCOT): a randomised, double-blind, placebo-controlled, parallel study of efficacy and safety
Management of Asthma in School age Children On Therapy (MASCOT): a randomised, double-blind, placebo-controlled, parallel study of efficacy and safety.
Health Technology Assessment, No. 17.4.
Lenney W, McKay AJ, Tudur Smith C, et al.; MASCOT Study Group.
Southampton (UK): NIHR Journals Library; 2013 Feb.
Copyright © Queen's Printer and Controller of HMSO 2013. This work was produced by Lenney et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

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