Body System ClassAdverse EventFrequency
Body as a wholeAbdominal painCommon
Asthenia/fatigue, malaise, oedema,Very rare
Digestive System DisordersThirstCommon
Diarrhoea, dry mouth, dyspepsia, nausea, vomiting
Nervous System DisordersHeadacheCommon
Dizziness, drowsiness, paraesthesia/hypoesthesia, seizureVery rare
Psychiatric DisordersDream abnormalities including nightmares, hallucinations, insomnia, paraesthesia/hypoesthesia, irritability, agitation including aggressive behaviour, restlessness, anxiety, tremor, depression, suicidal thinking and behaviour (suicidality)Very rare
Musculo-Skeletal DisordersArthralgia, myalgia including muscle crampsVery rare
Hepato-Biliary DisordersElevated levels of serum transaminases (ALT, AST), cholestatic hepatitisVery rare
Cardiovascular DisordersPalpitationsVery rare
Skin & Subcutaneous Tissue DisordersAngiooedema, urticaria, pruritus, rash, erythema nodosum, bruisingVery rare
Immune System DisordersHypersensitivity reactions including anaphylaxis, hepatic eosinophilic infiltrationVery rare

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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