RT Journal Article SR Electronic T1 Safety of azithromycin in paediatrics: a systematic review protocol JF BMJ Paediatrics Open JO BMJ Paediatrics Open FD BMJ Publishing Group Ltd SP e000469 DO 10.1136/bmjpo-2019-000469 VO 3 IS 1 A1 Xu, Peipei A1 Zeng, Linan A1 Xiong, Tao A1 Choonara, Imti A1 Qazi, Shamim A1 Zhang, Lingli YR 2019 UL http://bmjpaedsopen.bmj.com/content/3/1/e000469.abstract AB Introduction Azithromycin is widely used in children not only in the treatment of individual children with infectious diseases, but also as mass drug administration (MDA) within a community to eradicate or control specific tropical diseases. MDA has also been reported to have a beneficial effect on child mortality and morbidity. However, concerns have been raised about the safety of azithromycin, especially in young children. The aim of this review is to systematically identify the safety of azithromycin in children of all ages.Methods and analysis MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, Embase, CINAHL, International Pharmaceutical Abstracts and adverse drug reaction (ADR) monitoring systems will be systematically searched for randomised controlled trials (RCTs), cohort studies, case–control studies, cross-sectional studies, case series and case reports evaluating the safety of azithromycin in children. The Cochrane risk of bias tool, Newcastle-Ottawa and quality assessment tools, and The Joanna Briggs Institute Critical Appraisal tools will be used for quality assessment. Meta-analyses will be conducted to the incidence of ADRs from RCTs if appropriate. Subgroup analyses will be performed in different age and azithromycin dosage groups.Ethics and dissemination Formal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication.PROSPERO registration number CRD42018112629