Adverse drug reactions among children with tuberculosis in China: a multicentre study, 2017-2022

Objective Although tuberculosis (TB) treatment, if adequately taken and adhered to, is highly effective. To investigate the occurrence, frequency and related factors of adverse drug reactions (ADRs) during anti-TB treatment in children in China. Methods We conducted a multicentre study and collected data from 11 representative paediatric specialists and general hospitals offering anti-TB treatment. The outcome of interest was the occurrence of any ADRs. Multivariable logistic regression was performed to explore factors associated with ADRs and to identify groups at high-risk for ADRs. Results In total, 482 patients were enrolled; of whom, 94 (19%) reported an ADR. The most common ADRs were blood system damage (24%) and gastrointestinal reactions (24%). Most ADRs occurred within the intensive treatment period and were of short duration. Children with severe TB or those treated with HRZ(E) + second-line drugs in the intensive phase were at higher odds of developing ADRs (OR = 2.44, 95% CI: 1.36-4.39, p = 0.003; OR = 3.70, 95% CI: 2.01-6.81, p Conclusions ADRs are prevalent in Chinese paediatric TB patients, predominantly haematological or gastrointestinal, transient during the intensive phase. Severe disease and HRZ(E) + second-line regimens confer elevated risk, necessitating targeted surveillance and optimized paediatric therapies balancing efficacy and safety.