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Background and aim To date few studies have shown a significant association between the off-label drug use and adverse drug reactions. (ADRs). The main aims of this study are to evaluate the relationship between adverse drug reactions and unlicensed or off-label drugs prospectively in hospitalised children and to provide more information on prescribing practice, the amplitude, nature and consequences of unlicensed or off-label drug use in paediatric inpatients. Methods In this ongoing multi-centre prospective study, the French summaries of product characteristics in Theriaque (a prescription products guide ) are being used as a primary reference source for determining paediatric drug labelling. Detection of ADRs is carried out by health care professionals and research groups using a trigger tool and patients’ electronic health records. The causality between suspected ADRs and medication is evaluated using the Naranjo and the French methods of imputability. Preliminary results for a 6 month period: 40% of the 73 detected ADRs were estimated as severe. 1498 patients have been included. Conclusions This is the first large multi-centre prospective study in France that evaluates the relationship between adverse drug reactions and unlicensed or off-label drugs in hospitalised children. This study will help to identify the risk factors that could be used to adjust preventive actions in children care, guide future research in the field and increase the awareness of physicians in detecting and declaring ADRs. This study is funded by l’ANSM (French national agency of drug security).