The safety and efficacy of drugs may be different in children compared to adults. The available documentation at the time of approval for drug use in humans invariably lack data for use in children as generally children are not exposed to medicines in clinical trials. As such, in order to clarify a safety profile in children and to limit the occurrence of adverse drug reactions (ADR), long term data collection is necessary. There is a need to consider how pharmacovigilance is conducted for medicines used by children. It is the ethical responsibility of all health professionals to report ADR. Currently, ADRs in children does not appear to be at a critical level. Certainly, a high standard of care could be a reason but the possibility of health professionals underreporting ADRs has to be considered. Furthermore, many drugs used in children are not licensed for use in this age group. This may further limit the reporting of suspected ADRs to the pharmacovigilance systems.