Excipients are auxiliary substances involved in the composition of pharmaceuticals. Although excipients are defined as inert substances, this definition has been proved inadequate. Most excipients are used in low concentrations, although they can lead to untoward effects. In clinical practice, such reactions are wrongly attributed to the active drug, leaving out of account the fact that excipients are considered responsible for adverse effects. The objective of the present study was identify the presence of excipients which can possibly induce adverse reactions, present in drugs marketed for pediatric use in Brazil. This qualitative and exploratory study used the technique of document analysis to assess drug labels of liquid formulations listed in the Pharmaceutical Dictionary and directed at the pediatric population.

Four pharmaceuticals were selected:

acebrophylline, dimethicone, dipyrone and paracetamol. The excipients cited in the literature as possible inducers of adverse reactions were selected for this study from their identification in the pharmaceutical formulations studied. In 40 presentations assessed, 23 excipients were identified as possible inducers of adverse reactions. The presence of a risk excipient was identified in 97.5% of the formulations assessed, according to the following distribution: 24 contained methyl paraben, 20 propyl paraben, 11 sorbitol, 9 sodium benzoate, 5 tartrazine and 2 sodium bisulfite. Pediatric patients are exposed to adverse effects such as urticaria, bronchial asthma, gastrointestinal upset, nausea, vomiting and others, due to the presence of the excipients methylparaben and propylparaben, sodium benzoate, sulfites in general, tartrazine yellow dye and sorbitol, in most liquid formulations assessed, most of them marketed as over-the-counter drugs.