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Adverse effects on the oral mucosa after the use of dermal fillers have been reported due to their increased use for facial aesthetics.This study aimed to evaluate, clinically and histologically, the local and systemic effects of two concentrations of polymethylmethacrylate (PMMA) dermal filler in rats.Fifty-four female rats were allocated into three treatment groups (2% PMMA, 30% PMMA and 0.9% NaCl), according to the substance injected in the tongue, and three experimental periods: 7, 60 and 90 days. The rats were clinically evaluated and then euthanised, and their tongue and right kidney removed. The histological sections were stained with haematoxylin/eosin and picrosirius.Clinically, significant differences were found between test groups as to the occurrence of nodules (Kruskal–Wallis; p < 0.001). Histologically, there was greater inflammatory response in the PMMA compared with control (Kruskal–Wallis; p < 0.001). 30% PMMA had greater collagen formation (anova mixed models; p < 0.01). No migration of the material towards kidney was found.Polymethylmethacrylate induced intense reaction in the initial period of observation (7 days), followed by gradual decrease during the study, favouring the presence of fibroplasia adjacent to the material.