Genotoxic evaluation of pirfenidone using erythrocyte rodent micronucleus assay

► Fibroproliferative diseases are prominent causes of morbidity and mortality worldwide and may lead to metastatic cancer. ► Pirfenidone has been proposed as an alternative treatment in various pathologies that develop fibrosis. ► The erythrocyte micronucleus assay is a simple and highly informative method that detects in vivo chromosome aberrations. ► No evidence of genotoxic or cytotoxic effects of pirfenidone were observed in two adult rodent models. ► No genotoxic effects or cytotoxicity were observed in newborn rats transplacentally exposed to pirfenidone.