Summary  Severe cases of drug-induced liver injury (DILI), including cases with fatal outcome, have recently been reported in patients treated with Esbriet (pirfenidone).  Liver function tests (ALT, AST, bilirubin) should be performed before starting treatment with Esbriet (pirfenidone), every month for the first 6 months and then every 3 months for the duration of treatment.  Prompt clinical evaluation and liver function tests should be performed in patients with symptoms indicating drug-induced liver injury, such as fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.  Elevated transaminases may require dose reduction, interruption or permanent discontinuation of Esbriet (pirfenidone). In the event of significant elevation of liver aminotransferases with hyperbilirubinaemia or clinical signs and symptoms of drug-induced liver injury, the dose of Esbriet (pirfenidone) should be permanently discontinued.