Abstract Flutamide is a nonsteroidal antiandrogen, used like therapy a long term for the prostate cancer. Between the indirects effects the hepatic toxicity is included, which is very rarely reported. The case of an adult of 71 years old with prostate cancer appears that develops episode of cholestatic hepatitis during treatment with fl utami-de. After to suspend fl utamide the patient it recovers progressively his hepatic function, but he presented a recurrence more severely upon reintroduction of the drug.The resumption of the treatment after a fi rst episode of toxic hepatitis is not justifi ed and is necessary to consider the hepatic toxicity of the drug, when it is decided to indicate it like treatment. Key words Flutamide, hepatotoxicity, cholestatic hepatitis, prostate cancer. INTRODUCTION Hepatotoxicity induced by medications accounts for bet-ween 2% and 5% of cases hospitalized because of jaundice, including 40% of patients older than 50 years of age with hepatitis. Sgro et. al. found an annual incidence of 13.9% per 100,000 habitants. Th ey also found that it is the main cause of fulminant hepatic failure. It can be the result of any one of several medications, including fl utamide (1, 2).Flutamide is a nonsteroidal antiandrogen prescribed for the treatment of advanced prostate cancer, hirsutism (3, 4) and in benign prostatic hyperplasia (4-6). Th e eff ect is developed through an active metabolite, 2-Hidroxy-fl uta-mide. It competitively inhibits capture and/or union of androgens in target tissues, but it also inhibits liberation of gonadotropins from hypophysis (3, 7-9). Aft er administra-tion, it is well absorbed and circulates almost exclusively in the active form. It reaches maximum levels in 2 to 4 hours, and has an average life of 5 to 6 hours. It is metabolized in the liver and eliminated in urine (9). Even though Flutamide is a safe and well-tolerated medi-cation, it is not exempt from adverse eff ects. Th e most fre-quent (>10%) are: • Endocrinological and metabolic diseases: galactorrhea and gynecomastia (9% -42%), erectile dysfunction, decreased libido.• Gastrointestinal diseases: nausea, vomiting (11%-12%), diarrhea.• Hepatic diseases: mild increases of transaminases (mostly GPT) and of lactate dehydrogenase (LDH).In lesser proportion (1-10%):• Cardiovascular diseases: hypertension (1%).• Hematologic diseases: anemia (6%), leucopenia (3%), thrombocytopenia (1%).• Neuro-muscular diseases: muscle weakness (1%).It very seldom (< 1%) produces pneumonitis caused by hypersensitivity, pulmonary embolism, jaundice, hepatitis and hepatic failure.