Introduction: Drug induced liver injury (DILI) is one of the most prominent causes of hepatic dysfunction. Nevertheless, many cases tend to be underreported given its difficult diagnosis, which distorts the epidemiological reality of the condition. Objectives: To characterize the clinical and epidemiological features of DILI patients in a reference center from Brazil. Methods: Consecutive in and outpatient were enrolled with hepatotoxicity from Hospital Universitário Professor Edgard Santos between 2016-2020. The patients were selected as follows: adults with compatible chronology of drug exposure, excluding other etiologies and considering hepatotoxic potential of the drug. Histopathology was performed in inconclusive cases. All cases were followed until discharge and validated by an international reference center: Malaga University - Spain. Results: Out of 47 patients included, 33 were females (70%). The average age was 44,8 years (17-72). The main symptoms were fatigue, nausea and jaundice. The biochemical pattern was mostly hepatocellular (74%) - 17% has presented a cholestatic pattern and 9% were mixed. Table 1 provides an overview of the implicated substances and shows a high incidence of herbal and dietary supplements (21%) and anabolic steroids (8%). Antibiotics were responsible for hepatotoxicity in the majority of cases (13 patients - 27%), from which 4 were due to antitubercular medications (rifampicin and isoniazid).As a single agent, nimesulide, stanozolol and isoniazid were responsible for 8% each. 36% of the cases were considered mild, 53% were moderate and 11% were severe, from which one patient needed transplantation and one died. 57% of all patients needed hospitalization. Chronic cases represented 8% of the total. Conclusion: DILI is a underreported diseases and it is necessary local and multicentric consortiums cohorts to improve our knowledge about it. Special attention should be paid to the high relative frequency of DILI through the use of nimesulide, antituberculostatics, stanazolol, herbs and dietary supplements.
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