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OBJECTIVE: Drug-induced liver injury (DILI) is more often a challenge even for expert clinicians. Presently, there are limited data about the epidemiology, because the real incidence and prevalence of the disorder are underestimated, and further, sometimes the pharmacovigilance chain is unsuccessful as cases are largely underreported. We review available literature data and discuss our clinical experience regarding a prospective cohort of 185 patients with a diagnosis of DILI.MATERIALS AND METHODS: Significant papers were identified by literature search, and selected based on content including the epidemiology of DILI. By analyzing our prospective cohort, consecutively collected since January 2000 to December 2016 at our tertiary referral center for liver disease, we report the frequency of different drug classes involved in DILI and their related clinical outcomes.RESULTS: In our cohort of 185 patients, 56% were females and 44% males; the mean age was 53 years, even if about 70% of patients were 40 years old; only 2% had a previous chronic liver disease. At clinical presentation, 57.8% showed a hepatocellular pattern, whereas 18.3% a cholestatic and 23.2% a mixed one. Antibiotics were involved for 23.4%, NSAIDs for 35.5%, immunosuppressants for 10.9%, statins for 4.3%, anti-platelets and anti-psychiatric drugs for 7.6%, and other drugs for 9%. Regarding the evolution, antibiotics, NSAIDs, and immunosuppressant were frequently responsible for chronicity, whereas statins, anti-psychiatric and anti-platelets drugs were not.CONCLUSIONS: In this review, we discuss our clinical experience in the field of DILI, in which many efforts are required to reinforce the attention of a physician to the possibility that a patient with the acute liver disease could be diagnosed as a patient with DILI.