Auto-immune diseases, including auto-immune hepatitis may be associated with the use of drugs, such as anti-TNF-α inhibitors. The aim of the study was to analyze the characteristics of anti-TNF-α inhibitor-associated auto-immune hepatitis (ATIAIH) in a large international pharmacovigilance database. We analyzed all ICSRs classified as "Autoimmune hepatitis" according to the Medical Dictionary for Drug Regulatory Activities term (preferred term level) in VigiBase, the World Health Organization global pharmacovigilance database of adverse drug reactions collected by national drug authorities in >130 countries (>90% of the world population). Bayesian disproportionality analysis was used to compute IC