RT Journal Article T1 Nitrofurantoin‑induced liver injury: long‑term follow‑up in two prospective DILI registries A1 Bessone, Fernando A1 Ferrari, Antonella A1 Hernandez, Nelia A1 Mendizabal, Manuel A1 Zerega, Alina A1 Tanno, Federico A1 Reggiardo, Maria Virginia A1 Vorobioff, Julio A1 Tanno, Hugo A1 Arrese, Marco A1 Nunes, Vinicius A1 Tagle, Martin A1 Medina-Cáliz, Inmaculada A1 Robles‑Diaz, Mercedes A1 Niu, Hao A1 Álvarez-Álvarez, Ismael A1 Stephens, Camilla A1 Lucena-González, María Isabel A1 Andrade-Bellido, Raúl Jesús K1 Toxicología K1 Hepatitis K1 Antibióticos -- Efectos secundarios AB Nitrofurantoin is a synthetic antibiotic that is recommended as first-choice treatment for uncomplicated urinary tract infections. The prescription of this drug has increased dramatically, especially in Latin American countries. We described the demographics, clinical characteristics, biochemical features, and outcome of nitrofurantoin-induced liver injury. We analyzed 23 cases from the Latin American DILI Network (LATINDILI) and the Spanish DILI Registry. Causality was assessed with the RUCAM and RECAM scale. Of the 23 DILI cases included in our series, 96% patients were women, and the mean age of the whole cohort was 61 years. The median time of drug exposure was 175 days (interquartile range [IQR] 96–760), with 11 patients who were prescribed nitrofurantoin for more than six months. Hepatocellular damage was the most frequent pattern of liver injury (83%), and nearly half of the patients had an asymptomatic presentation (52%). Neither death nor liver transplantation was documented in this series. Overall, 65% of the patients (n = 15) presented with positive autoantibody titres. The median time to resolution was 81 days (IQR 57–141), and 15 patients (83%) recovered within six months. Five patients (22%) developed nitrofurantoin-induced autoimmune-like hepatitis (NI-AILH), of whom two were characterized by a persistent increase in transaminases that required immunosuppressive treatment to achieve normalization of liver enzymes. Clinicians who prescribe nitrofurantoin should be aware that patients who had taken nitrofurantoin for a long term may be at risk of developing nitrofurantoin-induced autoimmune-like hepatitis. PB Springer Nature YR 2022 FD 2022-11-22 LK https://hdl.handle.net/10630/26368 UL https://hdl.handle.net/10630/26368 LA eng NO Bessone, F., Ferrari, A., Hernandez, N., Mendizabal, M., Ridruejo, E., Zerega, A., ... & Andrade, R. J. (2023). Nitrofurantoin-induced liver injury: long-term follow-up in two prospective DILI registries. Archives of Toxicology, 97(2), 593-602. NO Open Access funding provided thanks to the CRUE-CSIC agreement with Springer Nature. Funding for open access charge: Universidad de Málaga / CBUA. The present study has been supported by grants of the Andalusian Health Service (SAS) (contract number: PI-0310-2018), Instituto de Salud Carlos III co-funded by Fondo Europeo de Desarrollo Regional – FEDER (contract numbers: PI18/00901, PI18/01804, PI21/01248), and Agencia Española del Medicamento. CIBERehd is funded by ISCIII. HN holds a postdoctoral research contract funded by Junta de Andalucia (POSTDOC_21_00780). IAA holds a Sara Borrell research contract from the National Health System, ISCIII (CD20/00083). This article/publication is based upon work from COST Action CA17112, supported by COST (European Cooperation in Science and Technology). www.cost.eu DS RIUMA. Repositorio Institucional de la Universidad de Málaga RD 20 ene 2026