{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T09:03:14Z","timestamp":1784624594643,"version":"3.55.0"},"reference-count":54,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T00:00:00Z","timestamp":1784592000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Background: Hepatotoxicity induced by atomoxetine (ATX) and methylphenidate (MPH) when used to treat ADHD is a rare but potentially serious complication. This study aims to describe the hepatic adverse drug reactions (ADRs) reported for ATX and MPH by analysing data from the EudraVigilance database. Methods: Individual case safety reports (ICSRs) listing ATX and\/or MPH as suspected drugs and reporting at least one adverse event (AE) within the \u2018hepatobiliary disorders\u2019 system organ class (SOC) were extracted for the period from 1 January 2012 to 20 May 2025. Descriptive and disproportionality analyses were then performed. Results: During the study period, 421 ICSRs reporting AEs classified under the \u201chepatobiliary disorders\u201d SOC and involving ATX and\/or MPH as suspected drugs were retrieved (ATX, N = 232; MPH, N = 181). Most cases involved adult (N = 261) and female (N = 222) patients. The majority of reports were classified as serious (N = 349). Overall, 375 AEs were identified. Drug-induced liver injury (DILI) was the most frequently reported AE (N = 103 ATX; N = 47 MPH), followed by hepatitis (N = 20 ATX; N = 9 MPH) and jaundice (N = 15 ATX; N = 20 MPH). The disproportionality analysis, based on a head-to-head comparison, showed a higher reporting frequency of hepatobiliary disorders for ATX compared to MPH (ROR 2.41 [95%CI 2.11\u20133.11]). Specifically, ATX was associated with significantly higher reporting frequencies than MPH for the AEs of DILI, hepatitis, and jaundice (6.42 [4.45\u20139.06]; 6.48 [2.95\u201314.24]; and 2.19 [1.12\u20134.27], respectively). Conclusions: This analysis, based on the EudraVigilance database, suggests that both drugs are associated with hepatobiliary adverse drug reactions, with a higher overall reporting frequency observed for ATX.<\/jats:p>","DOI":"10.3390\/ph19071122","type":"journal-article","created":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T08:14:27Z","timestamp":1784621667000},"page":"1122","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Hepatic Safety Profile of Atomoxetine and Methylphenidate in Patients with ADHD: Disproportionality Analysis Using EudraVigilance Database Data"],"prefix":"10.3390","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-4497-3836","authenticated-orcid":false,"given":"Raffaella","family":"Di Napoli","sequence":"first","affiliation":[{"name":"Department of Experimental Medicine, University of Campania \u201cL. Vanvitelli\u201d, 80138 Naples, Italy"},{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-8975-4019","authenticated-orcid":false,"given":"Ludovica Vittoria","family":"Laino","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, University of Campania \u201cL. Vanvitelli\u201d, 80138 Naples, Italy"},{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Concetta","family":"Rafaniello","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, University of Campania \u201cL. Vanvitelli\u201d, 80138 Naples, Italy"},{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luigi","family":"Di Costanzo","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, University of Campania \u201cL. Vanvitelli\u201d, 80138 Naples, Italy"},{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Giuseppa","family":"Sullo","sequence":"additional","affiliation":[{"name":"Azienda Ospedaliera Universitaria Luigi Vanvitelli, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9216-922X","authenticated-orcid":false,"given":"Cristina","family":"Scavone","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, University of Campania \u201cL. Vanvitelli\u201d, 80138 Naples, Italy"},{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"},{"name":"Department of Life Science, Health, and Health Professions, Link Campus University, 00165 Roma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annalisa","family":"Capuano","sequence":"additional","affiliation":[{"name":"Department of Experimental Medicine, University of Campania \u201cL. Vanvitelli\u201d, 80138 Naples, Italy"},{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,21]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"e20192528","DOI":"10.1542\/peds.2019-2528","article-title":"Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit\/Hyperactivity Disorder in Children and Adolescents","volume":"144","author":"Wolraich","year":"2019","journal-title":"Pediatrics"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"462","DOI":"10.1542\/peds.2010-0165","article-title":"Patterns of Comorbidity, Functioning, and Service Use for US Children with ADHD, 2007","volume":"127","author":"Larson","year":"2011","journal-title":"Pediatrics"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1016\/B978-0-444-64148-9.00003-X","article-title":"Attention Deficit Hyperactivity Disorder","volume":"174","author":"Antshel","year":"2020","journal-title":"Handb. 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