{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,14]],"date-time":"2026-04-14T21:22:45Z","timestamp":1776201765662,"version":"3.50.1"},"reference-count":34,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2024,9,7]],"date-time":"2024-09-07T00:00:00Z","timestamp":1725667200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,2,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background and Aims<\/jats:title>\n                  <jats:p>Corticosteroids are widely used in managing inflammatory bowel disease (IBD). While adverse events (AEs) of corticosteroids are well recognized, current understanding of corticosteroid-related AE burden in IBD remains incomplete.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>AE reports for prednisone\/prednisolone and budesonide were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) and VigiBase databases. Total and frequently reported AEs were tabulated, and AEs of special interest were compared with reports for all drugs using proportional reporting ratio criteria. Database reports were compared with AEs reported in a patient survey capturing corticosteroid exposure and AE recall.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In FAERS and VigiBase, 344\u00a0140 and 42\u00a0836 AEs were reported, respectively, in patients with IBD; among these, 10\u00a0157 (3.0%) and 11\u00a0391 (26.6%), respectively, were related to prednisone\/prednisolone or budesonide. AEs associated with corticosteroid use in IBD increased over time. Adrenal insufficiency, Cushingoid complications, osteonecrosis, osteoporosis, diabetes, and pancreatitis were disproportionately reported for corticosteroids. Among 9229 patients who responded to the survey, 6434 (69.7%) reported corticosteroid exposure. AEs were more frequently recalled by patients exposed to prednisone (61.9%) vs budesonide (27.4%; p\u2005=\u20050.0001). The most commonly recalled AEs differed from those reported in the pharmacovigilance databases and included weight gain, sleep problems, mood disturbance, and skin changes. Younger patients and those with mental health disorders were more likely to recall suicidal thoughts\/attempts.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Adverse events associated with IBD-related corticosteroid use were frequent. Patients reported AEs affecting quality of life, while clinicians disproportionately reported AEs based on objective diagnostic criteria.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjae138","type":"journal-article","created":{"date-parts":[[2024,9,7]],"date-time":"2024-09-07T17:31:42Z","timestamp":1725730302000},"source":"Crossref","is-referenced-by-count":4,"title":["Differences in the Adverse Event Burden of Corticosteroid Use in Inflammatory Bowel Disease as Reported Between Adverse Event Reporting Systems and a Patient Questionnaire"],"prefix":"10.1093","volume":"19","author":[{"given":"Eman","family":"Al Sulais","sequence":"first","affiliation":[{"name":"Department of Gastroenterology, Addenbrooke\u2019s Hospital, Cambridge University Hospitals , Cambridge ,","place":["UK"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edouard","family":"Louis","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, CHU Li\u00e8ge University Hospital , Li\u00e8ge ,","place":["Belgium"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2016-6991","authenticated-orcid":false,"given":"Bernd","family":"Bokemeyer","sequence":"additional","affiliation":[{"name":"Interdisciplinary Crohn Colitis Centre Minden , Minden ,","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Krisztina B","family":"Gecse","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology , Amsterdam UMC, Amsterdam ,","place":["The Netherlands"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5285-7714","authenticated-orcid":false,"given":"Gareth C","family":"Parkes","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Royal London Hospital , London ,","place":["UK"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miles","family":"Parkes","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Addenbrooke\u2019s Hospital, Cambridge University Hospitals , Cambridge ,","place":["UK"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Selinger","sequence":"additional","affiliation":[{"name":"Leeds Gastroenterology Institute, Leeds Teaching Hospitals NHS Trust , Leeds ,","place":["UK"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melvin","family":"Munsaka","sequence":"additional","affiliation":[{"name":"AbbVie Inc. , North Chicago, IL ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meng","family":"Liu","sequence":"additional","affiliation":[{"name":"AbbVie Inc. , North Chicago, IL ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Crooks","sequence":"additional","affiliation":[{"name":"AbbVie Ltd , Maidenhead ,","place":["UK"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tricia","family":"Finney-Hayward","sequence":"additional","affiliation":[{"name":"AbbVie Ltd , Maidenhead ,","place":["UK"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tim","family":"Raine","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Addenbrooke\u2019s Hospital, Cambridge University Hospitals , Cambridge ,","place":["UK"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2024,9,7]]},"reference":[{"key":"2025021912241515800_CIT0001","doi-asserted-by":"crossref","first-page":"e0158017","DOI":"10.1371\/journal.pone.0158017","article-title":"Corticosteroid use and complications in a US inflammatory bowel disease cohort","volume":"11","author":"Waljee","year":"2016","journal-title":"PLoS One"},{"key":"2025021912241515800_CIT0002","doi-asserted-by":"crossref","first-page":"497","DOI":"10.3399\/bjgp18X699341","article-title":"Using corticosteroids appropriately in inflammatory bowel disease: a guide for primary care","volume":"68","author":"Barrett","year":"2018","journal-title":"Br J Gen Pract"},{"key":"2025021912241515800_CIT0003","doi-asserted-by":"crossref","first-page":"753","DOI":"10.1016\/j.otc.2010.04.003","article-title":"A comprehensive review of the adverse effects of systemic corticosteroids","volume":"43","author":"Poetker","year":"2010","journal-title":"Otolaryngol Clin North Am"},{"key":"2025021912241515800_CIT0004","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1186\/1465-9921-15-37","article-title":"Evidence suggesting that oral corticosteroids increase mortality in stable chronic obstructive pulmonary disease","volume":"15","author":"Horita","year":"2014","journal-title":"Respir Res"},{"key":"2025021912241515800_CIT0005","doi-asserted-by":"crossref","first-page":"769","DOI":"10.1093\/ecco-jcc\/jjx009","article-title":"Third European evidence-based consensus on diagnosis and management of ulcerative colitis. 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