{"entity":{"id":"gadodiamide","kind":"drug","name":"Gadodiamide","aka":["gadodiamide","Omniscan"],"tldr":"An older MRI dye given into a vein for scans of the brain, spine, chest, abdomen and pelvis.","summary":"GE Healthcare's Omniscan (NDA 020123, first approved 8 January 1993) is indicated to \"Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues\" and to \"Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space\". ATC V08CA03. Like every gadolinium-based contrast agent in the United States, its label carries a boxed warning on the risks of intrathecal use and nephrogenic systemic fibrosis, a thickening of skin and organs seen in people with severe kidney disease.","status":"approved","asOf":"2026-11-04","links":[{"label":"Drugs@FDA Omniscan (NDA 020123)","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020123"},{"label":"DailyMed label: Omniscan","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a"},{"label":"WHO ATC index V08CA: paramagnetic contrast media","url":"https://atcddd.fhi.no/atc_ddd_index/?code=V08CA&showdescription=no"}],"tags":["contrast-agents-gaps-2026-11","diagnostic"],"related":[],"cancers":[],"sections":[],"technologies":["gadolinium-based-contrast-agents","mri"],"targets":[],"drugs":[],"companies":["ge-healthcare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo contrast agent gap fill (Drugs@FDA, FDA labels, DailyMed, EMA register, WHO ATC index)","editedOn":"2026-11-04"},"brand":"Omniscan","modality":"Gadolinium-based contrast agent for MRI (intravenous)","mechanism":"A gadolinium chelate that brightens tissue on MRI where it leaks from blood vessels.","approvals":[{"region":"US","year":1993,"indication":"MRI of lesions with abnormal vascularity in the central nervous system and the body","note":"NDA 020123; GE Healthcare"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/gadodiamide/","neighbours":{"technology":[{"id":"gadolinium-based-contrast-agents","kind":"technology","name":"Gadolinium-based and other MRI contrast agents","route":"/technologies/gadolinium-based-contrast-agents/"},{"id":"mri","kind":"technology","name":"MRI","route":"/technologies/mri/"}],"company":[{"id":"ge-healthcare","kind":"company","name":"GE HealthCare","route":"/companies/ge-healthcare/"}]}}