{"id":"iodixanol","rwe":[{"pmid":"41889701","year":"2026","title":"Adverse Drug Event Profile of Radiocontrast Iodine in Elderly: A Retrospective Focused Pharmacovigilance-Based Disproportionality Analysis Study.","finding":"","journal":"Hospital pharmacy","studyType":"Clinical Study"},{"pmid":"41790685","year":"2026","title":"Low concentration isotonic iodixanol on hepatic and portal veins imaging quality and renal function: A 320-detector CT dual-energy study.","finding":"","journal":"Medicine","studyType":"Clinical Study"},{"pmid":"41767248","year":"2025","title":"Plant-derived nanovesicles from Ginkgo biloba seeds mitigate LPS-induced endothelial dysfunction and promote vascular homeostasis.","finding":"","journal":"Frontiers in bioengineering and biotechnology","studyType":"Clinical Study"},{"pmid":"41747948","year":"2026","title":"An improved comprehensive method for collecting single nuclei from shrimp ovaries.","finding":"","journal":"Developmental and comparative immunology","studyType":"Clinical Study"},{"pmid":"41743965","year":"2026","title":"Transient cortical blindness following coronary angiography: a case report.","finding":"","journal":"Frontiers in cardiovascular medicine","studyType":"Clinical Study"}],"tags":[{"label":"Radiographic Contrast Agent","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"V08AB09","category":"atc"},{"label":"Intravascular","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Ge Healthcare","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Contrast Media","category":"pharmacology"},{"label":"Diagnostic Uses of Chemicals","category":"pharmacology"}],"phase":"marketed","safety":{"keyWarnings":["Extravasation an"],"boxedWarnings":["WARNING: NOT FOR INTRATHECAL USE Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Contraindications ( 4 ) and Adverse Reactions ( 5.1 )] . WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage,"],"safetySignals":[{"llr":451.808,"date":"","count":320,"signal":"Pruritus","source":"DrugCentral FAERS","actionTaken":"Reported 320 times (LLR=452)"},{"llr":328.23,"date":"","count":64,"signal":"Contrast media reaction","source":"DrugCentral FAERS","actionTaken":"Reported 64 times (LLR=328)"},{"llr":314.15,"date":"","count":190,"signal":"Urticaria","source":"DrugCentral FAERS","actionTaken":"Reported 190 times (LLR=314)"},{"llr":283.254,"date":"","count":187,"signal":"Erythema","source":"DrugCentral FAERS","actionTaken":"Reported 187 times (LLR=283)"},{"llr":239.744,"date":"","count":75,"signal":"Acute generalised exanthematous pustulosis","source":"DrugCentral FAERS","actionTaken":"Reported 75 times (LLR=240)"},{"llr":167.103,"date":"","count":227,"signal":"Rash","source":"DrugCentral FAERS","actionTaken":"Reported 227 times (LLR=167)"},{"llr":155.037,"date":"","count":186,"signal":"Acute kidney injury","source":"DrugCentral FAERS","actionTaken":"Reported 186 times (LLR=155)"},{"llr":144.321,"date":"","count":86,"signal":"Anaphylactic reaction","source":"DrugCentral FAERS","actionTaken":"Reported 86 times (LLR=144)"},{"llr":135.171,"date":"","count":69,"signal":"Rash maculo-papular","source":"DrugCentral FAERS","actionTaken":"Reported 69 times (LLR=135)"},{"llr":127.617,"date":"","count":20,"signal":"Contrast encephalopathy","source":"DrugCentral FAERS","actionTaken":"Reported 20 times (LLR=128)"},{"llr":114.745,"date":"","count":29,"signal":"Contrast media allergy","source":"DrugCentral FAERS","actionTaken":"Reported 29 times (LLR=115)"},{"llr":109.292,"date":"","count":56,"signal":"Eosinophilia","source":"DrugCentral FAERS","actionTaken":"Reported 56 times (LLR=109)"},{"llr":94.024,"date":"","count":19,"signal":"Anaphylactoid shock","source":"DrugCentral FAERS","actionTaken":"Reported 19 times (LLR=94)"},{"llr":90.565,"date":"","count":28,"signal":"Anaphylactoid reaction","source":"DrugCentral FAERS","actionTaken":"Reported 28 times (LLR=91)"},{"llr":90.469,"date":"","count":46,"signal":"Anaphylactic shock","source":"DrugCentral FAERS","actionTaken":"Reported 46 times (LLR=90)"}],"commonSideEffects":[{"effect":"Pruritus","drugRate":"LLR 452","severity":"common"},{"effect":"Contrast media reaction","drugRate":"LLR 328","severity":"common"},{"effect":"Urticaria","drugRate":"LLR 314","severity":"common"},{"effect":"Erythema","drugRate":"LLR 283","severity":"common"},{"effect":"Acute generalised exanthematous pustulosis","drugRate":"LLR 240","severity":"common"},{"effect":"Rash","drugRate":"LLR 167","severity":"common"},{"effect":"Acute kidney injury","drugRate":"LLR 155","severity":"common"},{"effect":"Anaphylactic reaction","drugRate":"LLR 144","severity":"common"},{"effect":"Contrast encephalopathy","drugRate":"LLR 128","severity":"common"},{"effect":"Contrast media allergy","drugRate":"LLR 115","severity":"common"},{"effect":"Eosinophilia","drugRate":"LLR 109","severity":"common"},{"effect":"Anaphylactoid shock","drugRate":"LLR 94","severity":"common"},{"effect":"Anaphylactoid reaction","drugRate":"LLR 91","severity":"common"},{"effect":"Anaphylactic shock","drugRate":"LLR 90","severity":"common"}],"specialPopulations":{"Lactation":"There are no data on the presence of iodixanol in human milk, the effects on the breastfed infant or the effects on milk production. Iodinated contrast agents are poorly excreted into human milk and are poorly absorbed by the gastrointestinal tract of breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for iodixanol and any potential adverse effects on the breastfed infant from iodixanol or its metabolites.","Pregnancy":"There are no data with iodixanol use in pregnant women to inform any drug-associated risks. In animal reproduction studies, no developmental toxicity occurred with intravenous iodixanol administration to rats and rabbits at doses up to 0.24 (rat) or 0.48 (rabbit) times the maximum recommended human intravenous dose. All pregnancies have background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.","Geriatric use":"In clinical studies of iodixanol, 254/757 (34%) of patients were 65 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients. Other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious usually starting at the low end of the dosing range.","Paediatric use":"The safety and efficacy of iodixanol have been established in pediatric patients down to birth for angiocardiography, cerebral arteriography, visceral arteriography, CT imaging of the head and body, and excretory urography. The safety and efficacy of iodixanol have also been established in pediatric patients 12 years and older for intra-arterial digital subtraction angiography, peripheral arteriography, peripheral venography and CCTA."}},"trials":[],"aliases":[],"company":"GE HealthCare","patents":[],"pricing":[],"allNames":"visipaque 270","offLabel":[],"synonyms":["iodixanol","visipaque"],"timeline":[{"date":"1996-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from GE HEALTHCARE to Ge Healthcare"},{"date":"1996-03-22","type":"positive","source":"DrugCentral","milestone":"FDA approval (Ge Healthcare)"},{"date":"2022-05-19","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Visipaque 270 (iodixanol) is a radiographic contrast agent developed by GE Healthcare, currently owned by the same company. It is a small molecule drug used to enhance the visibility of internal structures during medical imaging procedures. Visipaque 270 is off-patent and has a generic manufacturer. It has a half-life of 2.1 hours and was FDA-approved in 1996. The exact target of Visipaque 270 is unknown.","approvals":[{"date":"1996-03-22","orphan":false,"company":"GE HEALTHCARE","regulator":"FDA"}],"brandName":"Visipaque 270","ecosystem":[],"mechanism":{"novelty":"Follow-on","moaClass":"X-Ray Contrast Activity","modality":"Small Molecule","drugClass":"Radiographic Contrast Agent","explanation":"Intravascular injection of iodixanol opacifies vessels in the path of flow of the contrast agent, permitting visualization of internal structures.In imaging of the body, iodinated contrast agents diffuse from the vascular into the extravascular space. In normal brain with an intact blood-brain barrier, contrast does not diffuse into the extravascular space. In patients with disrupted blood-brain barrier, contrast agent accumulates in the interstitial space in the region of disruption.","oneSentence":"Visipaque 270 works by increasing the density of fluids in the body, making them visible on X-ray images.","technicalDetail":"Visipaque 270 is a non-ionic, isosmolar iodinated contrast agent that works by increasing the attenuation of X-rays as they pass through the body, allowing for improved visualization of internal structures during medical imaging procedures."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Iodixanol","title":"Iodixanol","extract":"Iodixanol, sold under the brand name Visipaque, is an iodine-containing non-ionic radiocontrast agent.","wiki_society_and_culture":"==Society and culture==\n===Available forms===\nThe contrast can either be given intra-arterialy or intravenously."},"commercial":{"launchDate":"1996","_launchSource":"DrugCentral (FDA 1996-03-22, GE HEALTHCARE)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/3302","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=IODIXANOL","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=IODIXANOL","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Iodixanol","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T12:07:35.827296","biosimilars":[],"competitors":[{"drugName":"metrizamide","drugSlug":"metrizamide","fdaApproval":"1978-08-23","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"iohexol","drugSlug":"iohexol","fdaApproval":"1985-12-26","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ioxaglic acid","drugSlug":"ioxaglic-acid","fdaApproval":"1985-07-26","relationship":"same-class"},{"drugName":"iopamidol","drugSlug":"iopamidol","fdaApproval":"1985-12-31","genericCount":7,"patentStatus":"Off-patent — generic 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