{"id":"iopromide","rwe":[{"pmid":"41896766","year":"2026","title":"Iopromide CT peritoneography for diagnosis and management of dialysate scrotal leakage in continuous ambulatory peritoneal dialysis.","finding":"","journal":"BMC nephrology","studyType":"Clinical Study"},{"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":"41801438","year":"2026","title":"A novel sirolimus-coated balloon versus a paclitaxel-coated balloon for coronary artery disease: the SELSEQ registry.","finding":"","journal":"Clinical research in cardiology : official journal of the German Cardiac Society","studyType":"Clinical Study"},{"pmid":"41724881","year":"2026","title":"Iodinated Contrast-Induced AGEP and ALEP: Recognition, Diagnosis, and Management.","finding":"","journal":"International journal of dermatology","studyType":"Clinical Study"},{"pmid":"41719700","year":"2026","title":"Intravenous iodinated contrast media transiently increases urine specific gravity and pH without affecting other urinalysis parameters after computed tomography examination in dogs.","finding":"","journal":"Journal of the American Veterinary Medical Association","studyType":"Clinical Study"}],"tags":[{"label":"Radiographic Contrast Agent","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"V08AB05","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Intra-Arterial","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Bayer Hlthcare","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Contrast Media","category":"pharmacology"},{"label":"Diagnostic Uses of Chemicals","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":["WARNING: NOT FOR INTRATHECAL USE WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning. Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ULTRAVIST is not approved for intrathecal use. (5.1)"],"safetySignals":[{"llr":753.144,"date":"","count":355,"signal":"Urticaria","source":"DrugCentral FAERS","actionTaken":"Reported 355 times (LLR=753)"},{"llr":423.447,"date":"","count":81,"signal":"Contrast media reaction","source":"DrugCentral FAERS","actionTaken":"Reported 81 times (LLR=423)"},{"llr":396.416,"date":"","count":137,"signal":"Anaphylactic shock","source":"DrugCentral FAERS","actionTaken":"Reported 137 times (LLR=396)"},{"llr":381.074,"date":"","count":120,"signal":"Nephropathy toxic","source":"DrugCentral FAERS","actionTaken":"Reported 120 times (LLR=381)"},{"llr":311.654,"date":"","count":209,"signal":"Erythema","source":"DrugCentral FAERS","actionTaken":"Reported 209 times (LLR=312)"},{"llr":306.432,"date":"","count":270,"signal":"Pruritus","source":"DrugCentral FAERS","actionTaken":"Reported 270 times (LLR=306)"},{"llr":289.455,"date":"","count":63,"signal":"Contrast media allergy","source":"DrugCentral FAERS","actionTaken":"Reported 63 times (LLR=289)"},{"llr":277.526,"date":"","count":40,"signal":"Contrast encephalopathy","source":"DrugCentral FAERS","actionTaken":"Reported 40 times (LLR=278)"},{"llr":235.891,"date":"","count":82,"signal":"Sneezing","source":"DrugCentral FAERS","actionTaken":"Reported 82 times (LLR=236)"},{"llr":178.613,"date":"","count":289,"signal":"Dyspnoea","source":"DrugCentral FAERS","actionTaken":"Reported 289 times (LLR=179)"},{"llr":161.76,"date":"","count":102,"signal":"Blood pressure decreased","source":"DrugCentral FAERS","actionTaken":"Reported 102 times (LLR=162)"},{"llr":148.527,"date":"","count":119,"signal":"Loss of consciousness","source":"DrugCentral FAERS","actionTaken":"Reported 119 times (LLR=149)"},{"llr":133.264,"date":"","count":48,"signal":"Eyelid oedema","source":"DrugCentral FAERS","actionTaken":"Reported 48 times (LLR=133)"},{"llr":128.506,"date":"","count":84,"signal":"Anaphylactic reaction","source":"DrugCentral FAERS","actionTaken":"Reported 84 times (LLR=129)"},{"llr":118.674,"date":"","count":39,"signal":"Laryngeal oedema","source":"DrugCentral FAERS","actionTaken":"Reported 39 times (LLR=119)"}],"commonSideEffects":[{"effect":"Headache","drugRate":"4%","severity":"common"},{"effect":"Nausea","drugRate":"3.7%","severity":"common"},{"effect":"Vasodilatation","drugRate":"2.6%","severity":"mild"},{"effect":"Vomiting","drugRate":"1.9%","severity":"mild"},{"effect":"Back pain","drugRate":"1.9%","severity":"mild"},{"effect":"Urinary urgency","drugRate":"1.8%","severity":"mild"},{"effect":"Chest pain","drugRate":"1.6%","severity":"mild"},{"effect":"Dysgeusia","drugRate":"1.3%","severity":"mild"},{"effect":"Abnormal vision","drugRate":"1.1%","severity":"mild"},{"effect":"Injection site and infusion site reactions","drugRate":"3.7%","severity":"common"},{"effect":"One or more adverse reactions","drugRate":"24%","severity":"serious"},{"effect":"Sensations of warmth","drugRate":"reported","severity":"unknown"},{"effect":"Bradycardia","drugRate":"reported","severity":"unknown"},{"effect":"Atrioventricular block (complete)","drugRate":"reported","severity":"unknown"},{"effect":"Ventricular extrasystole","drugRate":"reported","severity":"unknown"},{"effect":"Abdominal discomfort","drugRate":"reported","severity":"unknown"},{"effect":"Abdominal pain","drugRate":"reported","severity":"unknown"},{"effect":"Constipation","drugRate":"reported","severity":"unknown"},{"effect":"Diarrhea","drugRate":"reported","severity":"unknown"},{"effect":"Dry mouth","drugRate":"reported","severity":"unknown"},{"effect":"Dyspepsia","drugRate":"reported","severity":"unknown"},{"effect":"Gastrointestinal disorder","drugRate":"reported","severity":"unknown"},{"effect":"Gastrointestinal pain","drugRate":"reported","severity":"unknown"},{"effect":"Salivation increased","drugRate":"reported","severity":"unknown"},{"effect":"Stomach discomfort","drugRate":"reported","severity":"unknown"},{"effect":"Rectal tenesmus","drugRate":"reported","severity":"unknown"}],"specialPopulations":{"Lactation":"There are no data on the presence of iopromide 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.","Pregnancy":"There are no data on ULTRAVIST Injection use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Iopromide crosses the placenta and reaches fetal tissues in small amounts.","Geriatric use":"Middle-aged and elderly patients, without significantly impaired renal function, who received ULTRAVIST injection in doses corresponding to 9-30 iodine, had mean steady-state volumes of distribution that ranged between 30-40 L.","Paediatric use":"The safety and efficacy of ULTRAVIST injection 300 mg iodine per mL have been established in pediatric patients over 2 years of age for CT of the body and head."}},"trials":[],"aliases":[],"company":"Bayer","patents":[],"pricing":[],"allNames":"ultravist 370","offLabel":[],"synonyms":["iopromide","iopromidum"],"timeline":[{"date":"1995-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from BAYER HLTHCARE to Bayer Hlthcare"},{"date":"1995-05-10","type":"positive","source":"DrugCentral","milestone":"FDA approval (Bayer Hlthcare)"}],"aiSummary":"Ultravist 370 (Iopromide) is a radiographic contrast agent, a small molecule developed by Bayer Healthcare, which remains under the company's ownership. It is used to enhance the visibility of internal structures during medical imaging procedures. Although its target is unknown, it has been FDA-approved since 1995 for various indications. As an off-patent product, there are currently no generic manufacturers. Key safety considerations include its 2.6-hour half-life.","approvals":[{"date":"1995-05-10","orphan":false,"company":"BAYER HLTHCARE","regulator":"FDA"}],"brandName":"Ultravist 370","ecosystem":[],"mechanism":{"novelty":"Follow-on","moaClass":"X-Ray Contrast Activity","modality":"Small Molecule","drugClass":"Radiographic Contrast Agent","explanation":"ULTRAVIST injection is nonionic, water soluble, tri-iodinated x-ray contrast agent for intravascular administration. Intravascular injection of ULTRAVIST injection opacifies those vessels in the path of flow of the contrast agent, permitting radiographic visualization of the internal structures until significant hemodilution occurs.","oneSentence":"Ultravist 370 works by accumulating in body fluids and tissues, allowing for enhanced contrast in medical imaging.","technicalDetail":"Iopromide is a non-ionic, tri-iodinated contrast agent that distributes throughout the extracellular space, providing high contrast for radiographic imaging."},"commercial":{"launchDate":"1995","_launchSource":"DrugCentral (FDA 1995-05-10, BAYER HLTHCARE)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1468","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=IOPROMIDE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=IOPROMIDE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T12:08:25.784665","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 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