{"id":"gadoteridol","rwe":[{"pmid":"41889470","year":"2026","title":"Brain Tumor Imaging with Iopamidol CEST MRI: In Vivo Detection and Validation.","finding":"","journal":"Chemical & biomedical imaging","studyType":"Clinical Study"},{"pmid":"41720517","year":"2026","title":"Gadolinium-Enhanced Portable Ultra-Low Field MRI for Evaluating Various Intracranial Pathologies.","finding":"","journal":"AJNR. American journal of neuroradiology","studyType":"Clinical Study"},{"pmid":"41712162","year":"2026","title":"Microbubble-free mechanical sonoporation for MR-guided drug delivery in solid tumours: a proof-of-concept study.","finding":"","journal":"Drug delivery and translational research","studyType":"Clinical Study"},{"pmid":"41670634","year":"2026","title":"Determination of selected gadolinium-based contrast agents in soil: method validation and application.","finding":"","journal":"Analytical and bioanalytical chemistry","studyType":"Clinical Study"},{"pmid":"41593341","year":"2026","title":"Contrast-enhanced T(1)-weighted MRI, (11)C-DPA-713 PET and (11)C-CPPC PET as predictive imaging biomarkers of neuroinflammation in radiotherapy-induced brain injury.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"}],"tags":[{"label":"Paramagnetic Contrast Agent","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"V08CA04","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Bracco","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Contrast Media","category":"pharmacology"},{"label":"Diagnostic Uses of Chemicals","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":["WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadoteridol injection is not approved for intrathecal use [see Warnings and Precautions ( 5.1 )] . Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired e"],"safetySignals":[{"llr":1190.465,"date":"","count":222,"signal":"Nephrogenic systemic fibrosis","source":"DrugCentral FAERS","actionTaken":"Reported 222 times (LLR=1190)"},{"llr":441.798,"date":"","count":90,"signal":"Skin induration","source":"DrugCentral FAERS","actionTaken":"Reported 90 times (LLR=442)"},{"llr":440.246,"date":"","count":92,"signal":"Skin hypertrophy","source":"DrugCentral FAERS","actionTaken":"Reported 92 times (LLR=440)"},{"llr":383.142,"date":"","count":83,"signal":"Skin tightness","source":"DrugCentral FAERS","actionTaken":"Reported 83 times (LLR=383)"},{"llr":369.756,"date":"","count":47,"signal":"Contrast media deposition","source":"DrugCentral FAERS","actionTaken":"Reported 47 times (LLR=370)"},{"llr":234.464,"date":"","count":57,"signal":"Fibrosis","source":"DrugCentral FAERS","actionTaken":"Reported 57 times (LLR=234)"},{"llr":210.106,"date":"","count":41,"signal":"Skin fibrosis","source":"DrugCentral FAERS","actionTaken":"Reported 41 times (LLR=210)"},{"llr":183.31,"date":"","count":41,"signal":"Joint contracture","source":"DrugCentral FAERS","actionTaken":"Reported 41 times (LLR=183)"},{"llr":179.363,"date":"","count":57,"signal":"Scar","source":"DrugCentral FAERS","actionTaken":"Reported 57 times (LLR=179)"},{"llr":165.94,"date":"","count":65,"signal":"Joint range of motion decreased","source":"DrugCentral FAERS","actionTaken":"Reported 65 times (LLR=166)"},{"llr":152.506,"date":"","count":49,"signal":"Anhedonia","source":"DrugCentral FAERS","actionTaken":"Reported 49 times (LLR=153)"},{"llr":149.799,"date":"","count":62,"signal":"Emotional distress","source":"DrugCentral FAERS","actionTaken":"Reported 62 times (LLR=150)"},{"llr":143.184,"date":"","count":77,"signal":"Anaphylactic reaction","source":"DrugCentral FAERS","actionTaken":"Reported 77 times (LLR=143)"},{"llr":140.217,"date":"","count":30,"signal":"Contrast media reaction","source":"DrugCentral FAERS","actionTaken":"Reported 30 times (LLR=140)"},{"llr":119.122,"date":"","count":35,"signal":"Skin hyperpigmentation","source":"DrugCentral FAERS","actionTaken":"Reported 35 times (LLR=119)"}],"commonSideEffects":[{"effect":"Nephrogenic systemic fibrosis","drugRate":"LLR 1190","severity":"serious"},{"effect":"Skin induration","drugRate":"LLR 442","severity":"common"},{"effect":"Skin hypertrophy","drugRate":"LLR 440","severity":"common"},{"effect":"Skin tightness","drugRate":"LLR 383","severity":"common"},{"effect":"Contrast media deposition","drugRate":"LLR 370","severity":"common"},{"effect":"Skin fibrosis","drugRate":"LLR 210","severity":"common"},{"effect":"Joint contracture","drugRate":"LLR 183","severity":"common"},{"effect":"Scar","drugRate":"LLR 179","severity":"common"},{"effect":"Joint range of motion decreased","drugRate":"LLR 166","severity":"common"},{"effect":"Anhedonia","drugRate":"LLR 153","severity":"common"},{"effect":"Emotional distress","drugRate":"LLR 150","severity":"common"},{"effect":"Anaphylactic reaction","drugRate":"LLR 143","severity":"common"},{"effect":"Contrast media reaction","drugRate":"LLR 140","severity":"common"},{"effect":"Skin hyperpigmentation","drugRate":"LLR 119","severity":"common"}],"specialPopulations":{"Pregnancy":"Use only if imaging is essential during pregnancy and cannot be delayed. GBCAs cross the placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive. In animal reproduction studies in rats, gadoteridol doubled the incidence of post-implantation loss at up to 16 times the recommended human dose.","Geriatric use":"No overall differences in safety were observed between elderly subjects and the younger subjects. ProHance is known to be substantially excreted by the kidneys, and the risk of toxic reactions from ProHance may be greater in patients with impaired renal function.","Paediatric use":"The safety and effectiveness of ProHance have been established for use with MRI to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues in pediatric patients from birth, including term neonates, to 17 years of age.","Renal impairment":"The risk of toxic reactions from ProHance may be greater in patients with impaired renal function."}},"trials":[],"aliases":[],"company":"Bracco","patents":[],"pricing":[],"allNames":"prohance","offLabel":[],"synonyms":["gadoteridol","Gadolinium-HP-DO 3A","ProHance"],"timeline":[{"date":"1992-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from BRACCO to Bracco"},{"date":"1992-11-16","type":"positive","source":"DrugCentral","milestone":"FDA approval (Bracco)"},{"date":"2003-10-09","type":"positive","source":"FDA Orange Book","milestone":"Prohance Multipack approved — 279.3MG/ML"},{"date":"2025-02-11","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Prohance (Gadoteridol) is a paramagnetic contrast agent developed by Bracco, used in medical imaging to enhance the visibility of internal structures. It is a small molecule modality that works by interacting with magnetic fields to produce detailed images. Prohance is off-patent and has a single generic manufacturer, approved for use in various medical imaging procedures. The drug has a half-life of 1.6 hours and was FDA-approved in 1992. Key safety considerations include its potential to cause nephrogenic systemic fibrosis in patients with severe kidney impairment.","approvals":[{"date":"1992-11-16","orphan":false,"company":"BRACCO","regulator":"FDA"}],"brandName":"Prohance","ecosystem":[],"mechanism":{"novelty":"Follow-on","moaClass":"Magnetic Resonance Contrast Activity","modality":"Small Molecule","drugClass":"Paramagnetic Contrast Agent","explanation":"Imagine your body is like a city with many buildings and streets. Prohance helps doctors see the city by making the buildings and streets stand out more clearly, allowing them to diagnose and treat medical conditions more effectively.","oneSentence":"Prohance works by interacting with magnetic fields to produce detailed images of internal structures.","technicalDetail":"Prohance is a gadolinium-based contrast agent that works by shortening the T1 relaxation time of hydrogen nuclei in the body, allowing for the creation of detailed images through magnetic resonance imaging (MRI) procedures."},"commercial":{"launchDate":"1992","_launchSource":"DrugCentral (FDA 1992-11-16, BRACCO)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1268","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=GADOTERIDOL","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=GADOTERIDOL","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":"2026-03-30T14:54:29.400230","biosimilars":[],"competitors":[{"drugName":"gadopentetate 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protected","relationship":"same-class"}],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"gadoteridol","indications":{"approved":[],"offLabel":[],"pipeline":[]},"currentOwner":"Bracco","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"gadopentetate-dimeglumine","brandName":"gadopentetate dimeglumine","genericName":"gadopentetate 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