Prescription medicine
Gadobenate Brand names: Multihance; first approved as Multihance Multipack
Gadobenate (Multihance) is a prescription medicine with an FDA approval on record since 2004. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the gadobenate FDA label on DailyMed (effective March 16, 2025, BRACCO DIAGNOSTICS INC); the NDA 21358 record on Drugs@FDA; every gadobenate label on DailyMed.
Highlights of the record
FDA label of March 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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. MultiHance 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 elimination of the drugs. Avoid use of MultiHance in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: chronic, severe kidney disease (GFR <30 mL/min/1.73m 2 ), or acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. […]
Used for
From the label: indications and usagemagnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and pediatric patients (including term neonates), to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues (1.1) magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.
Forms and strengths
- 529 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- November 23, 2004 Multihance Multipack, Bracco; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2012 0 Class I among all firms' recalls; latest April 16, 2012
- FAERS reports
- 4,380 through July 30, 2026
What is gadobenate used for?
From the label: indications and usagemagnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and pediatric patients (including term neonates), to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues (1.1) magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease. […]
FDA pharmacologic class: Gadolinium-based Contrast Agent.
Source: FDA drug label (MultiHance), BRACCO DIAGNOSTICS INC, effective March 16, 2025 (SPL set f63abe56-46d9-4e32-afb1-f4e22370717d), via openFDA; the full label on DailyMed
What does the patient leaflet for gadobenate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about MULTIHANCE?GBCAs like MULTIHANCE may cause serious side effects including death, coma, encephalopathy, and seizures when it is given intrathecally (injection given into the spinal cord). It is not known if MULTIHANCE is safe and effective with intrathecal use. MULTIHANCE is not approved for this use. MULTIHANCE contains a metal called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years). It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys. Rarely, patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium. There are different GBCAs that can be used for your MRI exam. The amount of gadolinium that stays in the body is different for different gadolinium medicines. Gadolinium stays in the body more after Omniscan or Optimark than after Eovist, Magnevist, or MultiHance. Gadolinium stays in the body the least after Dotarem, Gadavist, or ProHance. People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body. Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis). Your healthcare provider should screen you to see how well your kidneys are working before you receive MULTIHANCE.
Source: FDA drug label (MultiHance), BRACCO DIAGNOSTICS INC, effective March 16, 2025 (SPL set f63abe56-46d9-4e32-afb1-f4e22370717d), via openFDA; the full label on DailyMed
Is there a generic for gadobenate (Multihance)?
No generic gadobenate is approved (Drugs@FDA, October 8, 2026).
- 2004 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has gadobenate been recalled?
The FDA's Enforcement Report lists 2 recalls naming gadobenate since 2012: 0 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 16, 2012 | Class III | Bracco Diagnostics Inc | Short Fill: The product is being recalled due to a potential underfill of the affected vials. |
| April 16, 2012 | Class II | Bracco Diagnostics Inc | Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the gadobenate label say about other medicines?
The gadobenate label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name gadobenate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cisplatin | drug interactions | Therefore MultiHance may prolong the systemic exposure of drugs such as cisplatin, anthracyclines (e.g. doxorubicin, daunorubicin), vinca alkaloids (e.g. vincristine), methotrexate, etoposide, tamoxifen, and paclitaxel. |
| Daunorubicin | drug interactions | Therefore MultiHance may prolong the systemic exposure of drugs such as cisplatin, anthracyclines (e.g. doxorubicin, daunorubicin), vinca alkaloids (e.g. vincristine), methotrexate, etoposide, tamoxifen, and paclitaxel. |
| Doxorubicin | drug interactions | Therefore MultiHance may prolong the systemic exposure of drugs such as cisplatin, anthracyclines (e.g. doxorubicin, daunorubicin), vinca alkaloids (e.g. vincristine), methotrexate, etoposide, tamoxifen, and paclitaxel. |
| Etoposide | drug interactions | Therefore MultiHance may prolong the systemic exposure of drugs such as cisplatin, anthracyclines (e.g. doxorubicin, daunorubicin), vinca alkaloids (e.g. vincristine), methotrexate, etoposide, tamoxifen, and paclitaxel. |
| Gadobutrol | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs [Dotarem (gadoterate meglumine), Gadavist (gadobutrol), ProHance (gadoteridol)]. |
| Gadodiamide | warnings and precautions | At equivalent doses, gadolinium retention varies among the linear agents with Omniscan (gadodiamide) and Optimark (gadoversetamide) causing greater retention than other linear agents [Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine)]. |
| Gadoterate | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs [Dotarem (gadoterate meglumine), Gadavist (gadobutrol), ProHance (gadoteridol)]. |
| Gadoteridol | warnings and precautions | Retention is lowest and similar among the macrocyclic GBCAs [Dotarem (gadoterate meglumine), Gadavist (gadobutrol), ProHance (gadoteridol)]. |
| Gadoxetate | warnings and precautions | At equivalent doses, gadolinium retention varies among the linear agents with Omniscan (gadodiamide) and Optimark (gadoversetamide) causing greater retention than other linear agents [Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine)]. |
| Methotrexate | drug interactions | Therefore MultiHance may prolong the systemic exposure of drugs such as cisplatin, anthracyclines (e.g. doxorubicin, daunorubicin), vinca alkaloids (e.g. vincristine), methotrexate, etoposide, tamoxifen, and paclitaxel. |
| Paclitaxel | drug interactions | Therefore MultiHance may prolong the systemic exposure of drugs such as cisplatin, anthracyclines (e.g. doxorubicin, daunorubicin), vinca alkaloids (e.g. vincristine), methotrexate, etoposide, tamoxifen, and paclitaxel. |
| Tamoxifen | drug interactions | Therefore MultiHance may prolong the systemic exposure of drugs such as cisplatin, anthracyclines (e.g. doxorubicin, daunorubicin), vinca alkaloids (e.g. vincristine), methotrexate, etoposide, tamoxifen, and paclitaxel. |
| Vincristine | drug interactions | Therefore MultiHance may prolong the systemic exposure of drugs such as cisplatin, anthracyclines (e.g. doxorubicin, daunorubicin), vinca alkaloids (e.g. vincristine), methotrexate, etoposide, tamoxifen, and paclitaxel. |
Source: FDA drug label (MultiHance), BRACCO DIAGNOSTICS INC, effective March 16, 2025 (SPL set f63abe56-46d9-4e32-afb1-f4e22370717d), via openFDA; the full label on DailyMed
What do FAERS reports show for gadobenate?
The FDA Adverse Event Reporting System holds 4,380 reports that list gadobenate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 206 are coded as a death and 775 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other gadolinium-based contrast agents
- the pharmacologic class, with prices and generics
- Gadobenate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other