Ultravist

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Ultravist

Property Description
Active Ingredient Iopromide
Form Aqueous Solution for Injection/Infusion
Pharmacological Class Iodinated Contrast Media
Common Use Radiographic Diagnosis / Contrast Enhancement
Origin Synthetic, Non-ionic Derivative

What Type of Medicine is Ultravist (Iopromide)?

Ultravist is a specialized, prescription-only (Rx Only) pharmaceutical preparation used exclusively as a radiographic contrast agent for medical diagnosis. Its medicinal identity is centered on the active ingredient, Iopromide, which is a synthetic molecule. It belongs to the Pharmacological Class of Iodinated Contrast Media. The preparation is manufactured and distributed by Bayer HealthCare, supporting its use in sophisticated imaging environments.

The compound is chemically defined as a non-ionic, low-osmolar (LOM) agent. This classification is significant as its low-osmolar nature is clinically recognized to offer improved physiological compatibility compared to older ionic contrast agents. Iopromide is a tri-iodinated derivative, meaning its unique structure incorporates three firmly bound iodine atoms, which is the foundational element that allows the substance to effectively absorb X-rays and produce contrast.


The Form and General Purpose of the Ultravist Solution

Ultravist is provided as a sterile, clear aqueous solution intended for injection or infusion, and its general purpose is to enhance the visibility of internal body structures during imaging procedures like X-ray and Computed Tomography (CT) scans. It is primarily administered via the intravascular route (into a vein or artery) to ensure rapid distribution through the circulatory system. This temporary and selective contrast enhancement is critical for radiographic diagnosis, enabling physicians to accurately visualize the size and condition of blood vessels and organs. The preparation is a single-ingredient product available in strengths such as Ultravist 300 and Ultravist 370, allowing the physician to select the iodine concentration appropriate for the specific diagnostic examination.

What side effects are possible with Ultravist?

Possible side effects and safety information

The safety profile for Ultravist (iopromide) is based on adverse reactions and specific limitations documented in official government regulatory documents.

Adverse Reaction Scope

Classification Examples of Documented Effects (System-Organ Class)
Common (Reported in 1% of patients) Headache, nausea, vomiting, feeling hot, vasodilatation, injection/infusion site reactions (General, Gastrointestinal, Nervous, Vascular disorders).
Uncommon / Rare (Reported in <1% of patients) Dizziness, pruritus (itching), urticaria (hives), and more severe hypersensitivity manifestations.

Serious Adverse Reactions and Safety Constraints

Serious adverse reactions officially listed in regulatory labeling include Anaphylactoid Reactions (which can be life-threatening), Acute Kidney Injury (AKI), and Severe Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson syndrome. Cardiovascular Adverse Reactions, including shock and cardiac arrest, may occur during or shortly after administration.

Population-Specific Safety Considerations:

  • Renal Impairment: Patients with pre-existing renal insufficiency, diabetes, or multiple myeloma have an increased risk of Contrast-Induced AKI.
  • Pediatric Patients (Aged 0 to 3 Years): These infants require monitoring for Thyroid Dysfunction (e.g., transient hypothyroidism) due to the iodine content.
  • Specific Conditions: Caution is advised for use in patients with known or suspected hyperthyroidism (risk of thyroid storm) or pheochromocytoma (risk of hypertensive crisis).

Administration and Exposure-Related Constraints:

  • Intrathecal Use (injection into the spine) is Contraindicated due to the risk of severe neurotoxicity.
  • Most severe reactions typically occur shortly after the start of injection, though delayed reactions, particularly SCARs, have been documented to occur hours to several weeks after administration.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Ultravist (iopromide) defines overdosage as a risk associated with an excessive volume or overly rapid injection. Life-threatening effects primarily impact the pulmonary and cardiovascular systems. Documented clinical manifestations of over-administration include signs of fluid and electrolyte imbalance, as well as potential for renal failure and other systemic complications.

A distinct, severe hazard officially warned against is the inadvertent intrathecal use (non-approved spinal injection). This mis-administration carries the risk of severe neurotoxic effects, including seizures, cerebral hemorrhage, coma, and death.


Emergency Response and Management

Immediate medical attention must be sought for any suspected overdosage or if life-threatening effects occur. Regulators advise that a regional poison control centre should be contacted for guidance, and all healthcare providers must be prepared for the prompt institution of emergency measures.

In managing overdosage, there is no specific pharmacological antidote known. Treatment must be directed toward the support of all vital functions and the prompt institution of symptomatic therapy, including compensation for water and electrolyte losses. The agent is dialyzable, meaning it can be removed from the body using hemodialysis. Patients with existing renal impairment or cardiovascular disease, as well as young infants, are officially noted to be susceptible to increased systemic effects.

Therapeutic Uses of Ultravist

What Ultravist Treats: Main Uses and Benefits

Ultravist (iopromide) is a medical X-ray contrast agent, meaning it does not treat disease or relieve symptoms directly. Its benefit is used to provide diagnostic clarity that may assist with precise treatment planning. It is commonly used across a wide range of imaging procedures.

Enhanced Visualization for Diagnosis

Ultravist provides enhanced visibility during imaging procedures (CT scans, angiography, etc.), which allows medical professionals to detect and assess various conditions presenting with systemic or localized discomfort. Indications for use include arteriography (assessing arteries), contrast enhancement for CT imaging of the head and body, and intravenous urography (assessing the urinary system). By highlighting tissues, it helps identify structural abnormalities and lesions that may be unclear on standard scans, contributing to easing the overall symptom load by supporting a more informed diagnostic process.

Critical Insight for Interventions

“The detailed images provided by Ultravist are relevant for guiding critical treatment decisions during complex medical interventions.” For patients undergoing procedures like coronary arteriography or tumor evaluation, the clear visualization assists the medical team in accurately mapping the area and assessing the extent of the condition. This supports patients during episodes of heightened discomfort and assists with maintaining functional stability by assisting with a more informed procedural approach.


Quick Fact: Relief for Diagnostic Uncertainty

The diagnostic clarity provided by Ultravist supports patients during episodes of heightened discomfort and assists with maintaining functional stability by promoting a more precise procedural approach.

Regulatory References

  1. U.S. National Library of Medicine label

Eligibility and Restrictions for Use

Ultravist (iopromide) eligibility is strictly defined by regulatory documents, outlining who may safely receive the medicine and who must not.

Absolute Contraindications

Ultravist is officially contraindicated and must not be used in patients with manifest hyperthyroidism or a known hypersensitivity to iopromide. The medicine is strictly prohibited from being administered via the intrathecal route (into the spinal canal) for all patients. Additionally, preparatory dehydration (e.g., fasting or fluid restriction) is contraindicated in pediatric patients due to the risk of renal failure.

Age and Condition Restrictions

Use is established for adults and pediatric patients aged two years and older for specific procedures. However, safety and effectiveness are not established for all indications in children under two. Caution is mandated for patients with pre-existing renal impairment, diabetes mellitus, and multiple myeloma due to the increased risk of acute kidney injury. Use in patients with a history of allergic disorders requires careful risk assessment.

Pregnancy and Lactation

Use during pregnancy is permitted only if clearly needed. For lactating women, interruption of breastfeeding is not necessary, though discarding milk for 12 to 24 hours after administration is an option to minimize infant exposure.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Ultravist (iopromide) has documented interactions with certain medicinal products and requires procedural precautions. The key concerns relate to the management of allergic reactions, the risk of kidney-related complications, and chemical incompatibilities.

Documented Interacting Categories

  • Biguanides (e.g., Metformin): Acute alterations in kidney function following the administration of an iodinated contrast agent can increase the risk of lactic acidosis in patients taking biguanides. Regulatory labeling advises following the biguanide product insert for guidance on temporary discontinuation around the procedure.
  • Beta-blockers: Patients receiving beta-blockers may exhibit resistance to the effects of beta-agonists (e.g., epinephrine) used in the emergency treatment of severe hypersensitivity or anaphylactoid reactions to the contrast medium.
  • Oral Cholecystographic Agents: Administration of Ultravist should be postponed in patients who have recently received an oral cholecystographic agent, due to reports of renal toxicity in patients with existing liver dysfunction.

Procedural Restriction

Due to the potential for chemical incompatibility, Ultravist must not be mixed or injected in intravenous administration lines that contain other drugs, solutions, or total nutritional admixtures.

Mechanism of Action

How Ultravist Works — Mechanism of Action

Core Physical Mechanism: X-ray Attenuation

The fundamental action of Ultravist (iopromide) is a physical interaction with external diagnostic radiation, not a biological interaction with molecular targets. The molecule contains a high concentration of iodine atoms (I3) which creates a dense medium. When traversing this medium, incident X-ray photons are physically absorbed and scattered (attenuation). This unique property results in the physiological effect of transient radiographic opacity in the tissues where the compound is concentrated.


Distribution and Pharmacokinetic Clearance

Following administration, the small, hydrophilic molecule passively diffuses rapidly from the bloodstream into the extracellular fluid compartment. The compound is generally excluded from areas protected by intact tight junctions, such as the Blood-Brain Barrier. This differential distribution dictates which physiological spaces are opacified. The termination of the drug's effect is achieved through rapid, non-metabolic elimination, primarily via glomerular filtration in the kidneys. This fast elimination cascade ensures the effect is transient, rapidly limiting the agent's residence time.

Dosage and Administration Information

How to Use Ultravist

Ultravist (iopromide) is a specialized diagnostic agent and its administration strictly follows official, procedure-specific guidelines. Its use is limited to a single administration event tied to the imaging procedure, with no scheduled maintenance regimen.

Administration and Dosing Principles

Feature Official Use Principle
Route of Administration Primarily Intravascular (Intra-arterial and Intravenous injection/infusion). Use in body cavities (e.g., arthrography) is approved in some regions. Intrathecal use is forbidden.
Dosing Rule The dose volume (mL) and iodine concentration are individualized based on the specific imaging procedure (e.g., CT, angiography) and administered as a single injection. Strict maximum total dose limits are set for each procedure.
Age-Group Rules For pediatric patients (2 years and older), dosing is calculated by milliliters per kilogram of body weight. For all patients, the dose should be minimized to the volume necessary for adequate visualization.

Key Procedural Requirements

Official instructions mandate precise conditions for its handling. The solution must be administered at or close to body temperature; warming the solution before injection is recommended to reduce its viscosity. It is a critical restriction that Ultravist must not be mixed or injected in intravenous lines containing any other drugs or nutritional admixtures due to potential incompatibilities. Patients must also be hydrated appropriately both before and after the agent is administered. Following the single-use procedure, any unused portion remaining in the container must be discarded.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Ultravist (Iopromide)


Evidence for Enhanced Imaging of Blood Vessels (Angiography and Arteriography)

Researchers have conducted short-term Randomized Controlled Trials (RCTs) and supporting clinical studies that examined the use of Iopromide in visualizing major arteries and blood vessels. These studies primarily included adults but also included pediatric patients aged two years and older. The research explored whether the contrast agent provided clear visual enhancement, which is a key component examined for diagnostic image quality.

The key measure studied was Diagnostic Opacification. Findings describe patterns that were observed when comparing Iopromide to similar contrast media. These assessments focused on acute visualization during the procedure itself. What remains uncertain is the long-term outcome of patients following the use of this agent, as follow-up durations were short-term, focused on the immediate post-injection period.


Evidence for Visualization in CT Scans and Urinary Tract Studies

The research foundation for using Ultravist for Computed Tomography (CT) scans and assessing the urinary system (Urography) is supported by clinical trials and large-scale observational studies. The studies examined how the substance was used to enhance the visibility of organs and blood vessels and to aid in the delineation of structural abnormalities.

Studies report how outcomes evolved and monitored the visual opacification of the urinary system. Research findings have noted that enhancement may be inconsistent across specific lesion types (e.g., certain gliomas). The available research describes group patterns and does not determine whether an individual will respond similarly. The evidence for long-term outcomes following this type of imaging remains limited.


Evidence in Special Populations (Children and Older Adults)

Ultravist was studied for use in specific special populations, including pediatric patients aged 2 years and older for certain heart and artery evaluations, as well as CT and urography procedures. Older adults (aged 65 years and above) participated within the broader study cohorts.

However, data for certain groups remain insufficient. For instance, data for the youngest pediatric patients (under age 2) remain insufficient, meaning results apply only to the populations studied. Furthermore, existing studies provide limited insight into long-term outcomes specifically tailored for the older adult population.

Key Studies & References

  1. Iopromide Injection Receives FDA Approval for Contrast-Enhanced Mammography
  2. ULTRAVIST 300 mg and 370 mg iodine/mL - HAS (Haute Autorité de Santé) Opinion on CEM

Frequently Asked Questions (FAQ)

Common questions about Ultravist (FAQ)

Q: What is Ultravist used for?

Ultravist (iopromide) is a radiographic contrast agent, also called a "dye." It is used in various medical procedures, such as X-rays and CT scans, to help healthcare providers see organs, blood vessels, and tissues in the body more clearly. Ultravist is injected into a vein or artery before the imaging procedure begins.


Q: What should I tell my doctor before receiving Ultravist?

It is important to tell your doctor if you have had an allergic reaction to any contrast agent in the past, or if you have kidney disease, thyroid problems, multiple myeloma, pheochromocytoma, or sickle cell anemia. Also, inform them of all medicines you are currently taking, including prescription, over-the-counter, and herbal supplements, and if you are pregnant or breastfeeding.


Q: What are the possible side effects of Ultravist?

Common side effects may include warmth or flushing, temporary pain or cold sensation at the injection site, or a metallic taste in the mouth. Less common but more serious side effects can include allergic reactions (like hives, difficulty breathing, or swelling of the face, lips, tongue, or throat) or kidney problems. If you experience any severe or concerning symptoms, you should seek medical attention immediately.


Q: How long will Ultravist stay in my system?

Ultravist is typically cleared from the body relatively quickly through the kidneys and urine. For most people with normal kidney function, the drug's concentration in the body significantly decreases within a few hours after injection. However, trace amounts may be present for longer. Your healthcare provider can give you more specific information based on your health status.

How should Ultravist be stored and disposed of?

Official Storage and Handling Requirements

Ultravist (iopromide) injection must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F), and must be protected from light. Before administration, the solution must be visually inspected for particulate matter, discoloration, or crystallization; if crystallization (a milky-cloudy appearance) is observed, the product must not be administered.

Container Type Post-Puncture Stability Limit
Single-Dose Vial Discard any unused portion immediately after the initial use.
Imaging Bulk Package (IBP) Maximum use time is 10 hours from the initial puncture.

Disposal Requirements

Disposal of unused Ultravist and related waste must be performed in accordance with existing federal, state, and local environmental control laws. The product must not be disposed of together with household garbage and must not be allowed to enter surface waters or groundwater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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