Lumason

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Lumason

What is Lumason?

Lumason is an ultrasound contrast agent composed of sulfur hexafluoride lipid-type A microspheres. It is used during diagnostic ultrasound procedures to improve the clarity and detail of internal medical images.

How It Works

When Lumason is administered, the microscopic bubbles (microspheres) circulate through the bloodstream or within specific body cavities. Because these gas-filled bubbles reflect ultrasound waves differently than surrounding tissues or fluids, they enhance the contrast between structures. This allows healthcare professionals to better visualize and evaluate certain areas of the body.

Clinical Applications

Lumason is primarily utilized in three types of diagnostic imaging:

  • Echocardiography: It is used to improve the visualization of the left ventricular chamber and the endocardial border of the heart, particularly when standard ultrasound images are not sufficiently clear.
  • Liver Imaging: It helps in the characterization of focal liver lesions, allowing for better differentiation between different types of tissue in both adult and pediatric patients.
  • Urinary Tract Imaging: In pediatric patients, it is used during ultrasonography of the urinary tract to help detect or evaluate suspected vesicoureteral reflux (the backward flow of urine from the bladder).

Regulatory References

  1. SonoVue (Lumason) EMA EPAR Summary

What side effects are possible with Lumason?

Possible side effects and safety information

The safety profile of Lumason (Sulfur Hexafluoride) is formally categorized in regulatory documents, identifying both common and serious potential adverse reactions.

Classification Examples of Adverse Reactions (by System)
Common (incidence ge 0.5%) Headache, Nausea, Dysgeusia (taste disturbance), Injection site pain
Uncommon Hypotension, Dizziness, Vomiting, Tachycardia, Rash, Pruritus (itching)

Serious Adverse Reactions and Safety Constraints

The label documents that Serious Cardiopulmonary Reactions (e.g., cardiac arrest, shock, respiratory distress) have occurred uncommonly during or shortly following the administration of ultrasound contrast agents, typically within 30 minutes. Serious hypersensitivity reactions (e.g., anaphylaxis, severe rash) have also been observed.

Safety Restrictions: Lumason is contraindicated in patients with known or suspected hypersensitivity to any of its components, including polyethylene glycol (PEG). Its use is also restricted in patients with right-to-left, bi-directional, or transient right-to-left cardiac shunts due to the risk of systemic embolization. Caution is advised for patients with unstable cardiopulmonary conditions. The use of high ultrasound mechanical index values (MI >0.8) is not recommended.

Population Note: Safety and effectiveness are established for use in pediatric patients for certain indications, with no unique adverse reaction signals reported in that population.

This framework ensures that the risks are characterized by frequency, system involvement (e.g., Nervous System, Cardiac), and specific patient constraints, structuring the official understanding of the medicine's safety profile.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents regarding Lumason (Sulfur Hexafluoride lipid-type A microspheres) provide specific guidance for a suspected overdosage. The governmental prescribing information explicitly states that no clinical signs or symptoms of overdosage have been reported to date. This official finding is supported by clinical data showing that doses significantly higher than the standard clinical dose were administered to healthy volunteers without resulting in serious adverse events. Therefore, no specific overdose syndrome is documented.

Required Emergency Actions

In the event of a suspected overdosage, the regulatory authorities mandate the following emergency actions and management approach:

  • Urgent Contact: The official labeling advises contacting a regional poison control centre immediately for guidance on managing the overdosage.
  • Treatment Focus: Any required treatment must be directed toward the support of all vital functions and the prompt institution of symptomatic therapy to address any emergent clinical changes.
  • Monitoring: The patient should be kept under continuous observation following the suspected event.

The official product labeling confirms that no specific antidote for Lumason overdosage is documented. The regulatory guidance does not specify any population-specific considerations regarding the management or presentation of overdosage in vulnerable groups.

Therapeutic Uses of Lumason

Lumason is an ultrasound enhancing agent generally used when standard imaging provides an unclear or insufficient picture, helping to resolve diagnostic limitations that may complicate clinical decisions. The primary role of the agent is to contribute to the potential for enhanced diagnostic clarity across several key diagnostic domains.

The agent is applied across conditions presenting with image ambiguity, primarily in cardiac assessment when heart ultrasound images are suboptimal, for characterizing focal liver lesions when the nature of the mass is uncertain, and for the evaluation of vesicoureteral reflux (VUR) in pediatric patients.

“The product supports the physician in gaining important information that may assist with decisions related to patient care.”

This agent is relevant in clinical settings where additional diagnostic support is needed. It helps address the challenge of lesion indeterminacy and supports the non-ionizing approach to diagnosis, particularly in children.


Quick Fact: Clarity for Unclear Images

Property Description
Symptom Domain Diagnostic Ambiguity, Image Indeterminacy
Main Use Enhancing visualization during ultrasonography
Patient Benefit Supports the potential for diagnostic clarity
Target Conditions Suboptimal echocardiograms, focal liver lesions, suspected VUR

Eligibility and Restrictions for Use

Who can and cannot use Lumason?

This section outlines the official population eligibility and non-eligibility information as documented in government regulatory sources.

Category Eligibility Status as Documented in Labeling
Populations for whom use is allowed Established for adult and pediatric patients for all approved indications: echocardiography, liver ultrasonography, and urinary tract ultrasonography.
Populations for whom use is contraindicated Patients with known or suspected hypersensitivity reactions to sulfur hexafluoride lipid microspheres or to components such as polyethylene glycol (PEG).
Eligibility-related restrictions Use carries an increased risk for serious cardiopulmonary reactions in patients with unstable cardiopulmonary conditions (e.g., acute myocardial infarction, unstable congestive heart failure).
Prohibited Administration Route Administration by intra-arterial injection is prohibited.
Condition-specific rules Patients with cardiac shunts require careful assessment for embolic phenomena following administration. No specific restrictions are documented based solely on renal or hepatic impairment.
Physiological Status Pregnancy and lactation eligibility status are not based on human data, but on a lack of significant findings in animal studies, with no formal contraindication documented.

The official eligibility profile is primarily defined by a singular absolute exclusion related to patient hypersensitivity to its components. Regulatory warnings classify patients with unstable cardiopulmonary conditions and those with cardiac shunts as requiring restricted or cautious use due to increased risk of serious reactions. Eligibility is established across adult and pediatric populations for the approved diagnostic indications, with no restrictions documented based solely on renal or hepatic function.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory labeling for Lumason (sulfur hexafluoride lipid-type A microspheres) is structured by the absence of documented pharmacological drug-drug interactions.

The active ingredient, Sulfur Hexafluoride, functions as an ultrasound contrast agent through a physical mechanism and is eliminated primarily via lung exhalation. This clearance pathway generally bypasses the major metabolic and renal systems (such as CYP450 enzymes and drug transporters) that are responsible for most drug interactions. Due to this pharmacological profile, the official prescribing information does not list any specific co-administered medicinal products with required restrictions or prohibitions.

Official Regulatory Status

Category Documentation Status
Specific interacting medicines None documented in regulatory labels.
Pharmacokinetic interactions (e.g., CYP) Not applicable. Clearance is via exhalation.
Timing-based separation rules None documented.

No clinical drug interaction studies involving metabolic or transporter pathways have been performed for this product. The regulatory documents explicitly state that no list of interacting medicines is provided. The only formal restriction is related to product components: the agent is contraindicated in individuals with known or suspected hypersensitivity to its components, including polyethylene glycol (PEG). This is a restriction based on hypersensitivity risk, not a traditional pharmacokinetic or pharmacodynamic interaction with co-administered medicines.

Mechanism of Action

How Lumason Works: Mechanism of Action

Physical Basis of Acoustic Contrast

The mechanism of Lumason is rooted in physical acoustics, not pharmacology. Its action is initiated by the introduction of Sulfur Hexafluoride ( SF6) gas microbubbles into the blood pool. These gas-filled spheres possess a dramatically lower acoustic impedance than blood, causing them to act as highly efficient physical reflectors of the ultrasound beam, creating a strong contrast for acoustic visualization.

Acoustic Cascade and Signal Generation

When subjected to ultrasound waves, the microbubbles undergo rapid resonance (oscillation), which generates a high-amplitude non-linear acoustic backscatter signal. This physical phenomenon amplifies the signal returning from the blood pool, providing a high signal-to-noise ratio that visually defines vascular structures and corresponds to dynamic blood flow and tissue perfusion.

Microbubble Stability and Circulatory Persistence

The microbubble's phospholipid shell provides crucial mechanical stability, preventing the SF6 gas core from rapidly dissolving into the plasma. This structural integrity ensures the contrast mechanism persists long enough for the microbubbles to circulate throughout the vascular system, thereby sustaining the acoustic enhancement for a prolonged period of circulation.

Dosage and Administration Information

Lumason (sulfur hexafluoride) is administered as a single-use diagnostic agent, with the dosage and route dependent on the specific imaging procedure.

Administration Routes and Dosing

Lumason is utilized via two distinct routes:

  • Intravenous (IV) Injection: Used for adult echocardiography and ultrasonography of the liver. The recommended dose for adult cardiac imaging is 2.0 mL of the reconstituted suspension, and for focal liver lesion imaging, it is 2.4 mL. A second, same-volume injection may be administered during a single examination if needed, but the total volume must not exceed 4.8 mL.
  • Intravesical Administration: This route, where the agent is instilled via a catheter into the bladder, is used for evaluating vesicoureteral reflux (VUR) in pediatric patients. The recommended volume for instillation is 1 mL of the suspension.

Preparation and Procedural Sequence

Lumason is supplied as a lyophilized powder and must be reconstituted immediately before use. The powder is mixed with 5 mL of 0.9% Sodium Chloride Injection, and the vial must be inverted and shaken vigorously for 20 seconds to form the microbubble suspension.

For intravenous use, the dose must be administered as a rapid bolus injection over one to two seconds, immediately followed by a 5 mL saline flush. The functional image enhancement, which is the time window for the scan, typically lasts approximately four minutes for cardiac studies. The suspension is for single use, and any unused portion must be discarded.

Recent Clinical Evidence

Research evidence / Overview of studies for Lumason

The research evidence for Lumason is drawn from controlled clinical trials, comparative studies, and published scientific literature that inform regulatory decisions. This evidence focuses on measurements of diagnostic image quality, not on long-term patient health outcomes.


Evidence for Use in Echocardiography (Adult and Pediatric)

The clinical research primarily involved short-term, prospective, controlled clinical trials. These studies were designed to evaluate the agent's impact on imaging clarity in patients who had suboptimal heart ultrasound images.

Researchers focused on outcomes that measure immediate image quality, such as Left Ventricular Endocardial Border Delineation (EBD) scores, which quantify the number of heart wall segments that are measured as visualized. The findings describe patterns related to increased visualization measurements during the study period when the agent was studied compared to unenhanced ultrasound. The measured imaging effects were temporary and confined to the period immediately following administration.


Evidence for Use in Ultrasonography of Focal Liver Lesions

This research base includes multi-reader comparative studies and meta-analyses. These studies examined diagnostic accuracy metrics when characterizing focal liver lesions (FLLs) of uncertain cause. Studies described measurements related to improved diagnostic findings compared to the non-contrast approach, often assessing the lesion's enhancement pattern through various phases of blood flow.


Evidence for Use in Evaluation of Vesicoureteral Reflux (VUR)

Evidence for VUR evaluation in children consists primarily of comparative published studies. These studies explored how the results of contrast-enhanced voiding urosonography (VUS) compare to the standard fluoroscopic voiding cystourethrography (VCUG) for the detection and severity grading of VUR. The findings describe a close concordance in VUR detection and grading between the two methods, and the evidence contributed to the assessment of an alternative imaging approach.


What the Regulatory Evidence Does Not Yet Address

While studies report short-term patterns related to measured image clarity, there is limited information for long-term outcomes or how enhanced diagnostic accuracy translates into long-term clinical management success. Furthermore, data for very specific, small pediatric or high-risk subgroups remain insufficient, with some approvals relying on extrapolation from broader studies.

Frequently Asked Questions (FAQ)

Common questions about Lumason (FAQ)


Q: How long does the effect of Lumason last during an ultrasound?

The official product information describes the agent's effects as temporary, with image enhancement typically persisting for a short duration following administration. For heart studies, the agent is described as providing useful signal intensity for approximately two minutes after the injection. The specific time the enhancement lasts can vary based on the procedure and blood flow rate in the area being imaged.


Q: Are there any common interactions between Lumason and blood pressure medicine?

Regulatory labeling states that no specific drug-drug interactions, including those with common blood pressure medications, have been documented. This is because the agent functions through a physical mechanism and is eliminated primarily by lung exhalation, generally bypassing the major metabolic systems responsible for most drug interactions.


Q: Is it normal to feel a warming sensation after Lumason is administered?

A warming sensation is not explicitly listed among the common adverse reactions reported in formal regulatory documents or clinical trials. The most frequently reported common side effects include minor issues like headache, nausea, taste changes, and localized pain at the injection site.


Q: What are the most commonly reported side effects people mention online?

The official regulatory documents categorize common side effects as those reported in clinical trials with an incidence of 0.5% or greater. These frequently reported issues include headache, nausea, a taste disturbance known as dysgeusia, and pain at the site of injection.


Q: Can someone with kidney problems receive Lumason?

Official regulatory documents do not list specific restrictions or require dose adjustments solely based on the presence of kidney problems or renal impairment. This is because the agent is primarily eliminated by exhalation through the lungs rather than the kidneys.


Q: Does Lumason interact with common pain relievers like Tylenol or Advil?

Regulatory labeling states that there are no known or documented pharmacokinetic drug-drug interactions with co-administered medicinal products, which includes common over-the-counter pain relievers. The agent’s physical mechanism of action and clearance pathway via the lungs prevent the type of interactions often seen with other drugs.


Q: Are there special restrictions on activities after receiving Lumason?

The official documents focus mainly on the risk of serious, immediate reactions, which are noted to typically occur within the first 30 minutes following administration. They do not describe specific restrictions on post-procedure physical activities or patient movement after this observation period.


Q: Does having diabetes affect whether I can receive Lumason?

Diabetes is not listed as a contraindication or restriction in the official prescribing information. The formal restrictions are limited to hypersensitivity to the agent's components and certain unstable cardiopulmonary conditions.


Q: What are the typical conditions or patient groups where Lumason is not recommended?

The agent is formally contraindicated in patients with a known or suspected hypersensitivity to its components, such as polyethylene glycol (PEG). Caution is also advised for use in patients with unstable cardiopulmonary conditions, such as recent heart attacks or unstable congestive heart failure.


Q: Does taking blood thinners affect the use of Lumason?

Official regulatory labeling does not list blood thinners as specific interacting medicines. The agent is cleared through the lungs and generally avoids the metabolic systems responsible for most pharmacological drug interactions.


Q: What is the general information about Lumason's use in patients with high blood pressure?

High blood pressure (hypertension) alone is not listed as a contraindication in official documents. However, the regulatory warnings stress the importance of caution for all patients with unstable cardiopulmonary conditions.


Q: Do certain medications need to be stopped before receiving Lumason?

Regulatory documents do not list any specific co-administered medicinal products that must be restricted or stopped prior to receiving the agent. There are no documented timing-based separation rules for its use with other medicines.


Q: How long do I have to wait to breastfeed after receiving Lumason?

Due to the agent's rapid clearance from the body, US FDA information indicates that if the agent is required, it is not a reason to discontinue breastfeeding. Some regulatory information suggests that pumping and discarding milk once after receiving the agent may be considered.


Q: Can Lumason be used if I have a pacemaker?

Official regulatory documents do not list pacemakers as a contraindication or specific restriction. Warnings for use focus primarily on patients with cardiac shunts and unstable cardiopulmonary conditions, as well as the risk of ventricular arrhythmias related to certain ultrasound settings.


Q: Are there different brand names for the same medicine as Lumason?

Yes, the active ingredient in Lumason, sulfur hexafluoride lipid-type A microspheres, is marketed under the brand name SonoVue® in many countries outside of the United States.


Q: Is there research evidence about Lumason's use in non-cardiac or non-liver imaging?

Official indications for use are established based on clinical trial evidence for echocardiography (heart), ultrasonography of the liver, and ultrasonography of the urinary tract (evaluation of vesicoureteral reflux in pediatric patients). The regulatory documents define the approved uses based on evidence for these specific indications.


Q: What should I do if I am pregnant and need an ultrasound with contrast?

The US FDA official information states that use during pregnancy should occur only if clearly needed for the diagnostic procedure. While animal studies did not show evidence of harm to the fetus, adequate and well-controlled studies in pregnant women are not available to confirm safety.


Q: Is there a limit to how many times a person can receive Lumason?

The regulatory labeling specifies a maximum total volume that can be administered per single examination, but it does not define or impose a cumulative lifetime limit on the total number of times a patient may receive the agent.


Q: Does Lumason affect the safety or function of implanted devices?

Regulatory documents do not describe interference with the safety or function of implanted devices. However, warnings note a potential risk of ventricular arrhythmia related to the use of high ultrasound settings (mechanical index values greater than 0.8) in certain patients.


Q: What is the official safety classification of Lumason during pregnancy?

The US FDA has historically classified the agent under Pregnancy Category B. This designation indicates that animal studies failed to show a risk to the fetus, but adequate, controlled studies in pregnant women are not available.


Q: Why do some people report a strange taste after the injection?

A strange taste, formally known as dysgeusia, is listed as a common adverse reaction in the regulatory documents. The physiological reason for this side effect is not detailed in the public label, but it is a recognized, temporary event described in official sources.


Q: Is Lumason used for therapeutic purposes, or just for imaging?

The agent is classified as a diagnostic radiopharmaceutical and is indicated for use strictly as an ultrasound contrast agent. Its function is limited to improving visualization for diagnostic purposes and it is not used to treat any disease or condition.


Q: What kind of training does the person who gives the injection need?

Official labeling requires that resuscitation equipment and trained personnel always be readily available due to the risk of serious cardiopulmonary reactions. This indicates that the agent must be administered by qualified healthcare professionals who are prepared to manage potential severe events.


Q: If I have an allergic reaction to other medicines, am I more likely to react to Lumason?

The prescribing information notes that there may be an increased risk of serious reactions in patients who have a prior history of hypersensitivity reactions to the component polyethylene glycol (PEG). The agent is contraindicated if a known or suspected hypersensitivity to any of its components exists.


Q: Is there a chance that Lumason could interfere with lab test results?

The regulatory labeling does not describe any specific interference with standard laboratory blood or urine test results. Since the agent is cleared by lung exhalation, it generally avoids the metabolic systems that could cause drug-related diagnostic test interference.

How should Lumason be stored and disposed of?

How to Store and Dispose of Lumason

The storage and disposal of Lumason must adhere strictly to the conditions defined in the official regulatory labeling. The product is supplied as an unreconstituted kit, which includes the lyophilized powder vial, diluent, and accessories.

Storage Conditions

The unreconstituted kit must be stored at room temperature, specifically 25 C (77 F), with permitted temperature excursions up to 30 C (86 F). The product does not require refrigeration and must be kept in its original carton to protect it from light. The kit must also be kept out of the sight and reach of children.

Stability and Disposal

Once the powder is mixed, the reconstituted suspension should be used immediately. If immediate use is not possible, the suspension is stable at room temperature for a maximum of 3 hours from the time of preparation. Lumason is for single use only. Any unused portions of the suspension and all kit components must be properly discarded in accordance with local requirements for the disposal of medicinal products.

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

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