Lumason Side Effects Center

Last updated on RxList: 8/26/2022
Lumason Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Lumason?

Lumason (sulfur hexafluoride lipid-type A microspheres) is an ultrasound contrast agent indicated for use in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult patients with suboptimal echocardiograms, and in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients.

What Are Side Effects of Lumason?

Common side effects of Lumason include:

  • headache
  • nausea
  • changes in taste
  • injection site pain or warmth
  • feeling hot
  • chest discomfort or pain,
  • or dizziness

Lumason may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • skin redness,
  • rash,
  • warmth,
  • numbness or tingly feeling,
  • lightheadedness,
  • severe dizziness,
  • cold sweat,
  • chest pain,
  • wheezing,
  • trouble breathing,
  • fast or slow heartbeats,
  • seizure,
  • severe headache,
  • blurred vision,
  • pounding in your neck or ears,
  • slow heartrate,
  • weak pulse, and
  • weak or shallow breathing

Get medical help right away, if you have any of the symptoms listed above.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Lumason

The dosing of Lumason is based on the procedure being performed.

What Drugs, Substances, or Supplements Interact with Lumason?

Lumason may interact with other drugs. Tell your doctor all medications and supplements you use.

Lumason During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant before Lumason is administered. Lumason should be used during pregnancy only if prescribed. It is unknown if Lumason passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Lumason (sulfur hexafluoride lipid-type A microspheres) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Lumason Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives, skin redness, rash; warmth, numbness, or tingly feeling; trouble breathing, tight feeling in your throat; swelling of your face, lips, tongue, or throat.

In rare cases, serious or fatal reactions may occur during or shortly after the injection. Tell your caregivers right away if you have:

  • a light-headed feeling, like you might pass out;
  • severe dizziness, or a cold sweat;
  • chest pain, wheezing, trouble breathing;
  • fast or slow heartbeats;
  • a seizure;
  • severe headache, blurred vision, pounding in your neck or ears; or
  • slow heart rate, a weak pulse, weak or shallow breathing.

Common side effects may include:

  • nausea;
  • headache;
  • altered sense of taste;
  • feeling hot; or
  • pain or warmth where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lumason (Sulfur Hexafluoride Lipid-type A Microspheres Injectable Suspension)

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Heart Disease: Symptoms, Signs, and Causes See Slideshow
Lumason Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Cardiopulmonary reactions [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

In completed clinical trials, a total of 6984 adult subjects (128 healthy volunteers and 6856 patients) received Lumason at cumulative doses ranging from 0.2 to 161 mL (mean 9.8 mL). Lumason was administered mainly as single or multiple injections; however, some subjects received infusion dosing. The majority (75%) of subjects received Lumason at cumulative doses of 10 mL or less. There were 64% men and 36% women, with an average age of 59 years (range 17 to 99 years). A total of 79% subjects were White; 4% were Black; 16% were Asian; <1% were Hispanic; and <1% were in other racial groups or race was not reported.

In the clinical trials, serious adverse reactions were observed in 2 subjects; one who experienced a hypersensitivity-type rash and presyncope and another who experienced anaphylactic shock shortly following Lumason administration.

The most commonly reported adverse reactions among patients (occurring among at least 0.2% of patients) are listed below (Table 1). Most adverse reactions were mild to moderate in intensity and resolved spontaneously.

Table 1. Adverse Reactions in Adult Patients* n = 6856

Number (%) of Patients with Adverse Reactions 340 (5%)
Headache 65 (1%)
Nausea 37 (0.5%)
Dysgeusia 29 (0.4%)
Injection site pain 23 (0.3%)
Feeling Hot 18 (0.3%)
Chest discomfort 18 (0.3%)
Chest pain 12 (0.2%)
Dizziness 11 (0.2%)
Injection Site Warmth 11 (0.2%)
*occurring in at least 0.2% of patients

Pediatric Patients

In completed clinical trials for echocardiography, a total of 12 pediatric patients received Lumason at a dose of 0.03 mL/kg. No adverse reactions were identified in pediatric patients [see Clinical Studies].

Postmarketing Experience

In the international postmarketing clinical experience and clinical trials, serious adverse reactions have uncommonly been reported following administration of Lumason. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The serious adverse reactions include fatalities, especially in a pattern of symptoms suggestive of anaphylactoid/hypersensitivity reactions. Other serious reactions included arrhythmias and hypertensive episodes. These reactions typically occurred within 30 minutes of Lumason administration. These serious reactions may be increased among patients with pre-existing PEG hypersensitivity and/or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) [see WARNINGS AND PRECAUTIONS].

Hypersensitivity

Anaphylaxis, with manifestations that may include death, shock, bronchospasm, dyspnea, throat tightness, angioedema, edema (pharyngeal, palatal, mouth, peripheral, localized), swelling (face, eye, lip, tongue, upper airway), facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema.

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Lumason (Sulfur Hexafluoride Lipid-type A Microspheres Injectable Suspension)

QUESTION

In the U.S., 1 in every 4 deaths is caused by heart disease. See Answer

© Lumason Patient Information is supplied by Cerner Multum, Inc. and Lumason Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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