Xenon Xe-133 is a prescription medicine (Inhalation Diagnostic Agent). The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Prescription only (Rx)
- Drug class
- Inhalation Diagnostic Agent
- Taken
- Respiratory (inhalation)
- Label
- Shine Spect USA, LLC, revised September 10, 2026 · full label on DailyMed
- Generic
- No · details
What it is used for
Inhalation of Xenon Xe 133 Gas has proved valuable for the evaluation of pulmonary function and for imaging the lungs. It may also be applied to assessment of cerebral flow.
Who should not take it (contraindications)
None known.
Warnings
Xenon Xe 133 Gas delivery systems, i.e., respirators or spirometers, and associated tubing assemblies must be leakproof to avoid loss of radioactivity into the environs not specifically protected by exhaust systems. Xenon Xe 133 adheres to some plastics and rubber and should not be allowed to stand in tubing or respirator containers. The unrecognized loss of radioactivity from the dose for administration may render the study non-diagnostic. The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex.
Side effects (adverse reactions)
Adverse reactions related to the use of this agent have not been reported to date.
Pregnancy
Animal reproductive studies have not been conducted with Xenon Xe 133 Gas. It is also not known whether Xenon Xe 133 Gas can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Xenon Xe 133 Gas should be given to a pregnant woman only if clearly needed. Ideally, examination using radiopharmaceuticals, especially those elective in nature in a woman of childbearing capability, should be performed during the first few (approximately 10) days following the onset of menses.
Breastfeeding
It is not known whether Xenon Xe 133 is excreted in human milk. Many drugs are excreted in human milk, therefore formula feedings should be substituted for breast feeding, because of the potential for adverse reactions in nursing infants.
Use in children
Safety and effectiveness in the pediatric population has not been established.
Use in older adults
Clinical studies of Xenon Xe 133 Gas did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Is there a generic Xenon Xe-133?
No. The FDA has not approved a generic version yet.
Brand-name versions
- Xeneisol Mallinckrodt Discontinued
- Xenon Xe 133 Shine, approved 1974
Source: Drugs@FDA (via openFDA), checked October 29, 2026. Marketing status is what companies report to the FDA; whether a pharmacy stocks a product, and what your insurance covers, can differ.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Xenon xe-133 in the news
We have not covered this medicine yet. Latest news
Recalls
No recalls matched to this medicine in FDA enforcement reports from the last 3 years (or older ones still open). Search all recalls
Get alerts for Xenon Xe-133
We will email you if the FDA reports a recall, if its shortage status changes, or when we publish news about it — at most one email a day. No account needed.
Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 74f95143-d3b4-4e69-b200-e09bf811516b.