Quick answers
- What is Xenon XE-133 used for?
- The FDA-approved label (Xenon, Shine Spect USA, LLC, September 10, 2026) says: “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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Xenon XE-133 have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Xenon XE-133?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Xenon XE-133 been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Xenon XE-133?
- 3 companies list prescription products of Xenon XE-133 in the FDA NDC Directory, including Lantheus Medical Imaging, Inc., Shine Spect USA, LLC and Curium US LLC.
What Xenon XE-133 is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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.
— FDA label: Xenon, Shine Spect USA, LLC, effective September 10, 2026. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Gas |
|---|---|
| Route | Respiratory (inhalation) |
| Prescription products | 6 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Lantheus Medical Imaging, Inc.2 products
- Shine Spect USA, LLC2 products
- Curium US LLC2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017284 XENON XE 133 | Shine | October 10, 1974 | 11, latest June 10, 2016 2016: Manufacturing (CMC) · 2011: Labeling · 2003: Labeling |
| NDA018327 XENON XE 133 | Curium | March 9, 1982 | 3, latest March 9, 2016 2016: Manufacturing (CMC) · 1997: Manufacturing (CMC) · 1988: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | 74f95143-d3b4-4e69-b200-e09bf811516b |
|---|---|
| FDA labels (SPL) | 3 |
| FDA applications | NDA017284, NDA018327 |
| Active ingredients (FDA) | XENON XE-133 |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xenon, Shine Spect USA, LLC, effective September 10, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →