Quick answers
- What is Perflutren used for?
- The FDA-approved label (Definity Rt, Lantheus Medical Imaging, Inc., March 13, 2024) says: “DEFINITY RT is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Perflutren have a boxed warning?
- Yes. The FDA label for Definity Rt has a boxed warning (“WARNING: SERIOUS CARDIOPULMONARY REACTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Perflutren?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Perflutren been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Perflutren?
- 1 company lists prescription products of Perflutren in the FDA NDC Directory, including Lantheus Medical Imaging, Inc..
What Perflutren is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DEFINITY RT is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. …
— FDA label: Definity Rt, Lantheus Medical Imaging, Inc., effective March 13, 2024. Read the full label on DailyMed →
The FDA has 2 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.
This label has a boxed warning. Its heading: WARNING: SERIOUS CARDIOPULMONARY REACTIONS
. Read it on the full label →
2 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, suspension |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Definity Rt, Definity |
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
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021064 DEFINITY, DEFINITY RT | Lantheus Medcl | July 31, 2001 | 19, latest March 1, 2024 2024: Efficacy · 2023: Labeling · 2021: Labeling |
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 | 7b9de6ab-a3ac-40c9-8103-139dc7a464a2 |
|---|---|
| FDA labels (SPL) | 2 |
| FDA applications | NDA021064 |
| Active ingredients (FDA) | PERFLUTREN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Definity Rt, Lantheus Medical Imaging, Inc., effective March 13, 2024; 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 →