Prescription medicine
Perflutren Brand names: Definity
Perflutren (Definity) is a prescription medicine with an FDA approval on record since 2001. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the perflutren FDA label on DailyMed (effective March 13, 2024, Lantheus Medical Imaging, Inc.); the NDA 21064 record on Drugs@FDA; every perflutren label on DailyMed.
Highlights of the record
FDA label of March 13, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS CARDIOPULMONARY REACTIONS.
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes DEFINITY RT administration [see Contraindications (4) ]. Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1) ]. WARNING: SERIOUS CARDIOPULMONARY REACTIONS Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes DEFINITY RT administration ( 4 ). Always have resuscitation equipment and trained personnel readily available ( 5.1 ).
Used for
From the label: indications and usageDEFINITY 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.
Forms and strengths
- 6.52 mg/ml
Injection (suspension).
On the market
- Earliest approval on file
- July 31, 2001 Definity, Lantheus Medcl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 4, 2037 Definity injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5,692 through July 30, 2026
What is perflutren used for?
From the label: indications and usageDEFINITY 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. DEFINITY RT is an ultrasound contrast agent 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 pharmacologic class: Contrast Agent for Ultrasound Imaging.
Source: FDA drug label (DEFINITY RT), Lantheus Medical Imaging, Inc., effective March 13, 2024 (SPL set 7b9de6ab-a3ac-40c9-8103-139dc7a464a2), via openFDA; the full label on DailyMed
Is there a generic for perflutren (Definity)?
No generic perflutren is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 11 patents for Definity injection: the compound patent runs to December 28, 2035, and the last listed entry to May 4, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2001 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for perflutren?
The FDA Adverse Event Reporting System holds 5,692 reports that list perflutren among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 116 are coded as a death and 395 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other contrast agent for ultrasound imagings
- the pharmacologic class, with prices and generics
- Perflutren side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other