Prescription medicine
Human albumin microspheres and perflutren Brand names: Optison
Human albumin microspheres and perflutren (Optison) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the human albumin microspheres and perflutren FDA label on DailyMed (effective December 17, 2025, GE Healthcare Inc.); every human albumin microspheres and perflutren label on DailyMed.
Highlights of the record
FDA label of December 17, 2025; 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 [see Warnings and Precautions (5.1) ]. Assess all patients for the presence of any condition that precludes OPTISON administration [see Contraindications (4) ]. Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1) ]. WARNING: SERIOUS CARDIOPULMONARY REACTIONS See full prescribing information for complete boxed warning. Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration ( 5.1 ). Assess all patients for the presence of any condition that precludes OPTISON administration ( 4 ). Always have resuscitation equipment and trained personnel readily available ( 5.1 ).
Used for
From the label: indications and usageOPTISON is indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders.
Forms and strengths
- 10 mg/ml / 0.22 mg/ml
Injection (solution).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
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
- 134 through July 30, 2026
What is human albumin microspheres and perflutren used for?
From the label: indications and usageOPTISON is indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. OPTISON is an ultrasound contrast agent indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders ( 1 ).
FDA pharmacologic class: Contrast Agent for Ultrasound Imaging.
Source: FDA drug label (Optison Perflutren Protein-Type A Microspheres), GE Healthcare Inc., effective December 17, 2025 (SPL set 46bcf276-d423-408a-a410-f11383406a94), via openFDA; the full label on DailyMed
Is there a generic for human albumin microspheres and perflutren (Optison)?
No generic human albumin microspheres and perflutren is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for human albumin microspheres and perflutren?
The FDA Adverse Event Reporting System holds 134 reports that list human albumin microspheres and perflutren among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 17 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.
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
- Human albumin microspheres and perflutren side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other