Quick answers
- What is Human albumin microspheres and perflutren used for?
- The FDA-approved label (Optison Perflutren Protein-Type A Microspheres, GE Healthcare Inc., December 17, 2025) says: “OPTISON 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Human albumin microspheres and perflutren have a boxed warning?
- Yes. The FDA label for Optison Perflutren Protein-Type A Microspheres 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 Human albumin microspheres and perflutren?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Human albumin microspheres and perflutren been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Human albumin microspheres and perflutren?
- 1 company lists prescription products of Human albumin microspheres and perflutren in the FDA NDC Directory, including GE Healthcare Inc..
What Human albumin microspheres and perflutren is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
OPTISON 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. …
— FDA label: Optison Perflutren Protein-Type A Microspheres, GE Healthcare Inc., effective December 17, 2025. Read the full label on DailyMed →
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 →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Optison Perflutren Protein-Type a Microspheres |
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.
- GE Healthcare Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020899 OPTISON | Ge Healthcare | December 31, 1997 | 17, latest May 9, 2025 2025: Efficacy · 2021: 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 | 46bcf276-d423-408a-a410-f11383406a94 |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | NDA020899 |
| Active ingredients (FDA) | HUMAN ALBUMIN MICROSPHERES / PERFLUTREN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Optison Perflutren Protein-Type A Microspheres, GE Healthcare Inc., effective December 17, 2025; 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 →