Prescription medicine
Albumin human First approved as Optison
Albumin human (Optison) is a prescription medicine with an FDA approval on record since 1997. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the albumin human FDA label on DailyMed (effective December 31, 2024); the NDA 20899 record on Drugs@FDA; every albumin human label on DailyMed.
Highlights of the record
FDA label of December 31, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageALBUMINEX 25% is a 25% albumin solution indicated for adults and children: Hypovolemia ( 1.1 ) Ascites ( 1.2 ) Hypoalbuminemia including from burns ( 1.3 ) Acute Nephrosis ( 1.4 ) Acute Respiratory Distress Syndrome (ARDS) ( 1.5 ) Cardiopulmonary Bypass ( 1.6 ) 1.1 Hypovolemia ALBUMINEX 25% is indicated for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use
Forms and strengths
- 0.05 g/ml
- 0.25 g/ml
Solution.
On the market
- Earliest approval on file
- December 31, 1997 Optison, Ge Healthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
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
- 4,766 through July 30, 2026
What is albumin human used for?
From the label: indications and usageALBUMINEX 25% is a 25% albumin solution indicated for adults and children: Hypovolemia ( 1.1 ) Ascites ( 1.2 ) Hypoalbuminemia including from burns ( 1.3 ) Acute Nephrosis ( 1.4 ) Acute Respiratory Distress Syndrome (ARDS) ( 1.5 ) Cardiopulmonary Bypass ( 1.6 ) 1.1 Hypovolemia ALBUMINEX 25% is indicated for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate e.g. hypovolemia following shock due to trauma or sepsis, in surgical patients and in other similar conditions with volume deficiency when restoration and maintenance of circulating blood volume is required in both adult and pediatric patients. […]
FDA pharmacologic class: Human Serum Albumin.
Source: FDA drug label (ALBUMINEX), BPL, effective December 31, 2024 (SPL set 167f48d0-8ae5-4f7e-b050-9673dad78acc), via openFDA; the full label on DailyMed
Is there a generic for albumin human (Optison)?
No generic albumin human is approved (Drugs@FDA, October 8, 2026).
- 1997 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for albumin human?
The FDA Adverse Event Reporting System holds 4,766 reports that list albumin human among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,460 are coded as a death and 2,417 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?
- Albumin human side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other