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What the label lists and what reports show

Human albumin microspheres and perflutren side effects

Human albumin microspheres and perflutren's FDA label lists its adverse reactions in its own words. FAERS holds 134 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dizziness (13 reports).

  • 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.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following serious adverse reactions are described elsewhere in the labeling: Serious Cardiopulmonary Reactions [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Common adverse reactions (incidence ≥ 0.5%) were: headache, nausea and/or vomiting, warm sensation or flushing, dizziness, dysgeusia, chills or fever, flu-like symptoms, malaise/weakness/fatigue, chest pain, dyspnea, injection site discomfort, and erythema ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

Table 2. Adverse Reactions Reported in ≥ 0.5% of the Adult Patients who Received OPTISON in Controlled Clinical Studies

Adverse ReactionOPTISON n=279 % Body as a Whole
Headache5.4
Warm Sensation/Flushing3.6
Chills/fever1.4
Flu-like Symptoms1.1
Malaise/Weakness/Fatigue1.1
Dizziness2.5
Chest Pain1.1
Nausea and/or Vomiting4.3
Dyspnea1.1
Injection Site Discomfort1.1
Erythema0.7
Dysgeusia1.8

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

Source: FDA drug label, GE Healthcare Inc., effective December 17, 2025 (SPL set 46bcf276-d423-408a-a410-f11383406a94), via openFDA; the full label on DailyMed

What do FAERS reports show?

134 reports list human albumin microspheres and perflutren among the medicines taken, 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. Of the 21 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Dizziness (named in the label)13
  • Back Pain (named in the label)12
  • Drug Ineffective (a use or a product term, not a reaction)12
  • No Adverse Event (a use or a product term, not a reaction)12
  • Chest Pain (named in the label)11
  • Dyspnoea (named in the label)9
  • Nausea (named in the label)9
  • Feeling Hot7
  • Headache (named in the label)6
  • Off Label Use (a use or a product term, not a reaction)6
  • Product Quality Issue (a use or a product term, not a reaction)6
  • Tremor (named in the label)6
  • Anaphylactic Reaction (named in the label)5
  • Flushing (named in the label)5
  • Ventricular Tachycardia (named in the label)4
  • Vomiting (named in the label)4
  • Atrial Fibrillation (named in the label)3
  • Blood Pressure Decreased3
  • Cardiac Arrest3
  • Constipation3
  • Dysgeusia (named in the label)3
  • Dysphagia3
  • Pain3
  • Rash (named in the label)3
  • Swollen Tongue3

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Human albumin microspheres and perflutren: the full record
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Side effects hub
the most reported medicines and reactions