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What the label lists and what reports show

Albumin human side effects

Albumin human's FDA label: “The most common adverse reactions are rigors, hypotension/decreased BP, tachycardia/increased heart rate, pyrexia, feeling cold (chills), nausea, vomiting, dyspnea/bronchospasm, rash/pruritus.” FAERS holds 4,766 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 renal failure (391 reports).

  • No generic listed

Check it at the source: the albumin human FDA label on DailyMed (effective December 31, 2024); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reactions are rigors, hypotension/decreased BP, tachycardia/increased heart rate, pyrexia, feeling cold (chills), nausea, vomiting, dyspnea/bronchospasm, rash/pruritus.

From the label: adverse reactions, continued

The most common adverse reactions are rigors, hypotension/decreased BP, tachycardia/increased heart rate, pyrexia, feeling cold (chills), nausea, vomiting, dyspnea/bronchospasm, rash/pruritus. Stop the infusion if anaphylaxis, with or without shock, is observed. To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma, Inc. at 1-855-3KDRION (1-855-353-7466) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 General In general, human albumin solutions are well-tolerated and no specific, clinically relevant alterations in organ function or coagulopathy have been substantiated. 26 The most common adverse reactions associated with infusion of human albumin solutions are rigors, hypotension/decreased BP, tachycardia/increased heart rate, pyrexia, feeling cold (chills), nausea, vomiting, dyspnea/bronchospasm, rash/pruritus. Reactions usually resolve when the infusion is slowed or stopped. Anaphylaxis, with or without shock, may occur and in this situation, stop the infusion. 6.2 Clinical Trials Experience No clinical studies were done using ALBUMINEX 25%.

Source: FDA drug label, BPL, effective December 31, 2024 (SPL set 167f48d0-8ae5-4f7e-b050-9673dad78acc), via openFDA; the full label on DailyMed

What do FAERS reports show?

4,766 reports list albumin human among the medicines taken, 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. Of the 19 reactions below, 4 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.

Reports received each year

The 25 most reported reactions

  • Renal Failure391
  • Off Label Use (a use or a product term, not a reaction)365
  • Pyrexia (named in the label)328
  • Pain319
  • Drug Ineffective (a use or a product term, not a reaction)304
  • Dyspnoea (named in the label)278
  • Pneumonia273
  • Injury (a use or a product term, not a reaction)270
  • Hypotension (named in the label)264
  • Anxiety260
  • Renal Impairment251
  • Unevaluable Event248
  • Death (an outcome recorded in the report)228
  • Sepsis (a use or a product term, not a reaction)228
  • Fear219
  • Renal Injury197
  • Emotional Distress195
  • Anaemia191
  • Diarrhoea187
  • Respiratory Failure182
  • Stress (a use or a product term, not a reaction)173
  • Multi-Organ Failure172
  • Anhedonia156
  • Acute Kidney Injury154
  • Nausea (named in the label)147

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

What next?

Albumin human: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions