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What the label lists and what reports show

Hetastarch side effects

Hetastarch's FDA label lists its adverse reactions in its own words. FAERS holds 164 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 hypotension (35 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the hetastarch FDA label on DailyMed (effective May 20, 2026); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Serious adverse reactions reported in postmarketing clinical trials include increased mortality and AKI (including need for RRT) in critically ill subjects, including subjects with sepsis, and surgical subjects. Clinical trials have also shown increased mortality and AKI in blunt trauma subjects. Increased coagulopathy was reported in surgical subjects. In clinical trials comparing the plasma volume expanding properties of HEXTEND (n=60) with those of 6% Hetastarch in 0.9% Sodium Chloride Injection (n=59), there were no significant differences in the number of adverse or serious adverse events between the two groups. Reported adverse reactions with isotonic solutions containing 6% hetastarch include: General Hypersensitivity (see WARNINGS AND PRECAUTIONS ). …

Source: FDA drug label, Hospira, Inc., effective May 20, 2026 (SPL set fc79700c-6c3b-4998-8307-4dc8c81c5041), via openFDA; the full label on DailyMed

What do FAERS reports show?

164 reports list hetastarch among the medicines taken, each a report of something that happened, not proof the medicine caused it; 27 are coded as a death and 56 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, 5 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

  • Exposure During Pregnancy (a use or a product term, not a reaction)42
  • Hypotension (named in the label)35
  • Bradycardia (named in the label)34
  • Live Birth32
  • Stevens-Johnson Syndrome14
  • Toxic Epidermal Necrolysis13
  • Drug Interaction (a use or a product term, not a reaction)10
  • Rash (named in the label)10
  • Drug Ineffective (a use or a product term, not a reaction)9
  • Off Label Use (a use or a product term, not a reaction)9
  • Ovarian Hyperstimulation Syndrome7
  • Pneumonia7
  • Haematocrit Decreased6
  • Hypokalaemia6
  • Multi-Organ Failure6
  • Renal Failure6
  • Serotonin Syndrome6
  • Urticaria (named in the label)6
  • Acute Kidney Injury (named in the label)5
  • Dermatitis Bullous5
  • Dizziness5
  • Epidermolysis5
  • Hyperthyroidism5
  • Pain5
  • Pyrexia5

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

What next?

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