Hetastarch side effects: what 164 FDA adverse event reports show

Hetastarch · 7 reaction terms · 117 drug–reaction co-reports · data 2026-09-14

Drug class

Plasma Volume Expander

FDA label (Established Pharmacologic Class)

Who reports

164 reports · 93% serious · 27 with death outcome · 68% female

openFDA FAERS counts, all years, deduplication not applied

Used for

6% Hetastarch in 0.9% Sodium Chloride Injection is indicated in the treatment of hypovolemia when plasma volume expansion is desired in settings where adequate alternative treatment is unavailable. It is not a substitute for blood or plasma. The adjunc.

FDA label, Indications and Usage

What it is

6% Hetastarch in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic solution for intravenous administration. Each 100 mL contains: Hetastarch............................................................................ 6 g Sodium Chloride, USP........................................................

FDA label, Description section

Boxed warning

MORTALITY; KIDNEY INJURY; COAGULOPATHY • Use of hydroxyethyl starch (HES) products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, increases risk of o Mortality o Kidney injury ( 5.1 ) o Coagulopathy ( 5.2 ) • DO NOT use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 6 strongest signals

Labeled adverse reaction 1Reporting / coding artifact 1Not in label — unassessed 4

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Toxic epidermal necrolysis (severe skin peeling reaction)	13	111.0 65.9–187.0ROR 120.5 · χ² 1,309 / p 7e-287	95.7 EB05 59.5 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 68.1	no trial data cached
Exposure during pregnancy	42	86.9 67.0–112.8ROR 116.8 · χ² 3,491 / p <1e-300	83.7 EB05 64.5 · IC025 +4.9 3/3 methods agree	Reporting / coding artifact	serious PRR 80.2 · ♀ 100% (drug 68%)	no trial data cached
Bradycardia (slow heart rate)	34	82.4 61.1–111.1ROR 103.8 · χ² 2,657 / p <1e-300	78.8 EB05 59.0 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 52.3 · ♀ 97% (drug 68%)	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	14	80.9 49.0–133.5ROR 88.4 · χ² 1,026 / p 2e-225	73.1 EB05 46.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 50.0	no trial data cached
Hyperthyroidism	5	44.5 18.8–105.4ROR 45.9 · χ² 171 / p 2e-39	37.9 EB05 16.7 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 29.3	no trial data cached
Serotonin syndrome	6	40.4 18.4–88.5ROR 41.9 · χ² 193 / p 4e-44	35.8 EB05 17.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 25.0	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Exposure during pregnancy	42	86.9 67.0–112.8ROR 116.8 · χ² 3,491 / p <1e-300	83.7 EB05 64.5 · IC025 +4.9 3/3 methods agree	Reporting / coding artifact	serious PRR 80.2 · ♀ 100% (drug 68%)	no trial data cached
Bradycardia (slow heart rate)	34	82.4 61.1–111.1ROR 103.8 · χ² 2,657 / p <1e-300	78.8 EB05 59.0 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 52.3 · ♀ 97% (drug 68%)	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	14	80.9 49.0–133.5ROR 88.4 · χ² 1,026 / p 2e-225	73.1 EB05 46.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 50.0	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	13	111.0 65.9–187.0ROR 120.5 · χ² 1,309 / p 7e-287	95.7 EB05 59.5 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 68.1	no trial data cached
Serotonin syndrome	6	40.4 18.4–88.5ROR 41.9 · χ² 193 / p 4e-44	35.8 EB05 17.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 25.0	no trial data cached
Hyperthyroidism	5	44.5 18.8–105.4ROR 45.9 · χ² 171 / p 2e-39	37.9 EB05 16.7 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 29.3	no trial data cached
Product complaint	3	15.5 5.0–47.5ROR 15.7 · χ² 27 / p 8e-8	8.1 EB05 2.3 · IC025 +0.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Hetastarch?

In FDA FAERS, the most frequently co-reported reaction terms for Hetastarch are bradycardia, stevens-johnson syndrome, toxic epidermal necrolysis, serotonin syndrome, hyperthyroidism. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Hetastarch have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: MORTALITY; KIDNEY INJURY; COAGULOPATHY • Use of hydroxyethyl starch (HES) products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, increases risk of o Mortality o Kidney injury ( 5.1 ) o Coagulopathy ( 5.2 ) • DO NOT use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable.

Do FAERS signals prove that Hetastarch causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID d64f961a-3e1f-4b04-cf83-604474af2775, effective 20260430; matched on openfda.generic_name.exact:"HETASTARCH")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 7 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.