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Heparin and Dextrose side effects: what 706 FDA adverse event reports show

Heparin Sodium And Dextrose · 44 reaction terms · 1,635 drug–reaction co-reports · data 2026-09-14
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Drug class

Not stated in label

Label matched

Heparin Sodium And Dextrose (Heparin Sodium In Dextrose)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

706 reports · 90% serious · 132 with death outcome · 42% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Heparin Sodium in 5% Dextrose Injection is indicated for: Prophylaxis and treatment of venous thrombosis and pulmonary embolism Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation Treatment of acute and chronic.

FDA label, Indications and Usage

What it is

Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. It is composed of polymers of alternating derivations .

FDA label, Description section

Boxed warning

None in the current 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 40 strongest signals

Labeled adverse reaction 2Labeled (related wording) 3Likely indication confounding 4Reporting / coding artifact 5Lab value / disease marker 2Not in label — unassessed 24
What the badges mean

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. 4 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Appendicitis65209.1
165.7–263.9ROR 230.2 · χ² 13,169 / p <1e-300
195.8 EB05 159.0 · IC025 +5.9
3/3 methods agree
Not in label — unassessedserious PRR 135.0 · ♀ 3% (drug 42%) · 97% clinicianno trial data cached
Ventricular fibrillation66177.0
140.6–222.9ROR 195.2 · χ² 11,316 / p <1e-300
167.5 EB05 136.3 · IC025 +5.8
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious PRR 113.0 · ♀ 3% (drug 42%) · 97% clinicianno trial data cached
Cardiogenic shock63131.7
104.0–166.8ROR 144.5 · χ² 8,011 / p <1e-300
126.2 EB05 102.1 · IC025 +5.6
3/3 methods agree
Not in label — unassessedserious PRR 84.0 · ♀ 4% (drug 42%) · 97% clinicianno trial data cached
Incorrect route of product administration4579.7
60.1–105.8ROR 85.1 · χ² 3,414 / p <1e-300
77.0 EB05 59.9 · IC025 +4.9
3/3 methods agree
Reporting / coding artifactserious PRR 101.9 · ♀ 5% (drug 42%) · 100% clinicianno trial data cached
Multiple organ dysfunction syndrome7175.8
60.7–94.5ROR 84.1 · χ² 5,157 / p <1e-300
74.1 EB05 60.7 · IC025 +5.2
3/3 methods agree
Not in label — unassessedserious PRR 48.4 · ♀ 3% (drug 42%) · 97% clinicianno trial data cached
Hyperlipidaemia2869.5
48.4–100.0ROR 72.4 · χ² 1,820 / p <1e-300
66.4 EB05 48.2 · IC025 +4.3
3/3 methods agree
Not in label — unassessedserious PRR 49.0 · ♀ 8% (drug 42%) · 100% clinicianno trial data cached
Ascites6666.8
53.1–84.1ROR 73.6 · χ² 4,208 / p <1e-300
65.4 EB05 53.2 · IC025 +5.1
3/3 methods agree
Not in label — unassessedserious PRR 43.3 · ♀ 3% (drug 42%) · 97% clinicianno trial data cached
Blood test abnormal2859.3
41.3–85.4ROR 61.8 · χ² 1,546 / p <1e-300
57.0 EB05 41.4 · IC025 +4.2
3/3 methods agree
Reporting / coding artifactserious PRR 58.1 · ♀ 16% (drug 42%) · 100% clinicianno trial data cached
Neuralgia4858.9
44.8–77.4ROR 63.1 · χ² 2,672 / p <1e-300
57.5 EB05 45.1 · IC025 +4.7
3/3 methods agree
Not in label — unassessedserious PRR 55.9 · ♀ 5% (drug 42%) · 100% clinicianno trial data cached
Ulcer2852.3
36.4–75.2ROR 54.4 · χ² 1,356 / p 3e-297
50.5 EB05 36.7 · IC025 +4.1
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 42.2 · ♀ 8% (drug 42%) · 100% clinicianno trial data cached
Gout2846.4
32.2–66.7ROR 48.2 · χ² 1,197 / p 1e-262
45.0 EB05 32.7 · IC025 +4.1
3/3 methods agree
Not in label — unassessedserious PRR 44.8 · ♀ 8% (drug 42%) · 100% clinicianno trial data cached
End stage renal disease2845.2
31.4–65.0ROR 47.0 · χ² 1,166 / p 7e-256
43.9 EB05 31.9 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious PRR 28.9 · ♀ 8% (drug 42%) · 100% clinicianno trial data cached
Aspiration1438.4
22.9–64.6ROR 39.2 · χ² 473 / p 3e-105
36.6 EB05 23.2 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious PRR 25.3no trial data cached
Hyponatraemia (low sodium)7238.1
30.6–47.4ROR 42.3 · χ² 2,567 / p <1e-300
37.7 EB05 30.9 · IC025 +4.5
3/3 methods agree
Not in label — unassessedserious PRR 25.0 · ♀ 3% (drug 42%) · 97% clinicianno trial data cached
Full blood count abnormal1336.7
21.4–62.8ROR 37.3 · χ² 416 / p 1e-92
34.9 EB05 21.7 · IC025 +3.0
3/3 methods agree
Lab value / disease markerserious PRR 31.2no trial data cached
Hypercholesterolaemia1134.2
19.0–61.5ROR 34.7 · χ² 322 / p 3e-72
32.4 EB05 19.3 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious PRR 23.3no trial data cached
Micturition urgency1231.5
18.0–55.2ROR 32.0 · χ² 324 / p 1e-72
30.1 EB05 18.3 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious PRR 33.3no trial data cached
Stress7330.2
24.3–37.5ROR 33.5 · χ² 2,035 / p <1e-300
29.9 EB05 24.6 · IC025 +4.3
3/3 methods agree
Not in label — unassessedserious PRR 32.1 · ♀ 6% (drug 42%) · 97% clinicianno trial data cached
Blood cholesterol increased4730.0
22.7–39.5ROR 32.0 · χ² 1,288 / p 2e-282
29.6 EB05 23.2 · IC025 +4.0
3/3 methods agree
Lab value / disease markerserious PRR 29.1 · ♀ 5% (drug 42%) · 100% clinicianno trial data cached
Disseminated intravascular coagulation1123.2
12.9–41.6ROR 23.5 · χ² 211 / p 3e-48
22.1 EB05 12.8 · IC025 +2.5
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious PRR 14.9no trial data cached
Thrombosis5921.7
17.0–27.8ROR 23.6 · χ² 1,150 / p 2e-252
21.6 EB05 17.3 · IC025 +3.8
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious PRR 14.4 · ♀ 7% (drug 42%) · 97% clinicianno trial data cached
Dry mouth5620.6
16.0–26.4ROR 22.2 · χ² 1,025 / p 3e-225
20.4 EB05 16.3 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious PRR 26.1 · ♀ 10% (drug 42%) · 100% clinicianno trial data cached
Pulmonary embolism (lung blood clot)6520.2
16.0–25.5ROR 22.2 · χ² 1,174 / p 1e-257
20.1 EB05 16.3 · IC025 +3.7
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious PRR 13.0 · ♀ 14% (drug 42%) · 97% clinicianno trial data cached
Sleep disorder4720.0
15.1–26.3ROR 21.3 · χ² 830 / p 8e-183
19.8 EB05 15.5 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious PRR 21.1 · ♀ 7% (drug 42%) · 100% clinicianno trial data cached
Liver function test increased1419.5
11.6–32.8ROR 19.9 · χ² 228 / p 9e-52
18.8 EB05 11.5 · IC025 +2.7
3/3 methods agree
Not in label — unassessedserious PRR 19.5no trial data cached
Diabetes mellitus5019.4
14.9–25.4ROR 20.8 · χ² 857 / p 1e-188
19.3 EB05 15.2 · IC025 +3.6
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 13.5 · ♀ 4% (drug 42%) · 100% clinicianno trial data cached
Sepsis (blood infection)7118.9
15.2–23.6ROR 20.9 · χ² 1,192 / p 2e-261
18.8 EB05 15.4 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious PRR 12.2 · ♀ 8% (drug 42%) · 97% clinicianno trial data cached
General physical health deterioration7318.9
15.2–23.5ROR 20.9 · χ² 1,225 / p 1e-268
18.8 EB05 15.4 · IC025 +3.7
3/3 methods agree
Reporting / coding artifactserious PRR 14.1 · ♀ 4% (drug 42%) · 97% clinicianno trial data cached
Transaminases increased1418.7
11.1–31.5ROR 19.1 · χ² 218 / p 1e-49
18.0 EB05 10.9 · IC025 +2.6
3/3 methods agree
Not in label — unassessedserious PRR 12.8no trial data cached
Abdominal distension (bloating)6518.6
14.7–23.4ROR 20.4 · χ² 1,068 / p 1e-234
18.5 EB05 15.0 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious PRR 21.0 · ♀ 5% (drug 42%) · 97% clinicianno trial data cached
Joint injury1216.7
9.5–29.2ROR 16.9 · χ² 162 / p 3e-37
15.6 EB05 8.6 · IC025 +2.4
3/3 methods agree
Not in label — unassessedserious PRR 13.9no trial data cached
Lower respiratory tract infection2516.4
11.2–24.1ROR 17.0 · χ² 347 / p 1e-77
16.0 EB05 11.2 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious PRR 11.1 · ♀ 9% (drug 42%) · 100% clinicianno trial data cached
Haematoma1416.0
9.5–26.9ROR 16.3 · χ² 182 / p 8e-42
15.1 EB05 8.8 · IC025 +2.5
3/3 methods agree
Not in label — unassessedserious PRR 11.1no trial data cached
Intentional product misuse4515.4
11.6–20.4ROR 16.4 · χ² 594 / p 2e-131
15.2 EB05 11.7 · IC025 +3.2
3/3 methods agree
Reporting / coding artifactserious PRR 22.4 · ♀ 5% (drug 42%) · 100% clinicianno trial data cached
Swelling4815.3
11.6–20.1ROR 16.3 · χ² 629 / p 5e-139
15.1 EB05 11.8 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious PRR 15.9 · ♀ 5% (drug 42%) · 100% clinicianno trial data cached
Coronary artery disease1413.6
8.1–22.9ROR 13.9 · χ² 152 / p 4e-35
12.5 EB05 7.2 · IC025 +2.3
3/3 methods agree
Not in label — unassessedserious PRR 8.9no trial data cached
Therapeutic product effect decreased1510.0
6.1–16.6ROR 10.2 · χ² 113 / p 9e-27
8.6 EB05 5.2 · IC025 +2.1
3/3 methods agree
Reporting / coding artifact–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.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
General physical health deterioration7318.9
15.2–23.5ROR 20.9 · χ² 1,225 / p 1e-268
18.8 EB05 15.4 · IC025 +3.7
3/3 methods agree
Reporting / coding artifactserious PRR 14.1 · ♀ 4% (drug 42%) · 97% clinicianno trial data cached
Stress7330.2
24.3–37.5ROR 33.5 · χ² 2,035 / p <1e-300
29.9 EB05 24.6 · IC025 +4.3
3/3 methods agree
Not in label — unassessedserious PRR 32.1 · ♀ 6% (drug 42%) · 97% clinicianno trial data cached
Hyponatraemia (low sodium)7238.1
30.6–47.4ROR 42.3 · χ² 2,567 / p <1e-300
37.7 EB05 30.9 · IC025 +4.5
3/3 methods agree
Not in label — unassessedserious PRR 25.0 · ♀ 3% (drug 42%) · 97% clinicianno trial data cached
Sepsis (blood infection)7118.9
15.2–23.6ROR 20.9 · χ² 1,192 / p 2e-261
18.8 EB05 15.4 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious PRR 12.2 · ♀ 8% (drug 42%) · 97% clinicianno trial data cached
Multiple organ dysfunction syndrome7175.8
60.7–94.5ROR 84.1 · χ² 5,157 / p <1e-300
74.1 EB05 60.7 · IC025 +5.2
3/3 methods agree
Not in label — unassessedserious PRR 48.4 · ♀ 3% (drug 42%) · 97% clinicianno trial data cached
Ascites6666.8
53.1–84.1ROR 73.6 · χ² 4,208 / p <1e-300
65.4 EB05 53.2 · IC025 +5.1
3/3 methods agree
Not in label — unassessedserious PRR 43.3 · ♀ 3% (drug 42%) · 97% clinicianno trial data cached
Ventricular fibrillation66177.0
140.6–222.9ROR 195.2 · χ² 11,316 / p <1e-300
167.5 EB05 136.3 · IC025 +5.8
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious PRR 113.0 · ♀ 3% (drug 42%) · 97% clinicianno trial data cached
Abdominal distension (bloating)6518.6
14.7–23.4ROR 20.4 · χ² 1,068 / p 1e-234
18.5 EB05 15.0 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious PRR 21.0 · ♀ 5% (drug 42%) · 97% clinicianno trial data cached
Pulmonary embolism (lung blood clot)6520.2
16.0–25.5ROR 22.2 · χ² 1,174 / p 1e-257
20.1 EB05 16.3 · IC025 +3.7
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious PRR 13.0 · ♀ 14% (drug 42%) · 97% clinicianno trial data cached
Appendicitis65209.1
165.7–263.9ROR 230.2 · χ² 13,169 / p <1e-300
195.8 EB05 159.0 · IC025 +5.9
3/3 methods agree
Not in label — unassessedserious PRR 135.0 · ♀ 3% (drug 42%) · 97% clinicianno trial data cached
Cardiogenic shock63131.7
104.0–166.8ROR 144.5 · χ² 8,011 / p <1e-300
126.2 EB05 102.1 · IC025 +5.6
3/3 methods agree
Not in label — unassessedserious PRR 84.0 · ♀ 4% (drug 42%) · 97% clinicianno trial data cached
Thrombosis5921.7
17.0–27.8ROR 23.6 · χ² 1,150 / p 2e-252
21.6 EB05 17.3 · IC025 +3.8
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious PRR 14.4 · ♀ 7% (drug 42%) · 97% clinicianno trial data cached
Dry mouth5620.6
16.0–26.4ROR 22.2 · χ² 1,025 / p 3e-225
20.4 EB05 16.3 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious PRR 26.1 · ♀ 10% (drug 42%) · 100% clinicianno trial data cached
Diabetes mellitus5019.4
14.9–25.4ROR 20.8 · χ² 857 / p 1e-188
19.3 EB05 15.2 · IC025 +3.6
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 13.5 · ♀ 4% (drug 42%) · 100% clinicianno trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Heparin ↔ Heparin-induced thrombocytopenia (HIT).

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 Heparin and Dextrose?

In FDA FAERS, the most frequently co-reported reaction terms for Heparin and Dextrose are stress, hyponatraemia, sepsis, multiple organ dysfunction syndrome, ascites, ventricular fibrillation. 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 Heparin and Dextrose have an FDA boxed warning?

No. The FDA label retrieved for Heparin and Dextrose has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Heparin and Dextrose 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

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.