Heparin and Dextrose side effects: what 706 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Heparin Sodium And Dextrose (Heparin Sodium In Dextrose)
Who reports
706 reports · 90% serious · 132 with death outcome · 42% female
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.
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 .
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
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.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 4 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Appendicitis | 65 | 209.1 165.7–263.9ROR 230.2 · χ² 13,169 / p <1e-300 | 195.8 EB05 159.0 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 135.0 · ♀ 3% (drug 42%) · 97% clinician | no trial data cached |
| Ventricular fibrillation | 66 | 177.0 140.6–222.9ROR 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% clinician | no trial data cached |
| Cardiogenic shock | 63 | 131.7 104.0–166.8ROR 144.5 · χ² 8,011 / p <1e-300 | 126.2 EB05 102.1 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 84.0 · ♀ 4% (drug 42%) · 97% clinician | no trial data cached |
| Incorrect route of product administration | 45 | 79.7 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 artifact | serious PRR 101.9 · ♀ 5% (drug 42%) · 100% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 71 | 75.8 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 — unassessed | serious PRR 48.4 · ♀ 3% (drug 42%) · 97% clinician | no trial data cached |
| Bacterial infection | 47 | 75.3 57.1–99.4ROR 80.7 · χ² 3,368 / p <1e-300 | 73.0 EB05 57.1 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 55.7 · ♀ 5% (drug 42%) · 100% clinician | no trial data cached |
| Hyperlipidaemia | 28 | 69.5 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 — unassessed | serious PRR 49.0 · ♀ 8% (drug 42%) · 100% clinician | no trial data cached |
| Ascites | 66 | 66.8 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 — unassessed | serious PRR 43.3 · ♀ 3% (drug 42%) · 97% clinician | no trial data cached |
| Blood test abnormal | 28 | 59.3 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 artifact | serious PRR 58.1 · ♀ 16% (drug 42%) · 100% clinician | no trial data cached |
| Neuralgia | 48 | 58.9 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 — unassessed | serious PRR 55.9 · ♀ 5% (drug 42%) · 100% clinician | no trial data cached |
| Ulcer | 28 | 52.3 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% clinician | no trial data cached |
| Gout | 28 | 46.4 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 — unassessed | serious PRR 44.8 · ♀ 8% (drug 42%) · 100% clinician | no trial data cached |
| End stage renal disease | 28 | 45.2 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 — unassessed | serious PRR 28.9 · ♀ 8% (drug 42%) · 100% clinician | no trial data cached |
| Aspiration | 14 | 38.4 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 — unassessed | serious PRR 25.3 | no trial data cached |
| Hyponatraemia (low sodium) | 72 | 38.1 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 — unassessed | serious PRR 25.0 · ♀ 3% (drug 42%) · 97% clinician | no trial data cached |
| Full blood count abnormal | 13 | 36.7 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 marker | serious PRR 31.2 | no trial data cached |
| Hypercholesterolaemia | 11 | 34.2 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 — unassessed | serious PRR 23.3 | no trial data cached |
| Micturition urgency | 12 | 31.5 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 — unassessed | serious PRR 33.3 | no trial data cached |
| Stress | 73 | 30.2 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 — unassessed | serious PRR 32.1 · ♀ 6% (drug 42%) · 97% clinician | no trial data cached |
| Blood cholesterol increased | 47 | 30.0 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 marker | serious PRR 29.1 · ♀ 5% (drug 42%) · 100% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 50 | 28.5 21.8–37.2ROR 30.6 · χ² 1,302 / p 2e-285 | 28.2 EB05 22.2 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 21.3 · ♀ 4% (drug 42%) · 100% clinician | no trial data cached |
| Disseminated intravascular coagulation | 11 | 23.2 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 14.9 | no trial data cached |
| Thrombosis | 59 | 21.7 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% clinician | no trial data cached |
| Dry mouth | 56 | 20.6 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 — unassessed | serious PRR 26.1 · ♀ 10% (drug 42%) · 100% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 65 | 20.2 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% clinician | no trial data cached |
| Sleep disorder | 47 | 20.0 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 — unassessed | serious PRR 21.1 · ♀ 7% (drug 42%) · 100% clinician | no trial data cached |
| Liver function test increased | 14 | 19.5 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 — unassessed | serious PRR 19.5 | no trial data cached |
| Diabetes mellitus | 50 | 19.4 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% clinician | no trial data cached |
| Sepsis (blood infection) | 71 | 18.9 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 — unassessed | serious PRR 12.2 · ♀ 8% (drug 42%) · 97% clinician | no trial data cached |
| General physical health deterioration | 73 | 18.9 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 artifact | serious PRR 14.1 · ♀ 4% (drug 42%) · 97% clinician | no trial data cached |
| Transaminases increased | 14 | 18.7 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 — unassessed | serious PRR 12.8 | no trial data cached |
| Abdominal distension (bloating) | 65 | 18.6 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 — unassessed | serious PRR 21.0 · ♀ 5% (drug 42%) · 97% clinician | no trial data cached |
| Joint injury | 12 | 16.7 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 — unassessed | serious PRR 13.9 | no trial data cached |
| Lower respiratory tract infection | 25 | 16.4 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 — unassessed | serious PRR 11.1 · ♀ 9% (drug 42%) · 100% clinician | no trial data cached |
| Haematoma | 14 | 16.0 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 — unassessed | serious PRR 11.1 | no trial data cached |
| Intentional product misuse | 45 | 15.4 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 artifact | serious PRR 22.4 · ♀ 5% (drug 42%) · 100% clinician | no trial data cached |
| Swelling | 48 | 15.3 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 — unassessed | serious PRR 15.9 · ♀ 5% (drug 42%) · 100% clinician | no trial data cached |
| Cardiovascular disorder | 13 | 15.1 8.8–25.9ROR 15.4 · χ² 157 / p 2e-36 | 14.0 EB05 7.9 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.4 | no trial data cached |
| Coronary artery disease | 14 | 13.6 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 — unassessed | serious PRR 8.9 | no trial data cached |
| Therapeutic product effect decreased | 15 | 10.0 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)
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 |
|---|---|---|---|---|---|---|
| General physical health deterioration | 73 | 18.9 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 artifact | serious PRR 14.1 · ♀ 4% (drug 42%) · 97% clinician | no trial data cached |
| Stress | 73 | 30.2 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 — unassessed | serious PRR 32.1 · ♀ 6% (drug 42%) · 97% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 72 | 38.1 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 — unassessed | serious PRR 25.0 · ♀ 3% (drug 42%) · 97% clinician | no trial data cached |
| Sepsis (blood infection) | 71 | 18.9 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 — unassessed | serious PRR 12.2 · ♀ 8% (drug 42%) · 97% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 71 | 75.8 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 — unassessed | serious PRR 48.4 · ♀ 3% (drug 42%) · 97% clinician | no trial data cached |
| Ascites | 66 | 66.8 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 — unassessed | serious PRR 43.3 · ♀ 3% (drug 42%) · 97% clinician | no trial data cached |
| Ventricular fibrillation | 66 | 177.0 140.6–222.9ROR 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% clinician | no trial data cached |
| Abdominal distension (bloating) | 65 | 18.6 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 — unassessed | serious PRR 21.0 · ♀ 5% (drug 42%) · 97% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 65 | 20.2 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% clinician | no trial data cached |
| Appendicitis | 65 | 209.1 165.7–263.9ROR 230.2 · χ² 13,169 / p <1e-300 | 195.8 EB05 159.0 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 135.0 · ♀ 3% (drug 42%) · 97% clinician | no trial data cached |
| Cardiogenic shock | 63 | 131.7 104.0–166.8ROR 144.5 · χ² 8,011 / p <1e-300 | 126.2 EB05 102.1 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 84.0 · ♀ 4% (drug 42%) · 97% clinician | no trial data cached |
| Thrombosis | 59 | 21.7 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% clinician | no trial data cached |
| Dry mouth | 56 | 20.6 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 — unassessed | serious PRR 26.1 · ♀ 10% (drug 42%) · 100% clinician | no trial data cached |
| Diabetes mellitus | 50 | 19.4 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% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 50 | 28.5 21.8–37.2ROR 30.6 · χ² 1,302 / p 2e-285 | 28.2 EB05 22.2 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 21.3 · ♀ 4% (drug 42%) · 100% clinician | no 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.
- Appendicitis — n=65, PRR 209.1
- Cardiogenic shock — n=63, PRR 131.7
- Multiple organ dysfunction syndrome — n=71, PRR 75.8
- Hyperlipidaemia — n=28, PRR 69.5
- Ascites — n=66, PRR 66.8
- Neuralgia — n=48, PRR 58.9
- Gout — n=28, PRR 46.4
- End stage renal disease — n=28, PRR 45.2
- Hyponatraemia — n=72, PRR 38.1
- Stress — n=73, PRR 30.2
✓ 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
- FDA label via openFDA (set ID 92a6f533-1a3d-4734-b413-d245592454e3, effective 20230731; matched on
openfda.generic_name.exact:"HEPARIN SODIUM AND DEXTROSE") - 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, fieldpatient.drug.openfda.generic_name.exact, 44 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.