Soybean Oil side effects: what 674 FDA adverse event reports show

Soybean Oil · 8 reaction terms · 239 drug–reaction co-reports · data 2026-09-14

Drug class

Lipid Emulsion

FDA label (Established Pharmacologic Class) · compare the class

Who reports

674 reports · 52% serious · 68 with death outcome · 48% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Nutrilipid ® 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated..

FDA label, Indications and Usage

What it is

Nutrilipid 20% is a homogenous white and milky sterile, nonpyrogenic lipid emulsion for intravenous administration. Each 100 mL of Nutrilipid 20% contains: Soybean Oil 20 g; Egg Yolk Phospholipid 1.2 g; Glycerin USP (glycerol) 2.5 g; Sodium Oleate 0.03 g; Water for Injection USP qs.

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 8 strongest signals

Labeled adverse reaction 1Reporting / coding artifact 1Not in label — unassessed 6

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. 0 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
Appendicitis	11	36.9 20.5–66.3ROR 37.5 · χ² 348 / p 5e-78	34.8 EB05 20.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 41.4	no trial data cached
Chills	134	35.5 30.5–41.4ROR 44.1 · χ² 4,484 / p <1e-300	35.3 EB05 30.6 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.7 · 96% clinician	no trial data cached
Temperature intolerance	11	33.5 18.7–60.3ROR 34.1 · χ² 315 / p 7e-71	31.8 EB05 18.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Device related infection	16	32.3 19.9–52.4ROR 33.0 · χ² 454 / p 4e-101	31.2 EB05 20.3 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 36.7	no trial data cached
Ventricular fibrillation	8	22.4 11.2–44.5ROR 22.6 · χ² 143 / p 4e-33	20.6 EB05 10.0 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 24.8	no trial data cached
Tachypnoea	7	16.1 7.7–33.6ROR 16.2 · χ² 85 / p 2e-20	13.3 EB05 5.4 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 10.5	no trial data cached
Cardiogenic shock	7	15.3 7.3–31.9ROR 15.4 · χ² 80 / p 2e-19	12.4 EB05 5.1 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 16.9	no trial data cached
Chest discomfort	45	13.7 10.4–18.2ROR 14.6 · χ² 521 / p 1e-115	13.5 EB05 10.4 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	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
Chills	134	35.5 30.5–41.4ROR 44.1 · χ² 4,484 / p <1e-300	35.3 EB05 30.6 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.7 · 96% clinician	no trial data cached
Chest discomfort	45	13.7 10.4–18.2ROR 14.6 · χ² 521 / p 1e-115	13.5 EB05 10.4 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.1	no trial data cached
Device related infection	16	32.3 19.9–52.4ROR 33.0 · χ² 454 / p 4e-101	31.2 EB05 20.3 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 36.7	no trial data cached
Temperature intolerance	11	33.5 18.7–60.3ROR 34.1 · χ² 315 / p 7e-71	31.8 EB05 18.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Appendicitis	11	36.9 20.5–66.3ROR 37.5 · χ² 348 / p 5e-78	34.8 EB05 20.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 41.4	no trial data cached
Ventricular fibrillation	8	22.4 11.2–44.5ROR 22.6 · χ² 143 / p 4e-33	20.6 EB05 10.0 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 24.8	no trial data cached
Cardiogenic shock	7	15.3 7.3–31.9ROR 15.4 · χ² 80 / p 2e-19	12.4 EB05 5.1 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 16.9	no trial data cached
Tachypnoea	7	16.1 7.7–33.6ROR 16.2 · χ² 85 / p 2e-20	13.3 EB05 5.4 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 10.5	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.

Chest discomfort — n=45, PRR 13.7

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 Soybean Oil?

In FDA FAERS, the most frequently co-reported reaction terms for Soybean Oil are chills, chest discomfort, temperature intolerance, appendicitis, ventricular fibrillation, cardiogenic shock. 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 Soybean Oil have an FDA boxed warning?

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

Do FAERS signals prove that Soybean Oil 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 193290b1-a0a1-4054-a22a-de5c9e7a8b73, effective 20260710; matched on openfda.generic_name.exact:"SOYBEAN OIL")
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, 8 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.