I.V. Fat Emulsion side effects: what 721 FDA adverse event reports show

I.V. Fat Emulsion · Intralipid · 21 reaction terms · 294 drug–reaction co-reports · data 2026-09-14

Drug class

Lipid Emulsion

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Intralipid

openFDA label

Who reports

721 reports · 86% serious · 85 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Intralipid ® is indicated as a source of calories and essential fatty acids for adult and pediatric patients requiring parenteral nutrition (PN) and as a source of essential fatty acids for prevention of essential fatty acid deficiency (EFAD). Intralip.

FDA label, Indications and Usage

What it is

Intralipid is a sterile, non-pyrogenic, white, homogenous lipid emulsion for intravenous infusion as a source of calories and essential fatty acids. The lipid content of Intralipid is 0.2 g/mL and comprises soybean oil. The phosphate content is 15 mmol/L.

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 19 strongest signals

Labeled adverse reaction 3Labeled (related wording) 1Reporting / coding artifact 4Not in label — unassessed 11

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.
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. 2 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
Temperature intolerance	16	45.6 28.1–74.1ROR 46.7 · χ² 654 / p 2e-144	43.4 EB05 28.3 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=16	no trial data cached
Tachypnoea	19	40.8 26.2–63.7ROR 41.9 · χ² 699 / p 3e-154	39.3 EB05 26.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 28.1	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	19	36.7 23.5–57.2ROR 37.7 · χ² 624 / p 5e-138	35.5 EB05 24.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 24.6	no trial data cached
Bacteraemia	11	27.2 15.1–48.9ROR 27.6 · χ² 252 / p 5e-57	26.0 EB05 15.3 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 18.4	no trial data cached
Drug dispensing error	14	26.3 15.7–44.2ROR 26.8 · χ² 316 / p 6e-71	25.4 EB05 16.0 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Chills	75	18.6 15.0–23.0ROR 20.6 · χ² 1,237 / p 3e-271	18.5 EB05 15.2 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 19.3 · 97% clinician	no trial data cached
Product preparation error	13	18.3 10.7–31.3ROR 18.6 · χ² 195 / p 1e-44	17.4 EB05 10.2 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious n=13	no trial data cached
Fistula	7	18.1 8.6–37.8ROR 18.2 · χ² 96 / p 4e-23	15.5 EB05 6.3 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.8	no trial data cached
Cholestasis (bile flow blockage)	11	16.8 9.3–30.1ROR 17.0 · χ² 148 / p 3e-34	15.5 EB05 8.2 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.3	no trial data cached
Shock	13	16.6 9.7–28.4ROR 16.9 · χ² 175 / p 3e-40	15.6 EB05 8.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.1	no trial data cached
Metabolic acidosis	16	14.7 9.1–23.9ROR 15.0 · χ² 191 / p 9e-44	13.9 EB05 8.4 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.3	no trial data cached
Hyperbilirubinaemia	5	14.1 5.9–33.8ROR 14.2 · χ² 49 / p 2e-12	9.7 EB05 3.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.7	no trial data cached
Insurance issue	7	13.7 6.6–28.7ROR 13.8 · χ² 70 / p 3e-17	10.7 EB05 4.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 19.0	no trial data cached
Anaphylactic shock	12	13.6 7.8–23.9ROR 13.8 · χ² 128 / p 5e-30	12.2 EB05 6.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Status epilepticus	5	12.9 5.4–30.8ROR 12.9 · χ² 43 / p 2e-11	8.5 EB05 3.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.6	no trial data cached
Complication associated with device	5	11.0 4.6–26.4ROR 11.1 · χ² 36 / p 1e-9	7.1 EB05 2.9 · IC025 +1.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.6	no trial data cached
Intentional overdose	19	8.7 5.6–13.5ROR 8.9 · χ² 122 / p 1e-28	7.6 EB05 5.0 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0	no trial data cached
Exposure during pregnancy	15	7.0 4.3–11.6ROR 7.1 · χ² 72 / p 1e-17	5.9 EB05 3.8 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 7.1	no trial data cached
Needle issue	5	5.1 2.1–12.2ROR 5.1 · χ² 13 / p 2e-4	3.7 EB05 1.8 · IC025 +0.3	Not in label — unassessed	serious n=5	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	75	18.6 15.0–23.0ROR 20.6 · χ² 1,237 / p 3e-271	18.5 EB05 15.2 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 19.3 · 97% clinician	no trial data cached
Intentional overdose	19	8.7 5.6–13.5ROR 8.9 · χ² 122 / p 1e-28	7.6 EB05 5.0 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	19	36.7 23.5–57.2ROR 37.7 · χ² 624 / p 5e-138	35.5 EB05 24.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 24.6	no trial data cached
Tachypnoea	19	40.8 26.2–63.7ROR 41.9 · χ² 699 / p 3e-154	39.3 EB05 26.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 28.1	no trial data cached
Metabolic acidosis	16	14.7 9.1–23.9ROR 15.0 · χ² 191 / p 9e-44	13.9 EB05 8.4 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.3	no trial data cached
Temperature intolerance	16	45.6 28.1–74.1ROR 46.7 · χ² 654 / p 2e-144	43.4 EB05 28.3 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=16	no trial data cached
Exposure during pregnancy	15	7.0 4.3–11.6ROR 7.1 · χ² 72 / p 1e-17	5.9 EB05 3.8 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 7.1	no trial data cached
Drug dispensing error	14	26.3 15.7–44.2ROR 26.8 · χ² 316 / p 6e-71	25.4 EB05 16.0 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Shock	13	16.6 9.7–28.4ROR 16.9 · χ² 175 / p 3e-40	15.6 EB05 8.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.1	no trial data cached
Product preparation error	13	18.3 10.7–31.3ROR 18.6 · χ² 195 / p 1e-44	17.4 EB05 10.2 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious n=13	no trial data cached
Anaphylactic shock	12	13.6 7.8–23.9ROR 13.8 · χ² 128 / p 5e-30	12.2 EB05 6.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Cholestasis (bile flow blockage)	11	16.8 9.3–30.1ROR 17.0 · χ² 148 / p 3e-34	15.5 EB05 8.2 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.3	no trial data cached
Bacteraemia	11	27.2 15.1–48.9ROR 27.6 · χ² 252 / p 5e-57	26.0 EB05 15.3 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 18.4	no trial data cached
Insurance issue	7	13.7 6.6–28.7ROR 13.8 · χ² 70 / p 3e-17	10.7 EB05 4.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 19.0	no trial data cached
Fistula	7	18.1 8.6–37.8ROR 18.2 · χ² 96 / p 4e-23	15.5 EB05 6.3 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.8	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 I.V. Fat Emulsion?

In FDA FAERS, the most frequently co-reported reaction terms for I.V. Fat Emulsion are chills, toxic epidermal necrolysis, tachypnoea, metabolic acidosis, temperature intolerance, 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 I.V. Fat Emulsion have an FDA boxed warning?

No. The FDA label retrieved for I.V. Fat Emulsion has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that I.V. Fat Emulsion 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 61e025f1-a38e-4af2-9e18-13ea12977cf5, effective 20251119; matched on openfda.generic_name.exact:"I.V. FAT EMULSION")
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, 21 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.