Soybean Oil

Nutrilipid 20% administered intravenously provides biologically utilizable source of calories and essential fatty acids. Fatty acids serve as an important substrate for energy production.

• 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. 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.

• Nutrilipid 20% injection is contraindicated in patients who have: Known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients in Nutrilipid 20% [see Warnings and Precautions (5.3) ]. Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride >1,000 mg/dL) [see Warnings and Precautions (5.7) ].contraindicated

Nutrilipid 20% Pharmacy Bulk Package is not intended for direct intravenous administration. ( 2.1 ) For intravenous infusion through a peripheral or central line ( 2.1 ) Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize and consideration of additional energy given to the patient. ( 2.4 ) For information on the age-appropriate infusion rate, see the full prescribing information. ( 2.4 , 5.1 ) Age Nutritional Requirements Initial Recommended Dosage Maximum Dosage Preterm and term infants (<1 year) 1 to 2 g/kg/day 3 g/kg/day Pediatric patients 1 to 10 years Pediatric patients 11 to <17 years 1 g/kg/day 2.5 g/kg/day Adults 1 to 1.5 g/kg/day 2.5 g/kg/day 2.1 Administration Instructions Nutrilipid 20% Pharmacy Bulk Package is not intended for direct intravenous administration. Nutrilipid 20% is for intravenous infusion through a peripheral or central line. When administered with dextrose and amino acids, the choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. Do not exceed the recommended maximum infusion rate in Table 1 [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ]. Use a non-vented infusion set or close the air vent on a vented set. Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Use a dedicated line without any connections.

Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants : Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported. ( 5.1, 8.4 ) Parenteral Nutrition-Associated Liver Disease : Increased risk in patients who receive parenteral nutrition for greater than 2 weeks, especially preterm neonates. Monitor liver tests; if abnormalities occur, consider discontinuation or dosage reduction. ( 5.2, 8.4 ) Hypersensitivity reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur. ( 5.3 ) Infections, Fat Overload Syndrome, and Refeeding Syndrome, Hypertriglyceridemia: Monitor for signs and symptoms; monitor laboratory parameters. ( 5.4 , 5.5 , 5.6, 5.7 ) Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm neonates. ( 5.8, 8.4 ) 5.1 Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants In the postmarketing setting, serious adverse reactions including acute respiratory distress, metabolic acidosis, and death have been reported in neonates and infants after rapid infusion of intravenous lipid emulsions. Hypertriglyceridemia was commonly reported. Strictly adhere to the recommended total daily dosage; the hourly infusion rate should not exceed 0.75 mL/kg/hour [see Dosage and Administration (2.4) ]. Preterm and small for gestational age infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.

Adverse Reactions described elsewhere in labeling: Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions (5.1) ] Risk of Parenteral Nutrition Associated Liver Disease [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Infections [see Warnings and Precautions (5.4) ] Fat Overload Syndrome [see Warnings and Precautions (5.5) ] Refeeding Syndrome [see Warnings and Precautions (5.6)] Hypertriglyceridemia [see Warnings and Precautions (5.7) ] Aluminum Toxicity [see Warnings and Precautions (5.8) ] Adverse reactions include administration site reactions (e.g., erythema, extravasation, pain, phlebitis, pruritus, swelling), hyperlipidemia, hypercoagulability, thrombophlebitis, thrombocytopenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-833-425-1464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions reported with other intravenous lipid emulsions include hyperlipidemia, hypercoagulability, thrombophlebitis, and thrombocytopenia.

8.1 Pregnancy Risk Summary There are no adequate or well controlled studies with Nutrilipid 20% in pregnant women. Additionally, animal reproduction studies have not been conducted with Nutrilipid 20%. It is not known whether Nutrilipid 20% can cause fetal harm when administered to a pregnant woman. Nutrilipid 20% should be given to a pregnant woman only if clearly needed. 8.3 Nursing Mothers It is not known whether Nutrilipid 20% is present in human milk. Because many drugs are present in human milk, caution should be exercised when Nutrilipid 20% is administered to a nursing woman. 8.4 Pediatric Use The evidence for safety and efficacy in pediatric patients of Nutrilipid 20% 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 is derived from the published literature and clinical experience with similar soybean oil-based intravenous lipid emulsions. In the postmarketing setting, clinical decompensation with rapid infusion of intravenous lipid emulsion in neonates and infants, sometimes fatal, has been reported [see Warnings and Precautions (5.1) ]. Patients, particularly preterm infants, are at risk for aluminum toxicity [see Warnings and Precautions (5.9) ] .

Metabolism

The infused lipid particles are removed from the bloodstream in a manner generally thought to be similar to the enzymatic clearance of naturally produced chylomicrons formed after enteral fat intake. Following infusion, there is a transient increase in plasma triglycerides.

In the event of overdose, serious adverse reactions may result [see Warnings and Precautions (5.1, 5.5) ]. Stop the infusion to allow lipids to clear from serum. The effects are usually reversible after the lipid infusion is stopped. If medically appropriate, further intervention may be indicated. The lipid administered and fatty acids produced are not dialyzable.

• May 28, 1993NDANDA019531B Braun
• Oct 3, 2013NDANDA204508Baxter Hlthcare Corp
• Aug 25, 2014NDANDA200656Fresenius Kabi Usa

1. 1Chills16415%
2. 2Pyrexia15815%
3. 3Nausea10910%
4. 4Vomiting756.9%
5. 5Chest Discomfort656.0%
6. 6Dyspnoea635.8%
7. 7Palpitations545.0%
8. 8Pruritus423.9%
9. 9Rash423.9%
10. 10Abdominal Distension373.4%
11. 11Abdominal Pain333.0%
12. 12Dizziness322.9%
13. 13Pneumonia322.9%
14. 14Anaemia302.8%
15. 15Asthenia302.8%

Recent PubMed references pinned to Soybean Oil as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Effect of Temperature and Water Content on the Physicochemical Properties of Crude Lecithin and Soybean Oil: A Response Surface Methodology Approach.
  Molecules (Basel, Switzerland) · 2026 · Mohammadi-Moghaddam T, Bakhshabadi H, Morshedi A, et al.
  PMID 42197301DOI 10.3390/molecules31101750
• Poly-100: One-Pot Toughening of Polylactide with Soybean-Derived Reactive Elastomers.
  Biomacromolecules · 2026 · Kuehl BW, Garg V, Hohmann A, et al.
  PMID 42154635DOI 10.1021/acs.biomac.6c00191
• Fully portable smartphone-integrated device coupled with nanozyme-based assay for sensitive detection of TBHQ in edible oils.
  Food chemistry · 2026 · Wu Q, da Silva Ferreira MV, Kamruzzaman M, et al.
  PMID 42143517DOI 10.1016/j.foodchem.2026.149610
• Complementary Surface Characterization Methods for Qualitative Detection of Oil Residues on Metallic Biomaterials.
  Journal of biomedical materials research. Part B, Applied biomaterials · 2026 · Mani G, LaSalle C, Gjerde M, et al.
  PMID 42135892DOI 10.1002/jbm.b.70091
• Inverse-Vulcanized Sulfur-Soybean Oil Polymers as Renewable Materials with Tunable Thermal Insulation Properties: Effect of Formulation and Biochar Incorporation.
  International journal of molecular sciences · 2026 · Rovatta LM, de Prada RE, Diego A, et al.
  PMID 42123620DOI 10.3390/ijms27094044
• Multi-marker UPLC-MS/MS detection of sesame, soybean, and peanut oil adulteration in camellia and olive oils: a high-sensitivity approach for food authenticity.
  Food chemistry · 2026 · Deng N, Wang H, Yin F, et al.
  PMID 42035646DOI 10.1016/j.foodchem.2026.149359
• Treatment-induced metabolic shifts of soybean seeds through amino acid-zinc biofortification enhances oil quality and micronutrient density.
  BMC plant biology · 2026 · Qureshi M, Sönmez İ, Güden B, et al.
  PMID 41987030DOI 10.1186/s12870-026-08751-z
• Alizarin-based soybean oil materials for the synthesis of 3D-photoprinted objects with efficient antibacterial properties.
  Journal of materials chemistry. B · 2026 · Elian C, Mouhoubi F, Hayek H, et al.
  PMID 41966138DOI 10.1039/d6tb00120c

The 10 most recently updated of 375 ClinicalTrials.gov registrations naming Soybean Oil as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• How a Plant-Based Diet Affects Blood Pressure and Gut Health in Kidney Transplant Patient
  Completed · Interventional · 102 enrolled · Mahidol University
  NCT06871722updated 2026-06-10
• Respiratory Effect of the LISA Method With Sedation by Propofol Versus Absence of Sedation.
  Completed · Phase 3 · Interventional · 233 enrolled · University Hospital, Grenoble
  NCT04016246updated 2026-06-09
• Poly-unsaturated Fats for Improving Nasal Polyps and Asthma
  Completed · Phase 3 · Interventional · 18 enrolled · Norfolk and Norwich University Hospitals NHS Foundation Trust
  NCT05613803updated 2026-06-08
• Efficacy and Safety Safety of Nutritears® in Adults With Dry Eye Syndrome
  Completed · Interventional · 131 enrolled · Applied Science & Performance Institute
  NCT05481450updated 2026-06-04
• Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation
  Active not recruiting · Interventional · 168 enrolled · University of Chicago
  NCT02647723updated 2026-05-27
• Therapeutic Omegas for Triglyceride Suppression
  Active not recruiting · Interventional · 40 enrolled · University of Colorado, Denver
  NCT04349475updated 2026-05-26
• Impact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being
  Recruiting · Interventional · 20 enrolled · King's College London
  NCT07599930updated 2026-05-20
• Analysis of MicroBial Metabolites After Eating Refined Food
  Completed · Interventional · 46 enrolled · The Cleveland Clinic
  NCT04308473updated 2026-05-11
• Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients
  Recruiting · Interventional · 48 enrolled · Indiana University
  NCT06250309updated 2026-05-08
• Vitamin D and n-3 Polyunsaturated Fatty Acids (PUFAs) to Prevent Chronic Pain Following Major Thermal Burn Injury
  Terminated · Phase 2 · Interventional · 24 enrolled · University of North Carolina, Chapel Hill
  NCT03313076updated 2026-05-08

Frequently asked questions

How does Soybean Oil work?

Nutrilipid 20% administered intravenously provides biologically utilizable source of calories and essential fatty acids. Fatty acids serve as an important substrate for energy production.

What is Soybean Oil used for?

According to FDA labeling, Soybean Oil carries indications including: 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. 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Soybean Oil?

Soybean Oil is classified as Lipid Emulsion, Immunologic Factor Interactions, Peroxisome Proliferator-activated Receptor Activity, Cell-mediated Immunity, Increased Histamine Release, Increased IgG Production, Increased T Lymphocyte Activation, Triglyceride Metabolism Alteration.

What are the brand names for Soybean Oil?

Soybean Oil is marketed under brand names including Clinolipid, Intralipid, Nutrilipid.

What are the contraindications for Soybean Oil?

Soybean Oil labeling lists contraindications including: Nutrilipid 20% injection is contraindicated in patients who have: Known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients in Nutrilipid 20% [see Warnings and Precautions (5.3) ]. Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride >1,000 mg/dL) [see Warnings and Precautions (5.7) ].. Always consult the full prescribing information and a clinician.