What the label lists and what reports show
Soybean oil side effects
Soybean oil's FDA label: “Most common adverse drug reactions (≥5%) from clinical trials in adults were nausea, vomiting, and pyrexia.” FAERS holds 1,386 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is chills (209 reports).
- No generic listed
Check it at the source: the soybean oil FDA label on DailyMed (effective November 19, 2025, Fresenius Kabi USA, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse drug reactions (≥5%) from clinical trials in adults were nausea, vomiting, and pyrexia.
Table 3: Adverse Reactions in >1% of Pediatric Patients Treated with Intralipid
| Adverse Reaction | Number of Patients in Intralipid Group (N=163) | Number of Patients in 4-Oil Mixed Lipid Emulsion Comparator Group (N=170) |
|---|---|---|
| Anemia | 33 (20%) | 30 (18%) |
| Vomiting | 16 (10%) | 16 (9%) |
| Gamma-glutamyltransferase increased | 12 (7%) | 10 (6%) |
| Cholestasis | 10 (6%) | 7 (4%) |
| Pyrexia | 7 (4%) | 7 (4%) |
| C-reactive protein increased | 7 (4%) | 6 (4%) |
| Hyperbilirubinemia | 7 (4%) | 5 (3%) |
| Bilirubin conjugated increased | 7 (4%) | 3 (2%) |
| Nosocomial infection | 6 (4%) | 10 (6%) |
| Blood alkaline phosphatase increased | 6 (4%) | 1 (1%) |
| Abdominal pain | 5 (3%) | 4 (2%) |
| Hematocrit decreased | 5 (3%) | 2 (1%) |
| Metabolic acidosis | 5 (3%) | 2 (1%) |
| Diarrhea | 4 (3%) | 3 (2%) |
| Tachycardia | 4 (3%) | 3 (2%) |
| Thrombocytopenia | 4 (3%) | 3 (2%) |
| Alanine aminotransferase increased | 3 (2%) | 1 (1%) |
| Aspartate aminotransferase increased | 3 (2%) | 0 (0%) |
| Parenteral nutrition-associated liver disease | 3 (2%) | 0 (0%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedAdverse reactions described elsewhere in this Prescribing Information are: • Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions ( 5.1 )] • Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders [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 )] Most common adverse drug reactions (≥5%) from clinical trials in adults were nausea, vomiting, and pyrexia. Most common adverse drug reactions (≥5%) from clinical trials in pediatric patients were anemia, vomiting, increased gamma-glutamyltransferase, and cholestasis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Fresenius Kabi USA, LLC, effective November 19, 2025 (SPL set 61e025f1-a38e-4af2-9e18-13ea12977cf5), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,386 reports list soybean oil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 153 are coded as a death and 397 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 16 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Soybean oil: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions