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SMOFlipid Side Effects

Generic Name: fat emulsion

Note: This document contains side effect information about fat emulsion. Some of the dosage forms listed on this page may not apply to the brand name SMOFlipid.

For the Consumer

Applies to fat emulsion: intravenous emulsion

Along with its needed effects, fat emulsion (the active ingredient contained in SMOFlipid) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking fat emulsion:

More Common

  • Bladder pain
  • bloody or cloudy urine
  • chills
  • difficult, burning, or painful urination
  • fever
  • frequent urge to urinate
  • lower back or side pain
  • sore throat
  • vomiting


Incidence Not Known

  • Abdominal or stomach pain
  • changes in skin color
  • changes in urination
  • fruit-like breath odor
  • increased thirst
  • rash
  • swelling and redness in the lower leg
  • unusual bleeding or bruising

Some side effects of fat emulsion may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Nausea
  • Redness, swelling, or pain at the injection site

Less Common

For Healthcare Professionals

Applies to fat emulsion: intravenous emulsion


Common (1% to 10%): Cholestasis, blood bilirubin increased

Uncommon (0.1% to 1%): Cytolytic hepatitis, cholecystitis, cholelithiasis, liver function test abnormalities, pancreatic enzyme increased

Frequency not reported: Increased gamma-glutamyltransferase, hepatomegaly, jaundice due to central lobular cholestasis, transient increases in liver function tests[Ref]


Common (1% to 10%): Anemia

Uncommon (0.1% to 1%): Leukopenia

Rare (less than 0.1%): Thrombocytopenia in neonates

Frequency not reported: Leukocytosis, hypercoagulability, splenomegaly, thrombocytopenia[Ref]


Common (1% to 10%): Hypertension, mean arterial pressure decreased

Uncommon (0.1% to 1%): Circulatory collapse, hypotension, hot flush

Frequency not reported: Tachycardia, thrombophlebitis, cyanosis, flushing, arrhythmia[Ref]


Frequency not reported: Allergic reaction, hypersensitivity[Ref]


Common (1% to 10%): Sepsis, device related infection

Frequency not reported: Pneumonia, infection, septicemia[Ref]


Common (1% to 10%): Pyrexia

Frequency not reported: Increased blood alkaline phosphatase, increased C-reactive protein, increase in temperature, pain in chest and back, slight pressure over the eyes, overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly, splenomegaly, and shock), intravenous fat pigment (deposition of brown pigmentation in the reticuloendothelial system), increased blood level of immunosuppressant drug, asthenia, malaise

Postmarketing reports: International normalized ration decreased[Ref]

Nervous system

Frequency not reported: Dysgeusia, headache, dizziness, sleepiness, cerebral edema, convulsion[Ref]


Common (1% to 10%): Muscle spasms

Uncommon (0.1% to 1%): Back pain, chills

Frequency not reported: Bone necrosis


Frequency not reported: Respiratory insufficiency[Ref]


Common (1% to 10%): Nausea, vomiting, flatulence, abdominal pain, dyspepsia, abdominal distension, epigastric discomfort

Frequency not reported: Diarrhea[Ref]


Frequency not reported: Pruritus, rash, sweating[Ref]


Common (1% to 10%): Urinary tract infection[Ref]


Frequency not reported: Irritation at sight of infusion[Ref]


Common (1% to 10%): Hyperglycemia, blood triglycerides increased, hyperproteinemia, hyperlipidemia

Frequency not reported: Hyperlipemia, diabetes mellitus inadequate control, hypoproteinemia[Ref]


1. "Product Information. Intralipid (fat emulsion, intravenous)." Baxter I.V. Systems Division, Round Lake, IL.

2. "Product Information. Smoflipid (fat emulsion, intravenous)." Fresenius Kabi USA, Lake Zurich, IL.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.