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Last reviewed on RxList: 5/21/2020
Smoflipid Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 4/10/2018

Smoflipid (lipid injectable emulsion), for intravenous use is a lipid injectable emulsion indicated in adults as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Common side effects of Smoflipid include:

The recommended dosage of Smoflipid depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize, and consideration of additional energy given to the patient. Smoflipid may interact with anticoagulants. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before receiving Smoflipid; it is unknown if it would affect a fetus. It is unknown if Smoflipid passes into breast milk. Consult your doctor before breastfeeding.

Our Smoflipid (lipid injectable emulsion), for intravenous use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


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Smoflipid Professional Information


Adverse reactions described elsewhere in labeling:

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 compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety database for Smoflipid reflects exposure in 229 patients exposed for 5 days to 4 weeks in 5 clinical trials. The pooled population exposed to Smoflipid was adult patients up to 89 years old (20 to 89 years of age), 43% female, and 99% Caucasian. The most frequently reported medical histories in the Smoflipid group were surgical and medical procedures (84%), neoplasms (57%), gastrointestinal disorders (53%), vascular disorders (37%), and infections and infestations (20%).

Smoflipid was used as a component of PN which also included dextrose, amino acids, vitamins, and trace elements. Two of the 5 studies were performed with Smoflipid as a component of PN delivered in a 3-chamber bag.

Adverse reactions occurring in at least 1% of patients who received Smoflipid are shown in Table 2.

Table 2: Adverse Reactions in > 1% of Patients Treated with Smoflipid

Adverse Reaction Number of Patients in Smoflipid Group (N=229) Number of Patients in Comparator Group (N=230)
Nausea 20 (9%) 26 (11%)
Vomiting 15 (7%) 12 (5%)
Hyperglycemia 12 (5%) 5 (2%)
Flatulence 10 (4%) 4 (2%)
Pyrexia 9 (4%) 11 (5%)
Abdominal pain 8 (4%) 5 (2%)
Blood triglycerides increased 6 (3%) 4 (2%)
Hypertension 6 (3%) 9 (4%)
Sepsis 5 (2%) 4 (2%)
Dyspepsia 5 (2%) 1 (0%)
Urinary tract infection 4 (2%) 3 (1%)
Anemia 4 (2%) 2 (1%)
Device related infection 4 (2%) 2 (1%)

Less common adverse reactions in ≤ 1% of patients who received Smoflipid were dyspnea, leukocytosis, diarrhea, pneumonia, cholestasis, dysgeusia, increased blood alkaline phosphatase, increased gamma-glutamyltransferase, increased C-reactive protein, tachycardia, liver function test abnormalities, headache, pruritis, dizziness, rash and thrombophlebitis.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Smoflipid in countries where it is registered. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure.

Infections and Infestations: infection

Respiratory, Thoracic and Mediastinal Disorders: dyspnea

Read the entire FDA prescribing information for Smoflipid (Smoflipid)


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© Smoflipid Patient Information is supplied by Cerner Multum, Inc. and Smoflipid Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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