Meta Information
ID:icosapent-ethyl
Name:
Schema Version:2.4_uniform_evidence_2026_06_18
Created
2026-05-21T22:30:00Z
Model
phase-a-upgrade-claude-sonnet-4.6
Interactions
Target id:
/dietary/meal
Target name:
Any Caloric Meal
Severity:
major
Interaction type:
requirement
Nature:
temporal
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Icosapent ethyl is a fat-soluble molecule, and its absorption into the bloodstream is significantly increased when taken with food, which is necessary for it to be effective.
Actionable advice:
Icosapent ethyl capsules should be taken with or immediately following a meal.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Take VASCEPA with or following a meal
Label source:
FDA label: Icosapent ethyl (Vascepa)
Action type:
informational_none
Target id:
/class/anticoagulants-antiplatelets
Target name:
Anticoagulants and Antiplatelets
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Icosapent ethyl has antiplatelet effects that can prolong bleeding time. Combining it with other blood-thinning medications significantly increases the risk of serious bleeding events.
Actionable advice:
This combination should be used only under strict medical supervision, and close monitoring for any signs of bleeding or easy bruising is important.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Monitor patients receiving VASCEPA and concomitant
Label source:
FDA label: Icosapent ethyl (Vascepa)
Action type:
monitor
Target id:
/procedure/elective-surgery
Target name:
Elective Surgery
Severity:
major
Interaction type:
adverse
Nature:
temporal
Temporal spacing:
Hours before target:
120
Hours after target:
24
Description:
Due to its effect on platelet function and increased bleeding risk, icosapent ethyl should be stopped before surgical procedures to minimize the risk of excessive bleeding during and after the operation.
Actionable advice:
Use should be discontinued 5 days prior to any planned surgery, or as specifically directed by a surgeon.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Exact phrase from label:
VASCEPA is associated with an increased risk of bleeding. In a double-blind, placebo-controlled cardiovascular outcomes trial of 8,179 patients, 482 (12%) patients receiving VASCEPA experienced a bleeding event compared to 404 (10%) patients receiving placebo. Serious bleeding events occurred in 111 (3%) of patients on VASCEPA vs. 85 (2%) of patients receiving placebo.
Label source:
FDA label: Icosapent ethyl (Vascepa)
Action type:
avoid
Target id:
/condition/bleeding-disorders
Target name:
Bleeding Disorders
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
In individuals with pre-existing conditions that impair blood clotting, the antiplatelet effect of icosapent ethyl can dangerously elevate the risk of spontaneous or prolonged bleeding.
Actionable advice:
Icosapent ethyl can modestly increase bleeding. If you have a bleeding disorder, avoid it unless your hematologist approves, and watch for easy bruising or bleeding.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Warnings and Precautions, Bleeding
Label source:
FDA label: Icosapent ethyl (Vascepa)
Action type:
avoid
Target id:
/condition/atrial-fibrillation-flutter
Target name:
History of Atrial Fibrillation or Flutter
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Large clinical trials have shown a higher incidence of hospitalization for atrial fibrillation or flutter in patients taking icosapent ethyl compared to placebo.
Actionable advice:
It is important to talk to a cardiologist about this potential risk, and to monitor for symptoms like heart palpitations, dizziness, or shortness of breath.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
VASCEPA was associated with an increased risk
Label source:
FDA label: Icosapent ethyl (Vascepa)
Action type:
monitor
Target id:
/class/nsaids
Target name:
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
NSAIDs (like ibuprofen and naproxen) also have mild antiplatelet effects, and their regular use with icosapent ethyl can additively increase the risk of bleeding, particularly in the gastrointestinal tract.
Actionable advice:
The use of NSAIDs is best limited, and it is worth watching out for any signs of bleeding, such as dark stools, when taken together.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Exact phrase from label:
Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in those studies has not exceeded normal limits and did not produce clinically significant bleeding episodes. Monitor patients receiving VASCEPA and concomitant anticoagulants and/or antiplatelet agents for bleeding.
Label source:
FDA label: Icosapent ethyl (Vascepa)
Action type:
monitor
Target id:
/class/herbal-anticoagulants
Target name:
Herbal Anticoagulants/Antiplatelets
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Supplements like ginkgo biloba, garlic, ginger, dong quai, and high-dose vitamin E can have blood-thinning properties, increasing the bleeding risk when combined with icosapent ethyl.
Actionable advice:
Disclose all supplement use to your doctor and use this combination with caution.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
over-the-counter medicines, vitamins, and dietary or herbal supplements
Label source:
FDA label: Icosapent ethyl (Vascepa)
Action type:
informational_none
Target id:
/condition/hepatic-impairment
Target name:
Hepatic Impairment
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Icosapent ethyl is metabolized by the liver. While it appears safe in mild-to-moderate liver disease, caution is advised in severe cases due to a lack of specific research.
Actionable advice:
This is best used with caution, with regular liver function monitoring in those with significant liver disease.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
In patients with hepatic impairment, alanine aminotransferase
Label source:
FDA label: Icosapent ethyl (Vascepa)
Action type:
monitor
Target id:
/biomarker/triglycerides
Target name:
Triglycerides
Severity:
major
Interaction type:
synergistic
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
The primary therapeutic purpose of icosapent ethyl is to significantly lower serum triglyceride levels by reducing their production in the liver and enhancing their clearance from the blood.
Actionable advice:
This is the intended therapeutic effect; expect a significant reduction in your triglyceride levels on lab tests.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Triglyceride
Label source:
FDA label: Icosapent ethyl (Vascepa)
Action type:
monitor
Target id:
/biomarker/ldl-c
Target name:
LDL Cholesterol
Severity:
minor
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
In some individuals, particularly those with very high baseline triglycerides, therapy with icosapent ethyl can cause a small to moderate increase in measured LDL-cholesterol levels.
Actionable advice:
It is generally a good idea to check a full lipid panel after starting therapy to observe any changes in LDL-C.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Exact phrase from label:
The reduction in TG observed with VASCEPA was not associated with elevations in LDL-C levels relative to placebo.
Label source:
FDA label: Icosapent ethyl (Vascepa)
Action type:
monitor
Target id:
/condition/fish-shellfish-allergy
Target name:
Fish or Shellfish Allergy
Severity:
minor
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Although it is a highly purified product derived from fish oil, a theoretical risk of an allergic reaction exists in individuals with a known hypersensitivity to fish or shellfish.
Actionable advice:
This is best used with caution, and it is worth monitoring for any signs of an allergic reaction in those with a known fish or shellfish allergy.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Potential for Allergic Reactions in Patients with Fish Allergy
Label source:
FDA label: Icosapent ethyl (Vascepa)
Action type:
monitor