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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 in at least 2% and at a greater rate than placebo for patients treated with VASCEPA based on pooled data across two clinical studies are listed in Table 1.
Table 1: Adverse Reactions Occurring at Incidence > 2%
and Greater than Placebo in Double-Blind, Placebo-Controlled Trials*
|*Studies included patients with triglycerides values of 200 to 2000 mg/dL.|
An additional adverse reaction from clinical studies was oropharyngeal pain.
Read the Vascepa (icosapent ethyl capsules) Side Effects Center for a complete guide to possible side effects »
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. Patients receiving treatment with VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
Drug Abuse And Dependence
VASCEPA does not have any known drug abuse or withdrawal effects.
Last reviewed on RxList: 8/9/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Vascepa Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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