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The following safety information highlights crucial warnings associated with the use of icosapent ethyl (Vascepa). It is vital to understand these risks and consult your healthcare provider if you have any questions or concerns.

• Heart Rhythm Issues: Icosapent ethyl (Vascepa) may increase the likelihood of developing irregular heart rhythms, such as atrial fibrillation or atrial flutter, which could necessitate hospitalization. Prior to using icosapent ethyl, inform your healthcare provider if you have a history of irregular heartbeats, heart disease, or diabetes with heart disease risk factors. Seek immediate medical advice if you experience symptoms like chest pain, dizziness, weakness, or shortness of breath.

• Allergic Reactions: As icosapent ethyl is derived from fish oil, individuals with fish or shellfish allergies may have an allergic reaction to this medication. It is important to disclose all allergies to your provider before beginning treatment, especially fish allergies. Discontinue use and seek emergency care if you develop hives, swelling of the lips or tongue, or breathing difficulties.

• Bleeding Risks: This medication can elevate the risk of bleeding, particularly if you are also taking anticoagulants (e.g., warfarin) or antiplatelet drugs (e.g., aspirin, clopidogrel). Urgent medical attention is needed if you encounter problems with bleeding cessation, blood in urine or stool, coughing up blood, or if you feel lightheaded or faint.

Please ensure to follow these guidelines and consult your healthcare provider for personalized advice tailored to your health needs.

When taking this medication, some individuals may experience mild side effects that typically do not cause concern. These include joint, muscle, or bone pain, constipation, and swelling in the arms, legs, hands, or feet. In addition, some people may encounter pain in the mouth and throat or symptoms of gout. While these side effects are usually mild, it is advisable to consult a healthcare provider if they persist or worsen.

Other side effects that have been reported include diarrhea, stomach pain, and pain in the limbs. If you experience these, especially if they are severe, contact your healthcare provider for advice.

On rare occasions, more serious side effects can occur. These include heart rhythm issues such as chest pain, dizziness, weakness, shortness of breath, fainting, or a fast or irregular heartbeat. Serious allergic reactions are also possible, manifesting as hives, swelling of the face, lips, or tongue, throat closure, or difficulty breathing. Additionally, some individuals might experience bleeding issues, presenting as lightheadedness, dizziness, trouble stopping a bleed, blood in urine or stool, coughing up blood, or severe bruising. If any of these serious side effects occur, immediate medical attention is necessary.