Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Vascepa (Icosapent-ethyl). If you are concerned about side effects, discuss the risks and benefits of Vascepa (Icosapent-ethyl) with your doctor.

The following side effects have been reported by at least 1% of people taking Vascepa (Icosapent-ethyl). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Constipation
• swelling of hands, feet, ankles, and lower legs

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• fast, slow, or pounding heartbeat

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of bleeding (e.g., nosebleeds, unexplained bruising, black tarry stools)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Vascepa (Icosapent-ethyl).

Each amber-coloured, oblong, soft-gelatin capsule imprinted with VASCEPA, contains 1 g of icosapent. Nonmedicinal ingredients: gelatin, glycerin, Hypromellose, maltitol, propylene glycol, purified water, sorbitol, titanium dioxide, and tocopherol.

Do not take Vascepa (Icosapent-ethyl) if you are allergic to icosapent or any ingredients of the medication.

There may be an interaction between icosapent and any of the following:

• anticoagulants (e.g., Apixaban, Edoxaban, dabigatran, Rivaroxaban, Warfarin)
• Aspirin (ASA)
• Clopidogrel
• Dipyridamole
• Heparin
• Ibrutinib
• low molecular weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, Naproxen)
• omega-3 fatty acids
• Prasugrel
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., Desvenlafaxine, Duloxetine, Venlafaxine)
• Ticagrelor
• Ticlopidine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Vascepa (Icosapent-ethyl). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Vascepa (Icosapent-ethyl).

Bleeding: Icosapent has been linked to increased or unexpected bleeding. This side effect is more common for people who take other medications that can cause increased bleeding, such as acetylsalicylic acid (Asa), blood thinners, and anti-inflammatory medications (e.g., Diclofenac, Ibuprofen, Ketoprofen). If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible.

Fish/shellfish allergies: Icosapent is a derived from fish. It is not known if people who are allergic to fish or shellfish are at increased risk of allergic reactions to Vascepa (Icosapent-ethyl). Inform your doctor if you are allergic to fish or shellfish before taking Vascepa (Icosapent-ethyl).

Omega-3 fatty acids: Vascepa (Icosapent-ethyl) is not the same as other omega-3 fatty acid products or dietary supplements and it should not be taken with these products. If you are taking nutritional supplements or natural health products, talk to your doctor or pharmacist.

Pregnancy: Vascepa (Icosapent-ethyl) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Vascepa (Icosapent-ethyl), contact your doctor immediately.

Breast-feeding: Vascepa (Icosapent-ethyl) may pass into breast milk. If you are a breast-feeding mother and are taking icosapent, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Vascepa (Icosapent-ethyl) have not been established for children.