Vascepa (icosapent ethyl) is a brand-name prescription medication. The Food and Drug Administration (FDA) has approved it to:

  • Lower the risk of stroke, heart attack, a specific type of heart surgery, or unstable angina that requires hospital treatment) in certain adults with high triglyceride levels. In this case, your doctor will recommend taking Vascepa in combination with a statin drug.
  • Decrease triglyceride levels in adults with very high triglyceride levels. In this case, you should use Vascepa along with changes in your diet.

Here are some fast facts about Vascepa:

  • Active ingredient: icosapent ethyl
  • Drug class: eicosapentaenoic acid, an omega-3 fatty acid
  • Drug form: oral capsule

If Vascepa works for you, your doctor will likely recommend that you take this medication long term.

As with other drugs, Vascepa can cause side effects (also known as adverse effects). Read on to learn about potential common, mild, and serious side effects. For a general overview of Vascepa, including details about its uses, see this article.

Vascepa can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Vascepa in clinical trials. These side effects can vary depending on which condition the drug is being used to treat.

More common side effects in people taking Vascepa to lower the risk of cardiovascular problems include:

More common side effects in people taking Vascepa to decrease triglyceride levels include:

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Vascepa use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Vascepa’s prescribing information.

Mild side effects that have been reported in people taking Vascepa to lower the risk of cardiovascular problems include:

Mild side effects that have been reported in people taking Vascepa to decrease triglyceride levels include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Vascepa and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.

Vascepa may cause serious side effects. Although uncommon, you should be aware of the risk of serious side effects so that you can tell your doctor right away if you develop any. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Vascepa’s prescribing information.

If you develop serious side effects while taking Vascepa, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

* For more information about this side effect, see “Side effect specifics” below.
† An allergic reaction is possible after using Vascepa. However, it’s not clear whether this side effect occurred in clinical trials.

Vascepa may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Does Vascepa cause hair loss?

No, you should not experience hair loss from taking Vascepa. This was not a side effect that people taking Vascepa reported in clinical trials.

In fact, some evidence suggests that omega-3 fatty acid supplements, such as fish oil, may increase hair growth. And Vascepa is made from fish oil. So, it’s possible that this medication might benefit people trying to regrow hair. However, no clinical trials have specifically studied Vascepa for this use.

If you’re taking Vascepa and you’re experiencing hair loss, talk with your doctor or pharmacist. They can help determine what may be causing your hair loss and the best ways to treat it. In some cases, your doctor or pharmacist may be able to recommend an over-the-counter medication, such as Rogaine (minoxidil) to treat your hair loss.

Do the 0.5-gram and 1-gram strengths of Vascepa cause different side effects?

No, the same side effects may occur with either the 0.5-gram (g) or the 1-g strength of Vascepa. (Keep in mind that the recommended dosage of Vascepa is 2 g taken twice per day.)

If you have additional questions about the difference between the 0.5-g and 1-g Vascepa capsules, talk with your doctor or pharmacist.

Is erectile dysfunction one of Vascepa’s side effects?

No, erectile dysfunction (ED) is not known to be a side effect of Vascepa. ED was not reported in the drug’s clinical trials.

If you’re experiencing ED while taking Vascepa, talk with your doctor. They can help you determine what may be causing this symptom and the best way to treat it.

Should I expect diarrhea during Vascepa treatment?

It’s possible. Although diarrhea was not reported as a side effect in clinical trials, it was reported after Vascepa was approved by the FDA. In fact, Vascepa may commonly cause constipation.

If you experience diarrhea during your treatment with Vascepa, talk with your doctor or pharmacist. They may recommend staying hydrated or other medications that may decrease diarrhea from occurring.

How do side effects of Vascepa and fish oil compare?

The active ingredient in Vascepa is made from fish oil, so it may cause some of the same side effects as fish oil supplements. Both may increase the risk of bleeding or cause constipation. However, some side effects may be different.

Vascepa may cause other side effects, such as joint, muscle, or bone pain, swelling of the arms or legs, or mouth or throat pain. And fish oil supplements may cause other side effects that Vascepa does not cause. For example, fish oil supplements can cause belching, nausea, or fishy smelling breath or taste in your mouth.

It’s important to note that Vascepa is FDA approved as a prescription medication with a specific dosage. Over-the-counter fish oils are considered dietary supplements. And dietary supplements are not regulated by the FDA. So the quality and amount of fish oil that’s in your supplement may not be as consistent as a drug that’s regulated by the FDA.

If you’d like to learn more about Vascepa or fish oils and how the side effects compare, talk with your doctor or pharmacist.

Be sure to talk with your doctor about your health history before you take Vascepa. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:

Liver problems. Tell your doctor if you have any liver problems before starting treatment with Vascepa. It’s possible for Vascepa to make your liver problems worse. So your doctor may monitor your liver function during your treatment with Vascepa to be sure that your condition is not worsening.

Allergic reaction or fish allergy. If you’ve had an allergic reaction to Vascepa or any of its ingredients, or if you have a fish or shellfish allergy, your doctor will likely not prescribe Vascepa. Ask your doctor what other medications may be better options for you.

Alcohol with Vascepa

There aren’t any known interactions between Vascepa and alcohol.

However, your doctor may recommend avoiding alcohol while you’re taking Vascepa to treat your condition. It’s possible for alcohol to increase your triglyceride levels, which can make your condition worse. So although alcohol may not increase the risk of Vascepa side effects, it can worsen your condition.

If you have questions about alcohol side effects, talk with your doctor to determine how much alcohol, if any, may be safe for you to drink.

Pregnancy and breastfeeding while taking Vascepa

It’s not known if it’s safe to take Vascepa during pregnancy or while you’re breastfeeding. There is not enough data in pregnant females* to determine if the drug is safe to take during pregnancy. It’s also unknown if Vascepa may increase the risk of congenital anomalies (also known as birth defects).

In animal studies, some studies showed that there may be a possible risk of congenital anomalies, but other studies showed there was not a risk to a developing fetus.

Vascepa may pass into breast milk. However, it’s unknown what effects Vascepa may have on a child who is breastfed.

If you are pregnant, planning to become pregnant, or breastfeeding, talk with your doctor before starting treatment with Vascepa.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Learn more about some of the side effects that Vascepa may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Vascepa.

Heart palpitations and other heart problems

It’s possible for Vascepa to cause heart problems, such as heart palpitations. Heart palpitations can be a sign of atrial fibrillation (A-fib) or atrial flutter. (With A-fib, your heartbeat is rapid and irregular. And with atrial flutter, your heartbeat is fast but has a regular rhythm.)

These side effects were not common in Vascepa’s clinical trials but led to hospitalization for some people.

Symptoms of heart problems can include:

What you can do

If you develop any symptoms of heart palpitations or other heart problems, tell your doctor. They will likely order some tests to determine if your heart is beating normally. In some cases, they may recommend monitoring your heart.

Tell your doctor if you have a history of heart problems or heart palpitations before starting treatment with Vascepa.

Constipation

You may experience constipation during your treatment with Vascepa. Constipation was a common side effect in clinical trials of Vascepa. This side effect specifically occurred in people taking the drug to decrease the risk of cardiovascular problems. You may notice symptoms of constipation, such as straining to use the bathroom, or using the bathroom less often than usual.

What you can do

If you have constipation during your treatment with Vascepa, talk with your doctor. They can recommend ways to reduce the chance of this side effect occurring. For example, your doctor may recommend taking an over-the-counter medication, such as MiraLAX (polyethylene glycol) to treat your constipation.

Joint pain

You may experience joint pain during your treatment with Vascepa. Joint pain was a common side effect reported in people using Vascepa for high triglyceride levels.

What you can do

If you experience joint pain during your treatment with Vascepa, tell your doctor. Your doctor or pharmacist may be able to recommend other medications to decrease your joint pain. For example, using an over-the-counter pain reliever, such as Tylenol (acetaminophen) or Advil (ibuprofen), may help decrease your joint pain.

Gout

It’s possible to develop gout from taking Vascepa. Gout is a type of arthritis, or joint pain. This condition was common in clinical trials involving people taking Vascepa to reduce the risk of heart problems.

Gout often affects your big toe. Symptoms of gout may include:

  • pain in the joints or toes
  • swelling of the joints
  • redness or discoloration of the big toe

What you can do

If you develop symptoms of gout, talk with your doctor. They can determine if gout may be causing the symptoms that you experience. In addition, your doctor may recommend a medication to treat your symptoms of gout.

Allergic reaction

As with most drugs, Vascepa can cause an allergic reaction in some people. It’s also possible that people with fish or shellfish allergies may have an allergic reaction to Vascepa. However, it’s not clear whether this allergic reaction occurred in clinical trials.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your lips, eyelids, feet, or hands
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Vascepa. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Side effects may occur from taking Vascepa. Most side effects are mild, however, it’s possible for serious side effects to occur. You should be aware of the possible side effects that may occur, so that you can talk with your doctor if you develop any.

If you’d like to learn more about Vascepa, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

  • More information about Vascepa. For details about other aspects of Vascepa, refer to this article.
  • Dosage details. For information about Vascepa’s dosage, see this article.
  • Product comparison. To learn how Vascepa compares with fish oil, read this article.
  • A look at high triglyceride levels. For details about high triglyceride levels, see our cholesterol hub and list of related articles.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.