MegaKrill

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• fever, chills, body aches, flu symptoms;
• chest pain; or
• uneven heartbeats.

Common side effects may include:

• upset stomach, belching;
• loss of appetite;
• diarrhea, constipation;
• back pain; or
• dry mouth, altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

There are many brands and forms of omega-3 polyunsaturated fatty acids available. Not all brands are listed on this leaflet.

Omega-3 polyunsaturated fatty acids are found in oil from certain types of fish, vegetables, and other plant sources. These fatty acids are not made by the body and must be consumed in the diet. Omega-3 polyunsaturated fatty acids work by lowering the body's production of triglycerides. High levels of triglycerides can lead to coronary artery disease, heart disease, and stroke.

Omega-3 polyunsaturated fatty acids are used together with diet and exercise to help lower triglyceride levels in the blood.

It is not known if omega-3 polyunsaturated fatty acids will prevent a heart attack or stroke. Talk to your doctor about your risk factors.

Omega-3 polyunsaturated fatty acids may also be used for purposes not listed in this medication guide.

You should not take this medicine if you are allergic to fish, shellfish, or soybeans.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

• diabetes;

• liver disease;

• a heart rhythm disorder;

• a pancreas disorder;

• underactive thyroid;

• if you drink more than 2 alcoholic beverages per day.

It is not known whether omega-3 polyunsaturated fatty acids will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

It is not known whether omega-3 polyunsaturated fatty acids pass into breast milk or if this could harm a nursing baby. Ask a doctor before using this medicine if you are breast-feeding a baby.

Do not give this medication to anyone under 18 years old.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• fever, chills, body aches, flu symptoms;

• chest pain; or

• uneven heartbeats.

Common side effects may include:

• upset stomach, belching;

• loss of appetite;

• diarrhea, constipation;

• back pain; or

• dry mouth, altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to omega-3 polyunsaturated fatty acids: oral capsule, oral delayed release capsule, oral kit, oral liquid, oral tablet chewable

Gastrointestinal

Common (1% to 10%): Eructation, dyspepsia, nausea, gastrointestinal disorders (including abdominal distension, abdominal pain, constipation, diarrhea, flatulence, gastroesophageal reflux disease, vomiting)
Uncommon (0.1% to 1%): Gastrointestinal hemorrhage, gastroenteritis
Rare (less than 0.1%): Gastrointestinal pain
Very rare (less than 0.01%): Lower gastrointestinal hemorrhage[Ref]

General

The most common adverse events were eructation, dyspepsia, and taste perversion[Ref]

Other

Common (1% to 10%): Infection, pain
Uncommon (0.1% to 1%): Death[Ref]

Dermatologic

Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Atopic dermatitis
Rare (less than 0.1%): Urticaria, acne, rash pruritic
Frequency not reported: Pruritus[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hypotension[Ref]

Musculoskeletal

Common (1% to 10%): Back pain[Ref]

Metabolic

Uncommon (0.1% to 1%): Hyperglycemia, gout, high triglycerides
Very rare (less than 0.01%): Blood lactate dehydrogenase increased[Ref]

Nervous system

Common (1% to 10%): Taste perversion
Uncommon (0.1% to 1%): Dizziness, dysgeusia, headache, hyperactivity[Ref]

Respiratory

Uncommon (0.1% to 1%): Epistaxis
Very rare (less than 0.01%): Nasal dryness
Frequency not reported: Influenza[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity
Postmarketing reports: Anaphylactic reaction[Ref]

Hematologic

Very rare (less than 0.01%): White blood count increased,
Frequency not reported: Slight prolongation of bleeding time
Postmarketing reports: Hemorrhagic diathesis[Ref]

Psychiatric

Uncommon (0.1% to 1%): Tics, tantrum, insomnia[Ref]

Hepatic

Rare (less than 0.1%): Liver disorders (including increased ALT, increased AST, and transaminases increased)[Ref]

Some side effects of MegaKrill may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Data not available