Omacor Side Effects
Generic name: omega-3 polyunsaturated fatty acids
Medically reviewed by Drugs.com. Last updated on Apr 25, 2024.
Note: This document provides detailed information about Omacor Side Effects associated with omega-3 polyunsaturated fatty acids. Some dosage forms listed on this page may not apply specifically to the brand name Omacor.
Applies to omega-3 polyunsaturated fatty acids: oral capsule.
Serious side effects of Omacor
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Fast or abnormal heartbeat.
- Dizziness or passing out.
- Shortness of breath.
- Chest pain.
- Any unexplained bruising or bleeding.
- Swelling in the arms or legs.
Other side effects of Omacor
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Burping.
- Change in taste.
- Upset stomach.
- Stomach pain or diarrhea.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
For healthcare professionals
Applies to omega-3 polyunsaturated fatty acids: oral capsule, oral delayed release capsule, oral kit, oral liquid, oral tablet chewable.
General adverse events
The most common adverse events were eructation, dyspepsia, and taste perversion[Ref]
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]
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
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
Hepatic
- Rare (less than 0.1%): Liver disorders (including increased ALT, increased AST, and transaminases increased)[Ref]
References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2012) "Product Information. Lovaza (omega-3 polyunsaturated fatty acids)." GlaxoSmithKline
4. (2017) "Product Information. Vayarin (omega-3 polyunsaturated fatty acids)." Vaya Pharma
5. (2017) "Product Information. Omega-3-Acid Ethyl Esters (omega-3 polyunsaturated fatty acids)." Apotex Corporation
6. (2017) "Product Information. Omega-3 D-3 Wellness Pack (omega-3 polyunsaturated fatty acids)." TMIG Inc
Frequently asked questions
More about Omacor (omega-3 polyunsaturated fatty acids)
- Check interactions
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- Reviews (2)
- Drug images
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: nutraceutical products
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Further information
Omacor side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.