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Omacor Side Effects

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Common Omacor Side Effects


The most commonly reported Omacor side effects (click to view or check a box to report):

Off Label Use (29)
Nausea (22)
Eructation (19)
Chest Pain (18)
Condition Aggravated (17)
Abdominal Distension (16)
Dizziness (16)
Pruritus (15)
Rash (14)
Therapeutic Response Unexpected (13)
Diarrhoea (12)
Constipation (12)
Dyspnoea (12)
Treatment Noncompliance (11)
Pain (11)
Angina Pectoris (10)
Blood Triglycerides Increased (10)
Pain In Extremity (10)
Hyperglycaemia (9)
Dysphagia (8)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Omacor Side Effects Reported to FDA



Omacor Side Effect Report#9934822
Coronary Artery Disease
This is a report of a 76-year-old male patient (weight: NA) from RU, suffering from the following health symptoms/conditions: myocardial infarction, who was treated with Omacor (dosage: 1000mg Per Day, start time:
Jul 29, 2013), combined with:
  • Nitroglycerin
  • Clexane
  • Coplavix
  • Omeprazole
  • Enalapril
  • Concor
and developed a serious reaction and side effect(s): Coronary Artery Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Omacor treatment in male patients, resulting in Coronary Artery Disease side effect. The patient was hospitalized and became disabled.
Omacor Side Effect Report#9882389
Acute Myocardial Infarction, Angina Pectoris, Systolic Dysfunction
This report suggests a potential Omacor Acute Myocardial Infarction side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from RU was diagnosed with the following symptoms/conditions: myocardial infarction and used Omacor (dosage: 1000mg Per Day) starting
Jun 20, 2013. After starting Omacor the patient began experiencing various side effects, including: Acute Myocardial Infarction, Angina Pectoris, Systolic DysfunctionAdditional drugs used concurrently:
  • Ticagrelor (90mg Twice Per Day)
  • Acetyl Salicylic Acid (100mg Per Day)
  • Bisoprolol (5mg Per Day)
  • Rosuvastatin (10mg Per Day)
The patient was hospitalized. Although Omacor demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Acute Myocardial Infarction, may still occur.
Omacor Side Effect Report#9842235
Cardiac Failure Congestive
This Cardiac Failure Congestive problem was reported by a physician from RU. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: myocardial infarction,atrial fibrillation. On
Apr 29, 2013 this consumer started treatment with Omacor (dosage: 1000mg Per Day). The following drugs were being taken at the same time:
  • Warfarin Sodium (7.5mg Per Day)
  • Bisoprolol (10mg Per Day)
  • Candesartan (16mg Per Day)
  • Amlodipine (10mg Per Day)
  • Atorvastatin (20mg Per Day)
  • Clopidogrel (75mg Per Day)
  • Hydrochlorothiazide (25mg Per Day)
When using Omacor, the patient experienced the following unwanted symptoms/side effects: Cardiac Failure CongestiveThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Failure Congestive, may become evident only after a product is in use by the general population.
Omacor Side Effect Report#9779829
Cholecystitis, Abdominal Abscess, Pain
This Cholecystitis side effect was reported by a physician from RU. A 51-year-old male patient (weight:NA) experienced the following symptoms/conditions: myocardial infarction.The patient was prescribed Omacor (drug dosage: 1000mg Per Day), which was initiated on
Feb 18, 2013. Concurrently used drugs:
  • Aspirin (100mg Per Day)
  • Clopidogrel (75mg Per Day)
  • Bisoprolol (5mg Per Day)
  • Perindopril (5mg Per Day)
  • Atorvastatin Calcium (20mg Per Day)
.After starting to take Omacor the consumer reported adverse symptoms, such as: Cholecystitis, Abdominal Abscess, PainThese side effects may potentially be related to Omacor. The patient was hospitalized.
Omacor Side Effect Report#9779811
Haematuria, Haemorrhage Subcutaneous, Gingival Bleeding, Overdose
This is a report of a 57-year-old male patient (weight: NA) from RU, suffering from the following health symptoms/conditions: myocardial infarction, who was treated with Omacor (dosage: 1000mg Per Day, start time:
Apr 02, 2013), combined with:
  • Warfarin (5mg Per Day)
  • Bisoprolol (5mg Per Day)
  • Perindopril (5mg Per Day)
  • Rosuvastatin (20mg Per Day)
  • Acetylsalicylic Acid (75mg Per Day)
  • Clopidogrel (75mg Per Day)
and developed a serious reaction and side effect(s): Haematuria, Haemorrhage Subcutaneous, Gingival Bleeding, Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Omacor treatment in male patients, resulting in Haematuria side effect. The patient was hospitalized.
Omacor Side Effect Report#9736092
Post Procedural Haemorrhage, Atrial Flutter, Atrioventricular Block
This report suggests a potential Omacor Post Procedural Haemorrhage side effect(s) that can have serious consequences. A 61-year-old male patient (weight: NA) from RU was diagnosed with the following symptoms/conditions: myocardial infarction,ventricular arrhythmia and used Omacor (dosage: 1000mg Per Day) starting
Jan 23, 2013. After starting Omacor the patient began experiencing various side effects, including: Post Procedural Haemorrhage, Atrial Flutter, Atrioventricular BlockAdditional drugs used concurrently:
  • Cordarone (200mg Per Day)
  • Bisoprolol (75mg Per Day)
  • Acetylsalicylic Acid (75mg Per Day)
  • Perindopril (5mg Per Day)
  • Atorvastatin (40mg Per Day)
  • Clopidogrel (75mg Per Day)
The patient was hospitalized. Although Omacor demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Post Procedural Haemorrhage, may still occur.
Omacor Side Effect Report#9646001
Loss Of Consciousness, Hypotension
This Loss Of Consciousness problem was reported by a physician from TH. A 77-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: myocardial infarction. On
Oct 01, 2013 this consumer started treatment with Omacor (dosage: 1000mg Per Day). The following drugs were being taken at the same time:
  • Ticagrelor (90mg Twice Per Day)
  • Warfarin (1.5mg Per Day)
  • Nitrazepam (15mg Per Day)
  • Omeprazole (20mg Per Day)
  • Enoxaparin Sodium (60mg Per Day)
  • Spironolactone (25mg Per Day)
  • Atorvastatin (20mg Per Day)
  • L-thyroxine (25mcg Per Day)
When using Omacor, the patient experienced the following unwanted symptoms/side effects: Loss Of Consciousness, HypotensionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Loss Of Consciousness, may become evident only after a product is in use by the general population.
Omacor Side Effect Report#9504259
Angina Unstable, Hypertension
This Angina Unstable side effect was reported by a physician from RU. A 55-year-old male patient (weight:NA) experienced the following symptoms/conditions: myocardial infarction.The patient was prescribed Omacor (drug dosage: 1000mg Per Day), which was initiated on
Aug 07, 2013. Concurrently used drugs:
  • Aspirin (100mg Per Day)
  • Clopidogrel (75mg Per Day)
  • Atorvastatin (20mg Per Day)
  • Bisoprolol (5mg Per Day)
  • Bisoprolol (5mg Per Day)
  • Perindopril (5mg Per Day)
  • Enalapril (10mg Twice Per Day)
  • Amlodipin (5mg Per Day)
.After starting to take Omacor the consumer reported adverse symptoms, such as: Angina Unstable, HypertensionThese side effects may potentially be related to Omacor. The patient was hospitalized.
Omacor Side Effect Report#9441153
Pruritus, Contusion
This is a report of a 66-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Omacor (dosage: 1000mg Per Day, start time: 2010), combined with:
  • Amitriptyline (100mg Per Day)
  • Carbocysteine (50mg Twice Per Day)
  • Ezetimibe (10mg Per Day)
  • Folic Acid (5mg Per Day)
  • Furosemide (80mg Per Day)
  • Hydroxychloroquine (200mg Twice Per Day)
  • Latanoprost
  • Nefopam (1ud Three Times Per Day)
and developed a serious reaction and side effect(s): Pruritus, Contusion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Omacor treatment in female patients, resulting in Pruritus side effect.
Omacor Side Effect Report#9375469
Atrial Fibrillation, Atrial Fibrillation, Arteriosclerosis Coronary Artery, Coronary Artery Stenosis
This report suggests a potential Omacor Atrial Fibrillation side effect(s) that can have serious consequences. A 60-year-old male patient (weight: NA) from RU was diagnosed with the following symptoms/conditions: myocardial infarction and used Omacor (dosage: 1000mg Per Day) starting
Feb 22, 2013. After starting Omacor the patient began experiencing various side effects, including: Atrial Fibrillation, Atrial Fibrillation, Arteriosclerosis Coronary Artery, Coronary Artery StenosisAdditional drugs used concurrently:
  • Aspirin (100mg Per Day)
  • Clopidogrel (75mg Per Day)
  • Metoprolol (150mg Per Day)
  • Enalapril (20mg Per Day)
  • Bisoprolol (5mg Per Day)
  • Perindopril (5mg Per Day)
The patient was hospitalized. Although Omacor demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Atrial Fibrillation, may still occur.
Omacor Side Effect Report#9375468
Pancreatitis Acute, Lipase Increased, Renal Failure Acute
This Pancreatitis Acute problem was reported by a physician from FR. A 86-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Omacor (dosage: 1000mg Per Day). The following drugs were being taken at the same time:
  • Sitagliptin Phosphate (100mg Per Day)
  • Lasix (20mg Per Day)
  • Stagid (700mg Per Day)
  • Cardensiel (5mg Per Day)
  • Creon
  • Inexium (20mg Per Day)
  • Kardegic (75mg Per Day)
When using Omacor, the patient experienced the following unwanted symptoms/side effects: Pancreatitis Acute, Lipase Increased, Renal Failure AcuteThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pancreatitis Acute, may become evident only after a product is in use by the general population.
Omacor Side Effect Report#9298773
Colitis Ischaemic
This Colitis Ischaemic side effect was reported by a physician from US. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Omacor (drug dosage: 1000mg Per Day), which was initiated on 200403. Concurrently used drugs:
  • Coumadin (5mg Per Day)
  • Coumadin (2.5mg Per Day)
  • Ezetimibe
  • Glipizide
  • Gabapentin
  • Furosemide
.After starting to take Omacor the consumer reported adverse symptoms, such as: Colitis IschaemicThese side effects may potentially be related to Omacor. The patient was hospitalized.
Omacor Side Effect Report#9228527
Stevens-johnson Syndrome
This is a report of a 81-year-old male patient (weight: NA) from ES, suffering from the following health symptoms/conditions: hypertriglyceridaemia,hypertension, who was treated with Omacor (dosage: 2000mg Per Day, start time: 2012), combined with:
  • Seguril (40mg Per Day)
  • Manidipine Hydrochloride (10mg Per Day)
  • Hidroferol (1amp Every Two Weeks)
  • Carvedilol (6.25mg Per Day)
  • Venofer
and developed a serious reaction and side effect(s): Stevens-johnson Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Omacor treatment in male patients, resulting in Stevens-johnson Syndrome side effect. The patient was hospitalized.
Omacor Side Effect Report#8628537
Benign Prostatic Hyperplasia, Haematuria
This report suggests a potential Omacor Benign Prostatic Hyperplasia side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from GR was diagnosed with the following symptoms/conditions: NA and used Omacor (dosage: 1000mg Per Day) starting 2012. After starting Omacor the patient began experiencing various side effects, including: Benign Prostatic Hyperplasia, HaematuriaAdditional drugs used concurrently: NA. Although Omacor demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Benign Prostatic Hyperplasia, may still occur.
Omacor Side Effect Report#8480334-4
Bradycardia, Malaise
This Bradycardia problem was reported by a physician from United Kingdom. A 70-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Feb 29, 2012 this consumer started treatment with Omacor (dosage: NA). The following drugs were being taken at the same time:
  • Simvastatin
  • Tramadol Hcl
  • Bisoprolol Fumarate
  • Cetirizine
  • Ketoconazole
  • Metformin Hcl
  • Lansoprazole
When using Omacor, the patient experienced the following unwanted symptoms/side effects: Bradycardia, MalaiseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bradycardia, may become evident only after a product is in use by the general population.
Omacor Side Effect Report#8478114-9
Depression, Suicidal Ideation
This Depression side effect was reported by a consumer or non-health professional from Ireland. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: blood cholesterol,hypertonic bladder.The patient was prescribed Omacor (drug dosage: 100 G, Unk), which was initiated on
Feb 01, 2011. Concurrently used drugs:
  • Toviaz (8 Mg Once/twice Daily)
  • Moviprep (13)
.After starting to take Omacor the consumer reported adverse symptoms, such as: Depression, Suicidal IdeationThese side effects may potentially be related to Omacor.
Omacor Side Effect Report#8428820-7
Caesarean Section, Premature Labour, Pancreatitis, Maternal Exposure During Pregnancy, Hyperglycaemia
This is a report of a 32-year-old female patient (weight: NA) from Denmark, suffering from the following health symptoms/conditions: blood triglycerides increased, who was treated with Omacor (dosage: 1000 Mg, Qd, Po, start time: NS), combined with:
  • Metformin Hydrochloride (1000 Mg, Qd, Po)
and developed a serious reaction and side effect(s): Caesarean Section, Premature Labour, Pancreatitis, Maternal Exposure During Pregnancy, Hyperglycaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Omacor treatment in female patients, resulting in Caesarean Section side effect. The patient was hospitalized.
Omacor Side Effect Report#8423092-1
Blister, Dyshidrosis
This report suggests a potential Omacor Blister side effect(s) that can have serious consequences. A 61-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: hypertriglyceridaemia,coronary artery disease,type 2 diabetes mellitus and used Omacor (dosage: NA) starting
Jan 01, 2007. After starting Omacor the patient began experiencing various side effects, including: Blister, DyshidrosisAdditional drugs used concurrently:
  • Plavix
  • Repaglinide
  • Aspirin
  • Onglyza
  • Tenormin
  • Crestor
  • Candesartan Cilexetil And Hydrochlorothiazide
Although Omacor demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blister, may still occur.
Omacor Side Effect Report#8405278-5
Pancreatitis, Premature Labour, Hyperglycaemia
This Pancreatitis problem was reported by a health professional from United Kingdom. A 32-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: blood triglycerides increased. On NS this consumer started treatment with Omacor (dosage: 8000 Milligram;). The following drugs were being taken at the same time:
  • Metformin Hcl (1000 Milligram;)
When using Omacor, the patient experienced the following unwanted symptoms/side effects: Pancreatitis, Premature Labour, HyperglycaemiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pancreatitis, may become evident only after a product is in use by the general population.
Omacor Side Effect Report#8403080-1
Off Label Use, Normal Newborn, Premature Labour, Hyperglycaemia, Pregnancy, Pancreatitis
This Off Label Use side effect was reported by a consumer or non-health professional from Germany. A 32-year-old female patient (weight:NA) experienced the following symptoms/conditions: blood triglycerides increased.The patient was prescribed Omacor (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Metformin Hcl
.After starting to take Omacor the consumer reported adverse symptoms, such as: Off Label Use, Normal Newborn, Premature Labour, Hyperglycaemia, Pregnancy, PancreatitisThese side effects may potentially be related to Omacor. The patient was hospitalized.
Omacor Side Effect Report#8168424-7
Pulmonary Embolism
This is a report of a 69-year-old male patient (weight: NA) from Greece, suffering from the following health symptoms/conditions: hypercholesterolaemia,colorectal cancer metastatic, who was treated with Omacor (dosage: Unk, start time:
Apr 05, 2011), combined with:
  • Vectibix (9 Mg/kg, Q3wk)
  • Ondansetron (8 Mg, Bid)
  • Diovan (80 Mg, Bid)
  • Bisoprolol Fumarate (10 Mg, Bid)
  • Metformin Hydrochloride (Unk Unk, Bid)
  • Bisoprolol Fumarate (Unk)
  • Xeloda (2000 Mg/m2, Q3wk)
  • Diamicron Mr (30 Mg, Unk)
and developed a serious reaction and side effect(s): Pulmonary Embolism after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Omacor treatment in male patients, resulting in Pulmonary Embolism side effect. The patient was hospitalized.
Omacor Side Effect Report#8070844-6
Hyperglycaemia, Off Label Use
This report suggests a potential Omacor Hyperglycaemia side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from Spain was diagnosed with the following symptoms/conditions: dyslipidaemia and used Omacor (dosage: 1000mg Per Day) starting
Aug 30, 2011. After starting Omacor the patient began experiencing various side effects, including: Hyperglycaemia, Off Label UseAdditional drugs used concurrently:
  • Crestor
Although Omacor demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyperglycaemia, may still occur.
Omacor Side Effect Report#8028907-7
Hyperglycaemia, Off Label Use
This Hyperglycaemia problem was reported by a physician from Spain. A 71-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: dyslipidaemia. On
Aug 30, 2011 this consumer started treatment with Omacor (dosage: 1000mg Per Day). The following drugs were being taken at the same time:
  • Crestor
When using Omacor, the patient experienced the following unwanted symptoms/side effects: Hyperglycaemia, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hyperglycaemia, may become evident only after a product is in use by the general population.
Omacor Side Effect Report#8024666-2
Febrile Neutropenia, Pulmonary Tuberculosis
This Febrile Neutropenia side effect was reported by a physician from Spain. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Omacor (drug dosage: NA), which was initiated on
Mar 25, 2011. Concurrently used drugs:
  • Vidaza (130 Milligram)
  • Atacand
  • Dutasteride/tamsulosin Hydrochloride
  • Lansoprazole
  • Indapamide
  • Ranitral
  • Atenolol
.After starting to take Omacor the consumer reported adverse symptoms, such as: Febrile Neutropenia, Pulmonary TuberculosisThese side effects may potentially be related to Omacor. The patient was hospitalized.
Omacor Side Effect Report#8009374-6
Bladder Cancer
This is a report of a 62-year-old female patient (weight: NA) from Germany, suffering from the following health symptoms/conditions: NA, who was treated with Omacor (eicosapentaenoic Acid, Docosahexanoic Acid) Omega 3 Ethyl Este (dosage: NA, start time:
Dec 02, 2010), combined with:
  • Dynorm Plus (hydrochlorothiazide, Cilazapril)
  • Actos (15 Mg (15 Mg, 1 In 1 D) Per Oral)
  • Avandia (Per Oral)
  • Lipidil
  • Metformin Hcl
and developed a serious reaction and side effect(s): Bladder Cancer after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Omacor (eicosapentaenoic Acid, Docosahexanoic Acid) Omega 3 Ethyl Este treatment in female patients, resulting in Bladder Cancer side effect.


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The appearance of Omacor on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Omacor Side Effects for Women?

Women Side EffectsReports
Off Label Use 16
Nausea 15
Eructation 12
Abdominal Distension 10
Chest Pain 9
Condition Aggravated 9
Pruritus 9
Dizziness 8
Therapeutic Response Unexpected 8
Constipation 7

What are common Omacor Side Effects for Men?

Men Side EffectsReports
Off Label Use 13
Chest Pain 9
Rash 9
Condition Aggravated 8
Diarrhoea 8
Dizziness 8
Platelet Count Decreased 8
Acute Myocardial Infarction 7
Dyspnoea 7
Eructation 7

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Omacor reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Omacor Safety Alerts, Active Ingredients, Usage Information

    Omacor Dosage, Warnings, Usage.

    Side Effects reported to FDA: 389

    Omacor safety alerts: No

    Reported deaths: 20

    Reported hospitalizations: 145

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