This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Omacor (Omega-3-Acid Ethyl Esters) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (35)
Death (5)
Life Threatening Events (4)
Reports by Reaction Type
Hyperglycaemia (9),
Off Label Use (7),
Premature Labour (6),
Pancreatitis (6),
Fatigue (5),
Liver Function Test Abnormal (5),
Blood Cholesterol Increased (5),
Arthralgia (5),
Blood Bilirubin Increased (4),
Blood Alkaline Phosphatase Increased (4),
Maternal Exposure During Pregnancy (4),
Petechiae (3)
Below are a few examples of reports where side effects / adverse reactions may be related to Omacor (Omega-3-Acid Ethyl Esters). For a complete list or a specific selection of reports, please use the links above.
Possible Omacor side effects in male
Reported by a physician from France on 2012-07-31
Patient: male
Reactions: Upper Gastrointestinal Haemorrhage
Drug(s) suspected as cause:
Omacor
Dosage: 1000mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2004-07-20
End date: 2010-03-17
Acenocoumarol
Indication: Prophylaxis
Start date: 2009-05-01
Other drugs received by patient: Diltiazem; Fenofibrate; Pentoxifylline; Valsartan; Simvastatin
Possible Omacor side effects in male
Reported by a physician from Spain on 2012-07-30
Patient: male
Reactions: Epistaxis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Omacor
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2005-08-11
End date: 2009-05-11
Warfarin Sodium
Indication: Product Used FOR Unknown Indication
Start date: 1993-01-01
Aspirin
Indication: Product Used FOR Unknown Indication
Start date: 2008-02-01
Other drugs received by patient: Simvastatin; Losartan Potassium; Fluticasone Propionate / Salmeterol; Furosemide
Possible Omacor side effects in male
Reported by a physician from Argentina on 2012-07-25
Patient: male
Reactions: Vomiting, Gastrointestinal Haemorrhage, Hypotension
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Omacor
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2005-08-17
Acetylsalicylic Acid SRT
Dosage: 250mg per day
Indication: Chest Pain
Start date: 2005-08-01
Lantus
Indication: Diabetes Mellitus
Start date: 2005-08-17
Other drugs received by patient: Atenolol; Glyburide; Vasodilators
Possible Omacor side effects in female
Reported by a physician from Canada on 2012-07-25
Patient: female
Reactions: Rectal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Omacor
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2004-04-21
End date: 2005-10-18
Aspirin
Dosage: 80mg per day
Indication: Prophylaxis
End date: 2005-10-18
Lantus
Indication: Diabetes Mellitus
Start date: 2005-04-21
Other drugs received by patient: Pantoprazole Sodium; Ramipril; Terazosin Hydrochloride; Furosemide; Diltiazem
Possible Omacor side effects in 70 year old male
Reported by a consumer/non-health professional from Greece on 2012-06-21
Patient: 70 year old male
Reactions: Haematuria, Benign Prostatic Hyperplasia
Drug(s) suspected as cause:
Omacor
Other drugs received by patient: Lipitor; Diltiazem HCL; Enalapril Maleate and Hydrochlorothiazide
Possible Omacor side effects in 32 year old female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-06-04
Patient: 32 year old female
Reactions: Caesarean Section, Maternal Exposure During Pregnancy, Hyperglycaemia, Pancreatitis, Premature Labour
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Omacor
Dosage: 1000 mg, qd, po
Administration route: Oral
Indication: Blood Triglycerides Increased
Metformin Hydrochloride
Dosage: 1000 mg, qd, po
Administration route: Oral
Indication: Blood Triglycerides Increased
Possible Omacor side effects in 32 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-03
Patient: 32 year old female
Reactions: Hyperglycaemia, Pancreatitis, Premature Labour
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Omacor
Dosage: 8000 milligram;
Administration route: Oral
Indication: Blood Triglycerides Increased
Metformin HCL
Dosage: 1000 milligram;
Administration route: Oral
Indication: Blood Triglycerides Increased
Possible Omacor side effects in 32 year old female
Reported by a consumer/non-health professional from Germany on 2012-06-01
Patient: 32 year old female
Reactions: Off Label Use, Normal Newborn, Hyperglycaemia, Pancreatitis, Premature Labour, Pregnancy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Omacor
Administration route: Oral
Indication: Blood Triglycerides Increased
Metformin HCL
Administration route: Oral
Indication: Blood Triglycerides Increased
Possible Omacor side effects in 32 year old female
Reported by a physician from United Kingdom on 2012-06-01
Patient: 32 year old female
Reactions: Caesarean Section, Hyperglycaemia, Maternal Exposure During Pregnancy, Pancreatitis, Premature Labour, Pregnancy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metformin HCL
Dosage: 1000 mg (1000 mg, 1 in 1 d), oral
Administration route: Oral
Indication: Blood Triglycerides Increased
Omacor
Dosage: 8000 mg (8000 mg, 1 in 1 d), oral
Administration route: Oral
Indication: Blood Triglycerides Increased
Possible Omacor side effects in
Reported by a physician from United Kingdom on 2012-06-01
Patient:
Reactions: Maternal Drugs Affecting Foetus, Caesarean Section, Exposure During Breast Feeding, Premature Baby
Drug(s) suspected as cause:
Omacor
Dosage: 8000 mg (8000 mg, 1 in 1 d), transplacental 8000 mg (8000 mg, 1 in 1 d), transmammary
Indication: Blood Triglycerides Increased
Metformin HCL
Dosage: 1000 mg (1000 mg, 1 in 1 d), transplacental 1000 mg (1000 mg, 1 in 1 d), transmammary
Indication: Blood Triglycerides Increased
Possible Omacor side effects in 32 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-25
Patient: 32 year old female
Reactions: Maternal Exposure During Pregnancy, Hyperglycaemia, Pancreatitis, Premature Labour
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metformin HCL
Dosage: 1000 mg, qd
Administration route: Oral
Indication: Blood Triglycerides Increased
Omacor
Dosage: 8000 mg, qd
Administration route: Oral
Indication: Blood Triglycerides Increased
Possible Omacor side effects in
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-25
Patient:
Reactions: Premature Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Metformin HCL
Omacor
Possible Omacor side effects in female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-14
Patient: female
Reactions: Off Label Use, Maternal Exposure During Pregnancy, Hyperglycaemia, Pancreatitis, Premature Labour
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metformin HCL
Dosage: 1000mg per day
Administration route: Oral
Indication: Blood Triglycerides Increased
Omacor
Dosage: 8000mg per day
Administration route: Oral
Indication: Blood Triglycerides Increased
Possible Omacor side effects in female
Reported by a physician from Norway on 2012-03-27
Patient: female
Reactions: Hypoglycaemia, Hyperglycaemia
Drug(s) suspected as cause:
Omacor
Other drugs received by patient: Atorvastatin; Ezetimibe; Vesicare; Amiloride HCL and Hydrochlorothiazide
Possible Omacor side effects in 69 year old female
Reported by a physician from Spain on 2012-03-19
Patient: 69 year old female
Reactions: Bronchopulmonary Aspergillosis, Urine Output Decreased, Hypotension, Petechiae, Hyperuricaemia, Multi-Organ Failure, Respiratory Failure, Chest Pain, Pleural Effusion, Aplastic Anaemia, Bronchospasm, Asthenia, Hypertension
Adverse event resulted in: death
Drug(s) suspected as cause:
Nolotil
Start date: 2009-10-01
End date: 2010-01-01
Omacor
Administration route: Oral
Start date: 2010-01-01
End date: 2010-07-14
Analgilasa
Administration route: Oral
Start date: 2009-11-01
End date: 2010-07-14
Furosemide
Administration route: Oral
Start date: 2010-01-01
End date: 2010-07-11
Omeprazole
Administration route: Oral
Start date: 2010-06-01
End date: 2010-07-14
Omeprazole
Administration route: Oral
Indication: Gastric Ulcer
Start date: 2009-11-01
End date: 2010-06-01
Telmisartan and Hydrochlorothiazide
Administration route: Oral
Indication: Hypertension
Start date: 2010-03-01
End date: 2010-07-14
Voltaren
Administration route: Oral
Start date: 2009-01-01
End date: 2010-01-01
Acetaminophen
Administration route: Oral
Start date: 2010-01-01
End date: 2010-07-14
Allopurinol
Administration route: Oral
Indication: Hyperuricaemia
Start date: 2010-03-01
End date: 2010-07-14
Possible Omacor side effects in 69 year old female
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-03-16
Patient: 69 year old female
Reactions: Petechiae, Aplastic Anaemia, Asthenia
Adverse event resulted in: death
Drug(s) suspected as cause:
Furosemide
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-01-01
End date: 2010-07-11
Acetaminophen
Administration route: Oral
Start date: 2010-01-01
End date: 2010-07-14
Dipyrone TAB
Indication: Product Used FOR Unknown Indication
Start date: 2009-10-01
End date: 2010-01-01
Omeprazole
Administration route: Oral
Indication: Gastric Ulcer
Start date: 2009-11-01
End date: 2010-07-14
Omacor
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-01-01
End date: 2010-07-14
Allopurinol
Administration route: Oral
Start date: 2010-03-01
End date: 2010-07-14
Voltaren
Dosage: unk
Administration route: Oral
Start date: 2009-01-01
End date: 2010-01-01
Telmisartan and Hydrochlorothiazide
Administration route: Oral
Indication: Hypertension
Start date: 2010-03-01
End date: 2010-07-14
Analgilasa
Dosage: monthly
Administration route: Oral
Indication: Osteoarthritis
Start date: 2009-11-01
End date: 2010-07-14
Other drugs received by patient: Vancomycin; Piperacillin and Tazobactam; Meropenem; Ambisome; Nitroglycerin; Linezolid
Possible Omacor side effects in 69 year old female
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-03-14
Patient: 69 year old female
Reactions: Aplastic Anaemia, Petechiae, Asthenia
Adverse event resulted in: death
Drug(s) suspected as cause:
Furosemide
Dosage: 20 mg
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-01-01
End date: 2010-07-11
Voltaren
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2009-01-01
End date: 2010-01-01
Allopurinol
Dosage: 300 mg
Administration route: Oral
Start date: 2010-03-01
End date: 2010-07-14
Omacor
Dosage: 2 g
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-01-01
End date: 2010-07-14
Telmisartan and Hydrochlorothiazide
Dosage: 1 anz
Administration route: Oral
Indication: Hypertension
Start date: 2010-03-01
End date: 2010-07-14
Acetaminophen
Dosage: 1.5 g
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-01-01
End date: 2010-07-14
Omeprazole
Dosage: 40 mg
Administration route: Oral
Indication: Gastric Ulcer
Start date: 2009-11-01
End date: 2010-07-14
Analgilasa
Administration route: Oral
Indication: Osteoarthritis
Start date: 2009-11-01
End date: 2010-07-14
Dipyrone TAB
Indication: Product Used FOR Unknown Indication
Start date: 2009-10-01
End date: 2010-01-01
Possible Omacor side effects in 81 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-02-07
Patient: 81 year old male
Reactions: Thrombocytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Triatec
Dosage: 1.25 mg, 1x/day
Administration route: Oral
Pravastatin
Dosage: 40 mg, 1x/day
Administration route: Oral
Levothyroxine Sodium
Dosage: 25 ug, 1x/day
Administration route: Oral
Omacor
Dosage: 1 df, 1x/day, on morning
Administration route: Oral
Inspra
Dosage: 12.5 mg, 1x/day
Administration route: Oral
Nexium
Dosage: 40 mg, 1x/day
Administration route: Oral
Carvedilol
Dosage: 3.125 mg, 2x/day
Administration route: Oral
Aspirin
Dosage: 75 mg, 1x/day
Administration route: Oral
Cetornan
Dosage: 5 g, 2x/day
Administration route: Oral
Lasix
Dosage: 20 mg, 1x/day
Administration route: Oral
Risperdal
Dosage: 0.5 mg, 1x/day
Administration route: Oral
Possible Omacor side effects in 47 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-02-06
Patient: 47 year old female
Reactions: Jaundice, Pruritus, Disseminated Intravascular Coagulation, Cholestasis, Hepatic Failure, Pyrexia, Hepatic Encephalopathy, Hepatitis Fulminant, Vomiting, Nausea, Cytolytic Hepatitis, Alanine Aminotransferase Increased, Gastrointestinal Disorder, Aspartate Aminotransferase Increased, Escherichia Infection, Septic Shock
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Ramipril
Dosage: unk
Administration route: Oral
Start date: 2009-04-15
End date: 2009-08-11
Plavix
Dosage: 75 mg, 1x/day
Administration route: Oral
Indication: Stent Placement
Start date: 2009-04-15
End date: 2009-08-11
Bisoprolol
Dosage: unk
Administration route: Oral
Indication: Myocardial Infarction
Start date: 2009-04-15
End date: 2009-08-28
Aspirin
Dosage: unk
Indication: Myocardial Infarction
Start date: 2009-04-15
End date: 2009-08-28
Omacor
Dosage: unk
Indication: Myocardial Infarction
Start date: 2009-04-15
End date: 2009-07-30
Atorvastatin
Dosage: unk
Administration route: Oral
Start date: 2009-04-15
End date: 2009-07-13
Possible Omacor side effects in 47 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-02-03
Patient: 47 year old female
Reactions: Hepatic Encephalopathy, Disseminated Intravascular Coagulation, Septic Shock, Cellulitis Enterococcal, Hepatitis Fulminant
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Atorvastatin
Dosage: unk
Administration route: Oral
Start date: 2009-04-15
End date: 2009-07-13
Ramipril
Dosage: unk
Administration route: Oral
Start date: 2009-04-15
End date: 2009-08-11
Plavix
Dosage: unk
Administration route: Oral
Start date: 2009-04-15
End date: 2009-08-11
Aspirin
Dosage: unk
Administration route: Oral
Start date: 2009-04-15
End date: 2009-08-28
Bisoprolol Fumarate
Dosage: unk
Administration route: Oral
Start date: 2009-04-15
End date: 2009-08-28
Omacor
Dosage: unk
Administration route: Oral
Start date: 2009-04-15
End date: 2009-08-11
Possible Omacor side effects in 71 year old male
Reported by a physician from Spain on 2012-01-25
Patient: 71 year old male, weighing 87.0 kg (191.4 pounds)
Reactions: Off Label Use, Hyperglycaemia
Drug(s) suspected as cause:
Omacor
Other drugs received by patient: Crestor
Possible Omacor side effects in 71 year old male
Reported by a physician from Spain on 2012-01-06
Patient: 71 year old male, weighing 87.0 kg (191.4 pounds)
Reactions: Off Label Use, Hyperglycaemia
Drug(s) suspected as cause:
Omacor
Other drugs received by patient: Crestor
Possible Omacor side effects in female
Reported by a consumer/non-health professional from United Kingdom on 2012-01-04
Patient: female
Reactions: Off Label Use, Atrial Fibrillation
Drug(s) suspected as cause:
Omacor
Possible Omacor side effects in 65 year old female
Reported by a consumer/non-health professional from United States on 2011-12-21
Patient: 65 year old female, weighing 81.4 kg (179.1 pounds)
Reactions: Benign Colonic Neoplasm
Drug(s) suspected as cause:
Tramadol HCL
Indication: Back Pain
Neurontin
Administration route: Oral
Indication: Neuropathy Peripheral
Detrol LA
Administration route: Oral
Indication: Urinary Incontinence
Omacor
Administration route: Oral
Indication: Blood Cholesterol Abnormal
Other drugs received by patient: Zoloft; Atenolol; Spironolactone; Isosorbide Mononitrate; Furosemide; Multi-Vitamins; Calcium; Zyrtec; Cozaar; Simvastatin; Fenofibrate; Methocarbamol; Omeprazole; Sertraline Hydrochloride; Synthroid; Lysine; Oxybutynin; Plavix; Acetylsalicylic Acid SRT
Possible Omacor side effects in 56 year old male
Reported by a consumer/non-health professional from United States on 2011-12-21
Patient: 56 year old male
Reactions: Chest Pain, Flatulence, Abdominal Distension
Drug(s) suspected as cause:
Omacor
Other drugs received by patient: Pentasa; Alprazolam; Centrum Vitamin; Aspirin; GAS X
Possible Omacor side effects in male
Reported by a physician from France on 2011-12-14
Patient: male
Reactions: Off Label Use, Haemoptysis, Coagulation Time Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Omacor
Other drugs received by patient: Irbesartan and Hydrochlorothiazide; Crestor
Possible Omacor side effects in male
Reported by a physician from France on 2011-12-06
Patient: male
Reactions: Off Label Use, Haemoptysis, Coagulation Time Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Omacor
Other drugs received by patient: Irbesartan and Hydrochlorothiazide; Crestor
Possible Omacor side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-11-28
Patient: 70 year old female
Reactions: Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Fatigue, Arthralgia, Liver Function Test Abnormal, Blood Cholesterol Increased
Drug(s) suspected as cause:
Bezafibrate
Dosage: unk
Atorvastatin Calcium
Dosage: 80 mg, unk
Omacor
Dosage: 4000 mg, 1x/day
Start date: 2011-07-01
End date: 2011-08-23
Atorvastatin Calcium
Dosage: unk
Start date: 2011-09-19
Omacor
Dosage: 1000 mg, unk
Indication: Myocardial Infarction
Start date: 2011-01-28
Possible Omacor side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-11-23
Patient: 70 year old female
Reactions: Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Fatigue, Arthralgia, Liver Function Test Abnormal, Blood Cholesterol Increased
Drug(s) suspected as cause:
Bezafibrate
Dosage: unk
Indication: Product Used FOR Unknown Indication
Atorvastatin Calcium
Dosage: unk
Start date: 2011-09-19
Omacor
Dosage: 1000 mg, 1x/day
Indication: Myocardial Infarction
Start date: 2011-01-28
Omacor
Dosage: 4000 mg, unk
Administration route: Oral
Start date: 2011-07-01
End date: 2011-08-23
Atorvastatin Calcium
Dosage: 80 mg, unk
Indication: Product Used FOR Unknown Indication
Possible Omacor side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-11-23
Patient: 70 year old female
Reactions: Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Fatigue, Arthralgia, Liver Function Test Abnormal, Blood Cholesterol Increased
Drug(s) suspected as cause:
Atorvastatin Calcium
Dosage: unk
Start date: 2011-09-19
Atorvastatin Calcium
Dosage: 80 mg, unk
Omacor
Dosage: 4000 mg, 1x/day
Start date: 2011-07-01
End date: 2011-08-23
Omacor
Dosage: 1000 mg, unk
Indication: Myocardial Infarction
Start date: 2011-01-28
Bezafibrate
Dosage: unk
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