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Omacor (Omega-3-Acid Ethyl Esters) - Side Effect Reports to FDA

 
 



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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