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Lovaza (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 Lovaza (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 (483)
Death (8)
Life Threatening Events (5)
Disability (5)

Reports by Reaction Type

Product Quality Issue (50)Nausea (35)Dysgeusia (35)Diarrhoea (35)Eructation (30)Drug Ineffective (28)Blood Triglycerides Increased (27)Abdominal Pain Upper (23)Therapeutic Response Unexpected (22)Abdominal Discomfort (20)Malaise (18)Back Pain (18)

Below are a few examples of reports where side effects / adverse reactions may be related to Lovaza (Omega-3-Acid Ethyl Esters). For a complete list or a specific selection of reports, please use the links above.

Possible Lovaza side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 55 year old female

Reactions: Vitamin D Deficiency, Muscle Atrophy, Pain in Extremity, Myocardial Infarction, LOW Density Lipoprotein Increased, Muscle Rupture, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Indication: Product Used FOR Unknown Indication

Lipitor
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Lovaza
    Dosage: 4cap per day
    Administration route: Oral
    Indication: Blood Triglycerides Increased
    Start date: 2008-05-01

Pravachol
    Indication: Product Used FOR Unknown Indication

Trilipix
    Indication: Blood Triglycerides Increased

Other drugs received by patient: Metformin HCL; Calcium; Lisinopril; Aspirin; Fenofibrate; Metoprolol; Plavix; Imdur



Possible Lovaza side effects in 58 year old female

Reported by a lawyer from United States on 2012-08-20

Patient: 58 year old female, weighing 80.5 kg (177.1 pounds)

Reactions: Hyperlipidaemia, Off Label Use, Osteoarthritis, Ageusia, Anosmia, Hypertension, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Lovaza

Other drugs received by patient: Lipitor; Hyzaar; Concurrent Medications



Possible Lovaza side effects in 73 year old male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 73 year old male

Reactions: Leukaemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Avodart
    Dosage: .5mg unknown
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-06-05

Lovaza
    Dosage: 1g unknown
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-06-05



Possible Lovaza side effects in

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient:

Reactions: Alanine Aminotransferase Increased, Blood Triglycerides Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gemfibrozil
    Indication: Product Used FOR Unknown Indication

Lovaza
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-01



Possible Lovaza side effects in 88 year old male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 88 year old male

Reactions: Off Label Use, Gastrointestinal Haemorrhage, Pericarditis, Cardiac Arrest, Respiratory Tract Infection, Cardiac Failure Congestive

Adverse event resulted in: death

Drug(s) suspected as cause:
Lovaza

Other drugs received by patient: Ascorbic Acid; Aspirin; Ferrous Sulfate TAB; Colace; Flexeril; Claritin; Lasix; Albuterol; Proscar; Proventil; Uloric; Synthroid; Atrovent; Minocycline HCL; Hydrocortisone Cream; Ultram; Metrogel; Folic Acid; Multi-Vitamin; Flomax; Zantac



Possible Lovaza side effects in 58 year old female

Reported by a lawyer from United States on 2012-08-09

Patient: 58 year old female, weighing 80.5 kg (177.1 pounds)

Reactions: Hyperlipidaemia, Osteoarthritis, Off Label Use, Ageusia, Anosmia, Hypertension, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Lovaza

Other drugs received by patient: Concurrent Medications; Hyzaar; Lipitor



Possible Lovaza side effects in 36 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-08

Patient: 36 year old male, weighing 126.0 kg (277.2 pounds)

Reactions: Nausea, Diarrhoea, Hyperglycaemia, Dizziness, Drug Interaction, Eye Swelling, Vision Blurred, Headache, DRY Eye, Eye Pruritus

Drug(s) suspected as cause:
Lovaza
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Simvastatin
    Dosage: 40mg taken in one day. 20mg tablet in the morning and another in the evening as prescribed.
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2012-05-28
    End date: 2012-06-10

Other drugs received by patient: Glucophage; Diamicron; Fexofenadine Hydrochloride



Possible Lovaza side effects in 50 year old male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 50 year old male

Reactions: Atrial Fibrillation

Drug(s) suspected as cause:
Lovaza

Other drugs received by patient: ACE Inhibitor; Statins; Folic Acid; Multi-Vitamin; Aspirin; Beta-Blocker; Plavix



Possible Lovaza side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: female

Reactions: Abdominal Pain, Vomiting, Diarrhoea, Abdominal Pain Upper

Drug(s) suspected as cause:
Lovaza



Possible Lovaza side effects in 36 year old male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-01

Patient: 36 year old male, weighing 126.0 kg (277.2 pounds)

Reactions: Nausea, Hyperglycaemia, Drug Interaction, Headache, Diarrhoea, Dizziness, Eye Swelling, Vision Blurred, DRY Eye, Eye Pruritus

Drug(s) suspected as cause:
Lovaza

Simvastatin
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2012-05-28
    End date: 2012-06-10

Other drugs received by patient: Glucophage XR; Diamicron MR; Fexofenadine Hydrochloride



Possible Lovaza side effects in 54 year old male

Reported by a physician from United States on 2012-07-27

Patient: 54 year old male

Reactions: Pancreatitis Acute, Abdominal Pain Upper

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Lovaza

Other drugs received by patient: Lopid; Crestor



Possible Lovaza side effects in 46 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-09

Patient: 46 year old female, weighing 74.8 kg (164.7 pounds)

Reactions: Fatigue, Vomiting, Staphylococcal Infection, Nausea, Gait Disturbance, Arthropod Bite, Hepatic Steatosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lovaza
    Dosage: new-06/26/2012 - take 2 caps, twice daily, po
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    End date: 2012-06-26

Lovaza
    Dosage: take 4 caps - then (07/08/2010), once a day, po
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2010-07-08
    End date: 2010-07-12



Possible Lovaza side effects in female

Reported by a physician from United States on 2012-07-02

Patient: female, weighing 180.0 kg (396.0 pounds)

Reactions: Diarrhoea, Anaphylactic Shock, Dermatitis Exfoliative

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Ibuprofen
    Dosage: 2400 milligram;
    Administration route: Oral
    Start date: 2011-06-01

Lovaza
    Administration route: Oral
    Start date: 2011-09-07

Omeprazole
    Dosage: 20 milligram;
    Administration route: Oral

Rosuvastatin
    Dosage: 20 milligram;
    Administration route: Oral
    Start date: 2011-06-01

Savella
    Dosage: 50 milligram;
    Administration route: Oral
    Start date: 2011-09-10
    End date: 2011-09-12

Savella
    Dosage: 12.5 milligram;
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2011-09-07
    End date: 2011-09-07

Torsemide
    Dosage: 80 milligram;
    Administration route: Oral
    Start date: 2011-07-13

Other drugs received by patient: Metformin Hydrochloride; Potassium; Amoxicillin; Cinnamon; Vaccinium Macrocarpon; Bupropion HCL; Lisinopril; M.v.i.; Warfarin Sodium; Allopurinol; Amitriptyline HCL; Glimepiride; Propranolol; Fenofibrate; Oxybutynin; Colecalciferol; Vicodin; Phentermine Hydrochloride; Levothyroxine Sodium



Possible Lovaza side effects in 46 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-02

Patient: 46 year old female, weighing 180.0 kg (396.0 pounds)

Reactions: Skin Chapped, Dyspnoea, Excoriation, Skin Exfoliation, Adverse Drug Reaction, Pain, Urticaria, Anaphylactic Shock, Faecal Incontinence, Skin Irritation, Diarrhoea, Rash Erythematous, Skin Lesion, Dermatitis Exfoliative, Rash Vesicular

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Dosage: 20mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-01

Ibuprofen
    Dosage: 800mg three times per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-01

Lovaza
    Dosage: 4g per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-07

Prilosec
    Dosage: 20mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-01

Savella
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2011-09-07
    End date: 2011-09-12

Torsemide
    Dosage: 40mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-13

Other drugs received by patient: Propranolol; Synthroid; Glimepiride; Adipex-P; Cinnamon; Cranberry; Fenofibrate; Vitamin D; Potassium; Warfarin Sodium; Vicodin; Metformin HCL; Oxybutynin; Amitriptyline HCL; Lisinopril; Amoxicillin; M.v.i.; Allopurinol; Wellbutrin



Possible Lovaza side effects in 46 year old female

Reported by a physician from United States on 2012-06-29

Patient: 46 year old female, weighing 180.0 kg (396.0 pounds)

Reactions: Diarrhoea, Adverse Drug Reaction, Anaphylactic Shock, Dermatitis Exfoliative

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Crestor
    Administration route: Oral
    Start date: 2011-06-01

Ibuprofen
    Start date: 2011-06-01

Lovaza
    Administration route: Oral
    Start date: 2011-09-07

Prilosec
    Administration route: Oral
    Start date: 2011-06-01

Savella
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2011-09-07
    End date: 2011-09-07

Savella
    Administration route: Oral
    Start date: 2011-09-08
    End date: 2011-09-09

Savella
    Administration route: Oral
    Start date: 2011-09-10
    End date: 2011-09-12

Torsemide
    Start date: 2011-07-13

Other drugs received by patient: Allopurinol; Propranolol; Amitriptyline HCL; Amoxicillin; Potassium Acetate; Metformin HCL; Multi-Vitamin; Cranberry; Synthroid; Lisinopril; Oxybutynin; Vicodin; Adipex-P; Glimepiride; Warfarin Sodium; Vitamin D; Cinnamon; Fenofibrate; Wellbutrin



Possible Lovaza side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-28

Patient: male

Reactions: Spleen Disorder, Gallbladder Disorder, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advair Diskus 100 / 50
    Start date: 2011-10-10

Coreg CR
    Dosage: 20mg unknown
    Start date: 2011-12-25

Lovaza
    Dosage: 1g unknown
    Start date: 2011-10-10



Possible Lovaza side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-06-26

Patient: 52 year old female

Reactions: Back Pain, Pain in Extremity, Chromaturia, Product Adhesion Issue, Product Physical Issue, Liver Disorder, Hepatic Enzyme Increased, Activities of Daily Living Impaired, Arthralgia, Dysuria

Drug(s) suspected as cause:
Lovaza
    Indication: Blood Triglycerides Increased

Lovaza
    Dosage: two tablets of unknown dose two times a day
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Pravastatin
    Dosage: daily
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2011-07-01

Premarin
    Dosage: 0.625 mg/g, daily 3 weeks on 1 week off
    Indication: Menopause
    Start date: 2012-02-01

Premarin
    Indication: Oestradiol Decreased

Tricor
    Dosage: daily
    Indication: Blood Cholesterol Increased
    End date: 2011-07-01

Other drugs received by patient: Estrogens Conjugated



Possible Lovaza side effects in 54 year old male

Reported by a consumer/non-health professional from United States on 2012-06-22

Patient: 54 year old male

Reactions: Pancreatitis Acute, Abdominal Pain Upper

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Lovaza

Other drugs received by patient: Unspecified Medications



Possible Lovaza side effects in 88 year old male

Reported by a consumer/non-health professional from United States on 2012-06-22

Patient: 88 year old male

Reactions: Off Label Use, Gastrointestinal Haemorrhage, Pericarditis, Cardiac Arrest, Respiratory Tract Infection, Cardiac Failure Congestive

Adverse event resulted in: death

Drug(s) suspected as cause:
Lovaza

Other drugs received by patient: Atrovent; Proventil; Uloric; Minocycline HCL; Flexeril; Synthroid; Albuterol; Flomax; Ascorbic Acid; Ultram; Zantac; Folic Acid; Multi-Vitamin; Ferrous Sulfate TAB; Hydrocortisone Cream; Lasix; Claritin; Metrogel; Aspirin; Colace; Proscar



Possible Lovaza side effects in 76 year old female

Reported by a consumer/non-health professional from United States on 2012-06-22

Patient: 76 year old female

Reactions: Migraine, Diplopia, Tinnitus, Vision Blurred, Visual Acuity Reduced, Arteriovenous Fistula

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lovaza

Other drugs received by patient: Doxepin; Evista; Calcium + D; Pravastatin; Tricor; Multi-Vitamin



Possible Lovaza side effects in

Reported by a physician from United States on 2012-06-18

Patient:

Reactions: Headache

Drug(s) suspected as cause:
Effexor XR
    Dosage: 150 mg, am and pm
    Indication: Depression

Effexor XR
    Indication: Anxiety

Lovaza
    Dosage: 1 g, 2x/day
    Indication: Blood Cholesterol Abnormal

Omeprazole
    Dosage: 20 mg, 7 am
    Indication: Gastric PH Increased

Trilipix
    Dosage: 135 mg, am
    Indication: Blood Cholesterol Abnormal

Zetia
    Dosage: 10 mg, 5pm
    Indication: Lipids Abnormal



Possible Lovaza side effects in female

Reported by a physician from United States on 2012-06-15

Patient: female, weighing 180.0 kg (396.0 pounds)

Reactions: Diarrhoea, Adverse Drug Reaction, Anaphylactic Shock, Dermatitis Exfoliative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Dosage: 20 mg
    Administration route: Oral
    Start date: 2011-06-01

Ibuprofen
    Dosage: 2400 mg
    Administration route: Oral
    Start date: 2011-06-01

Lovaza
    Dosage: 4 gm
    Administration route: Oral
    Start date: 2011-09-07

Prilosec
    Dosage: 20 mg
    Administration route: Oral
    Start date: 2011-06-01

Savella
    Dosage: 50 mg
    Administration route: Oral
    Start date: 2011-09-10
    End date: 2011-09-12

Savella
    Dosage: 25 mg
    Administration route: Oral
    Start date: 2011-09-08
    End date: 2011-09-09

Savella
    Dosage: 12.5 mg
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2011-09-07
    End date: 2011-09-07

Torsemide
    Dosage: 80 mg
    Administration route: Oral
    Start date: 2011-07-13

Other drugs received by patient: Adipex-P; Amoxicillin; Cranberry; Potassium Acetate; Amitriptyline HCL; Cinnamon; Wellbutrin; M.v.i.; Oxybutynin Chloride; Synthroid; Warfarin Sodium; Allopurinol; Fenofibrate; Propranolol; Vitamin D; Lisinopril; Vicodin; Glimepiride; Metformin HCL



Possible Lovaza side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: 52 year old female

Reactions: Back Pain, Pain in Extremity, Chromaturia, Product Adhesion Issue, Product Physical Issue, Hepatic Enzyme Increased, Liver Disorder, Arthralgia, Activities of Daily Living Impaired, Dysuria

Drug(s) suspected as cause:
Lovaza
    Dosage: 2 df, bid
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Lovaza
    Indication: Blood Triglycerides Increased

Pravastatin
    Dosage: daily
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2011-07-01

Premarin
    Dosage: 0.625 mg/g daily 3 wks on 1 wk off
    Indication: Blood Oestrogen Decreased
    Start date: 2012-02-01

Premarin
    Indication: Menopause

Tricor
    Dosage: unk
    Indication: Blood Cholesterol Increased
    End date: 2011-07-01

Other drugs received by patient: Pravastatin; Premarin; Premarin



Possible Lovaza side effects in 52 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-25

Patient: 52 year old female

Reactions: Liver Disorder, Hepatic Enzyme Increased

Drug(s) suspected as cause:
Lovaza



Possible Lovaza side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-24

Patient: female

Reactions: Cholelithiasis, Aspartate Aminotransferase Increased

Drug(s) suspected as cause:
Lovaza

Other drugs received by patient: NO Concurrent Medication



Possible Lovaza side effects in 52 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24

Patient: 52 year old female

Reactions: Back Pain, Pain in Extremity, Chromaturia, Product Adhesion Issue, Product Physical Issue, Hepatic Enzyme Increased, Liver Disorder, Off Label Use, Arthralgia, Activities of Daily Living Impaired, Dysuria

Drug(s) suspected as cause:
Lovaza
    Dosage: 2000mg twice per day
    Administration route: Oral
    Indication: Blood Triglycerides Increased

Pravastatin
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Premarin
    Dosage: .625mgg per day
    Indication: Blood Oestrogen Decreased
    Start date: 2012-02-01

Tricor
    Indication: Blood Cholesterol Increased
    End date: 2011-07-01

Other drugs received by patient: Conjugated Estrogens



Possible Lovaza side effects in 37 year old male

Reported by a consumer/non-health professional from United States on 2012-05-23

Patient: 37 year old male

Reactions: Hepatic Function Abnormal, Fatigue, Nausea, Headache

Drug(s) suspected as cause:
Lovaza

Other drugs received by patient: Claritin-D 24 Hour; Prevacid; Vitamin TAB



Possible Lovaza side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-23

Patient: male

Reactions: Pulmonary Embolism, International Normalised Ratio Fluctuation

Drug(s) suspected as cause:
Lovaza



Possible Lovaza side effects in 52 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-21

Patient: 52 year old female

Reactions: Back Pain, Pain in Extremity, Chromaturia, Product Adhesion Issue, Product Physical Issue, Liver Disorder, Hepatic Enzyme Increased, Activities of Daily Living Impaired, Arthralgia, Dysuria

Drug(s) suspected as cause:
Lovaza
    Indication: Blood Triglycerides Increased

Lovaza
    Indication: Blood Cholesterol Increased

Pravastatin
    Dosage: daily
    Administration route: Oral
    Indication: Blood Cholesterol Increased
    Start date: 2011-07-01

Premarin
    Dosage: 0.625 mg/g daily 3 wks on 1 wk off
    Indication: Blood Oestrogen Decreased
    Start date: 2012-02-01

Tricor
    Indication: Blood Cholesterol Increased
    End date: 2011-07-01

Other drugs received by patient: Pravastatin; Premarin



Possible Lovaza side effects in female

Reported by a lawyer from United States on 2012-05-21

Patient: female

Reactions: Ageusia, Anosmia

Drug(s) suspected as cause:
Lovaza

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