Index of reports
> All Cases (483)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Lovaza (Omega-3-Acid Ethyl Esters) all cases. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 483 Next >>
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 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 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
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 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 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 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 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 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 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 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 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 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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