Adverse Reactions
Treatment-emergent adverse events reported in at least 1% of patients treated with Omacor 4 g per day or placebo during 8 randomized, placebo-controlled, double-blind, parallel-group studies for HTG are listed in Table 2. Adverse events led to discontinuation of treatment in 3.5% of patients treated with Omacor and 2.6% of patients treated with placebo.
Table 2. Adverse Events in Randomized, Placebo-Controlled, Double-Blind, Parallel–Group Studies for Hypertriglyceridemia That Used Omacor 4 g per Day |
BODY SYSTEM
Adverse Event |
Omacor
(N = 226) |
Placebo*
(N = 228) |
| n | % | n | % |
| Subjects with at least 1 adverse event | 80 | 35.4 | 63 | 27.6 |
| Body as a whole | | | | |
| Back pain | 5 | 2.2 | 3 | 1.3 |
| Flu syndrome | 8 | 3.5 | 3 | 1.3 |
| Infection | 10 | 4.4 | 5 | 2.2 |
| Pain | 4 | 1.8 | 3 | 1.3 |
| Cardiovascular | | | | |
| Angina pectoris | 3 | 1.3 | 2 | 0.9 |
| Digestive | | | | |
| Dyspepsia | 7 | 3.1 | 6 | 2.6 |
| Eructation | 11 | 4.9 | 5 | 2.2 |
| Skin | | | | |
| Rash | 4 | 1.8 | 1 | 0.4 |
| Special senses | | | | |
| Taste perversion | 6 | 2.7 | 0 | 0.0 |
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Adverse events were coded using COSTART, version 5.0. Subjects were counted only once for each body system and for each preferred term.
*Placebo was corn oil for all studies. |
Additional adverse events reported by 1 or more patients from 22 clinical studies for HTG are listed below:
BODY AS A WHOLE: enlarged abdomen, asthenia, body odor, chest pain, chills, suicide, fever, generalized edema, fungal infection, malaise, neck pain, neoplasm, rheumatoid arthritis, sudden death, and viral infection.
CARDIOVASCULAR SYSTEM: arrhythmia, bypass surgery, cardiac arrest, hyperlipemia, hypertension, migraine, myocardial infarct, myocardial ischemia, occlusion, peripheral vascular disorder, syncope, and tachycardia.
DIGESTIVE SYSTEM: anorexia, constipation, dry mouth, dysphagia, colitis, fecal incontinence, gastritis, gastroenteritis, gastrointestinal disorder, increased appetite, intestinal obstruction, melena, pancreatitis, tenesmus, and vomiting.
HEMATOLOGIC-LYMPHATIC SYSTEM: lymphadenopathy.
METABOLIC AND NUTRITIONAL DISORDERS: edema, hyperglycemia, increased ALT, and increased AST.
MUSCULOSKELETAL SYSTEM: arthralgia, arthritis, myalgia, pathological fracture, and tendon disorder.
NERVOUS SYSTEM: central nervous system neoplasia, depression, dizziness, emotional lability, facial paralysis, insomnia, vasodilatation, and vertigo.
RESPIRATORY SYSTEM: asthma, bronchitis, increased cough, dyspnea, epistaxis, laryngitis, pharyngitis, pneumonia, rhinitis, and sinusitis.
SKIN: alopecia, eczema, pruritis, and sweating.
SPECIAL SENSES: cataract.
UROGENITAL SYSTEM: cervix disorder, endometrial carcinoma, epididymitis, and impotence.
DRUG ABUSE AND DEPENDENCE
Omacor does not have any known drug abuse or withdrawal effects.
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REPORTS OF SUSPECTED OMACOR SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Omacor. The information is not vetted and should not be considered as verified clinical evidence.
Possible Omacor side effects / adverse reactions in 70 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-11-03
Patient: 70 year old female
Reactions: Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Fatigue, Arthralgia, Liver Function Test Abnormal, Blood Cholesterol Increased
Suspect drug(s):
Atorvastatin Calcium
Dosage: 80 mg, unk
Bezafibrate
Dosage: 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
Atorvastatin Calcium
Dosage: unk
Start date: 2011-09-19
Possible Omacor side effects / adverse reactions 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
Suspect drug(s):
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
Possible Omacor side effects / adverse reactions 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
Suspect drug(s):
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
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