Omacor Side Effects

Please note - some side effects for Omacor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Omacor Side Effects - for the Professional

Omacor

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.

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.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects including eructation (4.9%), dyspepsia (3.1%), anorexia, constipation, dry mouth, dysphagia, colitis, fecal incontinence, gastritis, gastroenteritis, gastrointestinal disorder, increased appetite, intestinal obstruction, melena, pancreatitis, tenesmus, and vomiting have been reported.

General

General side effects including infection (4.4%), flu syndrome (3.5%), back pain (2.2%), pain (1.8%), enlarged abdomen, asthenia, body odor, chest pains, chills, suicide, fever, generalized edema, fungal infection, malaise, neck pain, sudden death, and viral infection have been reported.

Other

Other side effects including taste perversion (2.7%) and lymphadenopathy have been reported.

Dermatologic

Dermatologic side effects including rashes (1.8%), alopecia, eczema, pruritus, and sweating have been reported.

Cardiovascular

One study concluded that omega-3 fatty acid supplementation reduced heart rate and QRS duration in heart transplant recipients who were presumably devoid of vagal intervention. These findings suggest that omega-3 fatty acids may modify the electrophysiologic properties of the myocardium itself.

Cardiovascular side effects including angina pectoris (1.3%), arrhythmia, bypass surgery, cardiac arrest, hyperlipidemia, hypertension, migraine, myocardial infarct, myocardial ischemia, occlusion, peripheral vascular disorder, syncope, and tachycardia have been reported.

Musculoskeletal

Musculoskeletal side effects including rheumatoid arthritis, arthralgia, arthritis, myalgia, pathological fracture, and tendon disorder have been reported.

Metabolic

Metabolic side effects including edema, hyperglycemia, increased ALT and increased AST have been reported.

Nervous system

Nervous system side effects including depression, dizziness, emotional lability, facial paralysis, insomnia, vasodilation, and vertigo have been reported.

Respiratory

Respiratory side effects including asthma, bronchitis, increased cough, dyspnea, epistaxis, laryngitis, pharyngitis, pneumonia, rhinitis, and sinusitis have been reported.

Genitourinary

Genitourinary side effects including cervical disorder, endometrial carcinoma, epididymitis, and impotence have been reported.

Oncologic

Oncologic side effects including neoplasm and central nervous system neoplasia have been reported.

Ocular

Ocular side effects including cataract have been reported.

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