Lovaza Side Effects

Please note - some side effects for Lovaza 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).

Side Effects of Lovaza - for the Consumer

Lovaza

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lovaza:

Back pain; burping; flu-like symptoms (eg, fever, headache, muscle aches, tiredness); taste changes; upset stomach.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; chest pain; fast, slow, or irregular heartbeat; numbness of an arm or leg; severe stomach pain; signs of infection (eg, fever, chills, or persistent sore throat); sudden shortness of breath; sudden, severe headache, vomiting, dizziness, or fainting.

Lovaza Side Effects - for the Professional

Lovaza

Treatment-emergent adverse events reported in at least 1% of patients treated with Lovaza 4 g per day or placebo during 8 randomized, placebo-controlled, double-blind, parallel-group studies for HTG are listed in Table 3. Adverse events led to discontinuation of treatment in 3.5% of patients treated with Lovaza and 2.6% of patients treated with placebo.

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, and sudden death.

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.

Infections and Infestations

Viral infection.

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, pruritus, and sweating.

Special Senses

Cataract.

Urogenital System

Cervix disorder, endometrial carcinoma, epididymitis, and impotence.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the events described below have been identified during post-approval use of Lovaza. Because these events are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or to always establish a causal relationship to drug exposure.

The following events have been reported: anaphylactic reaction, hemorrhagic diathesis.

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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