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.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Lovaza:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Top

Lovaza Side Effects - for the Professional

Lovaza

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse reactions reported in at least 3% and at a greater rate than placebo for patients treated with Lovaza based on pooled data across 23 clinical studies are listed in Table 1.

Table 1. Adverse Reactions Occurring at Incidence ≥3% and Greater than Placebo in Clinical Studies of Lovaza

BODY SYSTEM Adverse Reaction*	Lovaza (N = 655)		Placebo (N = 370)
	n	%	n	%
Eructation	29	4	5	1
Dyspepsia	22	3	6	2
Taste perversion	27	4	1	<1

*  Studies included subjects with HTG and severe HTG.

Additional adverse reactions from clinical studies are listed below:

Digestive System: Constipation, gastrointestinal disorder and vomiting.

Metabolic and Nutritional Disorders: Increased ALT and increased AST.

Skin: Pruritus and rash.

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.

Top

Side Effects by Body System - for Healthcare Professionals

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.

Hypersensitivity

Hypersensitivity side effects including anaphylactic reaction 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.

Hematologic

Hematologic side effects including hemorrhagic diathesis have been reported.

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.