Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Omega-3-acid ethyl esters
Drug ID BADD_D01611
Description Omega-3-acid ethyl esters are prescription drugs that contain eicosapentaenoic acid-ethyl ester (EPA) and docosahexaenoic acid-ethyl ester (DHA) that are used in combination with changes in diet to lower triglyceride levels in adults with severe (≥ 500 mg/dL) hypertriglyceridemia[FDA Label][A176687]. Omega-3-acid ethyl esters are currently marketed in the US, EU, and many other regions under the brand name Lovaza[FDA Label][L5849].
Indications and Usage Omega-3-Acid Ethyl Esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG)[FDA Label][A176687].
Marketing Status approved; investigational
ATC Code Not Available
DrugBank ID DB09539
KEGG ID D05255
MeSH ID Not Available
PubChem ID 9831414
TTD Drug ID Not Available
NDC Product Code 11014-0200; 42806-552; 50268-676; 10888-5038; 60505-3170; 63629-2451; 72865-139; 60897-150; 60505-4462; 69452-175; 63629-7015; 64380-761; 0904-6706; 68197-0003; 60687-127; 69784-420; 61474-4264; 70518-3040; 10888-5022; 31722-936; 63629-2448; 65162-034; 71335-2024; 58135-001; 42291-657; 0254-3010; 50090-5799; 63629-1918; 68197-8503
UNII D87YGH4Z0Q
Synonyms Not Available
Chemical Information
Molecular Formula C46H70O4
CAS Registry Number 861006-80-6
SMILES CCC=CCC=CCC=CCC=CCC=CCCCC(=O)OCC.CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)OCC
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Back pain15.03.04.005--
Body temperature increased13.15.01.001--Not Available
Bronchitis22.07.01.001; 11.01.09.001--
Cardiac arrest02.03.04.001--
Cataract06.06.01.001--
Central nervous system neoplasm17.20.01.001; 16.30.01.001--Not Available
Cervix disorder21.06.01.003--Not Available
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011--Not Available
Chills15.05.03.016; 08.01.09.001--
Colitis07.08.01.001--
Completed suicide08.04.01.010; 19.12.01.001--Not Available
Constipation07.02.02.001--
Cough22.02.03.001--
Cyst16.02.02.002; 08.03.05.001--Not Available
Dermatitis23.03.04.002--Not Available
Discomfort08.01.08.003--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry mouth07.06.01.002--
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