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)
Malaise08.01.01.003--
Melaena07.12.02.004; 24.07.02.013---
Migraine17.14.02.001; 24.03.05.003---
Mood swings19.04.03.001---
Myalgia15.05.02.001--
Myocardial infarction02.02.02.007; 24.04.04.009--
Myocardial ischaemia02.02.02.008; 24.04.04.010---
Neck pain15.03.04.009--
Neoplasm16.16.02.001---
Oedema08.01.07.006; 14.05.06.010---
Pain08.01.08.004--
Pancreatitis07.18.01.001--
Peripheral vascular disorder24.03.01.003---
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
Pneumonia11.01.09.003; 22.07.01.003---
Proctalgia07.03.02.001--
Pruritus23.03.12.001--
Rash23.03.13.001---
Renal cyst16.27.01.001; 20.01.04.001---
Rheumatoid arthritis10.04.06.001; 15.01.03.001---
Rhinitis11.01.13.004; 22.07.03.006--
Shock24.06.02.002---
Sinusitis11.01.13.005; 22.07.03.007--
Skin odour abnormal23.03.03.012--
Sudden death02.03.04.013; 08.04.01.003--
Syncope02.11.04.015; 17.02.04.008; 24.06.02.012--
Tachycardia02.03.02.007---
Tendon disorder12.01.07.019; 15.07.01.002---
Vertigo04.04.01.003; 17.02.12.002--
Viral infection11.05.04.001---
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