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--Not Available
Migraine24.03.05.003; 17.14.02.001--Not Available
Mood swings19.04.03.001--Not Available
Myalgia15.05.02.001--
Myocardial infarction24.04.04.009; 02.02.02.007--
Myocardial ischaemia24.04.04.010; 02.02.02.008--Not Available
Neck pain15.03.04.009--
Neoplasm16.16.02.001--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Pain08.01.08.004--
Pancreatitis07.18.01.001--
Peripheral vascular disorder24.03.01.003--Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Proctalgia07.03.02.001--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Renal cyst20.01.04.001; 16.27.01.001--Not Available
Rheumatoid arthritis15.01.03.001; 10.04.06.001--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Shock24.06.02.002--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Skin odour abnormal23.03.03.012--
Sudden death08.04.01.003; 02.03.04.013--
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Tachycardia02.03.02.007--Not Available
Tendon disorder15.07.01.002; 12.01.07.019--Not Available
Vertigo17.02.12.002; 04.04.01.003--
Viral infection11.05.04.001--Not Available
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