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)
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.001--
Dysphagia07.01.06.003--
Dyspnoea02.11.05.003; 22.02.01.004--
Eczema23.03.04.006--
Endometrial cancer21.07.02.002; 16.12.02.001--Not Available
Epididymitis21.09.02.001; 11.01.19.005--Not Available
Epistaxis24.07.01.005; 22.04.03.001--
Eructation07.01.02.003--
Facial paralysis17.04.03.008--Not Available
Feeling abnormal08.01.09.014--Not Available
Fluid retention20.01.02.003; 14.05.06.002--Not Available
Fungal infection11.03.05.001--Not Available
Gastritis07.08.02.001--
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Generalised oedema14.05.06.007; 08.01.07.004--
Haemorrhagic disorder24.07.01.021; 01.01.03.004--Not Available
Hyperglycaemia05.06.02.002; 14.06.02.002--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypertension24.08.02.001--
Hypertriglyceridaemia14.08.02.001--
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Intestinal obstruction07.13.01.002--Not Available
Laryngitis22.07.03.001; 11.01.13.001--
Loss of consciousness17.02.04.004--Not Available
Lymphadenopathy01.09.01.002--Not Available
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