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).
Marketing Status Prescription
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 69452-175; 55700-873; 72189-024; 60505-4462; 61474-4264; 69784-420; 10888-5022; 31722-936; 62559-410; 58135-001; 10888-5038; 60897-150; 71335-2024; 70518-1636; 65162-034; 60687-127; 63629-2448; 63629-2451; 72998-850; 42291-657; 11014-0200; 42708-067; 64380-761; 0904-6706; 50090-3421; 50090-3956; 68197-0003; 50090-5799; 42806-552; 50090-3742; 50090-3957; 0254-3010; 44585-0004; 68197-8503; 63629-1918; 70518-3040; 50268-676; 72865-139; 60505-3170
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Cyst16.02.02.002; 08.03.05.001--Not Available
Death08.04.01.001--
Dehydration14.05.05.0010.000865%
Dermatitis23.03.04.002--Not Available
Diabetes mellitus14.06.01.001; 05.06.01.0010.000865%Not Available
Diarrhoea07.02.01.0010.002594%
Discomfort08.01.08.003--Not Available
Dizziness02.01.02.004; 24.06.02.007; 17.02.05.0030.001297%
Dry mouth07.06.01.002--
Dysgeusia17.02.07.003; 07.14.03.0010.001297%
Dyspepsia07.01.02.001--
Dysphagia07.01.06.003--
Dyspnoea02.01.03.002; 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; 22.04.03.0010.000865%
Eructation07.01.02.0030.001297%
Facial paralysis17.04.03.008--Not Available
Feeling abnormal08.01.09.014--Not Available
Fluid retention14.05.06.002; 20.01.02.003--Not Available
Fracture12.04.02.001; 15.08.02.0010.001729%
Fungal infection11.03.05.001--Not Available
Gait disturbance17.02.05.016; 08.01.02.0020.000865%
Gastritis07.08.02.001--
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.001297%Not Available
Generalised oedema14.05.06.007; 08.01.07.004--
Haemorrhagic disorder24.07.01.021; 01.01.03.004--Not Available
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