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)
Pancreatitis acute07.18.01.0020.000865%Not Available
Peripheral vascular disorder24.03.01.003--Not Available
Pharyngitis11.01.13.003; 07.05.07.004; 22.07.03.004--
Platelet count decreased13.01.04.0010.000865%
Pneumonia22.07.01.003; 11.01.09.0030.000865%Not Available
Proctalgia07.03.02.001--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Renal cancer20.01.04.002; 16.08.02.0010.000226%Not Available
Renal cyst20.01.04.001; 16.27.01.001--Not Available
Rhabdomyolysis15.05.05.0020.003458%
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--
Syncope24.06.02.012; 17.02.04.008; 02.01.02.008--
Tachycardia02.03.02.007--Not Available
Tendon disorder15.07.01.002--Not Available
Transient ischaemic attack17.08.04.001; 24.04.06.0050.000865%
Vertigo17.02.12.002; 04.04.01.003--
Viral infection11.05.04.001--Not Available
Vomiting07.01.07.0030.001297%
Large intestine polyp16.05.02.006; 07.20.01.010--Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Affect lability19.04.01.001--Not Available
Haemorrhage24.07.01.0020.001729%Not Available
Rectal tenesmus07.03.03.001; 15.05.03.011--Not Available
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