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
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.001297%Not Available
Abdominal distension07.01.04.001--
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Anaphylactic shock10.01.07.002; 24.06.02.004--Not Available
Angina pectoris02.02.02.002; 24.04.04.002--
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Aspartate aminotransferase increased13.03.01.0060.000865%
Asthenia08.01.01.001--Not Available
Asthma10.01.03.010; 22.03.01.002--Not Available
Back pain15.03.04.005--
Blood creatine phosphokinase increased13.04.01.0010.001297%
Blood triglycerides increased13.12.03.0010.003458%Not Available
Body temperature increased13.15.01.001--Not Available
Bronchitis11.01.09.001; 22.07.01.001--
Cardiac arrest02.03.04.001--
Cataract06.06.01.0010.000865%
Central nervous system neoplasm16.30.01.001; 17.20.01.001--Not Available
Cerebral haemorrhage17.08.01.003; 24.07.04.0010.000338%Not Available
Cerebral infarction17.08.01.004; 24.04.06.0020.002162%Not Available
Cervix disorder21.06.01.003--Not Available
Chest pain02.02.02.011; 08.01.08.002; 22.02.08.0030.001297%Not Available
Chills08.01.09.001; 15.05.03.016--
Colitis07.08.01.001--
Completed suicide08.04.01.010; 19.12.01.001--Not Available
Constipation07.02.02.0010.001297%
Cough22.02.03.001--
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