Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Omega-3-carboxylic acids
Drug ID BADD_D01612
Description The omega-3 carboxylic acid (OM3-CA) is a new formulation of omega-3 fatty acids that present an enhanced bioavailability in the treatment of dyslipidemia. The increased bioavailability is explained because OM3-CA is found in a form of polyunsaturated free fatty acids as opposed to other products whose form is as ethyl esters. It is a complex mixture of the free fatty acids form containing eicosapentaenoic acid and docosahexaenoic acid as the most abundant species found in a proportion of 55% and 20% respectively. The rest of the concentration is represented by docosapentaenoic acid and traces of some other components such as alpha-tocopherol, gelatin, glycerol, sorbitol and purified water.[A25808] It was developed by AstraZeneca Pharmaceuticals and firstly approved by the FDA on May 05, 2014.[L2386]
Indications and Usage OM3-CA is indicated as an adjunct to diet to reduce triglycerides levels in adults patients with severe hypertriglyceridemia (>500 mg/dL). The patients involved in this treatment should be laced with an appropriate lipid-lowering diet.[L2387] Hypertriglyceridemia is defined as an elevated plasma triglyceride concentration. It is usually correlated to other secondary conditions such as poor diet, alcohol use, obesity, metabolic syndrome and type 2 diabetes.[A32630]
Marketing Status approved; investigational
ATC Code Not Available
DrugBank ID DB09568
KEGG ID Not Available
MeSH ID D002264
PubChem ID 446284
TTD Drug ID Not Available
NDC Product Code Not Available
UNII F85N2YHE4E
Synonyms Carboxylic Acids | Acids, Carboxylic | Carboxylic Acid | Acid, Carboxylic
Chemical Information
Molecular Formula C20H30O2
CAS Registry Number 10417-94-4
SMILES CCC=CCC=CCC=CCC=CCC=CCCCC(=O)O
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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Arthralgia15.01.02.001--
Constipation07.02.02.001--
Diarrhoea07.02.01.001--
Dysgeusia17.02.07.003; 07.14.03.001--
Eructation07.01.02.003--
Fatigue08.01.01.002--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Vomiting07.01.07.003--
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