Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Icosapent ethyl
Drug ID BADD_D01126
Description Icosapent ethyl or ethyl eicosapentaenoic acid is a synthetic derivative of the omega-3 fatty acid eicosapentaenoic acid (EPA). It is used as adjunct therapy for severe hypertriglyceridemia (TG levels > 500 mg/dL). FDA approved on July 26, 2012.
Indications and Usage Icosapent ethyl is used as adjunct therapy to reduce triglyceride (TG) levels in adults with severe (>500 mg/dL) hypertriglyceridemia.
Marketing Status Prescription
ATC Code Not Available
DrugBank ID DB08887
KEGG ID D01892
MeSH ID C035276
PubChem ID 9831415
TTD Drug ID Not Available
NDC Product Code 44585-0003; 63629-8247; 11014-0430; 68279-001; 52937-001; 43598-267; 62009-0908; 52937-101; 52671-001; 10888-8142; 68279-002; 10888-8216; 60505-4033; 52937-003; 55209-1008; 0054-0508; 10888-8186; 68197-0006; 10888-8141; 71215-102; 10888-8143; 11014-0002; 10888-8198; 71215-101; 79568-000
Synonyms eicosapentaenoic acid ethyl ester | 5,8,11,14,17-eicosapentaenoic acid, ethyl ester, (5Z,8Z,11Z,14Z,17Z)- | ethyl (5Z,8Z,11Z,14Z,17Z)-icosa-5,8,11,14,17-pentaenoate | ethyl-EPA | ethyl eicosapentaenoate | ethyl icosapentaenoate | ethyl eicosapentaenoic acid | ethyl-eicosapentaenoic acid | icosapent ethyl | ethyl all-cis-5,8,11,14,17-icosapentaenoate | Epadel | AMR-101 | AMR101 | vascepa
Chemical Information
Molecular Formula C22H34O2
CAS Registry Number 86227-47-6
SMILES CCC=CCC=CCC=CCC=CCC=CCCCC(=O)OCC
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.010277%Not Available
Abdominal pain07.01.05.0020.003953%
Abdominal pain upper07.01.05.0030.001581%
Abnormal faeces07.01.03.0010.002372%Not Available
Acne23.02.01.0010.001581%Not Available
Alopecia23.02.02.0010.002372%
Anaphylactic reaction10.01.07.001; 24.06.03.0060.001581%
Arthralgia15.01.02.0010.012648%
Asthenia08.01.01.001--Not Available
Atrial fibrillation02.03.03.0020.002372%
Blood cholesterol increased13.12.01.0020.001581%
Blood glucose increased13.02.02.0020.001581%Not Available
Blood triglycerides abnormal13.12.03.0020.001581%Not Available
Blood triglycerides increased13.12.03.0010.029249%Not Available
Death08.04.01.001--
Diarrhoea07.02.01.0010.015020%
Dysgeusia07.14.03.001; 17.02.07.0030.002372%
Dyspepsia07.01.02.0010.003953%
Dysphagia07.01.06.0030.003162%
Dyspnoea02.01.03.002; 22.02.01.004--
Eructation07.01.02.0030.009486%
Fatigue08.01.01.002--
Feeling abnormal08.01.09.0140.001581%Not Available
Flatulence07.01.04.0020.001581%
Food allergy10.01.01.0120.002372%Not Available
Gastrooesophageal reflux disease07.02.02.0030.001581%
Gout14.09.01.001; 15.01.06.0010.002372%Not Available
Headache17.14.01.001--
High density lipoprotein decreased13.12.01.0030.003953%Not Available
Hypersensitivity10.01.03.0030.001581%
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