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
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)
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 reaction24.06.03.006; 10.01.07.0010.001581%
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%
Dyspnoea22.02.01.004; 02.01.03.002--
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%
Gout15.01.06.001; 14.09.01.0010.002372%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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