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 approved; investigational; nutraceutical
ATC Code Not Available
DrugBank ID DB08887
KEGG ID D01892
MeSH ID C035276
PubChem ID 9831415
TTD Drug ID Not Available
NDC Product Code 68279-001; 79568-000; 10888-8141; 10888-8142; 11014-0332; 11014-0333; 11014-0479; 52937-001; 10888-8219; 11014-0002; 10888-8186; 60505-4033; 0480-0127; 11014-0430; 68197-0006; 43598-267; 43598-746; 10888-8216; 10888-8222; 52937-101; 63629-9311; 10888-8143; 10888-8214; 10888-8215; 52937-003; 63629-8247; 63629-9312; 0054-0621; 44585-0003; 52671-001; 0480-0126; 0054-0508; 72603-129; 11014-0570; 71215-101; 10888-8198; 55209-1008; 62009-0908; 68279-002; 70468-001; 71215-102
UNII 6GC8A4PAYH
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
*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)
Myalgia15.05.02.001-
Nasal congestion22.04.04.001-
Nausea07.01.07.001-
Nightmare19.02.03.003-Not Available
Oedema14.05.06.010; 08.01.07.006-Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007-
Oral discomfort07.05.05.001-Not Available
Pain in extremity15.03.04.010-
Palpitations02.11.04.012-
Rash23.03.13.001-Not Available
Rash pruritic23.03.13.030-Not Available
Retching07.01.07.002-Not Available
Skin discolouration23.03.03.005-Not Available
Skin odour abnormal23.03.03.012-
Swelling08.01.03.015-Not Available
Therapeutic response decreased08.06.01.016-Not Available
Therapeutic response unexpected08.06.01.001-Not Available
Urticaria23.04.02.001; 10.01.06.001-
Musculoskeletal stiffness15.03.05.027-Not Available
Urine odour abnormal20.02.01.020-Not Available
Paraesthesia oral07.05.05.035; 17.02.06.008-Not Available
Adverse event08.06.01.010-Not Available
Drug intolerance08.06.01.013-Not Available
Oropharyngeal pain07.05.05.004; 22.12.03.016-
Anal incontinence17.05.01.021; 07.01.06.029-
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