Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Choline fenofibrate
Drug ID BADD_D00455
Description Fenofibric acid is a lipid-lowering agent that is used in severe hypertriglyceridemia, primary hyperlipidemia, and mixed dyslipidemia. It works to decrease elevated low-density lipoprotein cholesterol, total cholesterol, triglycerides, apolipoprotein B, while increasing high-density lipoprotein cholesterol.[A32038,L12855] Due to its high hydrophilicity and poor absorption profile,[A32038] prodrug ,[fenofibrate], and other conjugated compounds of fenofibric acid, such as choline fenofibrate, have been developed for improved solubility, gastrointestinal absorption, and bioavailability, and more convenient administration.[A32038,A193362]
Indications and Usage For use as an adjunctive therapy to diet to: (a) reduce triglyceride levels in adult patients with severe hypertriglyceridemia, and (b) reduce elevated total cholesterol, low-density-lipoprotein (LDL-C), triglycerides, and apolipoprotein B, and to increase high-density-lipoprotein (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). [FDA Label]
Marketing Status Prescription
ATC Code C10AB11
DrugBank ID DB13873
KEGG ID D08890
MeSH ID Not Available
PubChem ID 11350701
TTD Drug ID D01HKL
NDC Product Code 17337-0013; 17337-0042; 17180-0201; 17337-0412; 66039-874; 68294-0003; 66064-1007
Synonyms Not Available
Chemical Information
Molecular Formula C22H28ClNO5
CAS Registry Number 856676-23-8
SMILES CC(C)(C(=O)[O-])OC1=CC=C(C=C1)C(=O)C2=CC=C(C=C2)Cl.C[N+](C)(C)CCO
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Alanine aminotransferase increased13.03.01.003--
Anaemia01.03.02.001--
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Blood creatine phosphokinase increased13.04.01.001--
Bronchitis11.01.09.001; 22.07.01.001--
Cirrhosis alcoholic09.01.04.005--Not Available
Constipation07.02.02.001--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Dizziness02.01.02.004; 17.02.05.003; 24.06.02.007--
Dyspepsia07.01.02.001--
Fatigue08.01.01.002--
Headache17.14.01.001--
Hepatitis09.01.07.004--Not Available
Hypertension24.08.02.001--
Influenza11.05.03.001; 22.07.02.001--Not Available
Insomnia17.15.03.002; 19.02.01.002--
Laryngeal pain22.02.05.036--
Liver function test abnormal13.03.01.013--Not Available
Muscle spasms15.05.03.004--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Nasopharyngitis11.01.13.002; 22.07.03.002--Not Available
Nausea07.01.07.001--
Pain08.01.08.004--
Pain in extremity15.03.04.010--
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