Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fenofibric acid
Drug ID BADD_D00874
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 approved
ATC Code Not Available
DrugBank ID DB13873
KEGG ID D11579
MeSH ID C006012
PubChem ID 64929
TTD Drug ID D0NF1U
NDC Product Code 68543-3161; 70436-169; 24979-109; 42571-348; 66064-1003; 0115-1555; 69315-282; 69844-022; 42385-944; 0074-3161; 24979-112; 42385-945; 46708-244; 59651-216; 62332-244; 17337-0411; 0074-3162; 69315-281; 42571-347; 46708-245; 59651-217; 70436-168; 0115-1554; 62332-245; 69844-023; 68543-3162
UNII BGF9MN2HU1
Synonyms fenofibric acid | 2-(4-(4'-chlorophenoxy)phenoxy)propionic acid | fenofibric acid sodium salt | fenofibric acid potassium salt | fenofibric acid, (R)-isomer | HCG 004
Chemical Information
Molecular Formula C17H15ClO4
CAS Registry Number 42017-89-0
SMILES CC(C)(C(=O)O)OC1=CC=C(C=C1)C(=O)C2=CC=C(C=C2)Cl
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 pain07.01.05.002--
Alanine aminotransferase increased13.03.04.005--
Anaemia01.03.02.001--
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Blood creatine phosphokinase increased13.04.01.001--
Bronchitis22.07.01.001; 11.01.09.001--
Cirrhosis alcoholic09.01.04.005--Not Available
Constipation07.02.02.001--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.11.04.006--
Dyspepsia07.01.02.001--
Fatigue08.01.01.002--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Headache17.14.01.001--
Hepatitis09.01.07.004--Not Available
Hypertension24.08.02.001--
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Laryngeal pain22.12.03.010--
Liver function test abnormal13.03.04.030--Not Available
Muscle spasms15.05.03.004--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
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