Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fluvastatin
Drug ID BADD_D00948
Description Fluvastatin is an antilipemic agent that competitively inhibits hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase. HMG-CoA reductase catalyzes the conversion of HMG-CoA to mevalonic acid, the rate-limiting step in cholesterol biosynthesis. Fluvastatin belongs to a class of medications called statins and is used to reduce plasma cholesterol levels and prevent cardiovascular disease. It is also the first entirely synthetic HMG-CoA reductase inhibitor and is structurally distinct from the fungal derivatives of this therapeutic class. Fluvastatin is a racemate comprising equimolar amounts of (3R,5S)- and (3S,5R)-fluvastatin.
Indications and Usage To be used as an adjunct to dietary therapy to prevent cardiovascular events. May be used as secondary prevention in patients with coronary heart disease (CHD) to reduce the risk of requiring coronary revascularization procedures, for reducing progression of coronary atherosclerosis in hypercholesterolemic patients with CHD, and for the treatment of primary hypercholesterolemia and mixed dyslidipidemia.
Marketing Status Prescription; Discontinued
ATC Code C10AA04
DrugBank ID DB01095
KEGG ID D07983
MeSH ID D000077340
PubChem ID 446155
NDC Product Code 0378-8021; 0093-7442; 63629-8812; 0093-7443; 0378-8020; 63629-8737
Synonyms Fluvastatin | Fluvastatin Sodium | Fluvastatin Sodium Salt | Fluindostatin | Lescol | XU 62-320 | XU 62 320 | XU-62320 | XU62320 | XU 62320 | 7-(3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl)-3,5-dihydroxy-6-heptenoate
Chemical Information
Molecular Formula C24H26FNO4
CAS Registry Number 93957-54-1
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Acute myocardial infarctionStromelysin-1P08254T8670210190398; 12485468; 16323393; 9420339
Angina pectorisStromelysin-1P08254T8670210190398; 12485468; 16323393; 9420339
AngioplastyStromelysin-1P08254T8670210190398; 12485468; 16323393; 9420339
ArteriosclerosisLiver carboxylesterase 1P23141T763699420339; 14660992; 14998629; 14984434
Cerebrovascular accidentStromelysin-1P08254T8670210190398; 12485468; 16323393; 9420339
DeathStromelysin-1P08254T8670210190398; 12485468; 16323393; 9420339
Lipids abnormalAngiotensin-converting enzymeP12821T825778131299; 9298740; 8800107
Myocardial ischaemiaApolipoprotein EP02649T2168910736278; 7605354
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.003736%Not Available
Abdominal distension07.01.04.0010.003736%
Abdominal pain07.01.05.0020.005605%
Abdominal pain upper07.01.05.0030.003736%
Abortion spontaneous18.01.04.0010.003736%Not Available
Acute respiratory distress syndrome22.01.03.0010.001949%
Alanine aminotransferase increased13.03.01.0030.014946%
Anaphylactic reaction24.06.03.006;
Anaphylactic shock24.06.02.004; Available
Angioedema23.04.01.001; Available
Anhedonia19.15.02.0070.003736%Not Available
Arrhythmia02.03.02.001--Not Available
Arthropathy15.01.01.003--Not Available
Aspartate aminotransferase increased13.03.01.0060.016814%
Asthenia08.01.01.0010.016814%Not Available
Atrial fibrillation02.03.03.002--
Autoimmune hepatitis10.04.09.001; Available
Back pain15.03.04.0050.003736%
Blister23.03.01.001; Available
Blood alkaline phosphatase13.04.02.010--Not Available
Blood bilirubin13.03.01.040--Not Available
Blood bilirubin increased13.03.01.0080.005605%
Blood creatine phosphokinase increased13.04.01.0010.016814%
Blood creatine phosphokinase MB increased13.04.01.0060.003736%Not Available
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