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
TTD Drug ID D08GHB
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
SMILES CC(C)N1C2=CC=CC=C2C(=C1C=CC(CC(CC(=O)O)O)O)C3=CC=C(C=C3)F
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)
Ill-defined disorder08.01.03.049--Not Available
Blood disorder01.05.01.004--Not Available
Hepatobiliary disease09.01.08.003--Not Available
Renal impairment20.01.03.0100.003736%Not Available
Hepatic enzyme abnormal13.03.01.020--Not Available
Muscle swelling15.05.03.015--Not Available
Mixed liver injury09.01.07.0150.003736%Not Available
Liver injury12.01.02.003; 09.01.07.0220.003736%Not Available
Acute kidney injury20.01.03.016--
Immune-mediated necrotising myopathy15.05.05.008; 10.04.05.006--Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.005605%Not Available
Hepatic cancer16.07.02.004; 09.04.02.008--Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.010--Not Available
Drug reaction with eosinophilia and systemic symptoms23.03.05.005; 10.01.01.021--Not Available
Myocardial necrosis marker increased13.04.01.0130.005605%Not Available
Cardiac failure chronic02.05.01.0090.003736%Not Available
Concomitant disease progression08.01.03.0640.000975%Not Available
Cell death14.11.02.005; 08.03.03.0030.003736%Not Available
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