Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fluvastatin sodium
Drug ID BADD_D00949
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 D00892
MeSH ID D000077340
PubChem ID 23663976
TTD Drug ID D08GHB
NDC Product Code 0781-8017; 0078-0354; 65727-012; 0527-2580; 14501-0009; 0093-7446; 48087-0093
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 C24H25FNNaO4
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.[Na+]
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Acute myocardial infarctionStromelysin-1P08254T86702Not Available
Angina pectorisStromelysin-1P08254T86702Not Available
AngioplastyStromelysin-1P08254T86702Not Available
ArteriosclerosisLiver carboxylesterase 1P23141T76369Not Available
Cerebrovascular accidentStromelysin-1P08254T86702Not Available
DeathStromelysin-1P08254T86702Not Available
Lipids abnormalAngiotensin-converting enzymeP12821T82577Not Available
Myocardial ischaemiaApolipoprotein EP02649T21689Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Alopecia23.02.02.001--
Amnesia19.20.01.001; 17.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Angioedema23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002--
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Arthropathy15.01.01.003--Not Available
Asthenia08.01.01.001--Not Available
Atrial fibrillation02.03.03.002--
Blood alkaline phosphatase13.04.02.010--Not Available
Blood bilirubin13.03.01.040--Not Available
Blood bilirubin increased13.03.01.008--
Bronchitis22.07.01.001; 11.01.09.001--
Cataract06.06.01.001--
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Chills08.01.09.001; 15.05.03.016--
Cirrhosis alcoholic09.01.04.005--Not Available
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.001--
Death08.04.01.001--
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
Dermatitis bullous23.03.01.002--
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dry skin23.03.03.001--
Dysaesthesia17.02.06.003--
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