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)
Vomiting07.01.07.003--
Peripheral swelling08.01.03.053; 02.05.04.0150.003736%Not Available
Red blood cell sedimentation rate increased13.01.03.001--Not Available
Lupus-like syndrome23.03.02.004; 10.04.03.003; 15.06.02.004--Not Available
Facial paresis17.04.03.002--
Lymphatic disorder01.09.01.003--Not Available
Pruritus generalised23.03.12.0030.003736%Not Available
Musculoskeletal discomfort15.03.04.0010.011209%Not Available
Cerebral haematoma24.07.04.006; 17.08.01.0140.003736%Not Available
Nodule08.03.05.002--Not Available
Transaminases increased13.03.01.0150.003736%Not Available
Gastric disorder07.11.01.003--Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.005605%
Major depression19.15.01.0030.003736%Not Available
Peripheral nerve palsy17.01.04.017--Not Available
Angiopathy24.03.02.007--Not Available
Epidermal necrosis23.03.03.035--Not Available
Blood alkaline phosphatase increased13.04.02.0040.005605%
Antinuclear antibody positive13.06.01.003--Not Available
Hepatic enzyme increased13.03.01.0190.005605%Not Available
Hot flush08.01.03.027; 24.03.01.005; 21.02.02.001--
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.01.01.003--Not Available
Connective tissue disorder15.06.01.006--Not Available
Cranial nerve disorder17.04.01.001--Not Available
Infestation23.09.05.001; 11.09.01.001--Not Available
Inflammation08.01.05.0070.003736%Not Available
Mental disorder19.07.01.002--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.0010.003736%
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