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 approved
ATC Code C10AA04
DrugBank ID DB01095
KEGG ID D00892
MeSH ID D000077340
PubChem ID 23663976
TTD Drug ID D08GHB
NDC Product Code 0078-0354; 0781-8017; 0527-2580; 65727-012; 14501-0009; 48087-0093; 0093-7446
UNII PYF7O1FV7F
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
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)
Intermittent claudication24.04.03.001--Not Available
Interstitial lung disease22.01.02.003; 10.02.01.033--Not Available
Jaundice cholestatic09.01.01.005--Not Available
Lenticular opacities06.06.01.003--Not Available
Leukopenia01.02.02.001--Not Available
Libido decreased21.03.02.005; 19.08.03.001--
Loss of libido19.08.03.003--Not Available
Malaise08.01.01.003--
Memory impairment19.20.01.003; 17.03.02.003--
Mucosal dryness08.01.06.001--Not Available
Muscle spasms15.05.03.004--
Muscular weakness17.05.03.005; 15.05.06.001--
Myalgia15.05.02.001--
Myoglobinuria02.04.02.006; 20.02.01.010; 15.05.03.009--Not Available
Myopathy15.05.05.001--Not Available
Myositis15.05.01.001--
Nail disorder23.02.05.002--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Neuropathy peripheral17.09.03.003--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Ophthalmoplegia17.17.02.005; 06.05.02.003--Not Available
Pain in extremity15.03.04.010--
Pancreatitis07.18.01.001--
Paraesthesia23.03.03.094; 17.02.06.005--
Photosensitivity reaction23.03.09.003--
Polymyalgia rheumatica15.06.01.001; 10.04.05.003--Not Available
Pruritus23.03.12.001--
Purpura01.01.04.003; 24.07.06.005; 23.06.01.004--
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