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 approved
ATC Code C10AA04
DrugBank ID DB01095
KEGG ID D07983
MeSH ID D000077340
PubChem ID 446155
TTD Drug ID D08GHB
NDC Product Code 63629-8737; 0378-8020; 0093-7443; 0378-8021; 0093-7442; 63629-8812
UNII 4L066368AS
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
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)
Rectal haemorrhage24.07.02.018; 07.12.03.0010.000815%
Renal failure20.01.03.0050.001630%Not Available
Rhabdomyolysis15.05.05.0020.004076%
Rhinitis11.01.13.004; 22.07.03.006--
Shock24.06.02.002--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Skin discolouration23.03.03.005--Not Available
Skin discomfort23.03.03.006--Not Available
Skin disorder23.03.03.007--Not Available
Stevens-Johnson syndrome11.07.01.005; 10.01.01.045; 23.03.01.007; 12.03.01.014--
Subarachnoid haemorrhage24.07.04.004; 17.08.01.010; 12.01.10.0110.000815%Not Available
Swelling08.01.03.0150.000815%Not Available
Syncope02.11.04.015; 17.02.04.008; 24.06.02.012--
Systemic lupus erythematosus23.03.02.006; 15.06.02.003; 10.04.03.004--Not Available
Tenderness08.01.08.005--Not Available
Tendonitis15.07.01.003; 12.01.07.0070.001223%Not Available
Thrombocytopenia01.08.01.0020.000815%Not Available
Thyroid function test abnormal13.10.06.001--Not Available
Tooth disorder07.09.05.001--Not Available
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006--
Tremor17.01.06.002--
Type IIa hyperlipidaemia03.08.08.001; 14.08.01.002--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Vascular purpura01.01.04.007; 24.07.06.011; 23.06.01.008--Not Available
Vasculitis24.12.04.027; 10.02.02.006--
Vertigo17.02.12.002; 04.04.01.003--
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
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ADReCS-Target
Drug Name ADR Term Target
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