Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pravastatin
Drug ID BADD_D01824
Description Pravastatin is the 6-alpha-hydroxy acid form of [mevastatin].[T303] Pravastatin was firstly approved in 1991 becoming the second available statin in the United States. It was the first statin administered as the active form and not as a prodrug.[T274] This drug was developed by Sankyo Co. Ltd.; however, the first approved pravastatin product was developed by Bristol Myers Squibb and FDA approved in 1991.[L6142] Pravastatin is made through a fermentation process in which [mevastatin] is first obtained. The manufacturing process is followed by the hydrolysis of the lactone group and the biological hydroxylation with _Streptomyces carbophilus_ to introduce the allylic 6-alcohol group.[T239]
Indications and Usage Pravastatin is indicated for primary prevention of coronary events hypercholesterolemic patients without clinical evidence of coronary heart disease. Its use includes the reduction of risk on myocardial infarction, undergoing myocardial revascularization procedures and cardiovascular mortality.[T274] As well, pravastatin can be used as a secondary prevention agent for cardiovascular events in patients with clinically evident coronary heart disease. This indication includes the reduction of risk of total mortality by reducing coronary death, myocardial infarction, undergoing myocardial revascularization procedures, stroke, and stroke/transient ischemic attack as well as to slow the progression of coronary atherosclerosis.[T274] The term cardiovascular events correspond to all the incidents that can produce damage to the heart muscle including the interruption of blood flow.[L6028] As adjunctive therapy to diet, pravastatin is used in: - Patients with primary hypercholesterolemia and mixed dyslipidemias including hyperlipidemia type IIa and IIb. - Patients with elevated serum triglycerides including type IV hyperlipidemia. - Patients with heterozygous familial hypercholesterolemia in patients over 8 years of age with low-density lipoprotein (LDL) cholesterol higher than 190 mg/dl after diet modifications or LDL levels higher than 160 mg/dl and familial history of premature cardiovascular diseases or at least two cardiovascular risk factors.[T274] In patients that do not respond adequately to diet, pravastatin is used to treat patients with primary dysbetalipoproteinemia (type III hyperlipidemia).[T274] Dyslipidemia is defined as an elevation of plasma cholesterol, triglycerides or both as well as to the presence of low levels of high-density lipoprotein. This condition represents an increased risk for the development of atherosclerosis.[L6025]
Marketing Status approved
ATC Code C10AA03
DrugBank ID DB00175
KEGG ID D08410
MeSH ID D017035
PubChem ID 54687
TTD Drug ID D02RQU
NDC Product Code Not Available
UNII KXO2KT9N0G
Synonyms Pravastatin | Eptastatin | Vasten | CS-514 | CS 514 | CS514 | Lin-Pravastatin | Lin Pravastatin | Lipemol | Liplat | Nu-Pravastatin | Nu Pravastatin | Prareduct | Mevalotin | Pravachol | Elisor | Selektine | Lipostat | Pravacol | Pravasin | Pravastatin Monosodium Salt, (6 beta)-Isomer | Pravastatin Sodium | Pravastatin Sodium Salt | Sodium Salt, Pravastatin | Pravastatin tert-Octylamine Salt | Pravastatin tert Octylamine Salt | Pravastatin, (6 beta)-Isomer | RMS-431 | RMS 431 | RMS431 | SQ-31000 | SQ 31000 | SQ31000 | SQ-31,000 | SQ 31,000 | SQ31,000 | Apo-Pravastatin | Apo Pravastatin | Bristacol
Chemical Information
Molecular Formula C23H36O7
CAS Registry Number 81093-37-0
SMILES CCC(C)C(=O)OC1CC(C=C2C1C(C(C=C2)C)CCC(CC(CC(=O)O)O)O)O
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)
Conjunctival hyperaemia06.04.01.0040.000025%-
Foetor hepaticus07.01.06.026; 09.01.05.006---
Drug tolerance decreased08.06.01.0240.000057%-
Musculoskeletal discomfort15.03.04.001---
Nodule08.03.05.002---
Affect lability19.04.01.001---
Transaminases increased13.03.04.036---
Cognitive disorder17.03.03.003; 19.21.02.001--
Dyslipidaemia14.08.04.015---
Peripheral nerve palsy17.01.04.017---
Blood alkaline phosphatase increased13.04.02.004--
Antinuclear antibody positive13.06.01.003---
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.005--
Cardiac disorder02.11.01.003---
Decreased appetite08.01.09.028; 14.03.01.005--
Erectile dysfunction19.08.04.001; 21.03.01.007--
Ill-defined disorder08.01.03.049---
Drug intolerance08.06.01.0130.000066%-
Respiratory tract infection11.01.08.017; 22.07.07.001---
Muscle swelling15.05.03.015---
Chronic kidney disease20.01.03.017--
Type 2 diabetes mellitus05.06.01.003; 14.06.01.0030.000025%-
Acute kidney injury20.01.03.0160.000079%
Foetal growth restriction18.03.01.0020.000017%
Drug-induced liver injury09.01.07.023; 12.03.01.044---
Hepatic cancer09.04.02.008; 16.07.02.004---
Hepatocellular carcinoma09.04.02.010; 16.07.02.005---
Drug reaction with eosinophilia and systemic symptoms10.01.01.021; 12.03.01.064; 23.03.05.0050.000017%-
Multiple organ dysfunction syndrome08.01.03.0570.000025%
Liver function test increased13.03.04.031---
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ADReCS-Target
Drug Name ADR Term Target
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