Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pravastatin sodium
Drug ID BADD_D01825
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 D00893
MeSH ID D017035
PubChem ID 16759173
TTD Drug ID D02RQU
NDC Product Code 72789-161; 51846-1022; 42291-669; 50090-2024; 51655-976; 55111-229; 55700-994; 60505-0168; 63629-8909; 71205-294; 71335-0947; 71335-1243; 72162-1711; 72789-143; 16714-558; 0093-0771; 0093-7270; 43063-807; 60760-421; 63629-8835; 63629-8836; 68180-488; 68382-073; 68462-196; 70934-549; 0904-5892; 65862-634; 43063-443; 51655-708; 55111-274; 61919-707; 63187-415; 63629-7508; 63629-8906; 63629-8912; 65862-633; 65862-635; 68788-7660; 55111-231; 55154-7998; 57237-164; 61919-708; 63187-413; 63629-8904; 0480-7270; 70518-0549; 70518-1938; 71205-121; 71610-637; 0904-5893; 16729-009; 35356-919; 43063-444; 50090-0975; 50268-668; 51655-073; 60505-0169; 61919-709; 68382-070; 68382-071; 68788-7009; 68788-7779; 68788-8425; 70934-418; 71205-149; 71335-0692; 72162-1707; 72189-059; 72189-119; 82009-007; 0904-5891; 16714-560; 42291-667; 42291-668; 50268-667; 51655-343; 55111-230; 57237-165; 60687-169; 61919-801; 63629-8905; 65862-632; 68180-487; 68462-195; 68788-7584; 71205-516; 71335-0296; 16714-570; 16729-010; 43063-808; 50090-3258; 50090-6145; 51079-458; 51079-782; 60687-190; 63187-732; 63629-8833; 63629-8913; 63629-9165; 68462-197; 68462-198; 70518-2505; 70518-2887; 71335-0101; 71335-1022; 58623-0123; 68254-0004; 0093-7202; 42291-665; 51655-070; 55154-5365; 55154-7275; 60505-0170; 60687-178; 63629-8910; 63629-8911; 63629-9162; 63629-9163; 65841-741; 68180-485; 70377-047; 0615-8029; 72189-061; 65727-003; 16714-559; 16729-008; 0093-7201; 35356-125; 35356-921; 43353-964; 50090-5809; 50090-5927; 55154-5370; 63187-731; 63629-9164; 65841-742; 68382-072; 68788-8421; 0615-8410; 82009-006; 50090-1594; 50090-2025; 50090-3853; 50090-4206; 51655-594; 57237-166; 60505-1323; 65841-739; 65841-740; 68180-486; 70377-045; 70377-046; 70377-048; 70518-1157; 71335-9692; 0615-8030; 72162-1706; 72189-060; 82009-008; 16729-011; 43353-966; 50090-1533; 50268-665; 50268-666; 57237-167
UNII 3M8608UQ61
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 C23H35NaO7
CAS Registry Number 81131-70-6
SMILES CCC(C)C(=O)OC1CC(C=C2C1C(C(C=C2)C)CCC(CC(CC(=O)[O-])O)O)O.[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)
Dysuria20.02.02.002--
Eosinophilia01.02.04.001--
Erythema multiforme10.01.03.015; 23.03.01.003--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Gamma-glutamyltransferase increased13.03.04.024--
Gynaecomastia05.05.02.003; 21.05.04.003--
Haemolytic anaemia01.06.03.002---
Hair disorder23.02.06.003---
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Hepatic necrosis09.01.07.002--
Hepatic steatosis09.01.07.003; 14.08.04.005---
Hepatitis09.01.07.004---
Hepatitis chronic active09.01.07.006; 11.07.01.002---
Hypersensitivity10.01.03.003--
Influenza11.05.03.001; 22.07.02.001---
Insomnia17.15.03.002; 19.02.01.002--
Jaundice cholestatic09.01.01.005---
Leukopenia01.02.02.001---
Liver function test abnormal13.03.04.030---
Malaise08.01.01.003--
Memory impairment17.03.02.003; 19.20.01.003--
Mucosal dryness08.01.06.001---
Muscle spasms15.05.03.004--
Muscular weakness15.05.06.001; 17.05.03.005--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Myopathy15.05.05.001---
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