Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Atorvastatin calcium
Drug ID BADD_D00182
Description Atorvastatin (Lipitor®), is a lipid-lowering drug included in the statin class of medications. By inhibiting the endogenous production of cholesterol in the liver, statins lower abnormal cholesterol and lipid levels, and ultimately reduce the risk of cardiovascular disease. More specifically, statin medications competitively inhibit the enzyme hydroxymethylglutaryl-coenzyme A (HMG-CoA) Reductase,[A181421] which catalyzes the conversion of HMG-CoA to mevalonic acid. This conversion is a critical metabolic reaction involved in the production of several compounds involved in lipid metabolism and transport, including cholesterol, low-density lipoprotein (LDL) (sometimes referred to as "bad cholesterol"), and very-low-density lipoprotein (VLDL). Prescribing statins is considered standard practice for patients following any cardiovascular event, and for people who are at moderate to high risk of developing cardiovascular disease. The evidence supporting statin use, coupled with minimal side effects and long term benefits, has resulted in wide use of this medication in North America.[A181087, A181406] Atorvastatin and other statins including [lovastatin], [pravastatin], [rosuvastatin], [fluvastatin], and [simvastatin] are considered first-line treatment options for dyslipidemia.[A181087, A181406] The increasing use of this class of drugs is largely attributed to the rise in cardiovascular diseases (CVD) (such as heart attack, atherosclerosis, angina, peripheral artery disease, and stroke) in many countries.[A181084] An elevated cholesterol level (elevated low-density lipoprotein (LDL) levels in particular) is a significant risk factor for the development of CVD.[A181087,A181553] Several landmark studies demonstrate that the use of statins is associated with both a reduction in LDL levels and CVD risk.[A181090,A181093,A181096,A181427,A181475,A181538] Statins were shown to reduce the incidences of all-cause mortality, including fatal and non-fatal CVD, as well as the need for surgical revascularization or angioplasty following a heart attack.[A181087, A181406] Some evidence has shown that even for low-risk individuals (with <10% risk of a major vascular event occurring within five years) statin use leads to a 20%-22% relative reduction in the number of major cardiovascular events (heart attack, stroke, coronary revascularization, and coronary death) for every 1 mmol/L reduction in LDL without any significant side effects or risks.[A181397, A181403] Atorvastatin was first synthesized in 1985 by Dr. Bruce Roth and approved by the FDA in 1996.[T568] It is a pentasubstituted pyrrole [A177415] formed by two contrasting moieties with an achiral heterocyclic core unit and a 3,5-dihydroxypentanoyl side chain identical to its parent compound.[T571] Unlike other members of the statin group, atorvastatin is an active compound and therefore does not require activation.[A177436]
Indications and Usage Atorvastatin is indicated for the treatment of several types of dyslipidemias, including primary hyperlipidemia and mixed dyslipidemia in adults, hypertriglyceridemia, primary dysbetalipoproteinemia, homozygous familial hypercholesterolemia, and heterozygous familial hypercholesterolemia in adolescent patients with failed dietary modifications.[A177397] Dyslipidemia describes 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] Atorvastatin is indicated, in combination with dietary modifications, to prevent cardiovascular events in patients with cardiac risk factors and/or abnormal lipid profiles.[A177397] Atorvastatin can be used as a preventive agent for myocardial infarction, stroke, revascularization, and angina, in patients without coronary heart disease but with multiple risk factors and in patients with type 2 diabetes without coronary heart disease but multiple risk factors.[A177397] Atorvastatin may be used as a preventive agent for non-fatal myocardial infarction, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure and angina in patients with coronary heart disease.[A177397] Prescribing of statin medications is considered standard practice following any cardiovascular events and for people with a moderate to high risk of development of CVD. Statin-indicated conditions include diabetes mellitus, clinical atherosclerosis (including myocardial infarction, acute coronary syndromes, stable angina, documented coronary artery disease, stroke, trans ischemic attack (TIA), documented carotid disease, peripheral artery disease, and claudication), abdominal aortic aneurysm, chronic kidney disease, and severely elevated LDL-C levels.[A181087, A181406]
Marketing Status approved
ATC Code C10AA05
DrugBank ID DB01076
KEGG ID D02258
MeSH ID D000069059
PubChem ID 60822
TTD Drug ID D01QIN
NDC Product Code 72789-089; 65427-155; 16729-046; 42708-004; 43063-496; 43353-959; 43598-830; 43598-831; 50090-5181; 50090-5636; 50090-5639; 50090-6054; 55111-122; 59762-0158; 61919-632; 67877-511; 67877-512; 68071-5198; 68788-8315; 69097-946; 70377-077; 70518-3326; 71205-335; 71205-731; 71335-0767; 72189-226; 72789-084; 72789-153; 0904-6292; 65427-156; 0071-0157; 0093-5057; 42571-172; 42708-013; 42708-014; 43598-832; 50090-6057; 50090-6061; 50268-095; 50268-096; 51655-881; 53002-1440; 59762-0157; 60760-709; 60760-903; 61919-956; 62175-892; 63629-8469; 68071-3267; 68382-251; 68788-7979; 71205-247; 71335-0102; 71335-1929; 71610-036; 0615-8008; 0615-8009; 82137-019; 50370-0017; 65427-256; 16729-044; 0093-5058; 42708-003; 50228-452; 51079-209; 51407-079; 51655-613; 51655-921; 53002-2440; 55111-124; 55154-4384; 55154-7289; 60505-2671; 63187-346; 68071-2293; 68071-2964; 68071-5246; 68180-636; 68788-7631; 68788-7900; 68788-8416; 69097-911; 69097-944; 70377-080; 70518-1322; 70518-1514; 70518-3273; 70771-1445; 71335-1010; 71335-1336; 71335-1666; 71335-1710; 72189-295; 72205-025; 55154-6634; 59762-0156; 60505-2579; 63187-907; 68071-4220; 68071-5194; 68180-637; 68788-8094; 68788-8409; 70518-0186; 70518-2843; 70518-3298; 71610-168; 71610-169; 72205-023; 75834-256; 75834-257; 82137-017; 65427-258; 16714-175; 42708-108; 50090-5915; 50090-6333; 51407-080; 51407-081; 55154-5884; 55154-7628; 55154-7630; 63187-109; 67877-513; 68071-2967; 68084-097; 68084-098; 68180-638; 68382-250; 69097-945; 69539-093; 70518-3414; 70518-3461; 70771-1444; 71205-264; 71335-1388; 71335-1641; 71335-9723; 82137-018; 0904-6293; 15894-0023; 51927-5153; 65977-0127; 51655-747; 53002-1335; 60505-2578; 60505-2580; 63187-336; 0378-3951; 0378-3953; 68071-5237; 68180-635; 68382-249; 68788-7525; 68788-7874; 68788-7986; 68788-8132; 69097-899; 70518-1946; 71335-0931; 71335-1051; 72205-022; 82009-002; 0904-6291; 55488-0322; 65015-282; 0071-0155; 42708-005; 42708-141; 43063-453; 43598-833; 50268-094; 53002-1439; 55154-6646; 63304-828; 63629-8031; 0378-3952; 67877-514; 68071-2991; 68071-4472; 68071-5188; 69539-095; 70518-3037; 70518-3304; 70518-3339; 70771-1443; 70934-841; 71205-098; 71335-1126; 71335-1507; 71335-9711; 71610-170; 72205-024; 65427-158; 65427-255; 16714-174; 0093-5056; 42708-144; 50090-5184; 50090-5208; 50090-5634; 50090-6440; 50090-6482; 50090-6506; 55111-121; 55154-6635; 60760-979; 61919-258; 62175-891; 63187-108; 63304-830; 68071-2302; 68071-2871; 68071-5231; 68084-590; 68382-252; 69539-094; 70377-078; 70377-079; 70518-3649; 71335-0583; 71335-9646; 71610-022; 71610-163; 71610-633; 0615-8007; 50370-0046; 61947-0002; 65427-157; 65427-257; 0071-0158; 72640-007; 16714-173; 16729-045; 0093-5059; 42571-173; 42571-175; 50090-5921; 51079-210; 51655-946; 62175-890; 62175-897; 63304-829; 63629-8472; 68071-2276; 68071-2585; 68071-2680; 68071-2755; 68071-2765; 68071-2788; 68071-2872; 68788-8298; 68788-8370; 69097-898; 69097-947; 69539-096; 70518-1977; 70771-1446; 71205-765; 0615-8006; 72189-239; 72189-291; 75834-255; 82009-004; 82137-016; 0904-6290; 50370-0018; 42571-174; 43353-981; 50090-5207; 50090-6480; 51079-211; 51655-465; 51655-614; 55111-123; 55154-4166; 60760-829; 63187-656; 63304-827; 63629-8470; 63629-8471; 0378-3950; 67296-1143; 68071-2687; 68084-099; 68788-7630; 69097-897; 70934-989; 71205-246; 71335-0004; 71335-0169; 71335-1011; 71335-1613; 71610-180; 72162-1712; 75834-258; 82009-001; 82009-003; 22365-004; 62512-0022; 65015-810; 0071-0156; 68554-0057; 16714-176; 16729-047; 43063-474; 43063-487; 50090-5632; 50228-451; 50228-453; 50228-454; 50268-093; 51079-208; 51407-078; 53002-2335
UNII C0GEJ5QCSO
Synonyms Atorvastatin | (3R,5R)-7-(2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid | Atorvastatin Calcium | Atorvastatin, Calcium Salt | Liptonorm | Lipitor | Atorvastatin Calcium Hydrate | Atorvastatin Calcium Anhydrous | CI 981 | CI-981 | CI981 | Atorvastatin Calcium Trihydrate
Chemical Information
Molecular Formula C66H68CaF2N4O10
CAS Registry Number 134523-03-8
SMILES CC(C)C1=C(C(=C(N1CCC(CC(CC(=O)[O-])O)O)C2=CC=C(C=C2)F)C3=CC=CC=C3)C(=O)NC4=CC=CC =C4.CC(C)C1=C(C(=C(N1CCC(CC(CC(=O)[O-])O)O)C2=CC=C(C=C2)F)C3=CC=CC=C3)C(=O)NC4=C C=CC=C4.[Ca+2]
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)
Abdominal discomfort07.01.06.001---
Abdominal pain07.01.05.002--
Abnormal dreams17.15.02.001; 19.02.03.001---
Ageusia07.14.03.003; 17.02.07.001---
Agitation17.02.05.012; 19.06.02.001--
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Amblyopia06.02.01.001---
Amnesia17.03.02.001; 19.20.01.001--
Anaemia01.03.02.001--
Anaphylactic shock10.01.07.002; 24.06.02.004---
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001---
Arrhythmia02.03.02.001---
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001---
Asthma10.01.03.010; 22.03.01.002---
Back pain15.03.04.005--
Biliary colic09.02.01.001---
Bladder pain20.02.02.001---
Blood bilirubin increased13.03.04.018--
Blood creatine phosphokinase increased13.04.01.001--
Blood magnesium decreased13.11.01.008---
Body temperature increased13.15.01.001---
Breast enlargement21.05.04.001---
Bronchitis11.01.09.001; 22.07.01.001--
Bursitis12.04.03.010; 15.04.01.001---
Cerebral haemorrhage17.08.01.003; 24.07.04.001---
Cheilitis07.05.01.001; 23.03.03.025--
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