Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Bempedoic acid
Drug ID BADD_D02533
Description High levels of LDL cholesterol (LDL-C) are a major risk factor for cardiovascular events. Caused by genetic mutations or lifestyle factors, hypercholesterolemia can significantly reduce quality of life and increase the risk of mortality from cardiovascular disease.[L12153] About 1 in 4 patients, or 15 million Americans with elevated LDL-C, are insufficiently managed with maximally tolerated statin therapy alone, requiring additional treatment for hypercholesterolemia.[L12180] Bempedoic acid is first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor used once a day for reducing LDL cholesterol levels in statin-refractory patients.[L12144,L12147] It was developed by Esperion Therapeutics Inc. and approved by the FDA on February 21, 2020. A combination product of bempedoic acid and [ezetimibe] was approved on February 26, 2020 for increased control of LDL cholesterol levels in patients experiencing refractory elevations despite previous statin treatment.[L12144,L12150]
Indications and Usage Bempedoic acid is indicated as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or existing atherosclerotic cardiovascular disease that warrants additional lowering of LDL-C.[L12144] The combination of bempedoic and ezetimibe is also indicated with diet management and maximally tolerated statin therapy to treat elevated LDL-C levels in adults with heterozygous familial hypercholesterolemia or existing atherosclerotic cardiovascular disease who require further lowering of LDL-C.[L12150]
Marketing Status approved; investigational
ATC Code C10AX15
DrugBank ID DB11936
KEGG ID D10691
MeSH ID C581236
PubChem ID 10472693
TTD Drug ID D0D9NY
NDC Product Code 72426-118; 12869-170; 42765-039; 70447-0003; 82608-002; 81666-002; 59285-041; 71796-049
UNII 1EJ6Z6Q368
Synonyms 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid | bempedoic acid | nilemdo | nexletol | ETC-1002 | ESP55016 | ESP-55016
Chemical Information
Molecular Formula C19H36O5
CAS Registry Number 738606-46-7
SMILES CC(C)(CCCCCC(CCCCCC(C)(C)C(=O)O)O)C(=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)
Abdominal discomfort07.01.06.0010.000302%-
Abdominal pain07.01.05.0020.000073%
Anaemia01.03.02.0010.000073%
Arrhythmia02.03.02.0010.000021%-
Arthralgia15.01.02.0010.000302%
Atrial fibrillation02.03.03.0020.000021%
Back pain15.03.04.0050.000109%
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.0070.000193%
Drug ineffective08.06.01.0060.000364%-
Epistaxis22.04.03.001; 24.07.01.0050.000047%
Fatigue08.01.01.0020.000218%
Feeling abnormal08.01.09.0140.000120%-
Gastrointestinal disorder07.11.01.0010.000109%-
Gout14.09.01.001; 15.01.06.0010.000338%-
Headache17.14.01.0010.000328%
Hepatic steatosis09.01.07.003; 14.08.04.0050.000047%-
Hypersensitivity10.01.03.0030.000047%
Hypertension24.08.02.0010.000073%
Hyperuricaemia14.09.01.0030.000073%
Influenza like illness08.01.03.0100.000073%
Muscle spasms15.05.03.0040.000338%
Muscular weakness15.05.06.001; 17.05.03.0050.000073%
Myalgia15.05.02.0010.000848%
Nausea07.01.07.0010.000375%
Neck pain15.03.04.0090.000073%
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.0110.000047%
Pain in extremity15.03.04.0100.000182%
Paraesthesia17.02.06.005; 23.03.03.0940.000073%
Rotator cuff syndrome12.01.07.018; 15.01.08.0020.000073%
Swelling08.01.03.0150.000073%-
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