Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Evolocumab
Drug ID BADD_D00859
Description Evolocumab is a monoclonal antibody designed for the treatment of hyperlipidemia by Amgen. It is a subcutaneous injection approved by the FDA for individuals on maximum statin therapy who still require additional LDL-cholesterol lowering. It is approved for both homozygous and heterozygous familial cholesterolemia as an adjunct to other first-line therapies. Evolocumab is a human IgG2 monoclonal antibody that targets the proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that targets LDL receptors for degradation, therefore reducing the liver's ability to remove LDL-cholesterol (LDL-C), or "bad" cholesterol, from the blood. Evolocumab is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface, resulting in more LDL receptors on the surface of the liver to remove LDL-C from the blood. Evolocumab is the second PCSK9 inhibitor on the market, first being alirocumab.
Indications and Usage For the treatment of heterozygous/homozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease in patients on maximum tolerated statin therapy requiring additional LDL-cholesterol lowering.
Marketing Status approved
ATC Code C10AX13
DrugBank ID DB09303
KEGG ID D10557
MeSH ID C577155
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 68225-080; 55513-750; 72511-760; 72511-770; 72511-750; 55513-770; 55513-760
UNII LKC0U3A8NJ
Synonyms evolocumab | repatha | AMG-145 | AMG 145
Chemical Information
Molecular Formula Not Available
CAS Registry Number 1256937-27-5
SMILES Not Available
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)
Arthralgia15.01.02.001--
Back pain15.03.04.005--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Erythema23.03.06.001--Not Available
Fatigue08.01.01.002--
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Influenza22.07.02.001; 11.05.03.001--Not Available
Injection site reaction12.07.03.015; 08.02.03.014--
Low density lipoprotein13.12.01.011--Not Available
Muscle spasms15.05.03.004--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Pain08.01.08.004--
Sinusitis22.07.03.007; 11.01.13.005--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary tract infection20.08.02.001; 11.01.14.004--
Contusion24.07.06.001; 23.03.11.002; 12.01.06.001; 15.03.05.007--
Musculoskeletal discomfort15.03.04.001--Not Available
Cognitive disorder19.21.02.001; 17.03.03.003--
Immunology test13.06.03.007--Not Available
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