Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Alirocumab
Drug ID BADD_D00072
Description Alirocumab is a biopharmaceutical that obtained FDA approval in July 2015 as a second line treatment for high cholesterol in adults whose LDL-cholesterol (LDL-C) is not controlled by the combination of diet and statin treatment. It is a human monoclonal antibody part of the family of the PCSK9 inhibitors which are a novel class of anticholesterol therapeutics. From this family, it was the first agent to receive FDA approval. The FDA approval was contingent on the completion of further clinical trials to better determine efficacy and safety. PCSK9 inhibition facilitates more LDL-C clearance from the blood.
Indications and Usage Alirocumab is an antibody eliciting proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor activity that is indicated for: (i) use in reducing the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease [F4591], and/or (ii) use as an adjunct to diet or use alone or in combination with other lipid-lowering therapies (statins, ezetimibe, for example) for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C) levels in the body [F4591].
Marketing Status approved
ATC Code C10AX14
DrugBank ID DB09302
KEGG ID D10335
MeSH ID C571059
PubChem ID Not Available
TTD Drug ID D00GNI
NDC Product Code 61755-020; 61755-021; 0024-5903; 72733-5901; 0024-5901; 0024-5904; 72733-5902; 0024-5902
UNII PP0SHH6V16
Synonyms alirocumab | SAR236553 | SAR-236553 | REGN-727 | monoclonal antibody REGN727 | REGN727 monoclonal antibody | REGN727 | praluent
Chemical Information
Molecular Formula Not Available
CAS Registry Number 1245916-14-6
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)
Bronchitis22.07.01.001; 11.01.09.001--
Confusional state19.13.01.001; 17.02.03.005--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Drug specific antibody present13.17.01.001--Not Available
Eczema nummular23.03.04.035--Not Available
Hypersensitivity10.01.03.003--
Hypersensitivity vasculitis24.12.04.013; 23.06.02.005; 10.02.02.017; 01.01.04.008--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Injection site erythema12.07.03.001; 08.02.03.001; 23.03.06.015--Not Available
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Injection site pruritus23.03.12.007; 12.07.03.014; 08.02.03.013--Not Available
Injection site reaction08.02.03.014; 12.07.03.015--
Liver disorder09.01.08.001--Not Available
Memory impairment19.20.01.003; 17.03.02.003--
Muscle spasms15.05.03.004--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Urinary tract infection20.08.02.001; 11.01.14.004--
Contusion12.01.06.001; 15.03.05.007; 24.07.06.001; 23.03.11.002--
Injection site swelling12.07.03.018; 08.02.03.017--Not Available
Transaminases increased13.03.04.036--Not Available
Cognitive disorder19.21.02.001; 17.03.03.003--
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