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 indicated as an adjunct to diet and maximally tolerated statin therapy in adults who require additional LDL-cholesterol (LDL-C) lowering due to heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease.
Marketing Status Prescription
ATC Code C10AX14
DrugBank ID DB09302
KEGG ID D10335
MeSH ID C571059
PubChem ID Not Available
TTD Drug ID D00GNI
NDC Product Code 0024-5904; 0024-5901; 0024-5903; 72733-5902; 61755-021; 61755-020; 0024-5902; 72733-5901
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
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 vasculitis01.01.04.008; 24.05.02.012; 23.06.02.005; 10.02.02.017--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Injection site erythema23.03.06.015; 12.07.03.001; 08.02.03.001--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 reaction12.07.03.015; 08.02.03.014--
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 infection11.01.14.004; 20.08.02.001--
Contusion24.07.06.001; 23.03.11.002; 15.03.01.008; 12.01.06.001--
Injection site swelling12.07.03.018; 08.02.03.017--Not Available
Transaminases increased13.03.01.015--Not Available
Cognitive disorder19.21.02.001; 17.03.03.003--
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