Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pembrolizumab
Drug ID BADD_D01700
Description Pembrolizumab is a highly selective IgG4-kappa humanized monoclonal antibody against PD-1 receptor. It was generated by grafting the variable sequences of a very high-affinity mouse antihuman PD-1 antibody onto a human IgG4-kappa isotype with the containing a stabilizing S228P Fc mutation.[A18829] It contains 32 cysteine residues and the complete folded molecule includes 4 disulfide linkages as interchain bonds and 23 interchain bonds.[F136] It was developed by Merck & Co and firstly approved for the treatment of metastatic malignant melanoma. This is the first approved therapy against PD-1.[A7624] It was approved firstly by the FDA on September 4, 2014.[L2954] Its approval in melanoma was extended to several countries such as Australia, Israel, Korea, Macau, the European Union and the United Arab Emirates.[A33350] On June 12, 2018, Pembrolizumab was approved for the treatment of cervical cancer under the status of accelerated approval.[L2955]
Indications and Usage
Marketing Status Prescription
ATC Code L01FF02
DrugBank ID DB09037
KEGG ID D10574
MeSH ID C582435
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 53713-0048; 69497-0001; 75895-0136; 0006-3026
Synonyms pembrolizumab | SCH-900475 | lambrolizumab | MK-3475 | Keytruda
Chemical Information
Molecular Formula Not Available
CAS Registry Number 1374853-91-4
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)
Pleural effusion22.05.02.002--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pneumonitis22.01.01.006--
Pruritus23.03.12.001--
Pulmonary embolism22.06.02.001; 24.01.06.001--Not Available
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Renal failure20.01.03.005--Not Available
Sepsis11.01.11.003--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Vitiligo10.04.02.004; 23.05.02.004--Not Available
Vomiting07.01.07.003--
Infusion related reaction12.02.05.009; 10.01.01.017; 08.01.03.002--
Blood alkaline phosphatase increased13.04.02.004--
Decreased appetite14.03.01.005; 08.01.09.028--
Renal impairment20.01.03.010--Not Available
Immune-mediated adverse reaction10.02.01.044--Not Available
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