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 Pembrolizumab is indicated for the following conditions:[L38934]
Marketing Status approved
ATC Code L01FF02
DrugBank ID DB09037
KEGG ID D10574
MeSH ID C582435
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 0006-3026; 69497-0001; 75895-0136; 83012-010
UNII DPT0O3T46P
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
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 pain07.01.05.002--
Anaemia01.03.02.001--
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Back pain15.03.04.005--
Cellulitis11.02.01.001; 23.11.02.004---
Chills08.01.09.001; 15.05.03.016--
Colitis07.08.01.001--
Constipation07.02.02.001--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dyspnoea02.11.05.003; 22.02.01.004--
Endocrine disorder05.09.01.001---
Fatigue08.01.01.002--
Headache17.14.01.001--
Hepatitis09.01.07.004---
Hypercholesterolaemia14.08.01.001---
Hyperglycaemia05.06.02.002; 14.06.02.002--
Hypertriglyceridaemia14.08.02.001--
Hypoalbuminaemia09.01.02.003; 14.10.01.002--
Hypocalcaemia14.04.01.004--
Hyponatraemia14.05.04.002--
Insomnia17.15.03.002; 19.02.01.002--
Myalgia15.05.02.001--
Nausea07.01.07.001--
Nephritis20.05.02.001---
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Pain08.01.08.004--
Pain in extremity15.03.04.010--
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