Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Etanercept
Drug ID BADD_D00838
Description Dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1.[L14862,A216522] The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids. It is used to treat or manage a variety of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis (AS), and juvenile idiopathic poly-articular arthritis (JIA).
Indications and Usage Etanercept is indicated for the treatment of moderately to severely active rheumatoid arthritis in adults and in chronic moderate to severe plaque psoriasis in patients 4 years of age and older.[L14862] It is also used to manage signs and symptoms of polyarticular idiopathic arthritis in those aged 2 years and older. Etanercept is also used to manage the symptoms of psoriatic arthritis and ankylosing spondylitis.
Marketing Status approved; investigational
ATC Code L04AB01
DrugBank ID DB00005
KEGG ID D00742
MeSH ID D000068800
PubChem ID Not Available
TTD Drug ID D0I5QX
NDC Product Code 58406-044; 58406-055; 58406-032; 58406-010; 58406-021; 58406-425; 58406-446; 58406-435; 58406-455; 58406-445; 58406-456
UNII OP401G7OJC
Synonyms Etanercept | TNFR-Fc Fusion Protein | Fusion Protein, TNFR-Fc | TNFR Fc Fusion Protein | TNR 001 | TNT Receptor Fusion Protein | TNTR-Fc | TNR-001 | TNR001 | Etanercept-szzs | TNF Receptor Type II-IgG Fusion Protein | TNF Receptor Type II IgG Fusion Protein | Erelzi | Recombinant Human Dimeric TNF Receptor Type II-IgG Fusion Protein | Recombinant Human Dimeric TNF Receptor Type II IgG Fusion Protein | Enbrel
Chemical Information
Molecular Formula Not Available
CAS Registry Number 185243-69-0
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)
Seizure17.12.03.001--
Skin cancer23.08.02.002; 16.03.02.002--Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Thrombocytopenia01.08.01.002--Not Available
Toxic epidermal necrolysis12.03.01.015; 11.07.01.006; 10.01.01.006; 23.03.01.008--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urticaria23.04.02.001; 10.01.06.001--
Uveitis10.02.01.023; 06.04.03.003--
Vasculitis necrotising24.12.04.029; 10.02.02.008--Not Available
Lupus-like syndrome23.03.02.004; 15.06.02.004; 10.04.03.003--Not Available
Transaminases increased13.03.04.036--Not Available
Cutaneous lupus erythematosus23.03.02.008; 15.06.02.007; 10.04.03.007--Not Available
Neurological symptom17.02.05.010--Not Available
Autoantibody test13.06.01.006--Not Available
Antibody test13.06.03.009--Not Available
Blood disorder01.05.01.004--Not Available
Atypical mycobacterial infection11.04.02.002--Not Available
Respiratory tract infection22.07.07.001; 11.01.08.017--Not Available
Pneumocystis jirovecii pneumonia22.07.08.009; 11.03.07.005--Not Available
Aspergillus infection11.03.01.004--Not Available
Haemophagocytic lymphohistiocytosis10.02.01.077; 01.05.01.026; 16.32.03.038--Not Available
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