Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Siltuximab
Drug ID BADD_D02021
Description Siltuximab is a chimeric (human-mouse) monoclonal immunoglobulin G1-kappa antibody produced in a Chinese hamster ovary (CHO) cell line by recombinant DNA technology. Siltuximab prevents the binding of IL-6 to soluble and membrane-bound IL-6 receptors by forming high affinity complexes with human interleukin-6 (IL-6). Its use is indicated for the treatment of adult patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. MCD is a rare blood disorder caused by dysregulated IL-6 production, proliferation of lymphocytes, and subsequent enlargement of the lymph nodes. It is administered as a 1 hour intravenous infusion every 3 weeks.
Indications and Usage Siltuximab is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Siltuximab did not bind to virally produced IL-6 in a nonclinical study and was therefore not studied in patients with MCD who are HIV or HHV-8 positive.
Marketing Status approved; investigational
ATC Code L04AC11
DrugBank ID DB09036
KEGG ID D09669
MeSH ID C504234
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 73090-421; 73090-420
UNII T4H8FMA7IM
Synonyms siltuximab | CLLB8 | cClB8 monoclonal antibody | Sylvant | CNTO-328 | monoclonal antibody CNTO-328 | CNTO 328 monoclonal antibody | monoclonal antibody CNTO 328 | monoclonal antibody CNTO328
Chemical Information
Molecular Formula Not Available
CAS Registry Number 541502-14-1
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)
Rash maculo-papular23.03.13.004--
Rash papular23.03.13.017--Not Available
Rash pruritic23.03.13.030--Not Available
Skin hyperpigmentation23.05.01.003--
Thrombocytopenia01.08.01.002--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Vomiting07.01.07.003--
Weight increased13.15.01.006--
Localised oedema14.05.06.009; 08.01.07.011; 02.05.04.006--
Infusion related reaction12.02.05.009; 10.01.01.017; 08.01.03.002--
Antibody test13.06.03.009--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Renal impairment20.01.03.010--Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004--
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