Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Belimumab
Drug ID BADD_D00224
Description Belimumab is an intravenous immunosupressant for the adjunctive treatment of systemic lupus erythematosus (SLE). More specifically, it is a fully human recombinant IgG1λ monoclonal antibody produced from a recombinant NS0 cell line stably transfected with the belimumab heavy chain and light chain genes. It is the first biological treatment approved for the indication of SLE. Concomitant use with live or inactivated vaccines must be avoided. Belimumab was FDA approved on March 9, 2011. Belimumab consists of 2 heavy chains, and 2 light chains of the lambda subclass. Each heavy chain contains 452 amino acid residues and each light chain contains 214 amino acid residues. There are 3 post-translational modifications: a conserved N-linked glycosylation on the CH2 domain at Asn 303 of the heavy chain, the conversion of the N-terminal glutamine residue of the heavy chain into pyroglutamate, and loss of C-terminal lysine residue of the heavy chain.
Indications and Usage Adjunct treatment for auto-antibody-positive active systemic lupus erythematosus (SLE). The intravenous injectable form is the only FDA approved treatment for pediatric patients with SLE.
Marketing Status approved
ATC Code L04AA26
DrugBank ID DB08879
KEGG ID D03068
MeSH ID C511911
PubChem ID Not Available
TTD Drug ID D05IQX
NDC Product Code 71124-0025; 49401-088; 0409-9966; 49401-102; 49401-101
UNII 73B0K5S26A
Synonyms belimumab | BEL-114333 | BEL114333 | HGS-1006 | HGS1006 | LymphoStat-B | GSK-1550188 | GSK1550188 | Benlysta
Chemical Information
Molecular Formula Not Available
CAS Registry Number 356547-88-1
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)
Bronchitis11.01.09.001; 22.07.01.001--
Cystitis20.03.02.002; 11.01.14.001--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Drug specific antibody present13.17.01.001--Not Available
Gastroenteritis viral11.05.04.005; 07.19.03.005--Not Available
Infection11.01.08.002--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Leukopenia01.02.02.001--Not Available
Migraine24.03.05.003; 17.14.02.001--Not Available
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Pain in extremity15.03.04.010--
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pyrexia08.05.02.003--
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