Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Golimumab
Drug ID BADD_D01035
Description Golimumab is a human IgG1қ monoclonal antibody derived from immunizing genetically engineered mice with human TNFα. Golimumab binds and inhibits soluble and transmembrane human TNFα. Increased TNFα is associated with chronic inflammation. Thus golimumab is indicated for use in adults (i) as an adjunct to methotrexate treatment in patients with moderate to severe active rheumatoid arthritis (RA), (ii) alone or as an adjunct to methotrexate treatment in patients with active psoriatic arthritis (PsA), (iii) as a single agent in patients with active ankylosing spondylitis (AS), and (iv) as a single agent in patients with moderate to severe ulcerative colitis (UC) who require chronic steroids or have experienced intolerance or only a partial response to previous medications. In the U.S. and Canada, golimumab is marketed under the brand name Simponi®. The FDA label includes a black box warning of serious infections and malignancy. Additionally in children and adolescents taking golimumab, there have been lymphoma and other malignancies observed.
Indications and Usage Used in adults (i) as an adjunct to methotrexate treatment in patients with moderate to severe active rheumatoid arthritis (RA)[L16626], (ii) in patients 2 years old and above with active psoriatic arthritis (PsA)[L16626], (iii) as a single agent in patients with active ankylosing spondylitis (AS) or in combination with methotrexate[L16631], and (iv) as a single agent in patients with moderate to severe ulcerative colitis (UC) who require chronic steroids or have experienced intolerance or only a partial response to previous medications.[L16631] It is also indicated (v) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older.[L16626]
Marketing Status approved
ATC Code L04AB06
DrugBank ID DB06674
KEGG ID D04358
MeSH ID C529000
PubChem ID Not Available
TTD Drug ID D09FSG
NDC Product Code 57894-070; 65267-899; 57894-071; 57894-350
UNII 91X1KLU43E
Synonyms golimumab | CNTO-148 | CNTO 148 | Simponi
Chemical Information
Molecular Formula Not Available
CAS Registry Number 476181-74-5
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)
Acute hepatic failure09.01.03.001---
Alanine aminotransferase increased13.03.04.005--
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Aspartate aminotransferase increased13.03.04.011--
Bronchitis11.01.09.001; 22.07.01.001--
Constipation07.02.02.001--
Cutaneous vasculitis10.02.02.003; 23.06.02.001; 24.12.04.008---
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Fungal infection11.03.05.001---
Herpes virus infection11.05.02.008---
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Infection11.01.08.002---
Influenza11.05.03.001; 22.07.02.001---
Injection site bruising08.02.03.042; 12.07.03.042; 23.03.11.015; 24.07.06.017---
Injection site erythema08.02.03.001; 12.07.03.001; 23.03.06.015---
Injection site induration08.02.03.007; 12.07.03.007---
Injection site irritation08.02.03.027; 12.07.03.027---
Injection site pain08.02.03.010; 12.07.03.011---
Injection site paraesthesia08.02.03.049; 12.07.03.049; 17.02.06.029---
Injection site pruritus08.02.03.013; 12.07.03.014; 23.03.12.007---
Injection site reaction08.02.03.014; 12.07.03.015--
Injection site urticaria08.02.03.029; 10.01.06.003; 12.07.03.029; 23.04.02.003---
Laryngitis11.01.13.001; 22.07.03.001--
Leukaemia01.10.03.001; 16.01.03.001--
Nasopharyngitis11.01.13.002; 22.07.03.002---
Neoplasm malignant16.16.01.001---
Paraesthesia17.02.06.005; 23.03.03.094--
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
Psoriasis10.02.01.036; 23.03.14.002---
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