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--Not Available
Alanine aminotransferase increased13.03.04.005--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Aspartate aminotransferase increased13.03.04.011--
Bronchitis22.07.01.001; 11.01.09.001--
Constipation07.02.02.001--
Cutaneous vasculitis10.02.02.003; 24.12.04.008; 23.06.02.001--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Fungal infection11.03.05.001--Not Available
Herpes virus infection11.05.02.008--Not Available
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Injection site bruising24.07.06.017; 23.03.11.015; 12.07.03.042; 08.02.03.042--Not Available
Injection site erythema23.03.06.015; 12.07.03.001; 08.02.03.001--Not Available
Injection site induration12.07.03.007; 08.02.03.007--Not Available
Injection site irritation12.07.03.027; 08.02.03.027--Not Available
Injection site pain08.02.03.010; 12.07.03.011--Not Available
Injection site paraesthesia17.02.06.029; 12.07.03.049; 08.02.03.049--Not Available
Injection site pruritus23.03.12.007; 12.07.03.014; 08.02.03.013--Not Available
Injection site reaction08.02.03.014; 12.07.03.015--
Injection site urticaria23.04.02.003; 12.07.03.029; 10.01.06.003; 08.02.03.029--Not Available
Laryngitis22.07.03.001; 11.01.13.001--
Leukaemia01.10.03.001; 16.01.03.001--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Neoplasm malignant16.16.01.001--Not Available
Paraesthesia23.03.03.094; 17.02.06.005--
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Psoriasis23.03.14.002; 10.02.01.036--Not Available
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