Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Infliximab
Drug ID BADD_D01157
Description Infliximab is a tumor necrosis factor (TNF-alpha or TNF-α) blocker and a chimeric monoclonal IgG1 antibody composed of human constant (75%) and murine variable (25%) regions [A31469]. Infliximab is produced by a recombinant cell line cultured by continuous perfusion. Tumor necrosis factor-alpha (TNF-α) is a key proinflammatory cytokine involved in chronic inflammatory diseases [A31469]. Its hyperactivity and enhanced signalling pathways can be observed in inflammatory diseases where it activates further pro-inflammatory cascades. By binding to both the soluble subunit and the membrane-bound precursor of TNF-α [A106], infliximab disrupts the interaction of TNF-α with its receptors and may also cause lysis of cells that produce TNF-α [A106]. Infliximab was first approved by the FDA in 1998 under the market name Remicade as an intravenous injection. It is indicated for the treatment of various inflammatory disorders such as adult or pediatric Chron's disease, adult or pediatric ulcerative colitis, rheumatoid arthritis in combination with methotrexate, ankylosing spondyliti, psoriatic arthritis, and plaque psoriasis [FDA Label]. In clinical trials, multiple infusions of infliximab displayed in a reduction of signs and symptoms of inflammatory diseases and induction of remission in patients who have had an inadequate response to alternative first-line therapies for that disorder [FDA Label]. There are currently two biosilimars of infliximab available in the US market that demonstrate a high degree of similarity to the reference product, Remicade. They are approved for all eligible indications of the reference product. Inflectra, a first biosimilar drug product, was approved in 2016. In December 2017, Ixifi, a second biosimilar that was developed by Pfizer, was granted approval by the FDA.
Indications and Usage * Indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) **plaque psoriasis** who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.
Marketing Status Prescription
ATC Code L04AB02
DrugBank ID DB00065
KEGG ID D02598
MeSH ID D000069285
PubChem ID Not Available
TTD Drug ID D0PG5G
NDC Product Code 57894-160; 69438-0007; 68225-072; 65267-898; 78206-162; 71124-0004; 57894-030; 0006-4305; 71124-0008
Synonyms Infliximab | MAb cA2 | Monoclonal Antibody cA2 | Antibody cA2, Monoclonal | cA2, Monoclonal Antibody | Infliximab-dyyb | Infliximab dyyb | Inflectra | Remicade | Infliximab-abda | Infliximab abda | Renflexis
Chemical Information
Molecular Formula Not Available
CAS Registry Number 170277-31-3
SMILES Not Available
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Psoriasis23.03.14.002; 10.02.01.036--Not Available
Psoriatic arthropathy23.03.14.005; 15.01.10.001; 10.02.01.031--Not Available
Pulmonary oedema22.01.03.003; 02.05.02.003--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rash erythematous23.03.06.003--Not Available
Rash pustular23.03.10.003; 11.01.12.002--
Rheumatoid arthritis15.01.03.001; 10.04.06.001--Not Available
Sarcoidosis10.02.06.001--Not Available
Seizure17.12.03.001--
Sepsis11.01.11.003--
Serum sickness12.02.08.004; 10.01.03.004--
Sinusitis22.07.03.007; 11.01.13.005--
Skin ulcer24.04.03.007; 23.07.03.003--
Stevens-Johnson syndrome10.01.03.020; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Thrombocytopenia01.08.01.002--Not Available
Thrombophlebitis24.01.02.001--Not Available
Thrombotic thrombocytopenic purpura24.07.06.014; 23.06.01.011; 01.08.01.005--
Toxic epidermal necrolysis11.07.01.006; 10.01.01.006; 23.03.01.008; 12.03.01.015--
Tuberculosis11.04.01.006--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria10.01.06.001; 23.04.02.001--
Vasculitis24.05.02.001; 10.02.02.006--
Viral infection11.05.04.001--Not Available
Weight decreased13.15.01.005--
Lupus-like syndrome23.03.02.004; 15.06.02.004; 10.04.03.003--Not Available
Cardiopulmonary failure22.02.06.004; 02.05.01.004--Not Available
Haemorrhage24.07.01.002--Not Available
Chronic inflammatory demyelinating polyradiculoneuropathy17.09.04.004; 10.04.10.004--Not Available
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