Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Rituximab
Drug ID BADD_D01953
Description Rituximab is a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes. The antibody is an IgG1 kappa immunoglobulin containing murine light and heavy-chain variable region sequences and human constant region sequences [A40017], [FDA label]. It was originally approved by the U.S. FDA in 1997 as a single agent to treat patients with B-cell Non-Hodgkin's Lymphoma (NHL) [L4811], however, has now been approved for a variety of conditions [FDA label]. On November 28, 2018, the US FDA approved _Truxima_, the first biosimilar to Rituxan (Rituximab) [L4808].
Indications and Usage Rituximab is indicated in the following conditions [FDA label]: Non–Hodgkin’s Lymphoma (NHL) Chronic Lymphocytic Leukemia (CLL) Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) Moderate to severe Pemphigus Vulgaris (PV) in adult patients The biosimilar (approved in November 2018), _Truxima_, is indicated For the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy [L4808]. In September 2019, the rituximab injection was approved along with glucocorticoids to manage granulomatosis with polyangiitis (GPA) in addition to microscopic polyangiitis (MPA) in children of at least 2 years of age [L8920].
Marketing Status approved
ATC Code L01FA01
DrugBank ID DB00073
KEGG ID D02994
MeSH ID D000069283
PubChem ID Not Available
TTD Drug ID D09EXD
NDC Product Code 71124-0003; 50242-053; 50242-052; 50242-051
UNII 4F4X42SYQ6
Synonyms Rituximab | CD20 Antibody, Rituximab | Rituximab CD20 Antibody | Mabthera | IDEC-C2B8 Antibody | IDEC C2B8 Antibody | IDEC-C2B8 | IDEC C2B8 | GP2013 | Rituxan
Chemical Information
Molecular Formula Not Available
CAS Registry Number 174722-31-7
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)
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Alanine aminotransferase increased13.03.04.005--
Anaemia01.03.02.001--
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001---
Anxiety19.06.02.002--
Aplasia pure red cell01.03.03.001; 10.02.01.003---
Aplastic anaemia01.03.03.002---
Arrhythmia supraventricular02.03.03.001---
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Asthenia08.01.01.001---
Back pain15.03.04.005--
Blood immunoglobulin G decreased13.06.05.001---
Blood immunoglobulin M decreased13.06.05.006---
Blood lactate dehydrogenase increased13.04.02.002--
Bronchitis11.01.09.001; 22.07.01.001--
Bronchospasm10.01.03.012; 22.03.01.004--
Cardiac failure02.05.01.001--
Chest discomfort02.02.02.009; 08.01.08.019; 22.12.02.002---
Chills08.01.09.001; 15.05.03.016--
Cough22.02.03.001--
Death08.04.01.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Epistaxis22.04.03.001; 24.07.01.005--
Fatigue08.01.01.002--
Febrile neutropenia01.02.03.002; 08.05.02.004--
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ADReCS-Target
Drug Name ADR Term Target
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