{"id":"rituxan","rwe":[{"pmid":"30000857","year":"2006","title":"Rituximab.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"41793384","year":"2026","title":"Obinutuzumab (Gazyva) for lupus nephritis.","finding":"","journal":"The Medical letter on drugs and therapeutics","studyType":"Clinical Study"},{"pmid":"41283630","year":"2025","title":"Monoclonal Antibodies as a Breakthrough in Personalised Leukaemia Therapy: What Pharmacists and Doctors Should Know.","finding":"","journal":"Pharmacy (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41260436","year":"2025","title":"Multimodal mass spectrometric characterization of structural microheterogeneity in rituximab reference and biosimilars.","finding":"","journal":"International journal of biological macromolecules","studyType":"Clinical Study"},{"pmid":"41180948","year":"2025","title":"The Value of Punching It Out: Patient With Cowden Syndrome and MALT Lymphoma of the Lung.","finding":"","journal":"Case reports in oncological medicine","studyType":"Clinical Study"}],"tags":[{"label":"CD20-directed Cytolytic Antibody","category":"class"},{"label":"Monoclonal Antibody","category":"modality"},{"label":"B-lymphocyte antigen CD20","category":"target"},{"label":"MS4A1","category":"gene"},{"label":"L01FA01","category":"atc"},{"label":"Subcutaneous","category":"route"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Burkitt cell leukemia","category":"indication"},{"label":"Burkitt's lymphoma","category":"indication"},{"label":"CD20 positive diffuse large B cell non Hodgkin's lymphoma","category":"indication"},{"label":"Chronic lymphoid leukemia, disease","category":"indication"},{"label":"Follicular lymphoma","category":"indication"},{"label":"Granulomatosis with polyangiitis","category":"indication"},{"label":"Genentech","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Antineoplastic Agents, Immunological","category":"pharmacology"},{"label":"Antirheumatic Agents","category":"pharmacology"},{"label":"Immunologic Factors","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":8002.345,"date":"","count":25268,"signal":"Off label use","source":"DrugCentral FAERS","actionTaken":"Reported 25,268 times (LLR=8002)"},{"llr":3819.377,"date":"","count":23923,"signal":"Drug ineffective","source":"DrugCentral FAERS","actionTaken":"Reported 23,923 times (LLR=3819)"},{"llr":3786.466,"date":"","count":7434,"signal":"Contraindicated product administered","source":"DrugCentral FAERS","actionTaken":"Reported 7,434 times (LLR=3786)"},{"llr":3650.27,"date":"","count":8353,"signal":"Infusion related reaction","source":"DrugCentral FAERS","actionTaken":"Reported 8,353 times (LLR=3650)"},{"llr":2959.079,"date":"","count":8535,"signal":"Drug intolerance","source":"DrugCentral FAERS","actionTaken":"Reported 8,535 times (LLR=2959)"},{"llr":2740.494,"date":"","count":6546,"signal":"Treatment failure","source":"DrugCentral FAERS","actionTaken":"Reported 6,546 times (LLR=2740)"},{"llr":2485.527,"date":"","count":5717,"signal":"Intentional product use issue","source":"DrugCentral FAERS","actionTaken":"Reported 5,717 times (LLR=2486)"},{"llr":2426.069,"date":"","count":5332,"signal":"Pemphigus","source":"DrugCentral FAERS","actionTaken":"Reported 5,332 times (LLR=2426)"},{"llr":2294.727,"date":"","count":5622,"signal":"Systemic lupus erythematosus","source":"DrugCentral FAERS","actionTaken":"Reported 5,622 times (LLR=2295)"},{"llr":2142.59,"date":"","count":5206,"signal":"Synovitis","source":"DrugCentral FAERS","actionTaken":"Reported 5,206 times (LLR=2143)"},{"llr":2066.361,"date":"","count":5855,"signal":"Febrile neutropenia","source":"DrugCentral FAERS","actionTaken":"Reported 5,855 times (LLR=2066)"},{"llr":2029.26,"date":"","count":6016,"signal":"Arthropathy","source":"DrugCentral FAERS","actionTaken":"Reported 6,016 times (LLR=2029)"},{"llr":1993.705,"date":"","count":1607,"signal":"Progressive multifocal leukoencephalopathy","source":"DrugCentral FAERS","actionTaken":"Reported 1,607 times (LLR=1994)"},{"llr":1965.666,"date":"","count":7597,"signal":"Joint swelling","source":"DrugCentral FAERS","actionTaken":"Reported 7,597 times (LLR=1966)"},{"llr":1945.89,"date":"","count":6835,"signal":"Infection","source":"DrugCentral FAERS","actionTaken":"Reported 6,835 times (LLR=1946)"}],"commonSideEffects":[{"effect":"Infections","drugRate":"","severity":"common","organSystem":""},{"effect":"Neutropenia","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Constipation","drugRate":"","severity":"common","organSystem":""},{"effect":"Cough","drugRate":"","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"","severity":"common","organSystem":""},{"effect":"Alopecia","drugRate":"","severity":"common","organSystem":""},{"effect":"Anemia","drugRate":"","severity":"common","organSystem":""},{"effect":"Thrombocytopenia","drugRate":"","severity":"common","organSystem":""},{"effect":"Pyrexia","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Injection site erythema","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Administration-related reactions (FL/DLBCL)","drugRate":"34%","severity":"common","organSystem":""},{"effect":"Administration-related reactions (FL maintenance)","drugRate":"20%","severity":"common","organSystem":""},{"effect":"Administration-related reactions (CLL)","drugRate":"44%","severity":"common","organSystem":""},{"effect":"Chills","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Dyspnea","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Erythema","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Flushing","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Injection site pain","drugRate":"2%","severity":"common","organSystem":""}],"specialPopulations":{"Pregnancy":"Based on human data, rituximab-containing products can cause fetal harm due to B-cell lymphocytopenia in infants exposed to rituximab in-utero. There are no available data on RITUXAN HYCELA use in pregnant women to inform drug-associated risk of major birth defects and miscarriage. Advise pregnant women of the potential risk to fetus.","Geriatric use":"No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.","Paediatric use":"The safety and effectiveness of rituximab products, including RIABNI, have not been established in pediatric patients less than 2 years of age for GPA and MPA. Pediatric assessment for RIABNI demonstrates that RIABNI is safe and effective for pediatric patients in an indication for which Rituxan (rituximab) is approved."},"seriousAdverseEvents":[]},"trials":[],"aliases":[],"company":"Roche","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=rituxan","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:52:15.753232+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Rituxan","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:52:24.773679+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:52:23.006048+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:52:15.825668+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=rituxan","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:52:23.666347+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: B-lymphocyte antigen CD20 binding agent","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:52:24.773623+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201576/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:52:24.425989+00:00"}},"allNames":"mabthera, riabni, ruxience, truxima","offLabel":[],"synonyms":["rituximab","rituxan","MabThera","rituximab (genetical recombination)"],"timeline":[{"date":"1997-11-26","type":"positive","source":"DrugCentral","milestone":"FDA approval (Genentech)"},{"date":"1998-06-02","type":"positive","source":"DrugCentral","milestone":"EMA approval (Roche Registration GmbH)"},{"date":"2008-01-25","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Bayer Yakuhin, Nihon Schering, Zenyaku Kogyo)"}],"aiSummary":"Mabthera (Rituxan) is a CD20-directed cytolytic antibody developed by Genentech, targeting B-lymphocytes. It is a small molecule modality, FDA-approved in 1997 for various B-cell malignancies and autoimmune diseases. Mabthera is currently owned by Genentech and is not off-patent. Key safety considerations include infusion reactions, neutropenia, and increased risk of infections. As a patented product, it is not yet available as a generic.","brandName":"Mabthera","ecosystem":[{"indication":"Burkitt cell leukemia","otherDrugs":[],"globalPrevalence":null},{"indication":"Burkitt's lymphoma","otherDrugs":[{"name":"cyclophosphamide","slug":"cyclophosphamide","company":"Baxter Hlthcare"},{"name":"dexamethasone","slug":"dexamethasone","company":""},{"name":"doxorubicin","slug":"doxorubicin","company":""},{"name":"methotrexate","slug":"methotrexate","company":"Dava Pharms Inc"}],"globalPrevalence":null},{"indication":"CD20 positive diffuse large B cell non Hodgkin's lymphoma","otherDrugs":[],"globalPrevalence":null},{"indication":"Chronic lymphoid leukemia, disease","otherDrugs":[{"name":"bendamustine","slug":"bendamustine","company":"Cephalon"},{"name":"chlorambucil","slug":"chlorambucil","company":"Aspen Global Inc"},{"name":"cyclophosphamide","slug":"cyclophosphamide","company":"Baxter Hlthcare"},{"name":"duvelisib","slug":"duvelisib","company":"Verastem Inc"}],"globalPrevalence":null},{"indication":"Follicular lymphoma","otherDrugs":[{"name":"copanlisib","slug":"copanlisib","company":"Bayer Healthcare Pharms"},{"name":"interferon alfa-2b","slug":"interferon-alfa-2b","company":"Schering"},{"name":"lenalidomide","slug":"lenalidomide","company":"Celgene"},{"name":"tazemetostat","slug":"tazemetostat","company":"Epizyme Inc"}],"globalPrevalence":120000},{"indication":"Granulomatosis with polyangiitis","otherDrugs":[{"name":"avacopan","slug":"avacopan","company":"Chemocentryx"}],"globalPrevalence":120000},{"indication":"Microscopic polyangiitis","otherDrugs":[{"name":"avacopan","slug":"avacopan","company":"Chemocentryx"}],"globalPrevalence":342744},{"indication":"Microscopic polyarteritis nodosa","otherDrugs":[],"globalPrevalence":252800}],"mechanism":{"target":"B-lymphocyte antigen CD20","novelty":"First-in-class","targets":[{"gene":"MS4A1","source":"DrugCentral","target":"B-lymphocyte antigen CD20","protein":"B-lymphocyte antigen CD20"}],"moaClass":"CD20-directed Antibody Interactions","modality":"Monoclonal Antibody","drugClass":"CD20-directed Cytolytic Antibody","explanation":"","oneSentence":"","technicalDetail":"Mabthera is a monoclonal antibody that selectively binds to the CD20 antigen on the surface of B-lymphocytes, triggering antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), ultimately leading to cell death."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Rituximab","title":"Rituximab","extract":"Rituximab, sold under the brand name Rituxan among others, is a monoclonal antibody medication used to treat certain autoimmune diseases and types of cancer. It is used for non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, idiopathic thrombocytopenic purpura, pemphigus vulgaris, myasthenia gravis and Epstein–Barr virus-positive mucocutaneous ulcers. It is given by slow intravenous infusion.","wiki_history":"== History ==\nRituximab was developed by IDEC Pharmaceuticals under the name IDEC-C2B8. The US patent for the drug was issued in 1998 and expired in 2015.\n\nBased on its safety and effectiveness in clinical trials, rituximab was approved by the US Food and Drug Administration (FDA) in 1997 to treat B-cell non-Hodgkin lymphomas resistant to other chemotherapy regimens. Rituximab, in combination with CHOP chemotherapy, is superior to CHOP alone in the treatment of diffuse large B-cell lymphoma and many other B-cell lymphomas. In 2010, it was authorized by the European Commission for maintenance treatment after initial treatment of follicular lymphoma.\n\nIt is on the World Health Organization's List of Essential Medicines.\n\nIn June 2017, the US FDA granted regular approval to the combination of rituximab and hyaluronidase human (brand name Rituxan Hycela) for adults with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. The combination is not indicated for the treatment of non-malignant conditions. Rituximab was approved by the FDA to treat adults with granulomatosis with polyangiitis and microscopic polyangiitis in 2011. Efficacy was evaluated in Inter-B-NHL Ritux 2010, a global multicenter, open-label, randomized 1:1 trial of participants six months in age or older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or B-cell acute leukemia. Advanced stage was defined as stage III with elevated lactose dehydrogenase level (lactose dehydrogenase greater than twice the institutional upper limit of normal values) or stage IV B-cell non-Hodgkin's lymphoma or B-cell acute leukemia. Participants were randomized to Lymphome Malin B chemotherapy that consisted of corticosteroids, vincristine, cyclophosphamide, high-dose methotrexate, cytarabine, doxorubicin, etoposide, and triple drug (methotrexate/cytarabine/corticosteroid) intrathecal therapy alone or in combinati","wiki_society_and_culture":"== Society and culture ==\n\n=== Legal status ===\nRituximab was approved for medical use in the United States in November 1997. Ituxredi was authorized for medical use in the European Union in September 2024.\n\nA Rituximab biosimilar was approved in India in 2007.\n\n=== Economics ===\nIn 2014, Genentech reclassified Rituxan as a specialty drug, a class of drugs that are only available through specialty distributors in the US. Because wholesalers discounts and rebates no longer apply, hospitals would pay more. and in the United States. Biosimilars were approved in the United States, India, the European Union, Switzerland, Japan, and Australia. The US FDA approved rituximab-abbs (Truxima) in 2018, rituximab-pvvr (Ruxience) in 2019, Truxima and Riabni are approximately $3600 per 500 mg, wholesale - 10% less than Rituxan, while Ruxience is 24% less than Rituxan. The Indian biosimilar ituxredi retails for about 1/6 the price.\n\n==== Tailored-dosing ====\nTailored-dose rituximab is more cost-effective than fixed-dose. It is both more effective and less expensive."},"commercial":{"launchDate":"1997","revenueYear":2024,"_launchSource":"DrugCentral (FDA 1997-11-26, GENENTECH)","annualRevenue":3800,"revenueSource":"Verified: Roche AR","revenueCurrency":"USD","revenueConfidence":"verified"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4975","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=rituxan","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=rituxan","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Rituximab","fields":["history","overview"],"source":"Wikipedia"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T02:22:02.389241","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:52:26.069900+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","company":"Amgen Inc","brandName":"Riabni","isOriginal":false,"marketingStatus":"BLA"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","company":"Pfizer Laboratories Div Pfizer Inc","brandName":"Ruxience","isOriginal":false,"marketingStatus":"BLA"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","company":"Cephalon, Inc.","brandName":"Truxima","isOriginal":false,"marketingStatus":"BLA"}],"competitors":[{"drugName":"ofatumumab","drugSlug":"ofatumumab","fdaApproval":"2009-10-26","relationship":"same-class"},{"drugName":"obinutuzumab","drugSlug":"obinutuzumab","fdaApproval":"2013-11-01","relationship":"same-class"}],"genericName":"rituxan","indications":{"approved":[{"name":"Burkitt cell leukemia","source":"DrugCentral","snomedId":22197008,"regulator":"FDA","eligibility":null},{"name":"Burkitt's lymphoma","source":"DrugCentral","snomedId":77381001,"regulator":"FDA","eligibility":null},{"name":"CD20 positive diffuse large B cell non Hodgkin's lymphoma","source":"DrugCentral","snomedId":109969005,"regulator":"FDA","eligibility":null},{"name":"Chronic lymphoid leukemia, disease","source":"DrugCentral","snomedId":92814006,"regulator":"FDA"},{"name":"Follicular lymphoma","source":"DrugCentral","snomedId":55150002,"regulator":"FDA","eligibility":{"Adult patients with previously untreated follicular, CD20-positive, B-cell NHL":"in combination with first line chemotherapy and, in patients achieving complete or partial response to rituximab product in combination with chemotherapy, as single-agent maintenance therapy","Adult patients with relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL":"as single agent","Adult patients with non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL":"after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy"},"usPrevalence":null,"globalPrevalence":120000,"prevalenceMethod":"curated","prevalenceSource":"IARC GLOBOCAN, 2022"},{"name":"Granulomatosis with polyangiitis","source":"DrugCentral","snomedId":195353004,"regulator":"FDA","eligibility":{"Adult patients":"in combination with glucocorticoids"},"usPrevalence":null,"globalPrevalence":120000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (18771432[PMID]_9805179[PMID]_17553910[PMID]_14872461[PMID])"},{"name":"Microscopic polyangiitis","source":"DrugCentral","snomedId":1144805008,"regulator":"FDA","eligibility":{"Adult patients":"in combination with glucocorticoids"},"usPrevalence":null,"globalPrevalence":342744,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (25805746[PMID]_ORPHANET)"},{"name":"Microscopic polyarteritis nodosa","source":"DrugCentral","snomedId":239928004,"regulator":"FDA","eligibility":null,"usPrevalence":null,"globalPrevalence":252800,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (9805179[PMID]_14872461[PMID]_17553910[PMID]_ORPHANET)"},{"name":"Neuromyelitis optica","source":"DrugCentral","snomedId":25044007,"regulator":"FDA","eligibility":null,"usPrevalence":null,"globalPrevalence":165680,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (33310876[PMID])"},{"name":"Non-Hodgkin's lymphoma","source":"DrugCentral","snomedId":118601006,"regulator":"FDA","eligibility":{"Adult patients with previously untreated follicular, CD20-positive, B-cell NHL":"in combination with first line chemotherapy and, in patients achieving complete or partial response to rituximab product in combination with chemotherapy, as single-agent maintenance therapy","Adult patients with previously untreated diffuse large B-cell, CD20-positive NHL":"in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens","Adult patients with relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL":"as single agent","Adult patients with non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL":"after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy"},"usPrevalence":null,"globalPrevalence":123507000,"prevalenceMethod":"curated","prevalenceSource":"J Insur Med, 2023 (PMID:37725503)"},{"name":"Pemphigus foliaceus","source":"DrugCentral","snomedId":35154004,"regulator":"FDA","usPrevalence":null,"globalPrevalence":1440000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (European Medicines Agency[INST])"},{"name":"Pemphigus vulgaris","source":"DrugCentral","snomedId":49420001,"regulator":"FDA","usPrevalence":null,"globalPrevalence":1440000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (European Medicines Agency[INST])"},{"name":"Rheumatoid arthritis","source":"DrugCentral","snomedId":69896004,"regulator":"FDA","usPrevalence":1500000,"globalPrevalence":18000000,"prevalenceMethod":"curated","prevalenceSource":"Lancet Rheumatology, 2023"},{"name":"Systemic sclerosis","source":"DrugCentral","snomedId":89155008,"regulator":"FDA","usPrevalence":null,"globalPrevalence":136000000,"prevalenceMethod":"curated","prevalenceSource":"Rheumatology (Oxford), 2021 (PMID:33630060)"},{"name":"Thrombotic thrombocytopenic purpura","source":"DrugCentral","snomedId":78129009,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"ofatumumab","brandName":"ofatumumab","genericName":"ofatumumab","approvalYear":"2009","relationship":"same-class"},{"drugId":"obinutuzumab","brandName":"obinutuzumab","genericName":"obinutuzumab","approvalYear":"2013","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT00468546","phase":"PHASE3","title":"A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy","status":"COMPLETED","sponsor":"Hoffmann-La 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