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RITUXAN

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Rituxan Adverse Events Reported to the FDA Over Time

How are Rituxan adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Rituxan, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Rituxan is flagged as the suspect drug causing the adverse event.

Most Common Rituxan Adverse Events Reported to the FDA

What are the most common Rituxan adverse events reported to the FDA?

Febrile Neutropenia
394 (2.06%)
Pyrexia
344 (1.8%)
Progressive Multifocal Leukoencepha...
322 (1.68%)
Death
319 (1.67%)
Neutropenia
310 (1.62%)
Dyspnoea
282 (1.47%)
Pneumonia
243 (1.27%)
White Blood Cell Count Decreased
229 (1.2%)
Infusion Related Reaction
223 (1.16%)
Chills
180 (.94%)
Nausea
172 (.9%)
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Platelet Count Decreased
164 (.86%)
Sepsis
154 (.8%)
Vomiting
146 (.76%)
Pancytopenia
145 (.76%)
Thrombocytopenia
144 (.75%)
Diarrhoea
138 (.72%)
Hypotension
138 (.72%)
Haemoglobin Decreased
137 (.72%)
Anaemia
134 (.7%)
Hepatitis B
120 (.63%)
Respiratory Failure
118 (.62%)
Neutrophil Count Decreased
116 (.61%)
Fatigue
115 (.6%)
Pneumocystis Jiroveci Pneumonia
110 (.57%)
Renal Failure
100 (.52%)
Rash
97 (.51%)
Asthenia
95 (.5%)
Pleural Effusion
93 (.49%)
Interstitial Lung Disease
91 (.47%)
Convulsion
88 (.46%)
Infection
84 (.44%)
Headache
83 (.43%)
Pulmonary Embolism
81 (.42%)
Alanine Aminotransferase Increased
78 (.41%)
Drug Ineffective
78 (.41%)
Condition Aggravated
76 (.4%)
Myocardial Infarction
75 (.39%)
Chest Pain
74 (.39%)
Tumour Lysis Syndrome
74 (.39%)
Cough
73 (.38%)
Dizziness
73 (.38%)
Hepatic Failure
72 (.38%)
Aspartate Aminotransferase Increase...
71 (.37%)
Pruritus
71 (.37%)
Cerebrovascular Accident
70 (.37%)
Dehydration
70 (.37%)
Renal Failure Acute
70 (.37%)
Arthralgia
69 (.36%)
Cytomegalovirus Infection
69 (.36%)
Oxygen Saturation Decreased
69 (.36%)
Atrial Fibrillation
66 (.34%)
Hypersensitivity
65 (.34%)
Deep Vein Thrombosis
64 (.33%)
Oedema Peripheral
64 (.33%)
Pain
64 (.33%)
Abdominal Pain
62 (.32%)
Tremor
62 (.32%)
Malaise
61 (.32%)
Serum Sickness
61 (.32%)
Lymphopenia
60 (.31%)
Blood Pressure Decreased
59 (.31%)
Tachycardia
59 (.31%)
Acute Respiratory Distress Syndrome
57 (.3%)
Back Pain
57 (.3%)
Myelodysplastic Syndrome
57 (.3%)
Disseminated Intravascular Coagulat...
56 (.29%)
Neuropathy Peripheral
56 (.29%)
Cardiac Failure
54 (.28%)
Disease Progression
54 (.28%)
Hypoxia
54 (.28%)
Herpes Zoster
53 (.28%)
Pneumonitis
53 (.28%)
Lung Infiltration
52 (.27%)
Heart Rate Increased
51 (.27%)
Bone Marrow Failure
50 (.26%)
Hypertension
50 (.26%)
Anaphylactic Reaction
49 (.26%)
Chest Discomfort
49 (.26%)
Dysphagia
49 (.26%)
Pain In Extremity
49 (.26%)
Agranulocytosis
48 (.25%)
Leukopenia
48 (.25%)
Lymphoma
47 (.25%)
Urticaria
47 (.25%)
Erythema
45 (.23%)
Septic Shock
45 (.23%)
Sinusitis
45 (.23%)
Flushing
44 (.23%)
Gastrointestinal Haemorrhage
44 (.23%)
Loss Of Consciousness
42 (.22%)
Blood Pressure Increased
41 (.21%)
Multi-organ Failure
41 (.21%)
Rheumatoid Arthritis
41 (.21%)
White Blood Cell Count Increased
40 (.21%)
Blood Sodium Decreased
39 (.2%)
Body Temperature Increased
39 (.2%)
Cardiac Arrest
39 (.2%)
Lung Disorder
39 (.2%)
Confusional State
38 (.2%)
General Physical Health Deteriorati...
38 (.2%)

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This graph shows the top adverse events submitted to the FDA for Rituxan, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Rituxan is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Rituxan

What are the most common Rituxan adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Rituxan, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Rituxan is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Rituxan According to Those Reporting Adverse Events

Why are people taking Rituxan, according to those reporting adverse events to the FDA?

Non-hodgkins Lymphoma
1488
Rheumatoid Arthritis
849
Diffuse Large B-cell Lymphoma
630
Chronic Lymphocytic Leukaemia
623
Lymphoma
500
B-cell Lymphoma
411
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Drug Use For Unknown Indication
305
Product Used For Unknown Indication
296
Mantle Cell Lymphoma
255
Idiopathic Thrombocytopenic Purpura
166
Waldenstroms Macroglobulinaemia
138
Systemic Lupus Erythematosus
131
Anaemia Haemolytic Autoimmune
54
Wegeners Granulomatosis
45
Prophylaxis Against Transplant Reje...
34
Burkitts Lymphoma
30
Thrombotic Thrombocytopenic Purpura
29
Dermatomyositis
28
Central Nervous System Lymphoma
25
Renal Transplant
24
Lymphocytic Lymphoma
22
Vasculitis
22
Polymyositis
19
Hodgkins Disease
18
Neuromyelitis Optica
18
Lymphoproliferative Disorder
17
Hairy Cell Leukaemia
16
Graft Versus Host Disease
16
Sjogrens Syndrome
16
B-cell Small Lymphocytic Lymphoma
16
Neoplasm Malignant
15
Stem Cell Transplant
15
Non-hodgkins Lymphoma Stage Iii
15
Lupus Nephritis
15
Anti-neutrophil Cytoplasmic Antibod...
14
Follicle Centre Lymphoma, Follicula...
14
Multiple Sclerosis
14
Multiple Myeloma
14
Autoimmune Disorder
13
Extranodal Marginal Zone B-cell Lym...
13
Cryoglobulinaemia
12
Pancytopenia
11
Juvenile Arthritis
11
Transplant Rejection
10
Kidney Transplant Rejection
9
Epstein-barr Virus Associated Lymph...
9
Haemolytic Anaemia
9
Castlemans Disease
8
Lymphocytic Leukaemia
8
Epstein-barr Virus Infection
8
Myositis
8

Drug Labels

LabelLabelerEffective
RituxanGenentech, Inc.30-OCT-12

Rituxan Case Reports

What Rituxan safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Rituxan. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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