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Rituximab Adverse Events Reported to the FDA Over Time

How are Rituximab adverse event reports trending over time?

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

Most Common Rituximab Adverse Events Reported to the FDA

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

Febrile Neutropenia
1658 (2.8%)
Neutropenia
1135 (1.92%)
Pyrexia
956 (1.61%)
Pneumonia
803 (1.36%)
Anaemia
642 (1.08%)
Thrombocytopenia
580 (.98%)
Death
576 (.97%)
Dyspnoea
571 (.96%)
Sepsis
570 (.96%)
Diarrhoea
569 (.96%)
Nausea
564 (.95%)
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Infection
488 (.82%)
Pain
442 (.75%)
Vomiting
431 (.73%)
Arthralgia
419 (.71%)
Haemoglobin Decreased
416 (.7%)
Hypotension
400 (.68%)
Fatigue
387 (.65%)
White Blood Cell Count Decreased
383 (.65%)
Drug Ineffective
364 (.61%)
Dehydration
333 (.56%)
Headache
328 (.55%)
Leukopenia
328 (.55%)
Platelet Count Decreased
325 (.55%)
Respiratory Failure
325 (.55%)
Malaise
312 (.53%)
Pleural Effusion
312 (.53%)
Pancytopenia
311 (.52%)
Septic Shock
310 (.52%)
General Physical Health Deteriorati...
309 (.52%)
Pneumocystis Jiroveci Pneumonia
306 (.52%)
Asthenia
304 (.51%)
Chills
303 (.51%)
Pulmonary Embolism
297 (.5%)
Progressive Multifocal Leukoencepha...
285 (.48%)
Abdominal Pain
269 (.45%)
Hepatitis B
266 (.45%)
Renal Failure
266 (.45%)
Myelodysplastic Syndrome
262 (.44%)
Weight Decreased
261 (.44%)
Infusion Related Reaction
255 (.43%)
Mucosal Inflammation
251 (.42%)
Pain In Extremity
251 (.42%)
Hypertension
232 (.39%)
Multi-organ Failure
228 (.38%)
Hypersensitivity
224 (.38%)
Oedema Peripheral
216 (.36%)
Cytomegalovirus Infection
214 (.36%)
Cough
208 (.35%)
Renal Failure Acute
203 (.34%)
Chest Pain
201 (.34%)
Rheumatoid Arthritis
199 (.34%)
Urinary Tract Infection
191 (.32%)
Tachycardia
189 (.32%)
Rash
185 (.31%)
Condition Aggravated
183 (.31%)
Fall
178 (.3%)
Interstitial Lung Disease
175 (.3%)
Neutrophil Count Decreased
175 (.3%)
Syncope
175 (.3%)
Deep Vein Thrombosis
173 (.29%)
Disease Progression
173 (.29%)
Dizziness
172 (.29%)
Gait Disturbance
172 (.29%)
Myocardial Infarction
172 (.29%)
Atrial Fibrillation
168 (.28%)
Pruritus
166 (.28%)
Weight Increased
159 (.27%)
Depression
158 (.27%)
Herpes Zoster
158 (.27%)
Acute Respiratory Distress Syndrome
156 (.26%)
Confusional State
156 (.26%)
Constipation
156 (.26%)
Bone Marrow Failure
149 (.25%)
Alanine Aminotransferase Increased
148 (.25%)
Lymphopenia
148 (.25%)
Tumour Lysis Syndrome
146 (.25%)
Neutropenic Sepsis
142 (.24%)
Haemorrhage
140 (.24%)
Bone Pain
139 (.23%)
Rectal Haemorrhage
137 (.23%)
Back Pain
136 (.23%)
Febrile Bone Marrow Aplasia
136 (.23%)
Somnolence
136 (.23%)
Rash Maculo-papular
135 (.23%)
Neuropathy Peripheral
130 (.22%)
Pulmonary Oedema
129 (.22%)
Stomatitis
129 (.22%)
Erythema
126 (.21%)
Rash Erythematous
126 (.21%)
Acute Myeloid Leukaemia
124 (.21%)
Hypoxia
124 (.21%)
Melaena
123 (.21%)
Staphylococcal Infection
123 (.21%)
Vaginal Haemorrhage
121 (.2%)
Cerebrovascular Accident
120 (.2%)
Purpura
120 (.2%)
Agranulocytosis
119 (.2%)
Hypokalaemia
117 (.2%)
Sinusitis
117 (.2%)
Lung Infection
116 (.2%)

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This graph shows the top adverse events submitted to the FDA for Rituximab, 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 Rituximab 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 Rituximab

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

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This graph shows the top categories of adverse events submitted to the FDA for Rituximab, 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 Rituximab 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 Rituximab According to Those Reporting Adverse Events

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

Diffuse Large B-cell Lymphoma
2416
Rheumatoid Arthritis
2359
Non-hodgkins Lymphoma
1870
Chronic Lymphocytic Leukaemia
1458
B-cell Lymphoma
1397
Lymphoma
689
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Mantle Cell Lymphoma
687
Idiopathic Thrombocytopenic Purpura
380
Systemic Lupus Erythematosus
305
Drug Use For Unknown Indication
275
Product Used For Unknown Indication
243
Burkitts Lymphoma
178
Waldenstroms Macroglobulinaemia
110
Renal Transplant
91
Hodgkins Disease
86
Malignant Lymphoid Neoplasm
83
Chemotherapy
70
Haematology Test Abnormal
69
Anti-neutrophil Cytoplasmic Antibod...
67
Extranodal Marginal Zone B-cell Lym...
62
Lymphoproliferative Disorder
58
Vasculitis
56
Wegeners Granulomatosis
48
Immunosuppression
46
Epstein-barr Virus Associated Lymph...
45
Multiple Sclerosis
43
Central Nervous System Lymphoma
42
Acute Lymphocytic Leukaemia
41
Anaemia Haemolytic Autoimmune
38
Graft Versus Host Disease
37
Thrombotic Thrombocytopenic Purpura
36
Sjogrens Syndrome
35
Castlemans Disease
34
Evans Syndrome
33
Non-hodgkins Lymphoma Stage Iv
32
Non-hodgkins Lymphoma Recurrent
31
Antiphospholipid Syndrome
29
B-cell Small Lymphocytic Lymphoma
28
Stem Cell Transplant
28
Hairy Cell Leukaemia
27
Cryoglobulinaemia
26
Juvenile Arthritis
25
Burkitts Leukaemia
25
B-cell Lymphoma Recurrent
23
Transplant Rejection
23
Nephrotic Syndrome
23
Lymphoma Aids Related
22
Pemphigus
22
Autoimmune Thrombocytopenia
21
Non-hodgkins Lymphoma Unspecified H...
21
Drug Exposure During Pregnancy
20

Drug Labels

LabelLabelerEffective
RituxanGenentech, Inc.30-OCT-12

Rituximab Case Reports

What Rituximab 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 Rituximab. 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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