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MABTHERA

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Mabthera Adverse Events Reported to the FDA Over Time

How are Mabthera adverse event reports trending over time?

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

Most Common Mabthera Adverse Events Reported to the FDA

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

Neutropenia
572 (1.81%)
Pyrexia
540 (1.71%)
Progressive Multifocal Leukoencepha...
479 (1.52%)
Febrile Neutropenia
427 (1.35%)
Death
397 (1.26%)
Pneumonia
371 (1.18%)
Thrombocytopenia
343 (1.09%)
Dyspnoea
325 (1.03%)
Sepsis
293 (.93%)
Anaemia
236 (.75%)
Leukopenia
216 (.68%)
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Drug Ineffective
213 (.68%)
Diarrhoea
210 (.67%)
Infection
208 (.66%)
Nausea
202 (.64%)
Hypotension
200 (.63%)
Disease Progression
196 (.62%)
Chills
192 (.61%)
Malaise
191 (.61%)
Agranulocytosis
190 (.6%)
Arthralgia
190 (.6%)
Pneumocystis Jiroveci Pneumonia
183 (.58%)
Headache
181 (.57%)
Pulmonary Embolism
181 (.57%)
Renal Failure
178 (.56%)
Vomiting
178 (.56%)
Respiratory Failure
172 (.55%)
Asthenia
170 (.54%)
Pancytopenia
170 (.54%)
Cerebrovascular Accident
150 (.48%)
Infusion Related Reaction
148 (.47%)
Pain In Extremity
147 (.47%)
Pain
146 (.46%)
Rash
145 (.46%)
Septic Shock
144 (.46%)
Interstitial Lung Disease
143 (.45%)
Hypersensitivity
137 (.43%)
Urinary Tract Infection
135 (.43%)
Myocardial Infarction
131 (.42%)
Fatigue
130 (.41%)
Rheumatoid Arthritis
127 (.4%)
Bone Marrow Failure
126 (.4%)
Pleural Effusion
126 (.4%)
Confusional State
125 (.4%)
Hypertension
123 (.39%)
White Blood Cell Count Decreased
119 (.38%)
Pruritus
118 (.37%)
Multi-organ Failure
117 (.37%)
Platelet Count Decreased
117 (.37%)
Pulmonary Fibrosis
117 (.37%)
Weight Decreased
116 (.37%)
Haemoglobin Decreased
115 (.36%)
General Physical Health Deteriorati...
114 (.36%)
Lung Disorder
114 (.36%)
Oedema Peripheral
110 (.35%)
Dizziness
109 (.35%)
Cough
108 (.34%)
Hepatitis B
107 (.34%)
Myelodysplastic Syndrome
100 (.32%)
Chest Pain
99 (.31%)
Cardiac Failure
98 (.31%)
Tremor
96 (.3%)
Cardiac Arrest
95 (.3%)
Convulsion
95 (.3%)
Depression
94 (.3%)
Abdominal Pain
93 (.29%)
Tachycardia
93 (.29%)
Renal Failure Acute
92 (.29%)
Herpes Zoster
91 (.29%)
Urticaria
91 (.29%)
Deep Vein Thrombosis
87 (.28%)
Erythema
85 (.27%)
Dehydration
84 (.27%)
Fall
84 (.27%)
Syncope
83 (.26%)
Lymphopenia
82 (.26%)
Acute Myeloid Leukaemia
81 (.26%)
Gait Disturbance
81 (.26%)
Atrial Fibrillation
80 (.25%)
Alanine Aminotransferase Increased
79 (.25%)
Breast Cancer
79 (.25%)
Back Pain
77 (.24%)
Lung Infection
75 (.24%)
Condition Aggravated
74 (.23%)
Hepatic Failure
74 (.23%)
Mucosal Inflammation
74 (.23%)
Lymphoma
73 (.23%)
Acute Respiratory Distress Syndrome
72 (.23%)
Cytomegalovirus Infection
72 (.23%)
Hepatitis
72 (.23%)
Hyperhidrosis
67 (.21%)
Thrombosis
67 (.21%)
Febrile Bone Marrow Aplasia
66 (.21%)
Paraesthesia
66 (.21%)
Weight Increased
66 (.21%)
Anaphylactic Reaction
65 (.21%)
Pneumonitis
63 (.2%)
C-reactive Protein Increased
62 (.2%)
Constipation
62 (.2%)
Joint Swelling
61 (.19%)
Stomatitis
61 (.19%)

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

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

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

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

Rheumatoid Arthritis
2359
Non-hodgkins Lymphoma
1235
B-cell Lymphoma
806
Chronic Lymphocytic Leukaemia
797
Diffuse Large B-cell Lymphoma
664
Lymphoma
571
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Product Used For Unknown Indication
515
Drug Use For Unknown Indication
412
Systemic Lupus Erythematosus
354
Mantle Cell Lymphoma
218
Idiopathic Thrombocytopenic Purpura
134
Waldenstroms Macroglobulinaemia
98
Wegeners Granulomatosis
74
Burkitts Lymphoma
63
Vasculitis
55
Anaemia Haemolytic Autoimmune
55
Malignant Lymphoid Neoplasm
52
Sjogrens Syndrome
43
Lupus Nephritis
30
Pemphigus
29
Castlemans Disease
28
Nephrotic Syndrome
27
Renal Transplant
26
Juvenile Arthritis
26
Cryoglobulinaemia
25
Hairy Cell Leukaemia
25
Hodgkins Disease
22
Polyarthritis
22
Dermatomyositis
22
Anti-neutrophil Cytoplasmic Antibod...
21
Lymphoplasmacytoid Lymphoma/immunoc...
21
Lymphoproliferative Disorder
20
Polymyositis
20
Kidney Transplant Rejection
20
Extranodal Marginal Zone B-cell Lym...
19
Acute Lymphocytic Leukaemia
17
Organ Transplant
16
Central Nervous System Lymphoma
16
Thrombocytopenic Purpura
15
Transplant Rejection
15
Psoriatic Arthropathy
14
Evans Syndrome
14
Multiple Sclerosis
13
Primary Mediastinal Large B-cell Ly...
13
Lymphocytic Leukaemia
13
Lymphocytic Lymphoma
12
Chronic Graft Versus Host Disease
12
Arthritis
11
T-cell Lymphoma
11
Musculoskeletal Pain
11
Non-hodgkins Lymphoma Recurrent
11

Mabthera Case Reports

What Mabthera 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 Mabthera. 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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