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Tocilizumab Adverse Events Reported to the FDA Over Time

How are Tocilizumab adverse event reports trending over time?

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

Most Common Tocilizumab Adverse Events Reported to the FDA

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

Pneumonia
205 (1.58%)
Drug Ineffective
155 (1.19%)
Histiocytosis Haematophagic
143 (1.1%)
Arthralgia
139 (1.07%)
Urinary Tract Infection
129 (.99%)
Hypertension
124 (.95%)
Pain
124 (.95%)
Cellulitis
122 (.94%)
Sepsis
114 (.88%)
Interstitial Lung Disease
113 (.87%)
Hepatic Function Abnormal
112 (.86%)
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Rheumatoid Arthritis
112 (.86%)
Death
108 (.83%)
Pyrexia
108 (.83%)
Anaemia
99 (.76%)
Diarrhoea
98 (.75%)
Bronchitis
90 (.69%)
Platelet Count Decreased
86 (.66%)
Pruritus
86 (.66%)
Nasopharyngitis
84 (.65%)
White Blood Cell Count Decreased
82 (.63%)
Cardiac Failure
81 (.62%)
Upper Respiratory Tract Inflammatio...
80 (.62%)
Renal Failure Acute
79 (.61%)
Oedema Peripheral
77 (.59%)
Myocardial Infarction
75 (.58%)
Headache
70 (.54%)
Pain In Extremity
69 (.53%)
Rash
68 (.52%)
Malaise
66 (.51%)
Nausea
66 (.51%)
Pleural Effusion
63 (.48%)
Disseminated Intravascular Coagulat...
62 (.48%)
Skin Ulcer
62 (.48%)
Blood Cholesterol Increased
60 (.46%)
C-reactive Protein Increased
59 (.45%)
Fatigue
58 (.45%)
Abdominal Pain
56 (.43%)
Pulmonary Embolism
56 (.43%)
Hyperlipidaemia
54 (.42%)
Cerebral Infarction
53 (.41%)
Septic Shock
53 (.41%)
Deep Vein Thrombosis
52 (.4%)
Pleurisy
51 (.39%)
Chest Pain
50 (.38%)
Enterocolitis
50 (.38%)
Breast Cancer
49 (.38%)
Dyspnoea
49 (.38%)
Cerebrovascular Accident
48 (.37%)
Gastrointestinal Haemorrhage
48 (.37%)
Weight Increased
48 (.37%)
Infection
47 (.36%)
Liver Disorder
47 (.36%)
Peritonitis
47 (.36%)
Renal Failure
47 (.36%)
Vomiting
47 (.36%)
Cough
45 (.35%)
Pneumocystis Jiroveci Pneumonia
45 (.35%)
Multi-organ Failure
44 (.34%)
Aspartate Aminotransferase Increase...
43 (.33%)
Gastroenteritis
43 (.33%)
Hypersensitivity
42 (.32%)
Respiratory Failure
41 (.32%)
Arthropathy
40 (.31%)
Colitis Ulcerative
40 (.31%)
Diabetes Mellitus
40 (.31%)
Fall
40 (.31%)
Hypertriglyceridaemia
40 (.31%)
Pancytopenia
40 (.31%)
Dizziness
39 (.3%)
Asthenia
38 (.29%)
Lymphoma
38 (.29%)
Decreased Appetite
37 (.28%)
Arthritis
36 (.28%)
Ascites
36 (.28%)
Colitis
36 (.28%)
Neutropenia
36 (.28%)
Large Intestine Perforation
35 (.27%)
Thrombosis
35 (.27%)
Abortion Spontaneous
34 (.26%)
Acute Respiratory Distress Syndrome
34 (.26%)
Atrial Fibrillation
34 (.26%)
Hypercholesterolaemia
34 (.26%)
Leukopenia
34 (.26%)
Therapeutic Response Decreased
34 (.26%)
Sinusitis
33 (.25%)
Transient Ischaemic Attack
33 (.25%)
Weight Decreased
33 (.25%)
Constipation
32 (.25%)
Lymphocyte Count Decreased
32 (.25%)
Vasculitis
32 (.25%)
Chronic Obstructive Pulmonary Disea...
31 (.24%)
Colitis Ischaemic
31 (.24%)
Dysphonia
31 (.24%)
Lung Neoplasm Malignant
31 (.24%)
Renal Impairment
31 (.24%)
Hypoaesthesia
30 (.23%)
Iron Deficiency Anaemia
30 (.23%)
White Blood Cell Count Increased
30 (.23%)
Chills
29 (.22%)
Gait Disturbance
29 (.22%)

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

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

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

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

Rheumatoid Arthritis
2229
Juvenile Arthritis
114
Castlemans Disease
107
Product Used For Unknown Indication
61
Pancreatic Carcinoma Non-resectable
23
Drug Use For Unknown Indication
12
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Stills Disease Adult Onset
12
Polyarthritis
7
Pancreatic Carcinoma
5
Seronegative Arthritis
4
Musculoskeletal Pain
3
Systemic Lupus Erythematosus
3
Ankylosing Spondylitis
3
Drug Exposure During Pregnancy
2
Takayasus Arteritis
2
Polymyalgia Rheumatica
1
Erythema Nodosum
1
Systemic Sclerosis
1
Temporal Arteritis
1
Feltys Syndrome
1
Retroperitoneal Fibrosis
1

Drug Labels

LabelLabelerEffective
ActemraGenentech, Inc.24-OCT-12

Tocilizumab Case Reports

What Tocilizumab 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 Tocilizumab. 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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