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Cetuximab Adverse Events Reported to the FDA Over Time

How are Cetuximab adverse event reports trending over time?

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

Most Common Cetuximab Adverse Events Reported to the FDA

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

Dehydration
891 (3.15%)
Diarrhoea
823 (2.91%)
Nausea
678 (2.39%)
Vomiting
652 (2.3%)
Dyspnoea
482 (1.7%)
Neutropenia
474 (1.67%)
Pyrexia
452 (1.6%)
Pneumonia
443 (1.56%)
Fatigue
421 (1.49%)
Anaemia
385 (1.36%)
Pulmonary Embolism
382 (1.35%)
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Hypotension
369 (1.3%)
Mucosal Inflammation
367 (1.3%)
Febrile Neutropenia
364 (1.29%)
Thrombocytopenia
323 (1.14%)
Asthenia
296 (1.05%)
Sepsis
293 (1.03%)
Hypokalaemia
275 (.97%)
Abdominal Pain
260 (.92%)
Deep Vein Thrombosis
257 (.91%)
Dysphagia
247 (.87%)
Hypomagnesaemia
246 (.87%)
Malignant Neoplasm Progression
242 (.85%)
Haemoglobin Decreased
220 (.78%)
Hyponatraemia
206 (.73%)
Decreased Appetite
200 (.71%)
Respiratory Failure
184 (.65%)
General Physical Health Deteriorati...
183 (.65%)
Weight Decreased
177 (.62%)
Leukopenia
172 (.61%)
Pain
172 (.61%)
Stomatitis
171 (.6%)
Renal Failure
170 (.6%)
Rash
162 (.57%)
Anorexia
160 (.56%)
Infection
158 (.56%)
Renal Failure Acute
155 (.55%)
Death
153 (.54%)
White Blood Cell Count Decreased
147 (.52%)
Pleural Effusion
146 (.52%)
Syncope
144 (.51%)
Platelet Count Decreased
142 (.5%)
Atrial Fibrillation
136 (.48%)
Disease Progression
135 (.48%)
Hypoxia
129 (.46%)
Constipation
128 (.45%)
Confusional State
121 (.43%)
Chest Pain
119 (.42%)
Chills
115 (.41%)
Septic Shock
114 (.4%)
Hypocalcaemia
108 (.38%)
Dizziness
106 (.37%)
Infusion Related Reaction
106 (.37%)
Epistaxis
105 (.37%)
Pancytopenia
105 (.37%)
Neutrophil Count Decreased
103 (.36%)
Gastrointestinal Haemorrhage
100 (.35%)
Thrombosis
100 (.35%)
Blood Creatinine Increased
99 (.35%)
Pneumonitis
99 (.35%)
Tachycardia
97 (.34%)
Myocardial Infarction
94 (.33%)
Urinary Tract Infection
93 (.33%)
Cough
90 (.32%)
Oesophagitis
89 (.31%)
Dermatitis Acneiform
88 (.31%)
Haemoptysis
87 (.31%)
Aspartate Aminotransferase Increase...
86 (.3%)
Cellulitis
86 (.3%)
Hypersensitivity
85 (.3%)
Ileus
85 (.3%)
Staphylococcal Infection
85 (.3%)
Oedema Peripheral
79 (.28%)
Small Intestinal Obstruction
77 (.27%)
Blood Bilirubin Increased
71 (.25%)
Blood Magnesium Decreased
71 (.25%)
Mental Status Changes
70 (.25%)
Headache
68 (.24%)
Alanine Aminotransferase Increased
67 (.24%)
Cardio-respiratory Arrest
67 (.24%)
Cerebrovascular Accident
67 (.24%)
Anaphylactic Reaction
66 (.23%)
Ascites
66 (.23%)
Convulsion
66 (.23%)
Intestinal Obstruction
65 (.23%)
Pneumonia Aspiration
65 (.23%)
Fall
64 (.23%)
Haematocrit Decreased
62 (.22%)
Acute Myocardial Infarction
61 (.22%)
Blood Potassium Decreased
60 (.21%)
Cerebral Ischaemia
60 (.21%)
Hypertension
60 (.21%)
Lung Infiltration
60 (.21%)
Dermatitis
59 (.21%)
Loss Of Consciousness
59 (.21%)
Enteritis
58 (.2%)
Back Pain
55 (.19%)
Acute Respiratory Distress Syndrome
54 (.19%)
Blood Sodium Decreased
54 (.19%)
Electrolyte Imbalance
54 (.19%)
Multi-organ Failure
54 (.19%)

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

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

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

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

Non-small Cell Lung Cancer
2210
Head And Neck Cancer
1053
Colorectal Cancer Metastatic
959
Colorectal Cancer
518
Gastrooesophageal Cancer
431
Colon Cancer
304
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Squamous Cell Carcinoma
290
Oesophageal Carcinoma
228
Pancreatic Carcinoma
193
Neoplasm Malignant
164
Breast Cancer Metastatic
100
Non-small Cell Lung Cancer Metastat...
91
Rectal Cancer
91
Gastric Cancer
87
Cervix Carcinoma
77
Lung Cancer Metastatic
64
Colon Cancer Metastatic
61
Tonsil Cancer
58
Laryngeal Cancer
57
Metastatic Gastric Cancer
50
Transitional Cell Carcinoma
48
Tongue Neoplasm Malignant Stage Uns...
47
Bladder Cancer
41
Prostate Cancer
38
Anal Cancer
34
Oesophageal Adenocarcinoma
34
Hepatic Neoplasm Malignant
31
Lung Neoplasm Malignant
31
Neoplasm
27
Pharyngeal Cancer Stage Unspecified
26
Breast Cancer
25
Colon Cancer Stage Iii
25
Squamous Cell Carcinoma Of The Cerv...
25
Oesophageal Squamous Cell Carcinoma
22
Nasopharyngeal Cancer
20
Pancreatic Carcinoma Metastatic
20
Prostate Cancer Metastatic
20
Non-small Cell Lung Cancer Stage Iv
19
Oropharyngeal Cancer Stage Unspecif...
19
Bile Duct Cancer
18
Lip And/or Oral Cavity Cancer
17
Head And Neck Cancer Metastatic
17
Drug Use For Unknown Indication
17
Adenocarcinoma
16
Chemotherapy
16
Adenocarcinoma Pancreas
16
Metastases To Liver
15
Ovarian Cancer
15
Rectal Cancer Metastatic
12
Metastatic Squamous Cell Carcinoma
11
Astrocytoma
10

Drug Labels

LabelLabelerEffective
ErbituxImClone LLC04-MAR-13

Cetuximab Case Reports

What Cetuximab 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 Cetuximab. 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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