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ERBITUX

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Erbitux Adverse Events Reported to the FDA Over Time

How are Erbitux adverse event reports trending over time?

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

Most Common Erbitux Adverse Events Reported to the FDA

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

Rash
913 (3.49%)
Infusion Related Reaction
655 (2.51%)
Diarrhoea
622 (2.38%)
Dyspnoea
594 (2.27%)
Nausea
533 (2.04%)
Dehydration
494 (1.89%)
Vomiting
492 (1.88%)
Hypotension
401 (1.53%)
Dermatitis Acneiform
382 (1.46%)
Pyrexia
355 (1.36%)
Pruritus
283 (1.08%)
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Hypersensitivity
270 (1.03%)
Mucosal Inflammation
258 (.99%)
Fatigue
254 (.97%)
Anaphylactic Reaction
244 (.93%)
Chills
228 (.87%)
Hypomagnesaemia
227 (.87%)
Stomatitis
220 (.84%)
Pneumonia
207 (.79%)
Erythema
204 (.78%)
Dysphagia
203 (.78%)
Death
198 (.76%)
White Blood Cell Count Decreased
198 (.76%)
Asthenia
182 (.7%)
Decreased Appetite
181 (.69%)
Neutropenia
179 (.68%)
Anaemia
173 (.66%)
Abdominal Pain
158 (.6%)
Acne
156 (.6%)
Haemoglobin Decreased
156 (.6%)
Flushing
151 (.58%)
Febrile Neutropenia
150 (.57%)
Malignant Neoplasm Progression
149 (.57%)
Sepsis
149 (.57%)
Loss Of Consciousness
148 (.57%)
Blood Pressure Decreased
144 (.55%)
Platelet Count Decreased
144 (.55%)
Hypokalaemia
143 (.55%)
Weight Decreased
143 (.55%)
Urticaria
142 (.54%)
Pulmonary Embolism
136 (.52%)
Pain
135 (.52%)
Neutrophil Count Decreased
133 (.51%)
Chest Pain
130 (.5%)
Dizziness
129 (.49%)
Thrombocytopenia
126 (.48%)
Cardio-respiratory Arrest
121 (.46%)
Oxygen Saturation Decreased
117 (.45%)
Tachycardia
113 (.43%)
Dry Skin
112 (.43%)
Headache
110 (.42%)
Hyponatraemia
110 (.42%)
Renal Failure Acute
105 (.4%)
Malaise
103 (.39%)
Respiratory Failure
101 (.39%)
Infection
94 (.36%)
Hypocalcaemia
92 (.35%)
Anorexia
90 (.34%)
Chest Discomfort
87 (.33%)
Deep Vein Thrombosis
87 (.33%)
Myocardial Infarction
87 (.33%)
Convulsion
83 (.32%)
Hyperhidrosis
83 (.32%)
Cough
82 (.31%)
Respiratory Arrest
81 (.31%)
Blood Magnesium Decreased
80 (.31%)
Renal Failure
80 (.31%)
Oesophagitis
79 (.3%)
Atrial Fibrillation
78 (.3%)
Cardiac Arrest
77 (.29%)
Confusional State
77 (.29%)
Back Pain
75 (.29%)
Coma
75 (.29%)
Hypertension
75 (.29%)
Neoplasm Malignant
75 (.29%)
Cerebrovascular Accident
74 (.28%)
Syncope
74 (.28%)
Fall
73 (.28%)
Oedema Peripheral
71 (.27%)
Pneumonitis
68 (.26%)
Skin Exfoliation
68 (.26%)
Extravasation
67 (.26%)
Septic Shock
66 (.25%)
Hypoxia
65 (.25%)
Pleural Effusion
65 (.25%)
Radiation Skin Injury
65 (.25%)
Rash Pustular
65 (.25%)
Interstitial Lung Disease
64 (.24%)
Paronychia
64 (.24%)
Urinary Tract Infection
61 (.23%)
Constipation
59 (.23%)
Medication Error
59 (.23%)
Oral Pain
59 (.23%)
Blood Creatinine Increased
58 (.22%)
Skin Reaction
58 (.22%)
Disease Progression
56 (.21%)
Pancytopenia
56 (.21%)
Skin Disorder
56 (.21%)
Hypoalbuminaemia
55 (.21%)
Rash Generalised
55 (.21%)
Skin Fissures
55 (.21%)

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

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

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

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

Colon Cancer
985
Head And Neck Cancer
831
Colorectal Cancer
727
Colorectal Cancer Metastatic
691
Colon Cancer Metastatic
481
Non-small Cell Lung Cancer
458
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Neoplasm Malignant
457
Rectal Cancer
342
Squamous Cell Carcinoma
183
Tonsil Cancer
130
Tongue Neoplasm Malignant Stage Uns...
124
Oesophageal Adenocarcinoma
83
Laryngeal Cancer
77
Oesophageal Carcinoma
73
Pancreatic Carcinoma
69
Lung Neoplasm Malignant
68
Rectal Cancer Metastatic
65
Colorectal Cancer Recurrent
55
Colon Cancer Stage Iv
46
Oropharyngeal Cancer Stage Unspecif...
40
Cervix Carcinoma
40
Pharyngeal Cancer Stage Unspecified
39
Anal Cancer
37
Hypopharyngeal Cancer
34
Gastric Cancer
31
Breast Cancer Metastatic
30
Drug Use For Unknown Indication
30
Lip And/or Oral Cavity Cancer
30
Metastases To Liver
29
Gastrooesophageal Cancer
25
Oesophageal Squamous Cell Carcinoma
25
Lung Cancer Metastatic
23
Nasopharyngeal Cancer
20
Throat Cancer
20
Hepatic Neoplasm Malignant
19
Metastases To Lung
18
Neoplasm
17
Pancreatic Carcinoma Metastatic
15
Breast Cancer
15
Colorectal Cancer Stage Iv
15
Metastatic Neoplasm
13
Colon Cancer Stage Iii
13
Rectosigmoid Cancer
13
Chemotherapy
13
Large Intestine Carcinoma
12
Carcinoma
12
Squamous Cell Carcinoma Of The Cerv...
11
Adenocarcinoma
10
Colon Cancer Recurrent
10
Adenocarcinoma Of The Cervix
10
Gastrointestinal Carcinoma
9

Drug Labels

LabelLabelerEffective
ErbituxImClone LLC04-MAR-13

Erbitux Case Reports

What Erbitux 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 Erbitux. 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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