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ERLOTINIB

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Erlotinib Adverse Events Reported to the FDA Over Time

How are Erlotinib adverse event reports trending over time?

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

Most Common Erlotinib Adverse Events Reported to the FDA

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

Death
1294 (3.39%)
Diarrhoea
1192 (3.13%)
Rash
791 (2.07%)
Dehydration
671 (1.76%)
Anaemia
636 (1.67%)
Nausea
570 (1.5%)
Pneumonia
535 (1.4%)
Vomiting
531 (1.39%)
Dyspnoea
512 (1.34%)
Malignant Neoplasm Progression
474 (1.24%)
Disease Progression
473 (1.24%)
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Pyrexia
464 (1.22%)
Fatigue
458 (1.2%)
Pleural Effusion
399 (1.05%)
Decreased Appetite
395 (1.04%)
Haemoglobin Decreased
391 (1.03%)
Neoplasm Malignant
377 (.99%)
Asthenia
348 (.91%)
Pulmonary Embolism
337 (.88%)
Incorrect Dose Administered
334 (.88%)
General Physical Health Deteriorati...
260 (.68%)
Off Label Use
249 (.65%)
Abdominal Pain
248 (.65%)
Platelet Count Decreased
245 (.64%)
Hyponatraemia
231 (.61%)
Respiratory Failure
227 (.6%)
Hypotension
215 (.56%)
Interstitial Lung Disease
202 (.53%)
Confusional State
189 (.5%)
Constipation
188 (.49%)
White Blood Cell Count Decreased
186 (.49%)
Pain
182 (.48%)
Renal Failure Acute
176 (.46%)
Weight Decreased
173 (.45%)
Blood Bilirubin Increased
171 (.45%)
Non-small Cell Lung Cancer
169 (.44%)
Fall
167 (.44%)
Stomatitis
164 (.43%)
Thrombocytopenia
161 (.42%)
Hypoxia
160 (.42%)
Aspartate Aminotransferase Increase...
156 (.41%)
Infection
155 (.41%)
Hypokalaemia
154 (.4%)
Haemoptysis
152 (.4%)
Febrile Neutropenia
149 (.39%)
Dermatitis Acneiform
145 (.38%)
Ascites
144 (.38%)
Sepsis
144 (.38%)
Cough
142 (.37%)
Mucosal Inflammation
141 (.37%)
Dysphagia
140 (.37%)
Alanine Aminotransferase Increased
139 (.36%)
Oedema Peripheral
138 (.36%)
Chest Pain
137 (.36%)
Neutropenia
133 (.35%)
Deep Vein Thrombosis
129 (.34%)
Renal Failure
129 (.34%)
Gastrointestinal Haemorrhage
126 (.33%)
Blood Alkaline Phosphatase Increase...
118 (.31%)
Dizziness
118 (.31%)
Haematocrit Decreased
118 (.31%)
Hospitalisation
117 (.31%)
Mental Status Changes
115 (.3%)
Urinary Tract Infection
112 (.29%)
Convulsion
111 (.29%)
Malaise
109 (.29%)
Dry Skin
108 (.28%)
Pneumothorax
107 (.28%)
Atrial Fibrillation
105 (.28%)
Epistaxis
105 (.28%)
Blood Creatinine Increased
103 (.27%)
Hypertension
103 (.27%)
Lethargy
102 (.27%)
Headache
101 (.26%)
Back Pain
100 (.26%)
Hyperglycaemia
100 (.26%)
Lung Adenocarcinoma
100 (.26%)
Failure To Thrive
98 (.26%)
Neutrophil Count Decreased
97 (.25%)
Syncope
96 (.25%)
Metastases To Central Nervous Syste...
95 (.25%)
Pericardial Effusion
93 (.24%)
Blood Sodium Decreased
92 (.24%)
Hypophagia
92 (.24%)
Condition Aggravated
91 (.24%)
Anorexia
88 (.23%)
Hepatic Function Abnormal
88 (.23%)
Lung Neoplasm Malignant
88 (.23%)
Blood Glucose Increased
87 (.23%)
Cholangitis
87 (.23%)
Hypoalbuminaemia
87 (.23%)
Intestinal Obstruction
86 (.23%)
Atelectasis
85 (.22%)
Blood Albumin Decreased
84 (.22%)
Tachycardia
82 (.22%)
White Blood Cell Count Increased
82 (.22%)
Malignant Pleural Effusion
80 (.21%)
Paronychia
79 (.21%)
Pulmonary Oedema
78 (.2%)
Oesophagitis
77 (.2%)
International Normalised Ratio Incr...
76 (.2%)

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

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

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

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

Non-small Cell Lung Cancer
2638
Lung Carcinoma Cell Type Unspecifie...
864
Lung Neoplasm Malignant
656
Pancreatic Carcinoma
622
Lung Adenocarcinoma
538
Hepatic Neoplasm Malignant
436
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Pancreatic Carcinoma Metastatic
275
Adenocarcinoma Pancreas
183
Product Used For Unknown Indication
149
Non-small Cell Lung Cancer Metastat...
103
Ovarian Cancer
89
Oesophageal Carcinoma
89
Lung Squamous Cell Carcinoma Stage ...
87
Neoplasm Malignant
81
Colorectal Cancer Metastatic
77
Glioblastoma Multiforme
77
Head And Neck Cancer
57
Breast Cancer Metastatic
46
Glioblastoma
43
Renal Cell Carcinoma
41
Drug Use For Unknown Indication
37
Bile Duct Cancer
35
Colon Cancer Metastatic
34
Colorectal Cancer
33
Gastrointestinal Carcinoma
32
Squamous Cell Carcinoma
32
Colon Cancer
29
Breast Cancer
29
Bronchial Carcinoma
29
Non-small Cell Lung Cancer Stage Iv
29
Metastatic Neoplasm
26
Myelodysplastic Syndrome
24
Neoplasm
24
Lung Cancer Metastatic
20
Metastatic Renal Cell Carcinoma
20
Renal Cell Carcinoma Stage Unspecif...
19
Tonsil Cancer
16
Anaplastic Astrocytoma
16
Metastases To Lung
16
Rectal Cancer
14
Tracheal Cancer
14
Acute Myeloid Leukaemia
14
Glioma
13
Bronchioloalveolar Carcinoma
12
Tongue Neoplasm Malignant Stage Uns...
11
Adenocarcinoma
11
Non-small Cell Lung Cancer Stage Ii...
11
Brain Neoplasm Malignant
11
Lung Adenocarcinoma Metastatic
10
Lip And/or Oral Cavity Cancer
9
Gallbladder Cancer
9

Drug Labels

LabelLabelerEffective
TarcevaPhysicians Total Care, Inc.05-JAN-12
TarcevaGenentech, Inc.30-OCT-12

Erlotinib Case Reports

What Erlotinib 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 Erlotinib. 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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