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GEFITINIB

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Gefitinib Adverse Events Reported to the FDA Over Time

How are Gefitinib adverse event reports trending over time?

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

Most Common Gefitinib Adverse Events Reported to the FDA

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

Diarrhoea
49 (3.44%)
Interstitial Lung Disease
26 (1.82%)
Rash
24 (1.68%)
Dehydration
22 (1.54%)
Nausea
21 (1.47%)
Dyspnoea
20 (1.4%)
Pneumonia
20 (1.4%)
Vomiting
18 (1.26%)
Lethargy
17 (1.19%)
Malignant Neoplasm Progression
17 (1.19%)
Alanine Aminotransferase Increased
15 (1.05%)
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Anaemia
15 (1.05%)
Performance Status Decreased
14 (.98%)
Respiratory Failure
14 (.98%)
Thrombocytopenia
14 (.98%)
Fatigue
13 (.91%)
General Physical Health Deteriorati...
13 (.91%)
Asthenia
12 (.84%)
Convulsion
12 (.84%)
Hyponatraemia
11 (.77%)
Leukopenia
11 (.77%)
Renal Failure
11 (.77%)
Drug Toxicity
10 (.7%)
Fall
10 (.7%)
Hepatic Function Abnormal
10 (.7%)
Mucosal Inflammation
10 (.7%)
Aspartate Aminotransferase Increase...
9 (.63%)
Deep Vein Thrombosis
9 (.63%)
Depressed Level Of Consciousness
9 (.63%)
Disease Progression
9 (.63%)
Hepatic Enzyme Increased
9 (.63%)
Neutropenia
9 (.63%)
Skin Infection
9 (.63%)
Weight Decreased
9 (.63%)
Hypokalaemia
8 (.56%)
Pneumonitis
8 (.56%)
Pulmonary Embolism
8 (.56%)
Acute Myeloid Leukaemia
7 (.49%)
Dysphagia
7 (.49%)
Epistaxis
7 (.49%)
Haemoglobin Decreased
7 (.49%)
Headache
7 (.49%)
Hepatotoxicity
7 (.49%)
Impaired Self-care
7 (.49%)
Intestinal Obstruction
7 (.49%)
Lung Disorder
7 (.49%)
Pain
7 (.49%)
Pulmonary Toxicity
7 (.49%)
Skin Disorder
7 (.49%)
Somnolence
7 (.49%)
Stomatitis
7 (.49%)
Blood Alkaline Phosphatase Increase...
6 (.42%)
Blood Lactate Dehydrogenase Increas...
6 (.42%)
Death
6 (.42%)
Drug Interaction
6 (.42%)
Hemiparesis
6 (.42%)
Liver Function Test Abnormal
6 (.42%)
Lung Infiltration
6 (.42%)
Metastases To Central Nervous Syste...
6 (.42%)
Myocardial Infarction
6 (.42%)
Neutropenic Sepsis
6 (.42%)
Pleural Effusion
6 (.42%)
Pyrexia
6 (.42%)
Retroperitoneal Haemorrhage
6 (.42%)
Acne
5 (.35%)
Aphagia
5 (.35%)
Condition Aggravated
5 (.35%)
Decreased Appetite
5 (.35%)
Dizziness
5 (.35%)
Gamma-glutamyltransferase Increased
5 (.35%)
Gastrointestinal Haemorrhage
5 (.35%)
Haematuria
5 (.35%)
Haemoptysis
5 (.35%)
Hepatitis
5 (.35%)
Hyperlipidaemia
5 (.35%)
Hypotension
5 (.35%)
Lung Infection
5 (.35%)
Neoplasm Progression
5 (.35%)
Pain In Extremity
5 (.35%)
Platelet Count Decreased
5 (.35%)
Rectal Haemorrhage
5 (.35%)
Sinus Tachycardia
5 (.35%)
Abdominal Pain
4 (.28%)
Anorexia
4 (.28%)
Ascites
4 (.28%)
Back Pain
4 (.28%)
Blood Pressure Decreased
4 (.28%)
Blood Sodium Decreased
4 (.28%)
Chills
4 (.28%)
Contusion
4 (.28%)
Dermatitis Acneiform
4 (.28%)
Dyspepsia
4 (.28%)
Febrile Neutropenia
4 (.28%)
Fungal Skin Infection
4 (.28%)
Grand Mal Convulsion
4 (.28%)
Hepatic Fibrosis
4 (.28%)
Hepatic Necrosis
4 (.28%)
Hydronephrosis
4 (.28%)
Hyperglycaemia
4 (.28%)
Hypoxia
4 (.28%)
International Normalised Ratio Incr...
4 (.28%)

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

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

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

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

Non-small Cell Lung Cancer
118
Lung Adenocarcinoma
26
Glioblastoma Multiforme
24
Breast Cancer
13
Breast Cancer Metastatic
10
Lung Adenocarcinoma Stage Iv
9
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Lung Neoplasm Malignant
9
Prostate Cancer
9
Non-small Cell Lung Cancer Stage Iv
9
Neoplasm Malignant
7
Metastases To Liver
6
Chemotherapy
5
Chronic Myeloid Leukaemia
5
Adenocarcinoma
5
Colorectal Cancer
5
Metastatic Renal Cell Carcinoma
5
Glioma
4
Product Used For Unknown Indication
4
Ewings Sarcoma
3
Metastases To Central Nervous Syste...
3
Metastases To Bone
3
Malignant Ascites
3
Carcinoma
3
Chemotherapy Multiple Agents System...
2
Neoplasm Progression
2
Desmoplastic Small Round Cell Tumou...
2
Neuroblastoma
2
Lung Adenocarcinoma Stage Iii
2
Non-small Cell Lung Cancer Recurren...
2
Hepatic Neoplasm Malignant
2
Recurrent Cancer
2
Pancreatic Carcinoma
2
Metastatic Neoplasm
2
Squamous Cell Carcinoma
2
Lung Cancer Metastatic
1
Non-small Cell Lung Cancer Metastat...
1
Brain Neoplasm Malignant
1
Ovarian Cancer
1
Drug Use For Unknown Indication
1
Nasal Sinus Cancer
1
Hypopharyngeal Cancer
1
Bronchioloalveolar Carcinoma
1
Regional Chemotherapy
1
Renal Cell Carcinoma
1
Adenosquamous Cell Lung Cancer
1
Breast Cancer Female
1
Lung Adenocarcinoma Metastatic
1
Prostatic Specific Antigen Increase...
1
Non-small Cell Lung Cancer Stage Ii...
1
Metastatic Carcinoid Tumour
1
Rectal Cancer Metastatic
1

Drug Labels

LabelLabelerEffective
IressaAstraZeneca Pharmaceuticals LP17-FEB-10

Gefitinib Case Reports

What Gefitinib 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 Gefitinib. 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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