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Iressa Adverse Events Reported to the FDA Over Time

How are Iressa adverse event reports trending over time?

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

Most Common Iressa Adverse Events Reported to the FDA

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

Diarrhoea
692 (3.53%)
Rash
479 (2.44%)
Interstitial Lung Disease
422 (2.15%)
Pyrexia
340 (1.73%)
Pneumonia
332 (1.69%)
Hepatic Function Abnormal
324 (1.65%)
Vomiting
315 (1.6%)
Nausea
308 (1.57%)
Dyspnoea
284 (1.45%)
Disease Progression
249 (1.27%)
Lung Disorder
228 (1.16%)
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Dehydration
216 (1.1%)
Liver Disorder
181 (.92%)
Anaemia
172 (.88%)
Anorexia
170 (.87%)
Alanine Aminotransferase Increased
164 (.84%)
Respiratory Failure
163 (.83%)
Aspartate Aminotransferase Increase...
149 (.76%)
Malignant Neoplasm Progression
142 (.72%)
Pleural Effusion
141 (.72%)
Asthenia
134 (.68%)
Fatigue
133 (.68%)
Cough
128 (.65%)
Dry Skin
117 (.6%)
Death
110 (.56%)
Drug Ineffective
104 (.53%)
Renal Failure
103 (.52%)
Hypoxia
102 (.52%)
Pulmonary Embolism
100 (.51%)
Pruritus
97 (.49%)
Platelet Count Decreased
90 (.46%)
Malaise
88 (.45%)
Condition Aggravated
87 (.44%)
Metastases To Central Nervous Syste...
87 (.44%)
White Blood Cell Count Decreased
86 (.44%)
Disseminated Intravascular Coagulat...
85 (.43%)
Hypotension
85 (.43%)
Abdominal Pain
84 (.43%)
General Physical Health Deteriorati...
84 (.43%)
Haemoptysis
79 (.4%)
Dizziness
78 (.4%)
Depressed Level Of Consciousness
77 (.39%)
Stomatitis
75 (.38%)
Thrombocytopenia
74 (.38%)
Blood Creatinine Increased
73 (.37%)
Sepsis
73 (.37%)
Headache
71 (.36%)
Decreased Appetite
70 (.36%)
Dysphagia
70 (.36%)
Febrile Neutropenia
67 (.34%)
Blood Lactate Dehydrogenase Increas...
66 (.34%)
Renal Failure Acute
66 (.34%)
Alopecia
65 (.33%)
Weight Decreased
65 (.33%)
Blood Alkaline Phosphatase Increase...
64 (.33%)
Haemoglobin Decreased
64 (.33%)
Infection
64 (.33%)
Fall
63 (.32%)
Abdominal Pain Upper
62 (.32%)
Confusional State
62 (.32%)
Constipation
61 (.31%)
Cystitis Haemorrhagic
59 (.3%)
Mucosal Inflammation
59 (.3%)
Cardiac Failure
58 (.3%)
Deep Vein Thrombosis
58 (.3%)
Pain
57 (.29%)
Pneumothorax
57 (.29%)
Urinary Tract Infection
57 (.29%)
Pneumonitis
56 (.29%)
Gastrointestinal Haemorrhage
55 (.28%)
Haematuria
54 (.28%)
Liver Function Test Abnormal
54 (.28%)
Blood Pressure Decreased
53 (.27%)
Hyponatraemia
53 (.27%)
Acute Respiratory Distress Syndrome
52 (.26%)
Haematemesis
50 (.25%)
Dermatitis Acneiform
49 (.25%)
Gamma-glutamyltransferase Increased
49 (.25%)
Oedema Peripheral
49 (.25%)
Acne
48 (.24%)
Hypokalaemia
48 (.24%)
Skin Ulcer
47 (.24%)
Muscular Weakness
45 (.23%)
Renal Impairment
45 (.23%)
Lung Neoplasm Malignant
44 (.22%)
Pulmonary Oedema
44 (.22%)
Skin Disorder
44 (.22%)
Pneumonia Bacterial
43 (.22%)
Staphylococcal Infection
43 (.22%)
Multi-organ Failure
42 (.21%)
Pulmonary Alveolar Haemorrhage
41 (.21%)
Cerebral Infarction
40 (.2%)
Leukopenia
40 (.2%)
Acute Respiratory Failure
39 (.2%)
Back Pain
39 (.2%)
Erythema
39 (.2%)
Lung Infiltration
39 (.2%)
Neutropenia
39 (.2%)
Chills
38 (.19%)
Lymphangiosis Carcinomatosa
38 (.19%)
Pericardial Effusion
38 (.19%)

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

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

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

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

Non-small Cell Lung Cancer
2044
Lung Adenocarcinoma
924
Lung Neoplasm Malignant
908
Squamous Cell Carcinoma
136
Adenocarcinoma
111
Lung Squamous Cell Carcinoma Stage ...
85
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Non-small Cell Lung Cancer Stage Iv
83
Breast Cancer
71
Neoplasm Malignant
67
Pancreatic Carcinoma
54
Non-small Cell Lung Cancer Recurren...
50
Lung Adenocarcinoma Stage Iv
50
Oesophageal Carcinoma
50
Oropharyngeal Cancer Stage Unspecif...
48
Prostate Cancer
44
Bronchioloalveolar Carcinoma
41
Carcinoma
37
Ovarian Cancer
34
Breast Cancer Metastatic
30
Bronchial Carcinoma
29
Non-small Cell Lung Cancer Metastat...
28
Lung Cancer Metastatic
25
Renal Cell Carcinoma Stage Unspecif...
24
Colorectal Cancer
24
Lung Adenocarcinoma Stage Iii
22
Glioblastoma Multiforme
22
Non-small Cell Lung Cancer Stage Ii...
22
Lung Adenocarcinoma Recurrent
21
Metastases To Central Nervous Syste...
21
Metastatic Renal Cell Carcinoma
21
Transitional Cell Carcinoma
20
Large Cell Carcinoma Of The Respira...
19
Adenosquamous Cell Lung Cancer
14
Small Cell Lung Cancer Stage Unspec...
13
Drug Use For Unknown Indication
13
Lip And/or Oral Cavity Cancer Recur...
13
Colon Cancer Metastatic
12
Chronic Obstructive Pulmonary Disea...
12
Pancreatic Carcinoma Metastatic
12
Hypopharyngeal Cancer
12
Lung Carcinoma Cell Type Unspecifie...
12
Metastatic Neoplasm
11
Head And Neck Cancer
11
Nasopharyngeal Cancer
11
Colorectal Cancer Metastatic
10
Tonsil Cancer
10
Glioblastoma
10
Neoplasm
10
Colon Cancer
9
Non-small Cell Lung Cancer Stage Ii
9
Tongue Neoplasm Malignant Stage Uns...
9

Drug Labels

LabelLabelerEffective
IressaAstraZeneca Pharmaceuticals LP17-FEB-10

Iressa Case Reports

What Iressa 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 Iressa. 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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