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XELODA

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Xeloda Adverse Events Reported to the FDA Over Time

How are Xeloda adverse event reports trending over time?

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

Most Common Xeloda Adverse Events Reported to the FDA

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

Diarrhoea
2265 (5.62%)
Death
1504 (3.73%)
Palmar-plantar Erythrodysaesthesia ...
1126 (2.79%)
Nausea
910 (2.26%)
Vomiting
908 (2.25%)
Dehydration
624 (1.55%)
Disease Progression
612 (1.52%)
Fatigue
525 (1.3%)
Pyrexia
450 (1.12%)
Decreased Appetite
415 (1.03%)
Stomatitis
397 (.99%)
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Malignant Neoplasm Progression
380 (.94%)
Mucosal Inflammation
372 (.92%)
Asthenia
355 (.88%)
Neutropenia
344 (.85%)
Dyspnoea
336 (.83%)
Abdominal Pain
324 (.8%)
Rash
270 (.67%)
Thrombocytopenia
270 (.67%)
Sepsis
266 (.66%)
Pulmonary Embolism
250 (.62%)
Renal Failure Acute
226 (.56%)
Weight Decreased
209 (.52%)
Pain
207 (.51%)
Anaemia
200 (.5%)
Erythema
200 (.5%)
Oedema Peripheral
196 (.49%)
General Physical Health Deteriorati...
195 (.48%)
Malaise
194 (.48%)
Skin Exfoliation
189 (.47%)
Pain In Extremity
185 (.46%)
Febrile Neutropenia
181 (.45%)
Renal Failure
180 (.45%)
Neuropathy Peripheral
177 (.44%)
Constipation
172 (.43%)
Dizziness
169 (.42%)
White Blood Cell Count Decreased
166 (.41%)
Hypotension
165 (.41%)
Paraesthesia
158 (.39%)
Platelet Count Decreased
157 (.39%)
Pneumonia
157 (.39%)
Chest Pain
155 (.38%)
Hypokalaemia
153 (.38%)
Leukopenia
152 (.38%)
Pancytopenia
139 (.35%)
Metastases To Liver
134 (.33%)
Abdominal Pain Upper
131 (.33%)
Neoplasm Malignant
129 (.32%)
Interstitial Lung Disease
126 (.31%)
Intestinal Obstruction
126 (.31%)
Convulsion
125 (.31%)
Deep Vein Thrombosis
124 (.31%)
Back Pain
120 (.3%)
Pleural Effusion
120 (.3%)
Arthralgia
118 (.29%)
Infection
118 (.29%)
Blood Bilirubin Increased
115 (.29%)
Bone Marrow Failure
114 (.28%)
Headache
112 (.28%)
Hypoaesthesia
112 (.28%)
Drug Interaction
110 (.27%)
Dry Skin
110 (.27%)
Breast Cancer Metastatic
109 (.27%)
Jaundice
109 (.27%)
Ascites
108 (.27%)
Hepatic Failure
107 (.27%)
Disseminated Intravascular Coagulat...
105 (.26%)
Multi-organ Failure
105 (.26%)
Septic Shock
105 (.26%)
Anorexia
102 (.25%)
Epistaxis
101 (.25%)
Drug Ineffective
100 (.25%)
Haemoglobin Decreased
100 (.25%)
Neutrophil Count Decreased
100 (.25%)
Hypertension
98 (.24%)
Colitis
96 (.24%)
Confusional State
96 (.24%)
Fall
96 (.24%)
Ileus
95 (.24%)
Dysphagia
93 (.23%)
Gait Disturbance
91 (.23%)
Blister
90 (.22%)
Pruritus
88 (.22%)
Cardiac Arrest
87 (.22%)
Dihydropyrimidine Dehydrogenase Def...
86 (.21%)
Drug Toxicity
84 (.21%)
Pulmonary Oedema
81 (.2%)
Thrombosis
81 (.2%)
Cerebrovascular Accident
80 (.2%)
Myocardial Infarction
79 (.2%)
Respiratory Failure
79 (.2%)
Skin Discolouration
79 (.2%)
Abdominal Distension
78 (.19%)
Anxiety
76 (.19%)
Gastrointestinal Haemorrhage
75 (.19%)
Breast Cancer
72 (.18%)
Cough
70 (.17%)
Hyponatraemia
70 (.17%)
Urinary Tract Infection
70 (.17%)
Insomnia
68 (.17%)
Pancreatitis
68 (.17%)

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

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

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

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

Breast Cancer
1742
Product Used For Unknown Indication
1066
Drug Use For Unknown Indication
948
Breast Cancer Metastatic
921
Colon Cancer
846
Colorectal Cancer
554
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Rectal Cancer
465
Gastrooesophageal Cancer
442
Gastric Cancer
378
Colorectal Cancer Metastatic
359
Colon Cancer Metastatic
248
Large Intestine Carcinoma
167
Pancreatic Carcinoma
154
Rectal Cancer Metastatic
127
Metastatic Gastric Cancer
100
Neoplasm Malignant
72
Breast Cancer Recurrent
60
Oesophageal Carcinoma
58
Colon Cancer Recurrent
53
Hepatic Neoplasm Malignant
52
Rectal Cancer Recurrent
47
Chemotherapy
40
Metastases To Bone
40
Gastrointestinal Carcinoma
39
Bile Duct Cancer
38
Adenocarcinoma
35
Colon Cancer Stage Iii
35
Metastases To Liver
32
Pancreatic Carcinoma Metastatic
30
Colon Cancer Stage Iv
27
Metastatic Neoplasm
21
Breast Cancer Stage Iv
17
Metastases To Lung
16
Lung Neoplasm Malignant
15
Breast Cancer Female
15
Neoplasm
15
Ovarian Cancer
14
Oesophageal Cancer Metastatic
12
Rectosigmoid Cancer
11
Renal Cell Carcinoma
11
Inflammatory Carcinoma Of The Breas...
10
Gastric Cancer Recurrent
10
Oesophageal Adenocarcinoma
9
Gallbladder Cancer
9
Small Intestine Carcinoma
8
Nasopharyngeal Cancer
8
Head And Neck Cancer
8
Metastasis
8
Metastases To Central Nervous Syste...
8
Neuroendocrine Tumour
7
Tumour Marker Increased
7

Drug Labels

LabelLabelerEffective
XelodaState of Florida DOH Central Pharmacy20-MAY-10
XelodaGenentech, Inc.17-FEB-11
XelodaPhysicians Total Care, Inc.07-JUN-12

Xeloda Case Reports

What Xeloda 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 Xeloda. 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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