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OXALIPLATIN

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Oxaliplatin Adverse Events Reported to the FDA Over Time

How are Oxaliplatin adverse event reports trending over time?

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

Most Common Oxaliplatin Adverse Events Reported to the FDA

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

Diarrhoea
1999 (3.84%)
Vomiting
1219 (2.34%)
Dehydration
1122 (2.16%)
Nausea
1117 (2.15%)
Pyrexia
829 (1.59%)
Neutropenia
722 (1.39%)
Dyspnoea
639 (1.23%)
Abdominal Pain
586 (1.13%)
Thrombocytopenia
564 (1.08%)
Death
498 (.96%)
Sepsis
466 (.9%)
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Asthenia
454 (.87%)
Fatigue
431 (.83%)
Haemoglobin Decreased
421 (.81%)
Disease Progression
415 (.8%)
Anaemia
407 (.78%)
Pneumonia
393 (.76%)
Hypotension
379 (.73%)
Febrile Neutropenia
368 (.71%)
General Physical Health Deteriorati...
364 (.7%)
Renal Failure Acute
360 (.69%)
Leukopenia
330 (.63%)
Interstitial Lung Disease
324 (.62%)
Pulmonary Embolism
324 (.62%)
Platelet Count Decreased
323 (.62%)
Hypokalaemia
321 (.62%)
Mucosal Inflammation
306 (.59%)
Neuropathy Peripheral
300 (.58%)
Respiratory Failure
291 (.56%)
Decreased Appetite
286 (.55%)
Renal Failure
278 (.53%)
White Blood Cell Count Decreased
267 (.51%)
Stomatitis
258 (.5%)
Infection
257 (.49%)
Septic Shock
249 (.48%)
Hypertension
236 (.45%)
Cardiac Arrest
226 (.43%)
Deep Vein Thrombosis
216 (.42%)
Atrial Fibrillation
215 (.41%)
Loss Of Consciousness
215 (.41%)
Chills
212 (.41%)
Pleural Effusion
211 (.41%)
Anorexia
209 (.4%)
Blood Creatinine Increased
206 (.4%)
Intestinal Perforation
206 (.4%)
Malaise
203 (.39%)
Chest Pain
200 (.38%)
Myocardial Infarction
197 (.38%)
Neutrophil Count Decreased
190 (.37%)
Dizziness
186 (.36%)
Ascites
183 (.35%)
Disseminated Intravascular Coagulat...
183 (.35%)
Ileus
181 (.35%)
Palmar-plantar Erythrodysaesthesia ...
179 (.34%)
Intestinal Obstruction
177 (.34%)
Gastrointestinal Haemorrhage
170 (.33%)
Hyponatraemia
169 (.32%)
Malignant Neoplasm Progression
162 (.31%)
Paraesthesia
160 (.31%)
Syncope
160 (.31%)
Confusional State
155 (.3%)
Hypersensitivity
153 (.29%)
Multi-organ Failure
152 (.29%)
Blood Potassium Decreased
151 (.29%)
Colitis
151 (.29%)
Fall
149 (.29%)
Small Intestinal Obstruction
148 (.28%)
Constipation
147 (.28%)
Dysphagia
146 (.28%)
Weight Decreased
145 (.28%)
Oesophagitis
144 (.28%)
Hypoaesthesia
143 (.27%)
Hepatic Failure
142 (.27%)
Back Pain
140 (.27%)
Cerebrovascular Accident
137 (.26%)
Pain
134 (.26%)
Gastrointestinal Perforation
132 (.25%)
Peritonitis
130 (.25%)
Pancytopenia
129 (.25%)
Tachycardia
129 (.25%)
Blood Sodium Decreased
128 (.25%)
Rash
127 (.24%)
Sudden Death
127 (.24%)
Infusion Related Reaction
125 (.24%)
Enteritis
124 (.24%)
Aspartate Aminotransferase Increase...
120 (.23%)
Blood Glucose Increased
120 (.23%)
Blood Bilirubin Increased
118 (.23%)
Erythema
117 (.22%)
Shock
115 (.22%)
Acute Respiratory Distress Syndrome
114 (.22%)
Alanine Aminotransferase Increased
112 (.22%)
Convulsion
112 (.22%)
Urinary Tract Infection
112 (.22%)
Cough
111 (.21%)
Dermatitis Acneiform
109 (.21%)
Hypoxia
108 (.21%)
Laryngospasm
108 (.21%)
Drug Toxicity
106 (.2%)
Peripheral Sensory Neuropathy
106 (.2%)
Arrhythmia
105 (.2%)

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

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

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

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

Colon Cancer
2205
Colorectal Cancer
2006
Colorectal Cancer Metastatic
1856
Rectal Cancer
1008
Colon Cancer Metastatic
568
Gastric Cancer
435
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Drug Use For Unknown Indication
415
Pancreatic Carcinoma
282
Chemotherapy
228
Large Intestine Carcinoma
200
Rectal Cancer Metastatic
181
Oesophageal Carcinoma
176
Non-small Cell Lung Cancer
120
Hepatic Neoplasm Malignant
111
Metastatic Gastric Cancer
110
Colon Cancer Stage Iii
99
Product Used For Unknown Indication
92
Pancreatic Carcinoma Metastatic
92
Bile Duct Cancer
91
Colon Cancer Recurrent
88
Neoplasm Malignant
86
Adenocarcinoma Pancreas
85
Gastrooesophageal Cancer
72
Metastases To Liver
71
Rectal Cancer Recurrent
64
Adenocarcinoma
64
Gastrointestinal Carcinoma
63
Oesophageal Adenocarcinoma
56
Diffuse Large B-cell Lymphoma
46
Lung Neoplasm Malignant
42
Ovarian Cancer
42
Colon Cancer Stage Iv
37
Colorectal Cancer Stage Iii
36
Neoplasm
33
Neuroendocrine Carcinoma
32
Non-hodgkins Lymphoma
30
Metastatic Neoplasm
30
Metastasis
29
Prostate Cancer
26
Oesophageal Cancer Metastatic
24
Rectosigmoid Cancer
22
Lymphoma
21
Colorectal Cancer Stage Iv
21
Gastrointestinal Cancer Metastatic
21
Pancreatic Neoplasm
17
Breast Cancer
15
B-cell Lymphoma
15
Metastases To Lung
14
Gallbladder Cancer
14
Neuroendocrine Tumour
13
Rectal Cancer Stage Iv
12

Drug Labels

LabelLabelerEffective
OxaliplatinAPP Pharmaceuticals, LLC31-JUL-09
Oxaliplatin For InjectionSUN PHARMA GLOBAL INC.24-AUG-09
OxaliplatinHospira Worldwide, Inc.28-NOV-11
OxaliplatinSandoz Inc06-APR-12
OxaliplatinAPP Pharmaceuticals, LLC30-MAY-12
OxaliplatinPfizer Laboratories Div Pfizer Inc.03-JUL-12
OxaliplatinTeva Parenteral Medicines, Inc10-AUG-12
OxaliplatinSun Pharma Global FZE06-SEP-12
Eloxatinsanofi-aventis U.S. LLC26-OCT-12
OxaliplatinSagent Pharmaceuticals27-NOV-12
OxaliplatinPfizer Laboratories Div Pfizer Inc.14-FEB-13

Oxaliplatin Case Reports

What Oxaliplatin 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 Oxaliplatin. 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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