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Eloxatin (Oxaliplatin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Eloxatin (Oxaliplatin) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (271)
Death (57)
Life Threatening Events (30)
Disability (5)

Reports by Reaction Type

Death (26)Dyspnoea (25)Diarrhoea (23)Nausea (21)Abdominal Pain (18)Vomiting (17)Anaemia (15)Renal Failure Acute (12)Hypertension (12)Asthenia (12)Metabolic Acidosis (11)Thrombocytopenia (10)

Below are a few examples of reports where side effects / adverse reactions may be related to Eloxatin (Oxaliplatin). For a complete list or a specific selection of reports, please use the links above.

Possible Eloxatin side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female, weighing 67.3 kg (148.1 pounds)

Reactions: Drug Dose Omission, Vomiting, Headache, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Dosage: 664 mg

Eloxatin
    Dosage: 0 mg

Fluorouracil
    Dosage: 7392 mg

Leucovorin Calcium
    Dosage: 1408 mg

Other drugs received by patient: ...



Possible Eloxatin side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-21

Patient: female, weighing 79.8 kg (175.6 pounds)

Reactions: Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eloxatin
    Dosage: 153 mg
    End date: 2006-05-11

Fluorouracil
    Dosage: 720 mg
    End date: 2006-05-11

Leucovorin Calcium
    Dosage: 720 mg
    End date: 2006-05-11



Possible Eloxatin side effects in male

Reported by a physician from United States on 2012-08-16

Patient: male, weighing 95.0 kg (209.0 pounds)

Reactions: Haemorrhage, Gastrointestinal Stoma Complication, Tachycardia, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Dosage: 470 mg
    End date: 2012-06-26

Eloxatin
    Dosage: 144 mg
    End date: 2012-06-26

Fluorouracil
    Dosage: 4972 mg
    End date: 2012-06-26

Leucovorin Calcium
    Dosage: 860 mg
    End date: 2012-06-26



Possible Eloxatin side effects in female

Reported by a physician from United States on 2012-08-16

Patient: female, weighing 69.4 kg (152.7 pounds)

Reactions: Neutrophil Count Decreased

Drug(s) suspected as cause:
Eloxatin
    Dosage: 290 mg

Fluorouracil
    Dosage: 9480 mg



Possible Eloxatin side effects in male

Reported by a physician from United States on 2012-08-10

Patient: male, weighing 101.0 kg (222.2 pounds)

Reactions: Dysstasia, Gait Disturbance, Gaze Palsy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bevacizumab (Rhumab Vegf)
    Dosage: 512 mg

Eloxatin
    Dosage: 192 mg

Fluorouracil
    Dosage: 904 mg

Leucovorin Calcium
    Dosage: 904 mg

Other drugs received by patient: Filgrastim; Acyclovir; Docusate; Hydrochlorothiazide; Phenergan HCL



Possible Eloxatin side effects in 43 year old female

Reported by a consumer/non-health professional from Brazil on 2012-08-10

Patient: 43 year old female

Reactions: Organising Pneumonia, Respiratory Disorder, Respiratory Failure, Influenza

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Eloxatin

Other drugs received by patient: Leucovorin Calcium; Fluorouracil



Possible Eloxatin side effects in male

Reported by a physician from United States on 2012-08-06

Patient: male, weighing 103.6 kg (228.0 pounds)

Reactions: Blood Pressure Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bevacizumab (Rhumab Vegf)
    Dosage: 1036 mg

Eloxatin
    Dosage: 360 mg

Irinotecan Hydrochloride
    Dosage: 640 mg

Other drugs received by patient: Benicar; Toprol-XL



Possible Eloxatin side effects in male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-03

Patient: male

Reactions: Epilepsy

Drug(s) suspected as cause:
Eloxatin
    Dosage: route: infusion

Eloxatin
    Dosage: route: infusion
    Indication: Colorectal Cancer

Eloxatin
    Dosage: route: infusion
    Indication: Adjuvant Therapy

Eloxatin
    Dosage: route: infusion

Other drugs received by patient: Capecitabine



Possible Eloxatin side effects in 52 year old female

Reported by a consumer/non-health professional from Italy on 2012-08-03

Patient: 52 year old female

Reactions: Dermatitis Acneiform, Pruritus, Polyneuropathy

Drug(s) suspected as cause:
Eloxatin
    Indication: Colon Cancer
    Start date: 2011-09-28
    End date: 2012-03-12

Erbitux
    Dosage: 1 df:366 units nos,dose:200mg/m2 cyclical.
    Indication: Colon Cancer
    Start date: 2011-09-15
    End date: 2012-02-02

Other drugs received by patient: Fluorouracil; Leucovorin Calcium



Possible Eloxatin side effects in 43 year old female

Reported by a physician from Brazil on 2012-08-03

Patient: 43 year old female

Reactions: Organising Pneumonia, Respiratory Disorder, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eloxatin

Other drugs received by patient: Fluorouracil; Leucovorin Calcium



Possible Eloxatin side effects in male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-03

Patient: male

Reactions: Epilepsy

Drug(s) suspected as cause:
Eloxatin
    Dosage: route: infusion
    Indication: Adjuvant Therapy

Eloxatin
    Dosage: route: infusion

Eloxatin
    Dosage: route: infusion
    Indication: Colorectal Cancer

Eloxatin
    Dosage: route: infusion

Other drugs received by patient: Capecitabine



Possible Eloxatin side effects in female

Reported by a individual with unspecified qualification on 2012-08-02

Patient: female, weighing 57.3 kg (126.1 pounds)

Reactions: Diarrhoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bevacizumab (Rhumab Vegf)

Eloxatin

Fluorouracil
    Dosage: 660 mg by bolus injection 3960 mg by contionous infusion over 48 hours

Leucovorin Calcium



Possible Eloxatin side effects in 60 year old male

Reported by a physician from France on 2012-08-02

Patient: 60 year old male

Reactions: Device Related Infection, Catheter Site Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eloxatin
    Dosage: 85 mg/m2 every day
    Start date: 2012-05-12
    End date: 2012-05-15

Eloxatin
    Dosage: 85 mg/m2, in split daily doses for 3 days, alternating with fluorouracil, starting on day2
    Indication: Colorectal Cancer Metastatic
    Start date: 2012-03-22

Erbitux
    Dosage: 500 mg/m2, day1 (fisrt cycle)
    Indication: Colorectal Cancer Metastatic
    Start date: 2012-03-21

Fluorouracil
    Dosage: 2800 mg/m2 every day
    Start date: 2012-05-12
    End date: 2012-05-15

Fluorouracil
    Dosage: 500 mg/m2 every day (fourth cycle)
    Start date: 2012-05-11
    End date: 2012-05-11

Fluorouracil
    Dosage: 2800 mg/m2, in split daily doses for 3 days, alternating with oxaliplatin infusion, starting on day2
    Indication: Colorectal Cancer Metastatic
    Start date: 2012-03-22

Irinotecan Hydrochloride
    Dosage: 180 mg/m2, day2 (first cycle)
    Indication: Colorectal Cancer Metastatic
    Start date: 2012-03-22

Irinotecan Hydrochloride
    Dosage: 180 mg/m2 (fourth cycle)
    Start date: 2012-05-12
    End date: 2012-05-12



Possible Eloxatin side effects in male

Reported by a individual with unspecified qualification from United States on 2012-07-31

Patient: male, weighing 47.6 kg (104.7 pounds)

Reactions: Drug Dose Omission, Dyspnoea, Chest Pain, Amnesia, Delirium

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eloxatin
    Dosage: 110 mg

Fluorouracil
    Dosage: 470 mg

Other drugs received by patient: Benzodiazepine



Possible Eloxatin side effects in 83 year old female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 83 year old female, weighing 87.5 kg (192.6 pounds)

Reactions: Incorrect Dose Administered, Drug Interaction

Adverse event resulted in: death

Drug(s) suspected as cause:
Eloxatin



Possible Eloxatin side effects in female

Reported by a individual with unspecified qualification from United States on 2012-07-27

Patient: female, weighing 57.3 kg (126.1 pounds)

Reactions: Diarrhoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bevacizumab (Rhumab Vegf)
    Dosage: 286 mg

Eloxatin
    Dosage: 140 mg

Fluorouracil
    Dosage: 4620 mg, (660 mg by bolus injection;3960 mg by continuous infusion over 48 hours)

Leucovorin Calcium
    Dosage: 660 mg



Possible Eloxatin side effects in 45 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient: 45 year old female

Reactions: Fibrosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eloxatin
    Start date: 2011-12-13
    End date: 2011-12-13

Eloxatin
    Start date: 2012-06-06
    End date: 2012-06-06



Possible Eloxatin side effects in male

Reported by a physician from United Kingdom on 2012-07-25

Patient: male

Reactions: Epilepsy

Drug(s) suspected as cause:
Eloxatin
    Dosage: route: infusion
    Indication: Colorectal Cancer

Eloxatin
    Dosage: route: infusion

Eloxatin
    Dosage: route: infusion
    Indication: Adjuvant Therapy

Eloxatin
    Dosage: route: infusion

Other drugs received by patient: Capecitabine



Possible Eloxatin side effects in male

Reported by a consumer/non-health professional from United Kingdom on 2012-07-25

Patient: male

Reactions: Epilepsy

Drug(s) suspected as cause:
Eloxatin
    Dosage: route: infusion
    Indication: Adjuvant Therapy

Eloxatin
    Dosage: route: infusion

Eloxatin
    Dosage: route: infusion

Eloxatin
    Dosage: route: infusion
    Indication: Colorectal Cancer

Other drugs received by patient: Capecitabine



Possible Eloxatin side effects in 54 year old male

Reported by a pharmacist from United States on 2012-07-24

Patient: 54 year old male

Reactions: Electrocardiogram ST Segment Depression, Vomiting, Retching, Nausea, Tachycardia, Hyperhidrosis, Flushing, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eloxatin
    Indication: Colorectal Cancer
    Start date: 2012-05-07
    End date: 2012-05-07

Eloxatin
    Start date: 2012-05-21
    End date: 2012-05-21

Eloxatin
    Start date: 2012-06-11
    End date: 2012-06-11

Other drugs received by patient: Dexamethasone; Aloxi



Possible Eloxatin side effects in 73 year old male

Reported by a physician from United States on 2012-07-24

Patient: 73 year old male, weighing 82.7 kg (181.9 pounds)

Reactions: Peripheral Motor Neuropathy

Drug(s) suspected as cause:
Avastin
    Dosage: days 1, 15 total 413 mg given this course
    Start date: 2006-12-01
    End date: 2006-12-01

Avastin
    Dosage: days 1, 15
    Start date: 2006-11-17
    End date: 2006-11-17

Avastin
    Dosage: days 1, 15
    Indication: Colorectal Cancer
    Start date: 2006-06-02
    End date: 2006-06-02

Eloxatin
    Dosage: days 1, 15
    Indication: Colorectal Cancer
    Start date: 2006-06-02
    End date: 2006-06-02

Eloxatin
    Dosage: days 1, 15
    Start date: 2006-11-17
    End date: 2006-11-17

Irinotecan HCL
    Indication: Colorectal Cancer
    Start date: 2006-06-02
    End date: 2006-06-02

Irinotecan HCL
    Start date: 2006-11-17
    End date: 2006-11-17

Irinotecan HCL
    Dosage: total 228 mg given this course
    Start date: 2006-12-01
    End date: 2006-12-01

Other drugs received by patient: Ferrous Sulfate TAB; Hydrochlorothiazide; Potassium Chloride; Vasotec; Atorvastatin; Atenolol; Tamsulosin Hydrochloride



Possible Eloxatin side effects in 73 year old male

Reported by a physician from United States on 2012-07-24

Patient: 73 year old male, weighing 82.7 kg (181.9 pounds)

Reactions: Peripheral Motor Neuropathy

Drug(s) suspected as cause:
Avastin
    Dosage: days 1, 15
    Indication: Colorectal Cancer
    Start date: 2006-06-02
    End date: 2006-06-02

Avastin
    Dosage: days 1, 15 total 413 mg given this course
    Start date: 2006-12-01
    End date: 2006-12-01

Avastin
    Dosage: days 1, 15
    Start date: 2006-11-17
    End date: 2006-11-17

Eloxatin
    Dosage: days 1, 15
    Indication: Colorectal Cancer
    Start date: 2006-06-02
    End date: 2006-06-02

Eloxatin
    Dosage: days 1, 15
    Start date: 2006-11-17
    End date: 2006-11-17

Irinotecan HCL
    Start date: 2006-11-17
    End date: 2006-11-17

Irinotecan HCL
    Dosage: total 228 mg given this course
    Start date: 2006-12-01
    End date: 2006-12-01

Irinotecan HCL
    Indication: Colorectal Cancer
    Start date: 2006-06-02
    End date: 2006-06-02

Other drugs received by patient: Hydrochlorothiazide; Vasotec; Tamsulosin Hydrochloride; Atorvastatin; Ferrous Sulfate TAB; Potassium Chloride; Atenolol



Possible Eloxatin side effects in

Reported by a physician from United States on 2012-07-20

Patient:

Reactions: Portal Hypertension, Thrombocytopenia

Drug(s) suspected as cause:
Eloxatin



Possible Eloxatin side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-07-20

Patient: 73 year old female, weighing 75.0 kg (165.0 pounds)

Reactions: Speech Disorder, Anxiety, Neuropathy Peripheral, Visual Impairment, Respiratory Distress, Hypertension

Drug(s) suspected as cause:
Eloxatin

Other drugs received by patient: Kytril; Xeloda



Possible Eloxatin side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-07-19

Patient: 73 year old female, weighing 75.0 kg (165.0 pounds)

Reactions: Anxiety, Speech Disorder, Neuropathy Peripheral, Visual Impairment, Respiratory Distress, Hypertension

Drug(s) suspected as cause:
Eloxatin

Other drugs received by patient: Kytril; Xeloda



Possible Eloxatin side effects in female

Reported by a individual with unspecified qualification from United States on 2012-07-17

Patient: female, weighing 56.3 kg (123.9 pounds)

Reactions: Flushing, Vomiting, Chest Discomfort, ECG Signs of Myocardial Ischaemia, Nausea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eloxatin
    Dosage: 130 mg
    End date: 2012-06-11

Fluorouracil
    Dosage: 4327 mg
    End date: 2012-06-13

Leucovorin Calcium
    Dosage: 625 mg
    End date: 2012-06-11

Other drugs received by patient: Singulair; Aspirin; Xalitan; Crestor; Synthroid



Possible Eloxatin side effects in 72 year old male

Reported by a physician from United States on 2012-07-17

Patient: 72 year old male, weighing 65.0 kg (143.1 pounds)

Reactions: Death, Nausea, Hypotension, Asthenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Blinded Therapy
    Indication: Gastric Cancer
    Start date: 2012-01-27

Blinded Therapy
    End date: 2012-05-02

Eloxatin
    Indication: Gastric Cancer
    Start date: 2012-01-27
    End date: 2012-01-27

Eloxatin
    Start date: 2012-05-02
    End date: 2012-05-02

Fluorouracil
    Dosage: 400 mg/m2 iv bolus followed by 2400 mg/m2 continuous iv for 46-48 hours
    End date: 2012-05-02

Fluorouracil
    Dosage: 400 mg/m2 iv bolus followed by 2400 mg/m2 continuous iv for 46-48 hours
    Indication: Gastric Cancer
    Start date: 2012-01-27

Leucovorin Calcium
    Indication: Gastric Cancer
    Start date: 2012-01-27

Leucovorin Calcium
    End date: 2012-05-02

Other drugs received by patient: Lomotil; Atropine; Insulin Aspart; Sodium Chloride; Decadron; Diphenoxylate; Dextrose 5% and Sodium Chloride 0.45% IN Plastic Container; Octreotide Acetate; Kytril



Possible Eloxatin side effects in female

Reported by a physician from United States on 2012-07-16

Patient: female, weighing 69.9 kg (153.8 pounds)

Reactions: Ventricular Hypokinesia, Disseminated Intravascular Coagulation, Anaemia, Upper Gastrointestinal Haemorrhage, Ventricular Fibrillation, Cardiac Arrest, Myocardial Infarction, Intracardiac Thrombus, Retroperitoneal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eloxatin
    Dosage: 150mg

Taxotere
    Dosage: 105 mg

Xeloda
    Dosage: 11500 mg



Possible Eloxatin side effects in 72 year old male

Reported by a physician from United States on 2012-07-13

Patient: 72 year old male, weighing 65.0 kg (143.1 pounds)

Reactions: Death, Nausea, Hypotension, Asthenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Blinded Therapy
    End date: 2012-05-02

Blinded Therapy
    Indication: Gastric Cancer
    Start date: 2012-01-27

Eloxatin
    Start date: 2012-05-02
    End date: 2012-05-02

Eloxatin
    Indication: Gastric Cancer
    Start date: 2012-01-27
    End date: 2012-01-27

Fluorouracil
    Dosage: 400 mg/m2 iv bolus followed by 2400 mg/m2 continuous iv for 46-48 hours
    Indication: Gastric Cancer
    Start date: 2012-01-27

Fluorouracil
    Dosage: 400 mg/m2 iv bolus followed by 2400 mg/m2 continuous iv for 46-48 hours
    End date: 2012-05-02

Leucovorin Calcium
    Indication: Gastric Cancer
    Start date: 2012-01-27

Leucovorin Calcium
    End date: 2012-05-02

Other drugs received by patient: Dextrose 5% and Sodium Chloride 0.45% IN Plastic Container; Kytril; Lomotil; Sodium Chloride; Decadron; Octreotide Acetate



Possible Eloxatin side effects in 49 year old male

Reported by a physician from Italy on 2012-07-13

Patient: 49 year old male

Reactions: Metabolic Acidosis, Hyperkalaemia, Intravascular Haemolysis, Anaemia, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: 100 mg, daily
    Administration route: Oral
    Start date: 2012-01-01

Eloxatin
    Dosage: 140 mg, total
    Indication: Colon Cancer
    Start date: 2012-05-09
    End date: 2012-05-09

Ketorolac Tromethamine
    Dosage: 1 df (30 mg/ml), total
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-10
    End date: 2012-05-10

Leucovorin Calcium
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-11
    End date: 2012-05-11

Levofloxacin
    Dosage: 500 mg (one dose form), daily
    Administration route: Oral
    Indication: Pyrexia
    Start date: 2012-05-09
    End date: 2012-05-19

Ramipril
    Dosage: 2.5 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-01-01
    End date: 2012-05-09

Other drugs received by patient: Erythropoietin; Fluorouracil; Esomeprazole

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