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Erbitux (Cetuximab) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (1412)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Erbitux (Cetuximab) all cases. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 1412   Next >>

Possible Erbitux side effects in 72 year old male

Reported by a physician from United States on 2012-08-27

Patient: 72 year old male, weighing 67.4 kg (148.3 pounds)

Reactions: Syncope, Dysphagia, Dehydration, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cisplatin
    Dosage: 91 mg, every 3 weeks
    Indication: Head and Neck Cancer
    Start date: 2012-01-30

Erbitux
    Dosage: 455 mg, weekly
    Indication: Head and Neck Cancer
    Start date: 2012-01-09
    End date: 2012-04-16

Erbitux
    Dosage: 455 mg, weekly (1/w)
    Start date: 2012-05-07

Fluorouracil
    Dosage: 910 mg, per day for 4days q 3 weeks
    Indication: Head and Neck Cancer
    Start date: 2012-01-30

Other drugs received by patient: Trazodone; Metoprolol Tartrate and Hydrochlorothiazide; Magnesium Oxide; Minocycline Hydrochloride; Lorazepam; Dexamethasone; Pentoxifylline; Lorazepam; Ondansetron; Metformin; Rosuvastatin; Trazodone



Possible Erbitux side effects in 51 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 51 year old male

Reactions: Deafness Unilateral

Drug(s) suspected as cause:
Erbitux



Possible Erbitux side effects in 61 year old male

Reported by a physician from Germany on 2012-08-27

Patient: 61 year old male

Reactions: Superinfection Bacterial, Dermatitis, Radiation Skin Injury, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Metoprolol Tartrate; Novalgin; Spironolactone; Dexamethasone; Tepilta; Dynexan; Fenistil; Simvastatin; Lidocaine; Voltaren; Ranitidine; Acetylsalicylic Acid SRT



Possible Erbitux side effects in 61 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-27

Patient: 61 year old male, weighing 66.0 kg (145.2 pounds)

Reactions: Ileus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Fluorouracil; Oxaliplatin; Folinate



Possible Erbitux side effects in 73 year old male

Reported by a consumer/non-health professional from Germany on 2012-08-24

Patient: 73 year old male, weighing 62.0 kg (136.4 pounds)

Reactions: Paronychia, Dermatitis Acneiform, Pruritus, Seborrhoeic Dermatitis, DRY Skin, Altered State of Consciousness, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Levofloxacin



Possible Erbitux side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient: 60 year old female

Reactions: Aphthous Stomatitis, Renal Failure, Diarrhoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux
    Dosage: unk
    Indication: Colon Cancer
    Start date: 2012-03-05

Fluorouracil
    Dosage: unk
    Indication: Colon Cancer
    Start date: 2009-05-01

Irinotecan Hydrochloride
    Dosage: unk
    Indication: Colon Cancer
    Start date: 2010-05-01
    End date: 2012-04-02

Leucovorin Calcium
    Dosage: unk
    Indication: Colon Cancer
    Start date: 2009-05-01



Possible Erbitux side effects in 61 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-22

Patient: 61 year old male, weighing 105.0 kg (231.0 pounds)

Reactions: Leriche Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Leucovorin Calcium; Ramipril; Irinotecan Hydrochloride; Corticosteroid; Fluorouracil



Possible Erbitux side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-22

Patient: female, weighing 63.7 kg (140.1 pounds)

Reactions: Hypomagnesaemia, Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: 400 mg

Erbitux
    Dosage: 1200 mg

Taxol
    Dosage: 330 mg

Other drugs received by patient: Gabapentin; Iron; Pepcid; Atenolol; Prochlorperazine; Aspirin; M.v.i.; Nitroglycerin; Amlodipine; Calcium Carbonate; Hydromorphone HCL; Ondansetron; Alendronate Sodium; Vitamin D



Possible Erbitux side effects in 71 year old male

Reported by a pharmacist from Germany on 2012-08-22

Patient: 71 year old male

Reactions: Ileus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux
    Dosage: 30jan-30jan09-400mg/m2-1 in 1wk 09feb-ong-250mg/m2-1 in 1wk. inf
    Indication: Colon Cancer
    Start date: 2009-01-30
    End date: 2012-03-14

Irinotecan Hydrochloride
    Dosage: inf
    Indication: Colon Cancer
    Start date: 2009-01-30



Possible Erbitux side effects in 50 year old male

Reported by a consumer/non-health professional from Germany on 2012-08-21

Patient: 50 year old male

Reactions: Blood Pressure Increased, Blood Test Abnormal

Drug(s) suspected as cause:
Erbitux



Possible Erbitux side effects in male

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

Patient: male, weighing 88.9 kg (195.6 pounds)

Reactions: Vomiting, Nausea, Dehydration, Skin Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux



Possible Erbitux side effects in 61 year old male

Reported by a consumer/non-health professional from Germany on 2012-08-21

Patient: 61 year old male, weighing 96.0 kg (211.2 pounds)

Reactions: Arterial Thrombosis Limb

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Ramipril; Fluorouracil; Leucovorin Calcium; Corticosteroid; Irinotecan Hydrochloride



Possible Erbitux side effects in male

Reported by a individual with unspecified qualification from United States on 2012-08-20

Patient: male, weighing 77.3 kg (170.2 pounds)

Reactions: Weight Decreased, Oral Pain, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux



Possible Erbitux side effects in male

Reported by a physician from Japan on 2012-08-20

Patient: male, weighing 61.0 kg (134.2 pounds)

Reactions: Paronychia, Fatigue, Neuropathy Peripheral, Stomatitis, Diarrhoea, Hyperkalaemia, Hypomagnesaemia, Dermatitis Bullous, Neutrophil Count Decreased

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Irinotecan Hydrochloride; Leucovorin Calcium; Fluorouracil



Possible Erbitux side effects in 50 year old male

Reported by a physician from Germany on 2012-08-17

Patient: 50 year old male, weighing 55.0 kg (121.0 pounds)

Reactions: Gastrointestinal Haemorrhage

Drug(s) suspected as cause:
Erbitux



Possible Erbitux side effects in male

Reported by a physician from France on 2012-08-16

Patient: male

Reactions: Anaphylactic Shock, Headache, Hyperhidrosis, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Erbitux
    Dosage: 816mg single dose
    Indication: Tonsil Cancer
    Start date: 2012-07-24
    End date: 2012-07-24

Zofran
    Dosage: 8mg single dose
    Indication: Nausea
    Start date: 2012-07-24
    End date: 2012-07-24

Other drugs received by patient: Solu-Medrol; Polaramine



Possible Erbitux side effects in 80 year old male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 80 year old male, weighing 96.0 kg (211.2 pounds)

Reactions: White Blood Cell Count Decreased, Anaemia, Febrile Neutropenia, Platelet Count Decreased, Neutrophil Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cisplatin
    Dosage: 24aug10:55mg. delayed 8 dy dose reduced to 45mg.last dose on 08sep2010
    Indication: Oesophageal Adenocarcinoma
    Start date: 2010-07-27

Erbitux
    Dosage: 24aug10:570mg received 560 mg this course.last dose on 31aug2010.
    Indication: Oesophageal Adenocarcinoma
    Start date: 2010-07-27

Taxol
    Dosage: 24aug10:115mg. delayed 8 dy received 112mg this course.dose reduced to 90mg.last dose on 08sep2010
    Indication: Oesophageal Adenocarcinoma
    Start date: 2010-07-27



Possible Erbitux side effects in 73 year old male

Reported by a consumer/non-health professional from Germany on 2012-08-16

Patient: 73 year old male, weighing 91.0 kg (200.2 pounds)

Reactions: Amaurosis, Rash, Iritis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Pregabalin; Doxycycline HCL; Dexamethasone; Leucovorin Calcium; Fluorouracil; Flupirtine Maleate; Laxans; Glimepiride; Morphine Sulfate



Possible Erbitux side effects in 80 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-16

Patient: 80 year old female, weighing 53.0 kg (116.6 pounds)

Reactions: Femur Fracture, General Physical Health Deterioration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Granisetron; Folinate; Dextromethorphan Hydrobromide; Fluorouracil; Irinotecan HCL; Granisetron Hydrochloride; Corticosteroid; Ranitidine; Furosemide; Fenistil



Possible Erbitux side effects in female

Reported by a physician from Germany on 2012-08-15

Patient: female, weighing 77.0 kg (169.4 pounds)

Reactions: Infectious Pleural Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux
    Dosage: 250 mg/m2, unknown
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-06-19

Gemcitabine Hydrochloride
    Dosage: 1000 mg/m2, unknown
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-06-19

Other drugs received by patient: Metoclopramide; Ondansetron HCL



Possible Erbitux side effects in 63 year old female

Reported by a consumer/non-health professional from Israel on 2012-08-15

Patient: 63 year old female

Reactions: Platelet Count Decreased

Drug(s) suspected as cause:
Carboplatin
    Dosage: 100mg per m2
    Start date: 2012-06-14
    End date: 2012-06-24

Erbitux
    Dosage: total :890mg 5mg/ml is the strength last infu:19jun12
    Indication: Squamous Cell Carcinoma of THE Cervix
    Start date: 2012-06-19
    End date: 2012-06-24

Taxol
    Dosage: 50mg per m2
    Start date: 2012-06-14
    End date: 2012-06-24



Possible Erbitux side effects in 57 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-13

Patient: 57 year old male

Reactions: Acute Coronary Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux
    Dosage: dose:792 mg,09jul2012,28jun2012-stopped.
    Indication: Pharyngeal Neoplasm
    Start date: 2012-07-09

Fluorouracil
    Dosage: fluorouracil soln for injection. route:autofuseur.
    Indication: Pharyngeal Neoplasm
    Start date: 2012-07-09
    End date: 2012-07-14

Other drugs received by patient: Cisplatin



Possible Erbitux side effects in 69 year old female

Reported by a consumer/non-health professional from Germany on 2012-08-13

Patient: 69 year old female

Reactions: Blood Alkaline Phosphatase Increased, Blood Urea Increased, Gamma-Glutamyltransferase Increased, Alanine Aminotransferase Increased, Blood Calcium Increased, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Loratadine; Zocor; Simvastatin; Meloxicam; Dexamethasone; Irbesartan; Felodipine



Possible Erbitux side effects in 72 year old female

Reported by a physician from Italy on 2012-08-10

Patient: 72 year old female

Reactions: Febrile Neutropenia, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Irinotecan HCL



Possible Erbitux side effects in male

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

Patient: male

Reactions: Chest Discomfort, Nausea, Chills, Erythema, Chest Pain, Feeling Hot, Dizziness, Infusion Related Reaction

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Erbitux



Possible Erbitux side effects in 79 year old male

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

Patient: 79 year old male

Reactions: Confusional State, Chills, Tachycardia, Pyrexia, Fall, Viith Nerve Paralysis, Asthenia, Meningitis Aseptic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Vastarel; Acetaminophen; Pravastatin; Omeprazole; Acebutolol; Aspirin; Molsidomine; Amlodipine Besylate; Gaviscon; Imodium; Lorazepam; Furosemide; Prednisone TAB



Possible Erbitux side effects in 76 year old male

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

Patient: 76 year old male

Reactions: Confusional State, Transient Ischaemic Attack, Loss of Consciousness

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Irinotecan HCL



Possible Erbitux side effects in 66 year old male

Reported by a consumer/non-health professional from Germany on 2012-08-09

Patient: 66 year old male

Reactions: Prinzmetal Angina

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Irinotecan HCL



Possible Erbitux side effects in male

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

Patient: male

Reactions: Phlebitis, Neuropathy Peripheral, Pulmonary Embolism, Asthenia, Disease Progression

Drug(s) suspected as cause:
Avastin
    Indication: Colon Cancer
    Start date: 2008-06-18
    End date: 2008-09-12

Erbitux
    Start date: 2010-05-03
    End date: 2010-09-21

Other drugs received by patient: Leucovorin Calcium; Leucovorin Calcium; Leucovorin Calcium; Fluorouracil; Fluorouracil; Fluorouracil; Oxaliplatin; Irinotecan Hydrochloride; Irinotecan Hydrochloride



Possible Erbitux side effects in male

Reported by a physician from Germany on 2012-08-08

Patient: male

Reactions: Dermatitis Acneiform, Groin Abscess, Pelvic Abscess

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Fluorouracil; Granisetron; Sinseron; Polaramine; Dexamethasone Sodium Phosphate; Sodium Bicarbonate; Irinotecan HCL



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