This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Erbitux (Cetuximab) 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 (1412)
Death (139)
Life Threatening Events (89)
Disability (19)
Reports by Reaction Type
Rash (150),
Diarrhoea (84),
Dehydration (81),
Dyspnoea (74),
Nausea (70),
Vomiting (62),
Infusion Related Reaction (62),
Stomatitis (61),
Fatigue (50),
Acne (48),
Dermatitis Acneiform (45),
DRY Skin (44)
Below are a few examples of reports where side effects / adverse reactions may be related to Erbitux (Cetuximab). For a complete list or a specific selection of reports, please use the links above.
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 female
Reported by a consumer/non-health professional from Germany on 2012-08-08
Patient: female
Reactions: Dermatitis Acneiform, Impaired Healing, Wound Dehiscence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Erbitux
Other drugs received by patient: Granisetron; Irinotecan HCL; Polaramine; Dexamethasone Sodium Phosphate
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
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