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Erbitux (Cetuximab) - Stomatitis - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Stomatitis (61)

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

 Reports 1 - 30 of 61   Next >>

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 70 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient: 70 year old female, weighing 71.0 kg (156.2 pounds)

Reactions: Stomatitis, Radiation Injury, Oral Pain, Odynophagia, Thermal Burn

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dermoplast

Taxotere
    Dosage: 1st course docetaxel 30-mar-2005. weeks 2-7 docetaxel weekly 15 mg/m2. total dose:26.1mg
    Indication: Head and Neck Cancer
    Start date: 2005-05-10
    End date: 2005-05-10

Erbitux
    Dosage: 1st course:30-mar-2005. week 1 loading dose400 mg/m2. weeks 2-7, weekly 250 mg/m2. totaldose:435mg
    Indication: Head and Neck Cancer
    Start date: 2005-05-10
    End date: 2005-05-10

Other drugs received by patient: Colace; Cytomel; Allegra; Atenolol; Morphine Sulfate; Levaquin; Celebrex



Possible Erbitux side effects in male

Reported by a physician from United States on 2012-07-09

Patient: male, weighing 100.5 kg (221.0 pounds)

Reactions: Stomatitis, Dysphagia, Anal Abscess, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux



Possible Erbitux side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-07-09

Patient: 60 year old female

Reactions: Asthma, Pruritus, Tinnitus, Bone Pain, Urticaria, Headache, Muscle Tightness, Erythema, Lower Respiratory Tract Infection, Gastritis, Myalgia, Tongue Disorder, Dysphagia, Stomatitis, Skin Disorder, DRY Skin, Diarrhoea, Insomnia, Vision Blurred, Energy Increased

Drug(s) suspected as cause:
Erbitux
    Dosage: therapy dt:21mar,27mar,10apr12
    Indication: Breast Cancer
    Start date: 2012-03-13

Decadron



Possible Erbitux side effects in male

Reported by a consumer/non-health professional from Germany on 2012-07-06

Patient: male, weighing 62.0 kg (136.4 pounds)

Reactions: Stomatitis, Hyperammonaemia, Acne, DRY Skin

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fluorouracil
    Dosage: 19 cycles(500mg),iv bolus 19 cycles(3340mg),iv drip 19th cycle on 26apr12
    Indication: Colorectal Cancer Recurrent

Leucovorin Calcium
    Dosage: 19th cycle on 26apr12
    Indication: Colorectal Cancer Recurrent

Erbitux
    Dosage: 19th cycle on 26apr12
    Indication: Colorectal Cancer Recurrent
    Start date: 2011-07-07

Other drugs received by patient: BIO-Three; Antebate; Loxoprofen; Lansoprazole; Hirudoid; Dexaltin; Hirudoid



Possible Erbitux side effects in 68 year old male

Reported by a consumer/non-health professional from United States on 2012-07-02

Patient: 68 year old male, weighing 59.0 kg (129.8 pounds)

Reactions: Stomatitis, Recall Phenomenon

Drug(s) suspected as cause:
Cisplatin
    Dosage: last dose: 30-nov-2004
    Indication: Head and Neck Cancer
    Start date: 2004-11-09

Erbitux
    Dosage: no of course: 4 last dose:30nov04 loading dose:668mg
    Indication: Head and Neck Cancer
    Start date: 2004-11-04

Other drugs received by patient: Amifostine



Possible Erbitux side effects in 68 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-02

Patient: 68 year old male, weighing 59.0 kg (129.8 pounds)

Reactions: Stomatitis, Radiation Injury

Drug(s) suspected as cause:
Erbitux
    Dosage: no of course: 4 last dose:30nov04 loading dose:668mg
    Indication: Head and Neck Cancer
    Start date: 2004-11-04

Cisplatin
    Dosage: last dose: 30-nov-2004
    Indication: Head and Neck Cancer
    Start date: 2004-11-09

Other drugs received by patient: Amifostine



Possible Erbitux side effects in 69 year old male

Reported by a physician from Japan on 2012-06-27

Patient: 69 year old male, weighing 49.0 kg (107.8 pounds)

Reactions: Paronychia, Dysgeusia, Stomatitis, Diarrhoea, Acne, Decreased Appetite

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Fluorouracil
    Dosage: iv bolus 19mar-2apr12-600mg 1in2wk
    Indication: Colon Cancer
    Start date: 2012-03-05
    End date: 2012-04-02

Oxaliplatin
    Indication: Colon Cancer
    Start date: 2012-03-05
    End date: 2012-04-02

Erbitux
    Dosage: 12mar-2apr12 dose reduced to 375mg recent inf 2apr12
    Indication: Colon Cancer
    Start date: 2012-03-05
    End date: 2012-03-05

Leucovorin Calcium
    Indication: Colon Cancer
    Start date: 2012-03-05
    End date: 2012-04-02



Possible Erbitux side effects in 68 year old female

Reported by a consumer/non-health professional from Germany on 2012-06-19

Patient: 68 year old female

Reactions: Stomatitis, Diarrhoea, Febrile Neutropenia, Platelet Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux
    Dosage: last inf prior to event on 21oct11 (43d) and stopped re-intro on an unkn date
    Indication: Colon Cancer
    Start date: 2011-09-08

Irinotecan HCL
    Indication: Colon Cancer
    Start date: 2011-09-08
    End date: 2011-11-21



Possible Erbitux side effects in 68 year old female

Reported by a consumer/non-health professional from Germany on 2012-06-15

Patient: 68 year old female

Reactions: Stomatitis, Diarrhoea, Febrile Neutropenia, Platelet Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux
    Dosage: last inf prior to event on 21oct11 (43d) and stopped re-intro on an unkn date
    Indication: Colon Cancer
    Start date: 2011-09-08

Irinotecan HCL
    Indication: Colon Cancer
    Start date: 2011-09-08
    End date: 2011-10-21



Possible Erbitux side effects in 61 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-15

Patient: 61 year old male, weighing 65.0 kg (143.0 pounds)

Reactions: Vomiting, Dysphagia, Stomatitis, Nausea, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux
    Dosage: no of course: 1; last admin on 21may12; first 5cyc (d1,8,15,22,29); last cyc d36 was held.
    Indication: Oesophageal Adenocarcinoma
    Start date: 2012-04-23

Taxol
    Dosage: no of course: 1; last admin on 21may12; first 5cyc (d1,8,15,22,29); last cyc d36 was held.
    Indication: Oesophageal Adenocarcinoma
    Start date: 2012-04-23

Cisplatin
    Dosage: no of course: 1; last admin on 21may12; first 5cyc (d1,8,15,22,29); last cyc d36 was held.
    Indication: Oesophageal Adenocarcinoma
    Start date: 2012-04-23



Possible Erbitux side effects in 69 year old male

Reported by a consumer/non-health professional from Japan on 2012-06-08

Patient: 69 year old male, weighing 49.0 kg (107.8 pounds)

Reactions: Paronychia, Dysgeusia, Stomatitis, Diarrhoea, Acne, Decreased Appetite

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Leucovorin Calcium
    Indication: Colon Cancer
    Start date: 2012-03-05
    End date: 2012-04-02

Erbitux
    Dosage: 12mar-2apr12 dose reduced to 375mg recent inf 2apr12
    Indication: Colon Cancer
    Start date: 2012-03-05
    End date: 2012-03-05

Oxaliplatin
    Indication: Colon Cancer
    Start date: 2012-03-05
    End date: 2012-04-02

Fluorouracil
    Dosage: iv bolus 19mar-2apr12-600mg 1in2wk
    Indication: Colon Cancer
    Start date: 2012-03-05
    End date: 2012-04-02



Possible Erbitux side effects in male

Reported by a consumer/non-health professional from Germany on 2012-06-06

Patient: male, weighing 62.0 kg (136.4 pounds)

Reactions: Stomatitis, Hyperammonaemia, Acne, DRY Skin

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fluorouracil
    Dosage: 19 cycles(500mg),iv bolus 19 cycles(3340mg),iv drip 19th cycle on 26apr12
    Indication: Colorectal Cancer Recurrent

Leucovorin Calcium
    Dosage: 19th cycle on 26apr12
    Indication: Colorectal Cancer Recurrent

Erbitux
    Dosage: 19th cycle on 26apr12
    Indication: Colorectal Cancer Recurrent

Other drugs received by patient: Loxoprofen; Hirudoid; Lansoprazole; Antebate; Hirudoid; BIO-Three; Dexaltin



Possible Erbitux side effects in male

Reported by a consumer/non-health professional from Germany on 2012-05-17

Patient: male, weighing 62.0 kg (136.4 pounds)

Reactions: Stomatitis, Acne, Hyperammonaemia, DRY Skin

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux
    Dosage: 19th cycle on 26apr12
    Indication: Colorectal Cancer Recurrent

Leucovorin Calcium
    Dosage: 19th cycle on 26apr12
    Indication: Colorectal Cancer Recurrent

Fluorouracil
    Dosage: 19 cycles(500mg),iv bolus 19 cycles(3340mg),iv drip 19th cycle on 26apr12
    Indication: Colorectal Cancer Recurrent

Other drugs received by patient: Lansoprazole; BIO-Three; Hirudoid; Dexaltin; Antebate; Hirudoid; Loxoprofen



Possible Erbitux side effects in female

Reported by a individual with unspecified qualification from United States on 2012-04-30

Patient: female, weighing 44.7 kg (98.3 pounds)

Reactions: Dysphagia, Stomatitis, DRY Skin

Drug(s) suspected as cause:
Erbitux



Possible Erbitux side effects in 73 year old male

Reported by a consumer/non-health professional from Germany on 2012-04-26

Patient: 73 year old male, weighing 57.0 kg (125.4 pounds)

Reactions: Stomatitis, Neuropathy Peripheral, Interstitial Lung Disease, Skin Disorder

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Erbitux
    Dosage: also 380mg from 10mar-1sep11.
    Indication: Rectosigmoid Cancer
    Start date: 2011-03-10
    End date: 2011-09-01

Oxaliplatin
    Dosage: also iv drip 100 , 10mar-1sep11.
    Indication: Rectosigmoid Cancer
    Start date: 2011-03-10
    End date: 2011-09-01

Other drugs received by patient: Isovorin; Leucovorin Calcium; Fluorouracil



Possible Erbitux side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-22

Patient: female

Reactions: Pruritus, Stomatitis, Rash

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Isosorbide Mononitrate; Plavix; Furosemide; Budesonide; Lisinopril; Aspirin; Vitamin TAB; Metoprolol Succinate; Singulair; Simvastatin; Omeprazole; Amlodipine; Veramyst



Possible Erbitux side effects in 61 year old male

Reported by a consumer/non-health professional from United States on 2012-03-22

Patient: 61 year old male, weighing 86.0 kg (189.2 pounds)

Reactions: Stomatitis, Hypersensitivity, Skin Disorder, Rash

Drug(s) suspected as cause:
Erbitux



Possible Erbitux side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-22

Patient: female

Reactions: Malaise, Stomatitis

Drug(s) suspected as cause:
Erbitux



Possible Erbitux side effects in

Reported by a consumer/non-health professional from United States on 2012-03-22

Patient:

Reactions: Stomatitis, Alopecia

Drug(s) suspected as cause:
Erbitux



Possible Erbitux side effects in 76 year old female

Reported by a consumer/non-health professional from United States on 2012-03-22

Patient: 76 year old female

Reactions: Stomatitis, Pruritus, Rash

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Lisinopril; Metoprolol Succinate; Veramyst; Omeprazole; Vitamin TAB; Budesonide; Furosemide; Plavix; Amlodipine; Isosorbide Mononitrate; Singulair; Simvastatin; Aspirin



Possible Erbitux side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-22

Patient: male

Reactions: Stomatitis

Drug(s) suspected as cause:
Erbitux



Possible Erbitux side effects in 69 year old male

Reported by a consumer/non-health professional from United States on 2012-03-22

Patient: 69 year old male

Reactions: Stomatitis, DRY Skin, Rash Vesicular, Skin Fissures

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Metformin HCL; Amlodipine; Simvastatin; Aspirin



Possible Erbitux side effects in 73 year old male

Reported by a consumer/non-health professional from United States on 2012-03-22

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

Reactions: Stomatitis, Acne, Rash

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Irinotecan HCL



Possible Erbitux side effects in 73 year old female

Reported by a consumer/non-health professional from United States on 2012-03-22

Patient: 73 year old female, weighing 57.0 kg (125.4 pounds)

Reactions: Weight Decreased, Rash Pustular, Stomatitis, Dyspnoea, Nasopharyngitis, Pain in Extremity, Acne, Pyrexia, Blister Infected, Rash Pruritic, Loss of Consciousness, Malaise, Arthritis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cisplatin
    Dosage: jul-11 and aug-11; received along with second cetuximab infusion.

Erbitux
    Dosage: recent treatment on 16-dec-11.
    Indication: Head and Neck Cancer
    Start date: 2011-11-01

Other drugs received by patient: Synthroid; Aspirin; Theragran-M; Torsemide; Toprol-XL; Warfarin Sodium; Benadryl



Possible Erbitux side effects in

Reported by a physician from United States on 2012-03-22

Patient:

Reactions: Stomatitis

Drug(s) suspected as cause:
Erbitux



Possible Erbitux side effects in 69 year old male

Reported by a consumer/non-health professional from United States on 2012-03-22

Patient: 69 year old male

Reactions: Dysphagia, Stomatitis, LIP Blister, Fatigue, Salivary Hypersecretion, Rash

Drug(s) suspected as cause:
Erbitux



Possible Erbitux side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-03-22

Patient: 63 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Cheilitis, Stomatitis, Haemorrhage, Skin Exfoliation, Rash, DRY Skin, Skin Fissures

Drug(s) suspected as cause:
Erbitux

Other drugs received by patient: Compazine; Ambien; Imodium



Possible Erbitux side effects in male

Reported by a physician from United States on 2012-03-22

Patient: male

Reactions: Stomatitis, Dehydration, Rash

Drug(s) suspected as cause:
Erbitux



Possible Erbitux side effects in male

Reported by a individual with unspecified qualification from United States on 2012-03-13

Patient: male, weighing 99.1 kg (218.0 pounds)

Reactions: Stomatitis, Gout, Arthralgia, Dehydration, Hypophagia, Pyrexia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Erbitux



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