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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