Erbitux Safety Reports submitted to FDA

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Total Erbitux reports: 670.
Erbitux FDA safety alerts: 2005 .
Reported deaths: 108 Reported hospitalizations: 430.
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FDA Reported Erbitux Side Effects: dehydration, dyspnoea, infusion related reaction, nausea, vomiting, malignant neoplasm progression, diarrhoea, hypotension, mucosal inflammation, pyrexia, pneumonia aspiration.
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Erbitux Side Effects Report #5055799-0
Health Professional from UNITED STATES reported ERBITUX problem on July 18, 2006. Female patient, weighting 139.8 lb, was diagnosed with adenocarcinoma pancreas and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: abdominal pain, chills, nausea, pyrexia, vomiting. ERBITUX dosage: 69.6 MG/435 MG WEEKLY EVERY OTHER WEEK IV. During the same period patient was treated with GEMZAR, OXALIPLATIN, BENAZEPRIL HYDROCHLORIDE, SYNTHROID. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5055955-1
ERBITUX problem was reported by a Pharmacist from GERMANY on July 07, 2006. Male patient, 75 years of age, was diagnosed with colorectal cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: cardiac enzymes increased, myocardial infarction. ERBITUX dosage: unknown. During the same period patient was treated with CAMPTOSAR, POLARAMINE, METHYLPREDNISOLONE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5055961-7
Consumer or non-health professional from CANADA reported ERBITUX problem on Nov 25, 2004. Male patient, 54 years of age, weighting 145.5 lb, was diagnosed with colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: anaemia, exfoliative rash, petechiae, purpura. ERBITUX dosage: unknown. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5056000-4
ERBITUX problem was reported by a Health Professional from UNITED STATES on Feb 22, 2006. Male patient, 72 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, deep vein thrombosis, myocarditis, pleural effusion, pneumonia, pneumonia aspiration, sepsis. ERBITUX dosage: 5TH INFUSION. LOAD DOSE (400 MG/M2, 850 MG) GIVEN ON 13-JAN-06.. During the same period patient was treated with DOCETAXEL, CILOSTAZOL, VITAMIN, NAPROSYN. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5056382-3
Health Professional from UNITED STATES reported ERBITUX problem on Nov 23, 2005. Female patient, 38 years of age, weighting 233.7 lb, was diagnosed with breast cancer metastatic, rash, prophylaxis and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: abdominal pain, dehydration, diarrhoea, febrile neutropenia. ERBITUX dosage: unknown. During the same period patient was treated with CARBOPLATIN, ERYTHROMYCIN OINTMENT, ATIVAN. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5056383-5
ERBITUX problem was reported by a Health Professional from UNITED STATES on July 14, 2006. Female patient, 66 years of age, weighting 154.3 lb, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dyspnoea, erythema, pruritus, throat irritation, urticaria. ERBITUX dosage: unknown. Patient recovered.

Erbitux Side Effects Report #5056388-4
Health Professional from GERMANY reported ERBITUX problem on Nov 09, 2005. Female patient, 71 years of age, weighting 160.9 lb, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: acute pulmonary oedema, c-reactive protein increased, left ventricular failure. ERBITUX dosage: unknown. During the same period patient was treated with CISPLATIN, VINORELBINE, ISOSORBIDE, MOLSIDOMINE, ACETYLSALICYLIC ACID SRT, ONDANSETRON, DEXAMETHASONE, CLEMASTINE. Patient was hospitalized. Patient died on 09/10/2005.

Erbitux Side Effects Report #5056392-6
ERBITUX problem was reported by a Consumer or non-health professional from GERMANY on July 18, 2006. Male patient, 77 years of age, was diagnosed with squamous cell carcinoma and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: confusional state. ERBITUX dosage: unknown. During the same period patient was treated with CARBOPLATIN, FLUOROURACIL. Patient died on 10/30/2005.

Erbitux Side Effects Report #5056487-7
Health Professional from GERMANY reported ERBITUX problem on Jan 16, 2006. Male patient, 68 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. ERBITUX dosage: unknown. During the same period patient was treated with CISPLATIN, VINORELBINE, METOCLOPRAMIDE, ONDANSETRON, SYMBICORT, LOVENOX, DEXCHLORPHENIRAMINE, BECLOMETHASONE DIPROPIONATE. Patient died on 01/15/2006.

Erbitux Side Effects Report #5056496-8
ERBITUX problem was reported by a Health Professional from IRELAND on July 18, 2006. Male patient, 68 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased. ERBITUX dosage: unknown. During the same period patient was treated with CISPLATIN, VINORELBINE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5056499-3
Consumer or non-health professional from GERMANY reported ERBITUX problem on July 18, 2006. Male patient, 54 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: diarrhoea. ERBITUX dosage: unknown. During the same period patient was treated with CISPLATIN, VINORELBINE. Patient was hospitalized. Patient died on 12/12/2005.

Erbitux Side Effects Report #5056961-3
ERBITUX problem was reported by a Health Professional from GERMANY on Aug 19, 2005. Female patient, 66 years of age, was diagnosed with rectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: cataract, keratitis, ulcerative keratitis. ERBITUX dosage: unknown. During the same period patient was treated with IRINOTECAN, VITAMINS NOS, PROSTIGMIN, FLOXAL, ZOVIRAX, METOCLOPRAMIDE. Patient was hospitalized and became disabled. Patient recovered.

Erbitux Side Effects Report #5057048-6
Health Professional from UNITED STATES reported ERBITUX problem on May 17, 2006. Female patient, 76 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: ileus, small intestinal obstruction. ERBITUX dosage: unknown. During the same period patient was treated with CARBOPLATIN, TAXOTERE, VERAPAMIL, LANOXIN, QUESTRAN, FOLIC ACID, BENICAR, LOMOTIL. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5058183-9
ERBITUX problem was reported by a Health Professional from UNITED STATES on July 17, 2006. Male patient, weighting 180.8 lb, was diagnosed with squamous cell carcinoma and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: anorexia, application site pain, chills, nausea, neutrophil count decreased, oral pain, pyrexia, radiation injury. ERBITUX dosage: LOADING DOSE 15-MAY-06 (400 MG/M2) 250 MG/M2 X 6 WEEKS (22-MAY, 31-MAY, 07-JUN, 12-JUN, 19-JUN-06). During the same period patient was treated with TAXOTERE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5059743-1
Health Professional from UNITED STATES reported ERBITUX problem on June 20, 2006. Male patient, 69 years of age, was diagnosed with colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage, convulsion. ERBITUX dosage: unknown. During the same period patient was treated with IRINOTECAN, FOLINIC ACID, FLUOROURACIL. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5059746-7
ERBITUX problem was reported by a Consumer or non-health professional from GERMANY on July 18, 2006. Female patient, 71 years of age, was diagnosed with colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, metastases to liver, pyrexia, respiratory tract infection. ERBITUX dosage: unknown. During the same period patient was treated with IRINOTECAN, FOLINIC ACID, FLUOROURACIL. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5060014-8
Health Professional from FRANCE reported ERBITUX problem on July 20, 2006. Male patient, 64 years of age, was diagnosed with hepatic neoplasm malignant, varices oesophageal, infection prophylaxis, venous thrombosis, abdominal pain and was treated with ERBITUX. ERBITUX dosage: unknown. During the same period patient was treated with OXALIPLATIN, GEMCITABINE, PROPRANOLOL, NORFLOXACIN, TINZAPARIN, TRIMEBUTINE, MORPHINE. Patient died on 05/22/2006.

Erbitux Side Effects Report #5060016-1
ERBITUX problem was reported by a Health Professional from UNITED STATES on July 17, 2006. Male patient, 65 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dyspnoea. ERBITUX dosage: unknown. During the same period patient was treated with PACLITAXEL, CARBOPLATIN, ASPIRIN, CANDESARTAN CILEXETIL, FUROSEMIDE, ATORVASTATIN CALCIUM, HYDROCODONE BITARTRATE, ALBUTEROL SULPHATE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5060151-8
Health Professional from UNITED STATES reported ERBITUX problem on July 05, 2006. Female patient, 56 years of age, was diagnosed with squamous cell carcinoma and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dehydration, hypokalaemia, mental status changes, mucosal inflammation, rash. ERBITUX dosage: unknown. During the same period patient was treated with CARBOPLATIN, PACLITAXEL. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5060534-6
ERBITUX problem was reported by a Health Professional from UNITED STATES on July 19, 2006. Male patient, weighting 229.3 lb, was diagnosed with metastases to liver, rectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, loss of consciousness. ERBITUX dosage: 900 MG X1 DOSE IV BOLUS (DURATION: PT ONLY RECEIVED ONE DOSE). Patient died on 07/12/2006.

Erbitux Side Effects Report #5060553-X
Health Professional from UNITED STATES reported ERBITUX problem on July 17, 2006. Male patient, 63 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dehydration. ERBITUX dosage: unknown. During the same period patient was treated with TAXOL, CARBOPLATIN. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5060915-0
ERBITUX problem was reported by a Health Professional from UNITED STATES on July 20, 2006. Male patient, 76 years of age, weighting 177.0 lb, was diagnosed with disease recurrence, multiple myeloma and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, asthenia, cardiac failure congestive, epistaxis, hypervolaemia, hypoxia, mental status changes, volume blood increased. ERBITUX dosage: 525 MG -1X LOADING DOSE 840MG 1 X WEEK IV DRIP. During the same period patient was treated with DECADRON, ARANESP. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5061155-1
Physician from UNITED STATES reported ERBITUX problem on July 20, 2006. Female patient was diagnosed with neoplasm malignant and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: blood magnesium decreased, confusional state, dehydration, failure to thrive, hypokalaemia, incorrect dose administered, mental status changes, pulmonary embolism. ERBITUX dosage: 392.5 MG, WEEKLY, IV. During the same period patient was treated with PACLITAXEL, CARBOPLATIN, RADIATION. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5061945-5
ERBITUX problem was reported by a Health Professional from UNITED STATES on Apr 25, 2006. Male patient, 57 years of age, weighting 169.8 lb, was diagnosed with non-small cell lung cancer metastatic, hyperlipidaemia, gastrooesophageal reflux disease, insomnia and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, confusional state, dyspnoea, malignant neoplasm progression. ERBITUX dosage: unknown. During the same period patient was treated with PEMETREXED DI, PLAVIX, CARAFATE, RESTORIL, DEXAMETHASONE, ALBUTEROL SPIROS. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5061948-0
Consumer or non-health professional from UNITED STATES reported ERBITUX problem on July 19, 2006. Male patient, 69 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dyspnoea. ERBITUX dosage: unknown. During the same period patient was treated with TAXOL, CARBOPLATIN, METFORMIN, ASPIRIN, PEPCID AC. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5062554-4
ERBITUX problem was reported by a Consumer or non-health professional from UNITED STATES on July 19, 2006. Male patient was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: laryngeal oedema, mucosal inflammation. ERBITUX dosage: 100 MG/50 ML. Patient recovered.

Erbitux Side Effects Report #5062761-0
Health Professional from UNITED STATES reported ERBITUX problem on July 24, 2006. Female patient, weighting 157.6 lb, was diagnosed with neoplasm malignant and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dehydration, dysphagia, febrile neutropenia, mucosal inflammation. ERBITUX dosage: 493 MG IV/EVERY WEEK. During the same period patient was treated with ALIMTA. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5063088-3
ERBITUX problem was reported by a Consumer or non-health professional from IRELAND on Aug 01, 2005. Male patient, 63 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dyspnoea, febrile bone marrow aplasia. ERBITUX dosage: unknown. During the same period patient was treated with CISPLATIN, VINORELBINE. Patient was hospitalized. Patient died on 08/04/2005.

Erbitux Side Effects Report #5063175-X
Consumer or non-health professional from GERMANY reported ERBITUX problem on Feb 09, 2006. Male patient, 57 years of age, was diagnosed with squamous cell carcinoma and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: mucosal inflammation, neutropenia, thrombocytopenia. ERBITUX dosage: unknown. During the same period patient was treated with CISPLATIN, FLUOROURACIL. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5063489-3
ERBITUX problem was reported by a Health Professional from GERMANY on July 18, 2006. Male patient, 62 years of age, was diagnosed with squamous cell carcinoma and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: lung disorder. ERBITUX dosage: unknown. During the same period patient was treated with CISPLATIN, FLUOROURACIL. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5063492-3
Physician from GERMANY reported ERBITUX problem on July 18, 2006. Male patient, 74 years of age, was diagnosed with colorectal cancer stage iv and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: intestinal obstruction. ERBITUX dosage: unknown. During the same period patient was treated with IRINOTECAN, OMEPRAZOLE, LANSOPRAZOLE, BUPRENORPHINE. Patient was hospitalized and became disabled. Patient died on 04/29/2006.

Erbitux Side Effects Report #5063493-5
ERBITUX problem was reported by a Health Professional from UNITED STATES on Mar 24, 2006. Male patient, 65 years of age, was diagnosed with squamous cell carcinoma and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: bronchospasm, respiratory arrest. ERBITUX dosage: LOADING DOSE (708 MG). DISCONTINUED AFTER 16 CC.. During the same period patient was treated with ACETAMINOPHEN, DECADRON, BENADRYL. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5063524-2
Consumer or non-health professional from GERMANY reported ERBITUX problem on May 02, 2006. Male patient, 54 years of age, was diagnosed with squamous cell carcinoma and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: asthenia, bronchopneumonia, hypercreatininaemia, infection, renal failure acute. ERBITUX dosage: unknown. During the same period patient was treated with CISPLATIN, FLUOROURACIL. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5063586-2
ERBITUX problem was reported by a Consumer or non-health professional from GERMANY on May 02, 2006. Female patient, 59 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: cough, febrile neutropenia. ERBITUX dosage: unknown. During the same period patient was treated with CISPLATIN, VINORELBINE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5063591-6
Pharmacist from UNITED STATES reported ERBITUX problem on June 09, 2006. Female patient, 62 years of age, was diagnosed with neoplasm malignant and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dyspnoea, hypotension, mental impairment. ERBITUX dosage: INITIAL DOSE. ADMINISTERED 13 ML=26 MG OF A TOTAL DOSE OF 688 MG.. During the same period patient was treated with BENADRYL, HYDROCORTISONE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5063660-0
ERBITUX problem was reported by a Consumer or non-health professional from GERMANY on July 18, 2006. Male patient, 47 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: blister, rash. ERBITUX dosage: unknown. During the same period patient was treated with CISPLATIN, VINORELBINE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5063662-4
Health Professional from UNITED STATES reported ERBITUX problem on June 07, 2006. Male patient, 74 years of age, weighting 271.2 lb, was diagnosed with colorectal cancer metastatic, gastrooesophageal reflux disease, hypertension, insomnia and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction. ERBITUX dosage: unknown. During the same period patient was treated with IRINOTECAN, FOLINIC ACID, FLUOROPLEX, OMEPRAZOLE, NIFEDIPINE, NITRAZEPAM, AVAPRO HCT, PROPANOL. Patient died on 06/04/2006.

Erbitux Side Effects Report #5063817-9
ERBITUX problem was reported by a Health Professional from UNITED STATES on July 26, 2006. Female patient, weighting 157.6 lb, was diagnosed with neoplasm malignant and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: cardiac disorder, chills, dehydration, pyrexia. ERBITUX dosage: 493 MG IV /EVERY WEEK. During the same period patient was treated with ALIMTA. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5064401-3
Health Professional from UNITED STATES reported ERBITUX problem on July 10, 2006. Male patient, 66 years of age, weighting 138.9 lb, was diagnosed with metastatic carcinoma of the bladder and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dehydration, hypercalcaemia. ERBITUX dosage: unknown. During the same period patient was treated with TARCEVA, ASPIRIN, NAPROXEN, LEVAQUIN. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5064414-1
ERBITUX problem was reported by a Consumer or non-health professional from UNITED STATES on July 13, 2006. Male patient, 42 years of age, weighting 130.1 lb, was diagnosed with colon cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: infusion related reaction. ERBITUX dosage: unknown. During the same period patient was treated with BENADRYL, DECADRON, ATROPINE, ALOXI, IRINOTECAN, FOLIC ACID, PHENERGAN, KLONOPIN. Patient was hospitalized. Patient died on 03/23/2006.

Erbitux Side Effects Report #5064419-0
Health Professional from UNITED STATES reported ERBITUX problem on July 17, 2006. Male patient, weighting 180.8 lb, was diagnosed with squamous cell carcinoma and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: anorexia, chills, nausea, oral pain, pyrexia, skin exfoliation, stomatitis, vomiting. ERBITUX dosage: LOADING DOSE 15-MAY-06 (400 MG/M2) 250 MG/M2 X 6 WEEKS (22-MAY, 31-MAY, 07-JUN, 12-JUN, 19-JUN-06). During the same period patient was treated with TAXOTERE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5064420-7
ERBITUX problem was reported by a Health Professional from UNITED STATES on June 27, 2006. Female patient, 74 years of age, weighting 114.6 lb, was diagnosed with neoplasm malignant and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dysphagia, mucosal inflammation. ERBITUX dosage: unknown. During the same period patient was treated with CARBOPLATIN, CISPLATIN, PACLITAXEL. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5064423-2
Physician from GERMANY reported ERBITUX problem on July 18, 2006. Female patient, 67 years of age, weighting 163.1 lb, was diagnosed with colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: disseminated intravascular coagulation, gastrointestinal haemorrhage, haemolytic uraemic syndrome, infusion related reaction. ERBITUX dosage: unknown. During the same period patient was treated with OXALIPLATIN, FLUOROPLEX, LEUCOVORIN CALCIUM, DIMETINDENE, DEXAMETHASONE. Patient was hospitalized and became disabled. Patient died on 07/05/2006.

Erbitux Side Effects Report #5064550-X
ERBITUX problem was reported by a Health Professional from GERMANY on Dec 19, 2005. Male patient, 54 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: abdominal pain, intestinal perforation, metastases to peritoneum. ERBITUX dosage: unknown. During the same period patient was treated with CISPLATIN, VINORELBINE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5065658-5
Health Professional from UNITED STATES reported ERBITUX problem on July 24, 2006. Male patient, 50 years of age, was diagnosed with oesophageal adenocarcinoma, infection and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: cough, dehydration, dizziness, lung infection, oral infection, pyrexia. ERBITUX dosage: unknown. During the same period patient was treated with PACLITAXEL, CARBOPLATIN, AMOXICILLIN, FLAGYL. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5065663-9
ERBITUX problem was reported by a Physician from GERMANY on July 19, 2006. Female patient, 56 years of age, was diagnosed with colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: hirsutism. ERBITUX dosage: unknown. During the same period patient was treated with IRINOTECAN. Patient recovered.

Erbitux Side Effects Report #5065880-8
Health Professional from UNITED STATES reported ERBITUX problem on Aug 24, 2005. Female patient, 70 years of age, weighting 108.0 lb, was diagnosed with colon cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: diarrhoea, hypokalaemia, hypomagnesaemia, urinary tract infection. ERBITUX dosage: unknown. During the same period patient was treated with IRINOTECAN, XELODA, LISINOPRIL, COREG, TEGRETOL, TRAZODONE, ZOLOFT, SYNTHROID. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5065883-3
ERBITUX problem was reported by a Consumer or non-health professional from GERMANY on May 05, 2006. Male patient, 56 years of age, was diagnosed with colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: blast crisis in myelogenous leukaemia, chromosome analysis abnormal, chronic myeloid leukaemia, malignant neoplasm progression, metastases to lung. ERBITUX dosage: unknown. During the same period patient was treated with IRINOTECAN. Patient recovered.

Erbitux Side Effects Report #5065938-3
Physician from GERMANY reported ERBITUX problem on July 05, 2006. Male patient, 55 years of age, was diagnosed with colorectal cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: enterocolitis haemorrhagic, skin toxicity. ERBITUX dosage: unknown. During the same period patient was treated with CAMPTOSAR, OXALIPLATIN. Patient recovered.

Erbitux Side Effects Report #5065982-6
ERBITUX problem was reported by a Pharmacist from UNITED STATES on July 28, 2006. Male patient, weighting 227.1 lb, was diagnosed with colon cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: apnoeic attack, blood pressure immeasurable, convulsion, cyanosis, dysphoria, dyspnoea, hyperhidrosis, hypotension, infusion related reaction. ERBITUX dosage: 28.4 MG ONCE IV. During the same period patient was treated with BENADRYL, ALTACE, TOPROL, ASPIRIN. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5066509-5
Health Professional from UNITED STATES reported ERBITUX problem on July 21, 2006. Male patient, 68 years of age, was diagnosed with colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: diarrhoea, rectal haemorrhage. ERBITUX dosage: unknown. During the same period patient was treated with OXALIPLATIN, CAPECITABINE, AVASTIN, OXYCODONE, ACETAMINOPHEN, POTASSIUM CHLORIDE, FENTANYL. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5066886-5
ERBITUX problem was reported by a Health Professional from GERMANY on July 28, 2006. Male patient, 78 years of age, was diagnosed with colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, dyspnoea. ERBITUX dosage: unknown. During the same period patient was treated with FOLINIC ACID, IRINOTECAN, POLARAMINE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5067101-9
Health Professional from UNITED STATES reported ERBITUX problem on July 24, 2006. Male patient, 84 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dehydration, neutropenia, renal failure acute. ERBITUX dosage: unknown. During the same period patient was treated with CARBOPLATIN, TAXOTERE, PROSCAR, LEVOTHROID. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5067107-X
ERBITUX problem was reported by a Consumer or non-health professional from UNITED STATES on July 10, 2006. Male patient, 65 years of age, weighting 216.1 lb, was diagnosed with squamous cell carcinoma and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, atrial fibrillation, blood creatine phosphokinase increased, dehydration, diarrhoea, oesophagitis, renal failure. ERBITUX dosage: unknown. During the same period patient was treated with DOCETAXEL, ATENOLOL, CIALIS, HYZAAR, NORVASC, OXYCODONE, PILOCARPINE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5067108-1
Physician from GERMANY reported ERBITUX problem on July 07, 2006. Male patient, 66 years of age, was diagnosed with colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, convulsion, loss of consciousness. ERBITUX dosage: unknown. During the same period patient was treated with IRINOTECAN, LEUCOVORIN CALCIUM, FLUOROURACIL. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5067709-0
ERBITUX problem was reported by a Physician from GERMANY on July 07, 2006. Male patient, 65 years of age, was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: blood pressure immeasurable, convulsion, infusion related reaction, loss of consciousness, rash. ERBITUX dosage: unknown. During the same period patient was treated with NEXIUM, TRAMADOL, CHLORHEXIDINE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5068135-0
Health Professional from UNITED STATES reported ERBITUX problem on July 21, 2006. Female patient, weighting 114.6 lb, was diagnosed with neoplasm malignant and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dysphagia, mucosal inflammation. ERBITUX dosage: unknown. During the same period patient was treated with CARBOPLATIN. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5068147-7
ERBITUX problem was reported by a Health Professional from UNITED STATES on Apr 26, 2005. Male patient, 76 years of age, was diagnosed with colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: ascites, malignant neoplasm progression, pleural effusion, respiratory failure. ERBITUX dosage: unknown. During the same period patient was treated with IRINOTECAN. Patient was hospitalized. Patient died on 04/24/2005.

Erbitux Side Effects Report #5068149-0
Health Professional from UNITED STATES reported ERBITUX problem on Feb 16, 2005. Male patient, 72 years of age, was diagnosed with colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: malignant neoplasm progression. ERBITUX dosage: 495 TO 792 MG. HAS BEEN DOSE-ESCALATED TO 400 MG/M2 X 2 TREATMENTS.. Patient was hospitalized. Patient died on 03/11/2005.

Erbitux Side Effects Report #5068468-8
ERBITUX problem was reported by a Health Professional from UNITED STATES on Oct 13, 2005. Female patient, 70 years of age, was diagnosed with colon cancer metastatic, deep vein thrombosis and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: epistaxis, haemoglobin abnormal, international normalised ratio increased, malaise, rash. ERBITUX dosage: unknown. During the same period patient was treated with COUMADIN, CAMPTOSAR, PERCOCET, VITAMINS, POTASSIUM. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5069714-7
Health Professional from UNITED STATES reported ERBITUX problem on June 23, 2006. Male patient, 46 years of age, weighting 121.3 lb, was diagnosed with neoplasm malignant, pain, diarrhoea and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: abdominal pain, clostridial infection, diarrhoea, nausea, vomiting. ERBITUX dosage: 420 MG IV 60 MIN DAY 1, 8 AND 15. During the same period patient was treated with CISPLATIN, COLACE, ALBUTEROL, LORTAB, LOMOTIL, MUCINEX, NYSTATIN, FLAGYL. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5069837-2
ERBITUX problem was reported by a Health Professional from UNITED STATES on Aug 02, 2006. Male patient, weighting 165.0 lb, was diagnosed with neoplasm malignant and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: haemorrhage, tracheostomy malfunction. ERBITUX dosage: 483 MG IV/EVERY WEEK. During the same period patient was treated with ALIMTA. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5069882-7
Health Professional from UNITED STATES reported ERBITUX problem on July 17, 2006. Male patient, 66 years of age, weighting 202.8 lb, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: anaemia, diabetes mellitus, hypomagnesaemia, hypophosphataemia, localised infection. ERBITUX dosage: unknown. During the same period patient was treated with ALIMTA, FOLIC ACID, VITAMIN B, GLYBURIDE, INSULIN. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5069883-9
ERBITUX problem was reported by a Health Professional from UNITED STATES on June 23, 2006. Male patient, 57 years of age, weighting 127.9 lb, was diagnosed with neoplasm malignant and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: asthenia, dizziness, microcytic anaemia, neck pain, oesophagitis, rectal haemorrhage, syncope. ERBITUX dosage: unknown. During the same period patient was treated with MORPHINE SULPHATE, NEXIUM, THIAMINE, LORTAB, DURAGESIC, COLACE, DUONEB, ACETAMINOPHEN AND HYDROCODONE BITARTRATE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5070078-3
Health Professional from GERMANY reported ERBITUX problem on July 24, 2006. Male patient, 77 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: leukopenia, pyrexia, thrombocytopenia. ERBITUX dosage: unknown. During the same period patient was treated with CARBOPLATIN, GEMCITABINE, SIMVASTATIN, ALLOPURINOL, METOPROLOL TARTRATE, CIBADREX, TIOTROPIUM BROMIDE, FORMOTEROL. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5070081-3
ERBITUX problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 14, 2006. Male patient, 64 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: electrocardiogram qt corrected interval prolonged. ERBITUX dosage: unknown. During the same period patient was treated with CARBOPLATIN, PACLITAXEL, COREG, PRAVACHOL, PREVACID, TINZAPARIN. Patient recovered.

Erbitux Side Effects Report #5071651-9
Health Professional from UNITED STATES reported ERBITUX problem on Aug 03, 2006. Female patient, weighting 181.2 lb, was diagnosed with pancreatic carcinoma and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction. ERBITUX dosage: 780MG, 390MG, IV. Patient recovered.

Erbitux Side Effects Report #5071743-4
ERBITUX problem was reported by a Health Professional from UNITED STATES on July 17, 2006. Male patient, 63 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dehydration. ERBITUX dosage: unknown. During the same period patient was treated with TAXOL, CARBOPLATIN, TOPROL, FOLIC ACID, COMPAZINE, IMODIUM, ZOFRAN. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5072104-4
Health Professional from UNITED STATES reported ERBITUX problem on May 10, 2005. Female patient, 50 years of age, was diagnosed with colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dehydration, dyspnoea, malignant neoplasm progression. ERBITUX dosage: COURSE 2. START DATE 15-MAR-05 (756 MG), 22-MAR TO 19-APR (473MGX5), 26-APR TO 03-MAY-05 (458MG). During the same period patient was treated with VERAPAMIL, THEOPHYLLINE, LORATADINE, ZAFIRLUKAST, SEREVENT, FLUTICASONE PROPIONATE. Patient was hospitalized. Patient died on 06/21/2005.

Erbitux Side Effects Report #5072526-1
ERBITUX problem was reported by a Health Professional from UNITED STATES on Aug 03, 2006. Male patient, 72 years of age, weighting 160.9 lb, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dizziness, malignant neoplasm progression. ERBITUX dosage: unknown. During the same period patient was treated with PEMETREXED DI, FOLIC ACID, TOPROL, VITAMIN B. Patient was hospitalized. Patient died on 07/26/2006.

Erbitux Side Effects Report #5072773-9
Health Professional from UNITED STATES reported ERBITUX problem on Aug 02, 2006. Female patient, 57 years of age, weighting 116.8 lb, was diagnosed with pancreatic carcinoma and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: back pain, chest pain, malignant neoplasm progression, nausea, tachycardia, vomiting. ERBITUX dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, VACCINE. Patient was hospitalized. Patient died on 07/27/2006.

Erbitux Side Effects Report #5072775-2
ERBITUX problem was reported by a Health Professional from GERMANY on Jan 06, 2006. Female patient, 67 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, haemoglobin decreased, neutropenia, pharyngolaryngeal pain, pulmonary embolism, white blood cell count abnormal. ERBITUX dosage: unknown. During the same period patient was treated with CISPLATIN, VINORELBINE, LEVOFLOXACIN, PREDNISOLONE. Patient was hospitalized. Patient died on 10/28/2005.

Erbitux Side Effects Report #5073271-9
Health Professional from UNITED STATES reported ERBITUX problem on July 31, 2006. Female patient, 58 years of age, weighting 130.1 lb, was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dehydration, haemoglobin, hypokalaemia, hypomagnesaemia, lymphopenia, nausea, neutrophil count decreased, vomiting, white blood cell disorder. ERBITUX dosage: unknown. During the same period patient was treated with CARBOPLATIN, ALIMTA. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5073471-8
ERBITUX problem was reported by a Health Professional from UNITED STATES on Oct 20, 2005. Male patient, 80 years of age, was diagnosed with colorectal cancer metastatic, atrial fibrillation and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: diarrhoea, enterocolitis, febrile neutropenia. ERBITUX dosage: unknown. During the same period patient was treated with IRINOTECAN, ZOCOR, ATENOLOL, COUMADIN. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5073474-3
Health Professional from UNITED STATES reported ERBITUX problem on July 17, 2006. Male patient, 66 years of age, weighting 202.8 lb, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: anaemia, diabetes mellitus, hypomagnesaemia, hypophosphataemia, localised infection. ERBITUX dosage: unknown. During the same period patient was treated with ALIMTA, FOLIC ACID, VITAMIN B, GLYBURIDE, INSULIN. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5074127-8
ERBITUX problem was reported by a Consumer or non-health professional from UNITED STATES on July 19, 2006. Male patient, 69 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dyspnoea. ERBITUX dosage: unknown. During the same period patient was treated with TAXOL, CARBOPLATIN, METFORMIN, ASPIRIN, PEPCID AC. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5074171-0
Consumer or non-health professional from UNITED STATES reported ERBITUX problem on July 10, 2006. Male patient, 65 years of age, weighting 216.1 lb, was diagnosed with squamous cell carcinoma and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, atrial fibrillation, blood creatine phosphokinase increased, dehydration, diarrhoea, electrolyte imbalance, loss of consciousness, myositis. ERBITUX dosage: unknown. During the same period patient was treated with DOCETAXEL, ATENOLOL, CIALIS, HYZAAR, NORVASC, OXYCODONE, PILOCARPINE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5074177-1
ERBITUX problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 04, 2006. Male patient, 69 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. ERBITUX dosage: unknown. During the same period patient was treated with CARBOPLATIN, TAXOL, PREDNISONE, LOVENOX, OXYGEN. Patient died on 08/03/2006.

Erbitux Side Effects Report #5074179-5
Health Professional from UNITED STATES reported ERBITUX problem on Apr 26, 2005. Male patient, 76 years of age, was diagnosed with colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: ascites, malignant neoplasm progression, respiratory failure. ERBITUX dosage: unknown. During the same period patient was treated with IRINOTECAN. Patient was hospitalized. Patient died on 04/24/2005.

Erbitux Side Effects Report #5074197-7
ERBITUX problem was reported by a Consumer or non-health professional from UNITED STATES on May 17, 2006. Male patient, 59 years of age, weighting 169.8 lb, was diagnosed with squamous cell carcinoma and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: aspiration, cough, mucosal inflammation, pyrexia, rash. ERBITUX dosage: unknown. During the same period patient was treated with DOCETAXEL, SENOKOT, FLOMAX, ZYRTEC, OXYCODONE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5074967-5
Consumer or non-health professional from UNITED STATES reported ERBITUX problem on June 20, 2006. Female patient, weighting 143.3 lb, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: confusional state, convulsion, febrile neutropenia, haemoglobin decreased, hypocalcaemia, hypokalaemia, hypomagnesaemia, infection, lymphopenia. ERBITUX dosage: 7TH DOSE: 17-APR-06. GIVEN AT 400 MG/M2 DAY 1 THEN 250 MG/M2 WEEKLY (TOTAL OF 7 WEEKS TREATMENT).. During the same period patient was treated with CARBOPLATIN, ALPRAZOLAM, ALIMTA, OXYCONTIN, MORPHINE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5075191-2
ERBITUX problem was reported by a Pharmacist from UNITED STATES on Aug 03, 2006. Male patient, 57 years of age, weighting 96.10 lb, was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: apnoea, cardio-respiratory arrest, dyspnoea, heart rate decreased, hypotension, hypoventilation, increased viscosity of bronchial secretion, infusion related reaction, pulse abnormal. ERBITUX dosage: 570MG ONCE IV. Patient recovered.

Erbitux Side Effects Report #5075566-1
Physician from GERMANY reported ERBITUX problem on June 09, 2006. Male patient, 69 years of age, was diagnosed with hypopharyngeal cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: bronchitis bacterial, disease progression, ischaemic cerebral infarction, pneumonia. ERBITUX dosage: unknown. Patient was hospitalized. Patient died on 06/19/2006.

Erbitux Side Effects Report #5075717-9
ERBITUX problem was reported by a Health Professional from GERMANY on July 28, 2006. Male patient, 59 years of age, was diagnosed with lip and/or oral cavity cancer recurrent and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: intestinal perforation. ERBITUX dosage: unknown. During the same period patient was treated with MORPHINE. Patient was hospitalized. Patient died.

Erbitux Side Effects Report #5076021-5
Health Professional from UNITED STATES reported ERBITUX problem on Aug 08, 2006. Female patient, weighting 101.0 lb, was diagnosed with brain cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: breast cancer metastatic, loss of consciousness, malignant neoplasm progression. ERBITUX dosage: 365 MG Q WK IV. During the same period patient was treated with CARBOPLATIN. Patient died on 08/02/2006.

Erbitux Side Effects Report #5076023-9
ERBITUX problem was reported by a Health Professional from UNITED STATES on Aug 08, 2006. Female patient, weighting 101.0 lb, was diagnosed with brain cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dyspnoea, fatigue, pain, venous thrombosis, wheezing. ERBITUX dosage: 365 MG Q WEEK IV. During the same period patient was treated with CARBOPLATIN. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5076026-4
Health Professional from UNITED STATES reported ERBITUX problem on Aug 08, 2006. Female patient, 65 years of age, weighting 131.0 lb, was diagnosed with colon cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: abdominal pain, colon cancer metastatic, haematuria, hydronephrosis, malignant neoplasm progression, pelvic mass. ERBITUX dosage: 680 MG IV (LOADING DOSE) , 425 MG IV. During the same period patient was treated with CELEBREX, NEURONTIN, LORTAB, PREVACID, HYDROCHLOROTHIAZIDE, VIT B, ENALAPRIL MALEATE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5076488-2
ERBITUX problem was reported by a Consumer or non-health professional from GERMANY on Feb 09, 2006. Female patient, 61 years of age, was diagnosed with non-small cell lung cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dehydration, malignant neoplasm progression, nausea, pain. ERBITUX dosage: unknown. During the same period patient was treated with CISPLATIN, VINORELBINE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, GRANISETRON, DOMPERIDONE, TRAMADOL, CYCLIZINE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5076552-8
Pharmacist from UNITED STATES reported ERBITUX problem on Aug 08, 2006. Male patient, weighting 141.1 lb, was diagnosed with metastatic squamous cell carcinoma and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: hypotension, infusion related reaction, oxygen saturation decreased, pruritus, restlessness. ERBITUX dosage: 68.1 MG ONCE IV. During the same period patient was treated with HYZAAR, OXYCODONE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5076997-6
ERBITUX problem was reported by a Physician from UNITED STATES on Aug 04, 2006. Male patient, 67 years of age, was diagnosed with colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, heart rate increased, vomiting. ERBITUX dosage: unknown. During the same period patient was treated with BENADRYL. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5077033-8
Health Professional from UNITED STATES reported ERBITUX problem on July 16, 2004. Male patient, 76 years of age, was diagnosed with colorectal cancer, colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: diarrhoea, malignant neoplasm progression, neutropenia, thrombocytopenia. ERBITUX dosage: unknown. During the same period patient was treated with IRINOTECAN, ALDACTONE, LASIX. Patient was hospitalized. Patient died on 07/30/2004.

Erbitux Side Effects Report #5077660-8
ERBITUX problem was reported by a Health Professional from GERMANY on Aug 03, 2006. Male patient, 54 years of age, was diagnosed with nasopharyngeal cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: dehydration, oral candidiasis. ERBITUX dosage: unknown. During the same period patient was treated with CISPLATIN. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5077662-1
Consumer or non-health professional from UNITED STATES reported ERBITUX problem on July 10, 2006. Male patient, 60 years of age, was diagnosed with neoplasm malignant and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: myocardial infarction, neoplasm malignant, vision blurred. ERBITUX dosage: unknown. During the same period patient was treated with ETHYOL. Patient died on 06/28/2006.

Erbitux Side Effects Report #5078213-8
ERBITUX problem was reported by a Health Professional from UNITED STATES on Aug 04, 2006. Male patient, 55 years of age, weighting 145.5 lb, was diagnosed with neoplasm malignant and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, hypotension, somnolence. ERBITUX dosage: unknown. During the same period patient was treated with CISPLATIN, ATIVAN, LORTAB. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5078215-1
Health Professional from UNITED STATES reported ERBITUX problem on Apr 26, 2005. Male patient, 76 years of age, was diagnosed with colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: ascites, malignant neoplasm progression, respiratory failure. ERBITUX dosage: unknown. During the same period patient was treated with IRINOTECAN. Patient died on 04/24/2005.

Erbitux Side Effects Report #5078222-9
ERBITUX problem was reported by a Health Professional from UNITED STATES on Aug 03, 2006. Female patient, 64 years of age, weighting 130.1 lb, was diagnosed with pancreatic carcinoma and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: bile duct obstruction, blood glucose increased, hepatic function abnormal, pulmonary embolism. ERBITUX dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient was hospitalized. Patient recovered.

Erbitux Side Effects Report #5078313-2
Health Professional from GERMANY reported ERBITUX problem on June 19, 2006. Female patient, 73 years of age, was diagnosed with colorectal cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: pulmonary embolism. ERBITUX dosage: unknown. During the same period patient was treated with XELODA, AVASTIN, OXALIPLATIN. Patient died.

Erbitux Side Effects Report #5078320-X
ERBITUX problem was reported by a Health Professional from GERMANY on Aug 08, 2006. Male patient, 75 years of age, was diagnosed with colorectal cancer and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: asthenia, disease progression, dyspnoea. ERBITUX dosage: unknown. During the same period patient was treated with OXALIPLATIN, FOLINIC ACID, FLUOROURACIL. Patient was hospitalized. Patient died on 08/04/2006.

Erbitux Side Effects Report #5078610-0
Pharmacist from UNITED STATES reported ERBITUX problem on Aug 10, 2006. Male patient, 60 years of age, weighting 146.0 lb, was diagnosed with colon cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, cold sweat, dysarthria, incontinence, infusion related reaction, skin discolouration. ERBITUX dosage: PT RECEIVED 140 MG OF 1ST DOSE X1 IV DRIP. Patient recovered.

Erbitux Side Effects Report #5078885-8
ERBITUX problem was reported by a Health Professional from UNITED STATES on Feb 08, 2006. Female patient, 58 years of age, was diagnosed with colorectal cancer metastatic and was treated with ERBITUX. After drug was administered, patient experienced the following problems/side effects: ileus. ERBITUX dosage: unknown. During the same period patient was treated with IRINOTECAN, IMODIUM, CLINDAMYCIN, SENOKOT. Patient was hospitalized. Patient died on 03/01/2006.

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Drug Information: Cetuximab Injection

URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a607041.html

(se tux' i mab)

IMPORTANT WARNING:

Cetuximab may cause severe or life-threatening reactions while you receive the medication. These reactions are more common with the first dose of cetuximab, but may occur at any time during treatment. Your doctor will watch you carefully while you receive each dose of cetuximab and for at least one hour afterwards. Tell your doctor if you experience any of the following symptoms during or after your infusion: shortness of breath, wheezing or noisy breathing, hoarseness, hives, fainting, dizziness, blurred vision, nausea, or chest pain or pressure. If you experience a severe reaction, your doctor will stop your infusion and treat the symptoms of the reaction. You will not be able to receive treatment with cetuximab in the future. People with a head and neck cancer who are treated with radiation therapy and cetuximab may have an increased risk of cardiopulmonary arrest (condition in which the heart stops beating and breathing stops) and/or sudden death during or after their treatment. Tell your doctor if you have or have ever had coronary artery disease (condition that occurs when the blood vessels of the heart are narrowed by fat or cholesterol deposits); angina (chest pain or pressure); a heart attack; congestive heart failure; irregular heartbeat; other heart disease; or lower than normal levels of magnesium, potassium, or calcium in your blood.Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests during and after your treatment to check your body's response to cetuximab.Talk to your doctor about the risks of using cetuximab.

Why is this medication prescribed?

Cetuximab is used with or without radiation therapy to treat a certain type of cancer of the head and neck. Cetuximab is also used alone or in combination with another medication to treat a certain type of cancer of the colon (large intestine) or rectum that has spread to other parts of the body. Cetuximab has been shown to slow the growth of tumors in people who have cancer of the colon or rectum. However, it has not been shown to help people who have cancer of the colon or rectum feel better or live longer. Cetuximab is in a class of medications called monoclonal antibodies. It works by slowing or stopping the growth of cancer cells.

How should this medicine be used?

Cetuximab comes as a solution (liquid) to be infused (injected slowly) into a vein. Cetuximab is given by a doctor or nurse in a medical office or infusion center. It is usually given once a week.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before receiving treatment with cetuximab,

tell your doctor and pharmacist if you are allergic to cetuximab, any medications that are made from murine (mouse) proteins, or any other medications. Ask your doctor or pharmacist if you don't know whether a medication that you are allergic to is made from murine proteins.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention if you are receiving treatment with cisplatin (Platinol). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had lung disease.
tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control to prevent pregnancy during your treatment with cetuximab. If you become pregnant while using cetuximab, call your doctor.
tell your doctor if you are breast-feeding. You should not breastfeed during your treatment with cetuximab or for 60 days after you stop using the medication.
plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, a hat, sunglasses, and sunscreen. Cetuximab may make your skin sensitive to sunlight.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

If you miss an appointment to receive a dose of cetuximab, call your doctor right away.

What side effects can this medication cause?

Cetuximab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

acne-like rash
dry or cracking skin
swelling or pain in the fingernails or toenails
red, watery, or itchy eye(s)
red or swollen eyelid(s)
pain or burning sensation in eye(s)
sensitivity of eyes to light
hair loss
dry mouth
chapped lips
mouth sores
difficulty swallowing
headache
tiredness
weakness
difficulty falling asleep or staying asleep
depression
nausea
vomiting
constipation
stomach pain
heartburn
loss of appetite
weight loss
pain, especially in the back
pain, redness, or swelling at injection spot

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

swelling of the hands, feet, ankles, or lower legs
fast heartbeat
coughing up blood or dry cough
shortness of breath or unusual tiredness during exercise
fainting
decreased urination
muscle cramps
shaking of the hands that you cannot control
sudden tightening of the hands or feet
twitching of the body that you cannot control
sore throat, fever, chills, and other signs of infection
diarrhea
confusion
itching
hives
red, swollen, or infected skin

Cetuximab may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Ask your doctor if you have any questions about your treatment with cetuximab.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand name(s):

Erbitux®

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