|
Index of reports
> Life Threatening Events (40)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Tarceva (Erlotinib) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 40 Next >>
Possible Tarceva side effects in 79 year old male
Reported by a consumer/non-health professional from China on 2012-08-20
Patient: 79 year old male
Reactions: Productive Cough, Aphasia, Bronchial Carcinoma, Rash Pruritic, Poor Quality Sleep, Death, Incontinence, Oedema Peripheral, Blood Creatinine Increased, Epistaxis, Decreased Appetite, Emphysema, Dyspnoea, Blood Urea Increased, Stomatitis, Vomiting, Nausea, Rhinorrhoea, Diarrhoea, Cerebral Infarction, Depressed Level of Consciousness, Metastases To Bone, Asthenia
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Avastin
Indication: Rectal Cancer Metastatic
Tarceva
Administration route: Oral
Indication: Rectal Cancer Metastatic
Start date: 2012-06-01
End date: 2012-06-09
Xeloda
Administration route: Oral
Indication: Rectal Cancer Metastatic
End date: 2012-02-23
Possible Tarceva side effects in 79 year old male
Reported by a consumer/non-health professional from China on 2012-08-20
Patient: 79 year old male
Reactions: Asthma, Productive Cough, Urinary Incontinence, Bronchial Carcinoma, Aphasia, Rash Pruritic, Off Label Use, Poor Quality Sleep, Death, Oedema Peripheral, Blood Creatinine Increased, Epistaxis, Decreased Appetite, Emphysema, Stomatitis, Vomiting, Pneumonia, Dyspnoea, Blood Urea Increased, Nausea, Rhinorrhoea, Rash, Diarrhoea, Cerebral Infarction, Depressed Level of Consciousness, Metastases To Bone, Asthenia
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Tarceva
Dosage: 150 mg, uid/qd
Administration route: Oral
Indication: Rectal Cancer Metastatic
Start date: 2012-06-01
End date: 2012-06-09
Avastin
Dosage: unk
Indication: Rectal Cancer Metastatic
Xeloda
Dosage: 1.5 df, bid for 2 weeks followed by 7 day rest period
Administration route: Oral
Indication: Rectal Cancer Metastatic
End date: 2012-02-23
Possible Tarceva side effects in 61 year old male
Reported by a consumer/non-health professional from Ecuador on 2012-08-16
Patient: 61 year old male
Reactions: Glaucoma
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tarceva
Possible Tarceva side effects in 61 year old male
Reported by a consumer/non-health professional from Ecuador on 2012-08-07
Patient: 61 year old male
Reactions: Glaucoma, Bone Pain
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tarceva
Possible Tarceva side effects in male
Reported by a physician from Japan on 2012-07-31
Patient: male, weighing 47.0 kg (103.4 pounds)
Reactions: C-Reactive Protein Increased, Urinary Retention, Neutropenia, Thrombocytopenia, Renal Failure Acute
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tarceva
Dosage: 150 mg, uid/qd
Administration route: Oral
Indication: Large Cell Lung Cancer Stage IV
Start date: 2012-02-24
End date: 2012-02-26
Alimta
Dosage: 720 mg, uid/qd
Indication: Large Cell Lung Cancer Stage IV
Start date: 2012-02-23
End date: 2012-02-23
Other drugs received by patient: Panvitan / 07504101 /; Calblock; Olmesartan Medoxomil; Mucosolvan (Lasolvan); Isosorbide Dinitrate; Warfarin / 00014802 /; Gaslon N; Maglax; Aspirin; Epinastine Hydrochloride; Rinderon / 00309501 /; Codeine Phosphate Hemihydrate; Lipitor; Lisinopril; Hypen / 00613801 /
Possible Tarceva side effects in 79 year old male
Reported by a physician from United States on 2012-07-12
Patient: 79 year old male
Reactions: Dysgeusia, Off Label Use, Weight Decreased, Rash Erythematous, Rhinorrhoea, Hair Colour Changes, Decreased Appetite
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tarceva
Dosage: 150 mg, uid/qd, oral
Administration route: Oral
Indication: Hypertension
Start date: 2011-01-15
End date: 2012-01-01
Tarceva
Dosage: 150 mg, uid/qd, oral
Administration route: Oral
Indication: Hypercholesterolaemia
Start date: 2011-01-15
End date: 2012-01-01
Tarceva
Dosage: 150 mg, uid/qd, oral
Administration route: Oral
Indication: Lung Neoplasm Malignant
Start date: 2011-01-15
End date: 2012-01-01
Other drugs received by patient: Methadone Hydrochloride; Doxycycline; Toprol-XL; Bayer Aspirin (Acetylsalicylic Acid) Tablet; Nitroglycerine (Glyceryl Trinitrate) Capsule; Senokot (Senna Fruit) Tablet; Morphine Sulfate INJ; Zometa; OS-CAL (Calcium, Ergocalciferol) Tablet; Gabapentin (Gabapentin) Capsule; Plavix; Hydrocodone W / Apap (Hydrocodone, Paracetamol); Crestor
Possible Tarceva side effects in female
Reported by a physician from Japan on 2012-07-11
Patient: female, weighing 48.0 kg (105.6 pounds)
Reactions: Electrocardiogram ST Segment Abnormal, Enterococcal Sepsis, Interstitial Lung Disease, Respiratory Failure, Left Ventricular Hypertrophy, Lymphangiosis Carcinomatosa
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Tarceva
Other drugs received by patient: Ferromia / 00023520 /; Celebrex; Lansoprazole
Possible Tarceva side effects in 81 year old male
Reported by a physician from France on 2012-07-11
Patient: 81 year old male, weighing 65.0 kg (143.0 pounds)
Reactions: Vomiting, Diarrhoea, Nausea, Dehydration, General Physical Health Deterioration, Rash, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tarceva
Dosage: 150 mg, unknown/d
Administration route: Oral
Indication: Bronchial Carcinoma
Start date: 2012-05-01
End date: 2012-05-19
Tarceva
Indication: Metastases To Adrenals
Other drugs received by patient: Exforge; Amlodipine Besylate; Aspirin; Lasix
Possible Tarceva side effects in 84 year old female
Reported by a physician from Germany on 2012-07-11
Patient: 84 year old female
Reactions: Skin Necrosis, Skin Fissures, Epidermolysis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tarceva
Other drugs received by patient: Digoxin; Marcumar; Renacor; Simvastatin; Iressa
Possible Tarceva side effects in female
Reported by a physician from Japan on 2012-07-03
Patient: female, weighing 48.0 kg (105.6 pounds)
Reactions: Electrocardiogram ST Segment Abnormal, Enterococcal Sepsis, Interstitial Lung Disease, Respiratory Failure, Left Ventricular Hypertrophy, Lymphangiosis Carcinomatosa
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Tarceva
Other drugs received by patient: Lansoprazole; Celebrex; Ferromia / 00023520 /
Possible Tarceva side effects in 63 year old male
Reported by a physician from France on 2012-06-25
Patient: 63 year old male, weighing 75.0 kg (165.0 pounds)
Reactions: Acute Myeloid Leukaemia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tarceva
Dosage: 25 mg, uid/qd
Administration route: Oral
Indication: Neoplasm Malignant
Start date: 2008-10-01
End date: 2012-04-28
Cisplatin
Dosage: 145 mg, cyclic
Indication: Neoplasm Malignant
Start date: 2008-02-01
End date: 2008-05-01
Navelbine
Dosage: 55 mg, day 1 to day 8
Indication: Neoplasm Malignant
Start date: 2008-02-01
End date: 2008-05-01
Possible Tarceva side effects in female
Reported by a physician from Japan on 2012-06-25
Patient: female, weighing 48.0 kg (105.6 pounds)
Reactions: Electrocardiogram ST Segment Abnormal, Enterococcal Sepsis, Respiratory Failure, Interstitial Lung Disease, Left Ventricular Hypertrophy, Lymphangiosis Carcinomatosa
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Tarceva
Other drugs received by patient: Lansoprazole; Celebrex; Ferromia / 00023520 /
Possible Tarceva side effects in male
Reported by a physician from Japan on 2012-06-18
Patient: male, weighing 47.0 kg (103.4 pounds)
Reactions: C-Reactive Protein Increased, Urinary Retention, Neutropenia, Thrombocytopenia, Renal Failure Acute
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Alimta
Dosage: 720 mg, uid/qd
Indication: Large Cell Lung Cancer Stage IV
Start date: 2012-02-23
End date: 2012-02-23
Tarceva
Dosage: 150 mg, uid/qd
Administration route: Oral
Indication: Large Cell Lung Cancer Stage IV
Start date: 2012-02-24
End date: 2012-02-26
Other drugs received by patient: Aspirin; Epinastine Hydrochloride; Hypen / 00613801 /; Rinderon / 00309501 /; Lipitor; Olmesartan Medoxomil; Gaslon N; Isosorbide Dinitrate; Lisinopril; Warfarin / 00014802 /; Codeine Phosphate Hemihydrate; Calblock; Panvitan / 07504101 /; Maglax; Mucosolvan (Lasolvan)
Possible Tarceva side effects in
Reported by a physician from France on 2012-06-11
Patient:
Reactions: Vomiting, Diarrhoea, Nausea, General Physical Health Deterioration, Rash, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tarceva
Other drugs received by patient: Amlodipine Besylate; Aspirin; Lasix; Exforge
Possible Tarceva side effects in male
Reported by a physician from Japan on 2012-06-05
Patient: male, weighing 47.0 kg (103.4 pounds)
Reactions: Diarrhoea, Platelet Count Decreased, Acute Promyelocytic Leukaemia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tarceva
Dosage: 100 mg, uid/qd
Administration route: Oral
End date: 2012-01-25
Diltiazem HCL
Dosage: 100 mg, uid/qd
Administration route: Oral
Indication: Hypertension
Tarceva
Dosage: 100 mg, uid/qd
Administration route: Oral
Start date: 2011-07-29
End date: 2011-10-30
Cotrim
Dosage: unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Hormones and Related Agents
Dosage: unk
Indication: Product Used FOR Unknown Indication
Start date: 2011-07-29
Tarceva
Dosage: 150 mg, uid/qd
Administration route: Oral
Indication: Lung Neoplasm Malignant
Start date: 2011-04-20
End date: 2011-07-28
Plavix
Dosage: 75 mg, uid/qd
Administration route: Oral
Indication: Cerebral Infarction
Possible Tarceva side effects in
Reported by a physician from Japan on 2012-06-04
Patient: , weighing 47.0 kg (103.4 pounds)
Reactions: Diarrhoea, Acute Promyelocytic Leukaemia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tarceva
Dosage: 100 mg, uid/qd
Administration route: Oral
Start date: 2011-07-29
End date: 2012-01-25
Diltiazem HCL
Dosage: 100 mg, uid/qd
Administration route: Oral
Indication: Hypertension
Tarceva
Dosage: 150 mg, uid/qd
Administration route: Oral
Indication: Lung Neoplasm Malignant
Start date: 2011-04-20
End date: 2011-07-28
Plavix
Dosage: 75 mg, uid/qd
Administration route: Oral
Indication: Cerebral Infarction
Possible Tarceva side effects in
Reported by a physician from Japan on 2012-06-04
Patient: , weighing 47.0 kg (103.4 pounds)
Reactions: Diarrhoea, Platelet Count Decreased, Acute Promyelocytic Leukaemia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Cotrim
Dosage: unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Hormones and Related Agents
Dosage: unk
Indication: Product Used FOR Unknown Indication
Start date: 2011-07-29
Plavix
Dosage: 75 mg, uid/qd
Administration route: Oral
Indication: Cerebral Infarction
Tarceva
Dosage: 150 mg, uid/qd
Administration route: Oral
Indication: Lung Neoplasm Malignant
Start date: 2011-04-20
End date: 2011-07-28
Diltiazem HCL
Dosage: 100 mg, uid/qd
Administration route: Oral
Indication: Hypertension
Tarceva
Dosage: 100 mg, uid/qd
Administration route: Oral
Start date: 2011-07-29
End date: 2012-01-25
Possible Tarceva side effects in 76 year old male
Reported by a pharmacist from Canada on 2012-05-10
Patient: 76 year old male, weighing 62.0 kg (136.4 pounds)
Reactions: Respiratory Rate Increased, Dyspnoea, Bronchiectasis, Tachypnoea, Pulmonary Fibrosis, Oxygen Saturation Decreased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tarceva
Other drugs received by patient: Aspirin; Imodium
Possible Tarceva side effects in 84 year old female
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-18
Patient: 84 year old female
Reactions: Skin Necrosis, Epidermolysis, Skin Fissures
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tarceva
Other drugs received by patient: Digoxin; Simvastatin; Iressa; Renacor
Possible Tarceva side effects in
Reported by a physician from Japan on 2012-04-11
Patient: , weighing 47.0 kg (103.4 pounds)
Reactions: Diarrhoea, Acute Promyelocytic Leukaemia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tarceva
Dosage: 150 mg, uid/qd
Administration route: Oral
Indication: Lung Neoplasm Malignant
Start date: 2011-04-20
End date: 2011-07-28
Tarceva
Dosage: 100 mg, uid/qd
Administration route: Oral
Start date: 2011-07-29
End date: 2012-01-25
Diltiazem HCL
Dosage: 100 mg, uid/qd
Administration route: Oral
Indication: Hypertension
Plavix
Dosage: 75 mg, uid/qd
Administration route: Oral
Indication: Cerebral Infarction
Possible Tarceva side effects in 46 year old female
Reported by a consumer/non-health professional from United States on 2012-04-09
Patient: 46 year old female, weighing 54.4 kg (119.7 pounds)
Reactions: Liver Injury, Speech Disorder, Dysphagia, Interstitial Lung Disease, Toxicity To Various Agents, Gait Disturbance, Eating Disorder
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Tarceva
Possible Tarceva side effects in female
Reported by a physician from Spain on 2012-04-06
Patient: female
Reactions: Peripheral Ischaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xeloda
Dosage: date of last dose prior to sae: 13/nov/2011
Administration route: Oral
Indication: Pancreatic Carcinoma
Start date: 2011-10-31
End date: 2011-12-03
Tarceva
Dosage: last dose prior to sae: 13/nov/2011
Administration route: Oral
Indication: Pancreatic Carcinoma
Start date: 2011-10-31
End date: 2011-12-03
Gemcitabine Hydrochloride
Dosage: last dose prior to sae: 7/nov/2011
Indication: Pancreatic Carcinoma
Start date: 2011-10-31
End date: 2011-12-03
Other drugs received by patient: Gentamicin; Atorvastatin; Minocycline HCL; Insulin; Aspirin
Possible Tarceva side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-27
Patient: female
Reactions: Death, Cholecystitis Acute, Gallbladder Perforation, Infectious Peritonitis
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Tarceva
Administration route: Oral
Indication: Pancreatic Carcinoma
Xeloda
Indication: Product Used FOR Unknown Indication
Avastin
Indication: Product Used FOR Unknown Indication
Possible Tarceva side effects in male
Reported by a physician from Romania on 2012-03-22
Patient: male, weighing 83.0 kg (182.6 pounds)
Reactions: Grand MAL Convulsion, Vomiting, Coma, Motor Neurone Disease
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tarceva
Other drugs received by patient: Manitol; Dextrose; Metoclopramide
Possible Tarceva side effects in female
Reported by a physician from United States on 2012-03-16
Patient: female
Reactions: Death
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Tarceva
Possible Tarceva side effects in male
Reported by a physician from Romania on 2012-03-13
Patient: male, weighing 83.0 kg (182.6 pounds)
Reactions: Grand MAL Convulsion, Vomiting, Coma
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tarceva
Other drugs received by patient: Manitol; Metoclopramide; Dextrose
Possible Tarceva side effects in 60 year old male
Reported by a physician from France on 2012-03-01
Patient: 60 year old male
Reactions: Megacolon, Large Intestine Perforation, Pneumonia, Sepsis, Intestinal Obstruction
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Tiorfan
Dosage: unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Tarceva
Dosage: 150 mg, uid/qd
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-12
End date: 2012-01-31
Possible Tarceva side effects in
Reported by a physician from United Kingdom on 2012-03-01
Patient: , weighing 61.0 kg (134.2 pounds)
Reactions: Vomiting, Diarrhoea, Blood Albumin Decreased, Rash, Acute Myocardial Infarction, Cardiac Arrest
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tarceva
Possible Tarceva side effects in female
Reported by a individual with unspecified qualification from Spain on 2012-02-17
Patient: female
Reactions: Limb Amputation, Pancreatic Carcinoma, Clostridium Test Positive, Paraneoplastic Syndrome, Hepatic Lesion, Neoplasm Progression, Peripheral Ischaemia, Diarrhoea
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tarceva
Dosage: last dose prior to sae: 13/nov/2011
Administration route: Oral
Indication: Pancreatic Carcinoma
Start date: 2011-10-31
Xeloda
Dosage: date of last dose prior to sae: 13/nov/2011
Administration route: Oral
Indication: Pancreatic Carcinoma
Start date: 2011-10-31
Gemcitabine Hydrochloride
Dosage: last dose prior to sae: 7/nov/2011
Indication: Pancreatic Carcinoma
Start date: 2011-10-31
Other drugs received by patient: Insulin; Minocycline HCL; Atorvastatin; Aspirin; Gentamicin
Possible Tarceva side effects in female
Reported by a individual with unspecified qualification from Japan on 2012-02-16
Patient: female, weighing 42.0 kg (92.4 pounds)
Reactions: Renal Salt-Wasting Syndrome, Malaise, Hyponatraemia, Constipation, Altered State of Consciousness, Cough, Decreased Appetite
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Avastin
Indication: Lung Adenocarcinoma Recurrent
Start date: 2010-04-14
End date: 2010-04-14
Tarceva
Administration route: Oral
Indication: Lung Adenocarcinoma
Start date: 2008-07-03
End date: 2010-04-11
Cisplatin
Indication: Lung Adenocarcinoma Recurrent
Start date: 2010-04-14
End date: 2010-04-14
Other drugs received by patient: Alimta; Codeine Phosphate; MAO-Bushi-Saishin-TO; Dextromethorphan Hydrobromide; Resplen; Magnesium Oxide
Page 1 Next >>
|
