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Index of reports
> Life Threatening Events (24)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Tykerb (Lapatinib) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Tykerb side effects in 60 year old female
Reported by a physician from Canada on 2012-08-20
Patient: 60 year old female
Reactions: Vomiting, Nausea, Diarrhoea, Neoplasm Malignant, Dehydration, Disease Progression, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tykerb
Administration route: Oral
Xeloda
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Tykerb
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Hydromorphone Hydrochloride; Retinol; Prevacid; Micardis; Verapamil HCL; Celebrex; Colace; Vitamin D; Antihypertensive Medications; Actonel; Senokot
Possible Tykerb side effects in female
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-06
Patient: female
Reactions: Dyspnoea, Vomiting, Nausea, Headache, Pericardial Effusion, Dysgeusia, Diarrhoea, Chest Pain, Pulmonary Thrombosis, Decreased Appetite
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xeloda
Indication: Breast Cancer
Start date: 2012-01-23
End date: 2012-07-01
Tykerb
Indication: Breast Cancer
Start date: 2012-01-23
End date: 2012-07-01
Possible Tykerb side effects in 76 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-20
Patient: 76 year old female
Reactions: Disease Progression
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tykerb
Other drugs received by patient: Antiemetics
Possible Tykerb side effects in female
Reported by a physician from Japan on 2012-06-20
Patient: female, weighing 39.0 kg (85.8 pounds)
Reactions: Monoplegia, Interstitial Lung Disease, Lymphangiosis Carcinomatosa, Decreased Appetite
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Indication: Breast Cancer
Start date: 2010-09-09
End date: 2010-09-30
Xeloda
Dosage: 1500mg per day
Administration route: Oral
Start date: 2010-09-09
End date: 2010-09-22
Possible Tykerb side effects in female
Reported by a physician from Japan on 2012-05-22
Patient: female, weighing 34.0 kg (74.8 pounds)
Reactions: Pneumonia, Dehydration, Decreased Appetite, Infectious Pleural Effusion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xeloda
Dosage: 2400mg per day
Administration route: Oral
Start date: 2010-06-03
End date: 2010-11-24
Phenytoin Sodium CAP
Indication: Product Used FOR Unknown Indication
Tykerb
Dosage: 1000mg per day
Administration route: Oral
Start date: 2010-12-01
End date: 2010-12-07
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Start date: 2010-03-14
End date: 2010-05-19
Tykerb
Dosage: 750mg per day
Administration route: Oral
Start date: 2010-11-25
End date: 2010-11-30
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Indication: Breast Cancer
Start date: 2010-01-12
End date: 2010-03-09
Xeloda
Dosage: 2400mg per day
Administration route: Oral
Start date: 2011-01-06
End date: 2011-07-28
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Start date: 2010-06-03
End date: 2010-11-24
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Start date: 2010-12-15
End date: 2011-07-28
Xeloda
Dosage: 2400mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-01-12
End date: 2010-03-09
Xeloda
Dosage: 2400mg per day
Administration route: Oral
Start date: 2010-03-14
End date: 2010-05-19
Xeloda
Dosage: 1800mg per day
Administration route: Oral
Start date: 2010-11-25
End date: 2011-01-05
Other drugs received by patient: Depakene; Betamethasone; Phenytoin Sodium CAP; Gabapentin; Zonisamide; Famotidine
Possible Tykerb side effects in female
Reported by a physician from Japan on 2012-05-22
Patient: female, weighing 56.0 kg (123.2 pounds)
Reactions: Interstitial Lung Disease
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tykerb
Other drugs received by patient: Alloid G; Urso 250; Gemzar; Xeloda; Mucosta; Herceptin; Loxonin; Glycyron
Possible Tykerb side effects in female
Reported by a physician from Japan on 2012-05-16
Patient: female, weighing 34.0 kg (74.8 pounds)
Reactions: Pneumonia, Dehydration, Decreased Appetite, Infectious Pleural Effusion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tykerb
Dosage: 750mg per day
Administration route: Oral
Start date: 2010-11-25
End date: 2010-11-30
Tykerb
Dosage: 1000mg per day
Administration route: Oral
Start date: 2010-12-01
End date: 2010-12-07
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Start date: 2010-12-15
End date: 2011-07-28
Xeloda
Dosage: 2400mg per day
Administration route: Oral
Start date: 2010-06-03
End date: 2010-11-24
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Start date: 2010-03-14
End date: 2010-05-19
Xeloda
Dosage: 2400mg per day
Administration route: Oral
Start date: 2010-03-14
End date: 2010-05-19
Xeloda
Dosage: 2400mg per day
Administration route: Oral
Start date: 2011-01-06
End date: 2011-07-28
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Indication: Breast Cancer
Start date: 2010-01-12
End date: 2010-03-09
Xeloda
Dosage: 2400mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-01-12
End date: 2010-03-09
Xeloda
Dosage: 1800mg per day
Administration route: Oral
Start date: 2010-11-25
End date: 2011-01-05
Phenytoin Sodium CAP
Indication: Product Used FOR Unknown Indication
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Start date: 2010-06-03
End date: 2010-11-24
Other drugs received by patient: Betamethasone; Gabapentin; Depakene; Phenytoin Sodium CAP; Zonisamide; Famotidine
Possible Tykerb side effects in 59 year old female
Reported by a consumer/non-health professional from United States on 2012-05-08
Patient: 59 year old female, weighing 86.4 kg (190.1 pounds)
Reactions: Sudden Cardiac Death, Nausea, Cardiac Disorder, Apparent Death, Diarrhoea, Cardiac Failure, Electrolyte Imbalance, Stress Cardiomyopathy
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tykerb
Other drugs received by patient: Xeloda
Possible Tykerb side effects in female
Reported by a physician from Japan on 2012-05-01
Patient: female, weighing 56.0 kg (123.2 pounds)
Reactions: Interstitial Lung Disease
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tykerb
Other drugs received by patient: Urso 250; Xeloda; Glycyron; Loxonin; Gemzar; Mucosta; Herceptin; Alloid G
Possible Tykerb side effects in 45 year old female
Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-04-12
Patient: 45 year old female
Reactions: Vomiting, Nausea, Gastrointestinal Toxicity, Hepatitis, Transaminases Increased, Abdominal Pain Upper, Diarrhoea, Liver Function Test Abnormal
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tykerb
Possible Tykerb side effects in 81 year old female
Reported by a consumer/non-health professional from United States on 2012-04-11
Patient: 81 year old female, weighing 65.5 kg (144.1 pounds)
Reactions: Thrombosis, Intestinal Ischaemia, Diarrhoea, International Normalised Ratio Increased, Coagulopathy, Hypoxia, Intestinal Infarction
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Coumadin
Indication: Atrial Fibrillation
End date: 2012-02-21
Tykerb
Dosage: 250mg three times per day
Administration route: Oral
Indication: Breast Cancer
Start date: 2012-02-01
End date: 2012-02-19
Other drugs received by patient: Xeloda
Possible Tykerb side effects in 59 year old female
Reported by a consumer/non-health professional from United States on 2012-04-10
Patient: 59 year old female, weighing 86.4 kg (190.1 pounds)
Reactions: Nausea, Sudden Cardiac Death, Cardiac Disorder, Apparent Death, Diarrhoea, Cardiac Failure, Electrolyte Imbalance, Stress Cardiomyopathy
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tykerb
Other drugs received by patient: Xeloda
Possible Tykerb side effects in 81 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-20
Patient: 81 year old female
Reactions: Intestinal Ischaemia, Thrombosis, Diarrhoea, Coagulopathy, International Normalised Ratio Increased, Hypoxia
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Coumadin
Indication: Product Used FOR Unknown Indication
Tykerb
Dosage: 250mg three times per day
Administration route: Oral
Indication: Breast Cancer
Start date: 2012-02-01
End date: 2012-02-19
Other drugs received by patient: Xeloda
Possible Tykerb side effects in female
Reported by a physician from Japan on 2012-03-20
Patient: female, weighing 56.0 kg (123.2 pounds)
Reactions: Hepatic Function Abnormal, Palmar-Plantar Erythrodysaesthesia Syndrome, Femoral Neck Fracture, Hepatic Enzyme Increased
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Indication: Breast Cancer
Start date: 2010-10-12
End date: 2011-06-21
Xeloda
Dosage: 1800mg per day
Administration route: Oral
Start date: 2010-10-12
End date: 2011-06-14
Other drugs received by patient: Lendormin; Cortril; Famotidine; Chinese Medicine; Decadron; Chinese Medicine; Desmopressin Acetate
Possible Tykerb side effects in female
Reported by a physician from Indonesia on 2012-03-14
Patient: female
Reactions: Hepatic Failure
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tykerb
Possible Tykerb side effects in female
Reported by a physician from Japan on 2012-03-02
Patient: female, weighing 56.0 kg (123.2 pounds)
Reactions: Hepatic Function Abnormal, Palmar-Plantar Erythrodysaesthesia Syndrome, Femoral Neck Fracture, Hepatic Enzyme Increased
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Indication: Breast Cancer
Start date: 2010-10-12
End date: 2011-06-21
Xeloda
Dosage: 1800mg per day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-12
End date: 2011-06-14
Other drugs received by patient: Desmopressin Acetate; Cortril; Chinese Medicine; Lendormin; Chinese Medicine; Decadron; Famotidine
Possible Tykerb side effects in female
Reported by a physician from Brazil on 2012-02-15
Patient: female
Reactions: Vomiting, Gastrointestinal Toxicity, Diarrhoea, Nausea, Transaminases Increased, Hepatitis, Abdominal Pain Upper
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tykerb
Possible Tykerb side effects in 81 year old female
Reported by a physician from Japan on 2011-12-29
Patient: 81 year old female
Reactions: Interstitial Lung Disease
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Tykerb
Other drugs received by patient: Tagamet; Timoptol; Depakene; Xalatan; Xeloda; Trusopt; Betamethasone
Possible Tykerb side effects in female
Reported by a physician from Japan on 2011-11-28
Patient: female, weighing 50.1 kg (110.2 pounds)
Reactions: Cardiac Failure, Hypotension, Acute Myocardial Infarction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Indication: Breast Cancer
Start date: 2011-08-04
End date: 2011-08-11
Magmitt
Administration route: Oral
Indication: Constipation
Capecitabine
Dosage: 3000mg per day
Administration route: Oral
Indication: Breast Cancer
Start date: 2011-08-04
End date: 2011-08-12
Other drugs received by patient: Gasmotin; Zolpidem; Claritin; Lipitor; Mohrus Tape; Methylcobal; Lansoprazole; Zetia; Posterisan
Possible Tykerb side effects in female
Reported by a physician from Japan on 2011-11-23
Patient: female, weighing 56.0 kg (123.2 pounds)
Reactions: Weight Decreased, Colitis, Decreased Appetite
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xeloda
Dosage: 3000mg per day
Administration route: Oral
Start date: 2010-05-28
End date: 2010-10-14
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Indication: Breast Cancer
Start date: 2010-05-23
Xeloda
Dosage: 3000mg per day
Administration route: Oral
Start date: 2010-10-29
End date: 2010-12-10
Possible Tykerb side effects in 63 year old female
Reported by a consumer/non-health professional from United States on 2011-11-11
Patient: 63 year old female, weighing 87.7 kg (192.9 pounds)
Reactions: Subdural Haematoma, Haematocrit Decreased, Haematoma Evacuation, Ecchymosis, Pneumocephalus, Fall, Extradural Haematoma
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Indication: Breast Cancer
Warfarin Sodium
Dosage: 3mg per day
Administration route: Oral
Indication: Cardioversion
End date: 2011-10-01
Other drugs received by patient: Keppra; Zyprexa; Dilantin; Toprol-XL; Levophed; Haldol; Vitamin D; Femara; Amiodarone HCL; Lamictal
Possible Tykerb side effects in 63 year old female
Reported by a pharmacist from United States on 2011-10-26
Patient: 63 year old female
Reactions: Depressed Level of Consciousness, Fall, Haematoma
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Tykerb
Other drugs received by patient: Femara
Possible Tykerb side effects in female
Reported by a physician from Japan on 2011-10-04
Patient: female, weighing 50.1 kg (110.2 pounds)
Reactions: Cardiac Failure, Hypotension, Acute Myocardial Infarction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Indication: Breast Cancer
Start date: 2011-08-04
End date: 2011-08-11
Magmitt
Administration route: Oral
Indication: Constipation
Capecitabine
Dosage: 3000mg per day
Administration route: Oral
Indication: Breast Cancer
Start date: 2011-08-04
End date: 2011-08-12
Other drugs received by patient: Claritin; Lansoprazole; Zolpidem; Posterisan; Zetia; Mohrus Tape; Methylcobal; Gasmotin; Lipitor
Possible Tykerb side effects in female
Reported by a physician from Japan on 2011-10-03
Patient: female, weighing 50.1 kg (110.2 pounds)
Reactions: Cardiac Failure, Hypotension, Acute Myocardial Infarction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tykerb
Dosage: 1250mg per day
Administration route: Oral
Indication: Breast Cancer
Start date: 2011-08-04
End date: 2011-08-11
Capecitabine
Dosage: 3000mg per day
Administration route: Oral
Indication: Breast Cancer
Start date: 2011-08-04
End date: 2011-08-12
Other drugs received by patient: Claritin; Magmitt; Methylcobal; Posterisan; Lansoprazole; Gasmotin; Zolpidem; Zetia; Mohrus Tape; Lipitor
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