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Herceptin (Trastuzumab) - Ejection Fraction Decreased - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Ejection Fraction Decreased (53)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Herceptin (Trastuzumab) where reactions include ejection fraction decreased. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 53   Next >>

Possible Herceptin side effects in 92 year old female

Reported by a physician from Spain on 2012-08-22

Patient: 92 year old female

Reactions: Cardiac Failure, Ejection Fraction Decreased, Drug Intolerance

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in female

Reported by a physician from United States on 2012-08-06

Patient: female

Reactions: Tooth Loss, Generalised Anxiety Disorder, Chronic Fatigue Syndrome, Tympanic Membrane Disorder, Chronic Obstructive Pulmonary Disease, Positron Emission Tomogram Abnormal, Nervousness, Back Pain, Hypotension, Cardiomyopathy, Osteitis, Rhinitis Allergic, Angiopathy, Superinfection, Osteoporosis, Periodontal Disease, Fall, Bone Disorder, Depression, Dyspnoea, Musculoskeletal Pain, Arthralgia, JAW Disorder, Loose Tooth, Lung Infiltration, RED Blood Cell Sedimentation Rate Increased, Vitamin D Deficiency, Gingivitis, Osteomyelitis, Headache, Cough, Bowel Movement Irregularity, Cellulitis, Pneumonia, Pain in Extremity, General Physical Health Deterioration, Micturition Urgency, Osteonecrosis, Ventricular Dysfunction, Ear Pain, Otitis Media, Attention Deficit / Hyperactivity Disorder, Purulent Discharge, Atelectasis, Soft Tissue Disorder, Mouth Ulceration, Pain, Neoplasm Progression, Periodontitis, Blood Urea Nitrogen / Creatinine Ratio Increased, Hypokinesia, Toothache, Blood Glucose Increased, Pain in JAW, RIB Fracture, Dental Caries, Urinary Tract Infection, Osteolysis, Migraine With Aura, Anxiety, Osteoarthritis, Neoplasm Malignant, Osteonecrosis of JAW, Ejection Fraction Decreased, Spinal Osteoarthritis, Bronchitis, Superior Vena Cava Syndrome, Infection, Inflammation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zometa
    Dosage: 4 mg, unk
    Start date: 2001-01-01
    End date: 2006-03-01

Herceptin

Other drugs received by patient: Radiation Treatment; MS Contin; Skelaxin; Lortab; Percocet; Ibuprofen (Advil); Seroquel; Xanax; Lidocaine; Cymbalta; Zoloft; Ativan; Venlafaxine; Cipro; Hydrocodone Bitartrate; Unasyn; Bactrim; Toradol; Wellbutrin; Adriamycin PFS; Chemotherapeutics NOS; Herceptin; Alprazolam; Penicillin; Morphine Sulfate; Chlorhexidine Gluconate; Promethazine; Fioricet



Possible Herceptin side effects in 45 year old female

Reported by a physician from United States on 2012-08-06

Patient: 45 year old female

Reactions: Metastases To Liver, Liver Function Test Abnormal, Ejection Fraction Decreased, Metastases To Lung

Drug(s) suspected as cause:
Xeloda
    Indication: Breast Cancer Metastatic

Herceptin
    Indication: Breast Cancer Metastatic

Other drugs received by patient: Gemcitabine Hydrochloride; Navelbine; Carboplatin; Adriamycin PFS; Tykerb; Cytoxan; Taxol; Taxotere



Possible Herceptin side effects in 64 year old female

Reported by a physician from Canada on 2012-08-01

Patient: 64 year old female

Reactions: Ejection Fraction Decreased, Idiopathic Thrombocytopenic Purpura

Drug(s) suspected as cause:
Abraxane
    Indication: Breast Cancer Metastatic
    End date: 2011-11-17

Aceon
    Dosage: 2 mg, qd, oral
    Administration route: Oral
    Indication: Ejection Fraction Decreased
    Start date: 2011-10-26
    End date: 2011-11-17

Herceptin
    Dosage: intravenous
    Indication: Breast Cancer Metastatic



Possible Herceptin side effects in female

Reported by a physician from United States on 2012-08-01

Patient: female, weighing 75.4 kg (165.8 pounds)

Reactions: Vomiting, Lung Disorder, Neuropathy Peripheral, Fatigue, Hepatic Neoplasm Malignant, Ejection Fraction Decreased, Asthenia

Drug(s) suspected as cause:
Herceptin

Other drugs received by patient: Gemcitabine; Carboplatin; Taxotere; Navelbine



Possible Herceptin side effects in male

Reported by a physician from Italy on 2012-07-30

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Ventricular Hypokinesia, N-Terminal Prohormone Brain Natriuretic Peptide Increased, Ejection Fraction Decreased, Troponin Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cisplatin
    Dosage: last dose taken: 80mg/m2
    Indication: Gastric Cancer
    Start date: 2012-04-05

Herceptin
    Indication: Gastric Cancer
    Start date: 2012-04-04

Pertuzumab
    Indication: Gastric Cancer
    Start date: 2012-04-04

Xeloda
    Dosage: last dose taken: 500mg/m2
    Administration route: Oral
    Indication: Gastric Cancer
    Start date: 2012-04-04



Possible Herceptin side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-26

Patient: female

Reactions: Ejection Fraction Decreased, Myocardial Infarction

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in female

Reported by a physician from Poland on 2012-07-23

Patient: female

Reactions: Ejection Fraction Decreased, Pulmonary Embolism, Myocardial Infarction

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in male

Reported by a physician from Italy on 2012-07-13

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Ventricular Hypokinesia, N-Terminal Prohormone Brain Natriuretic Peptide Increased, Ejection Fraction Decreased, Troponin Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cisplatin
    Dosage: last dose taken: 80mg/m2
    Indication: Gastric Cancer
    Start date: 2012-04-05

Pertuzumab
    Indication: Gastric Cancer
    Start date: 2012-04-04

Herceptin
    Indication: Gastric Cancer
    Start date: 2012-04-04

Xeloda
    Dosage: last dose taken: 500mg/m2
    Administration route: Oral
    Indication: Gastric Cancer
    Start date: 2012-04-04



Possible Herceptin side effects in female

Reported by a physician from United States on 2012-07-10

Patient: female

Reactions: Tooth Loss, Weight Decreased, Primary Sequestrum, Abdominal Pain, Pruritus, Metastases To Liver, Osteomyelitis, Tooth Infection, Erythema, Pericardial Effusion, Cardiac Disorder, Asphyxia, Haemangioma of Liver, Ecchymosis, Hypoxia, Nail Disorder, Pathological Fracture, Fluid Retention, Pneumonia, Fistula, Cellulitis, Anaemia, Paraesthesia, Decreased Interest, Hepatic Cyst, Atelectasis, Exposed Bone in JAW, Pain, Hypokalaemia, Neuropathy Peripheral, Bone Loss, Chest Pain, Onychoclasis, Pleural Effusion, Depression, Injury, Thrombocytopenia, Lymphoedema, Metastases To Lung, Emphysema, Tooth Fracture, Dyspnoea, Dental Caries, Sensation of Heaviness, Rash, Hydropneumothorax, Bronchopleural Fistula, Osteonecrosis of JAW, Diarrhoea, Impaired Healing, Ejection Fraction Decreased, JAW Disorder, Sinus Tachycardia

Drug(s) suspected as cause:
Taxotere
    Dosage: 58 mg, qw

Herceptin
    Dosage: 162 mg, qw
    End date: 2007-06-11

Zometa
    Dosage: 4 mg, qmo
    Indication: Hypercalcaemia of Malignancy
    Start date: 2003-12-01
    End date: 2007-02-01

Zometa
    Indication: Breast Cancer

Zometa
    Indication: Metastases To Bone

Other drugs received by patient: Procrit; Decadron; Zofran; Coreg; Aranesp; Femara; Faslodex; Klor-CON; Torsemide; Lisinopril; Cleocin Hydrochloride; Vicodin; Adriamycin PFS; Carboplatin



Possible Herceptin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-04

Patient: female

Reactions: Abdominal Pain, Weight Decreased, Tooth Loss, Primary Sequestrum, Pruritus, Metastases To Liver, Osteomyelitis, Tooth Infection, Erythema, Cardiac Disorder, Asphyxia, Pericardial Effusion, Haemangioma of Liver, Ecchymosis, Nail Disorder, Hypoxia, Pathological Fracture, Fluid Retention, Pneumonia, Cellulitis, Fistula, Anaemia, Decreased Interest, Paraesthesia, Atelectasis, Exposed Bone in JAW, Pain, Bone Loss, Neuropathy Peripheral, Chest Pain, Onychoclasis, Pleural Effusion, Depression, Injury, Thrombocytopenia, Metastases To Lung, Emphysema, Dyspnoea, Tooth Fracture, Dental Caries, Sensation of Heaviness, Rash, Hydropneumothorax, Bronchopleural Fistula, Diarrhoea, Osteonecrosis of JAW, Impaired Healing, Ejection Fraction Decreased, JAW Disorder, Sinus Tachycardia

Drug(s) suspected as cause:
Zometa
    Dosage: 4 mg, qmo
    Indication: Hypercalcaemia of Malignancy
    Start date: 2003-12-01
    End date: 2007-02-01

Zometa
    Indication: Breast Cancer

Herceptin
    Dosage: 162 mg, qw
    End date: 2007-06-11

Taxotere
    Dosage: 58 mg, qw

Zometa
    Indication: Metastases To Bone

Other drugs received by patient: Lisinopril; Torsemide; Decadron; Femara; Zofran; Coreg; Aranesp; Cleocin Hydrochloride; Klor-CON; Procrit; Faslodex; Adriamycin PFS; Carboplatin; Vicodin



Possible Herceptin side effects in

Reported by a individual with unspecified qualification from United States on 2012-06-19

Patient:

Reactions: Thrombosis, Headache, Device Related Infection, Peripheral Sensory Neuropathy, Pericardial Effusion, Malaise, Dyspepsia, Granulocytopenia, Hypoxia, Pneumonitis, Blood Alkaline Phosphatase Increased, Hypotension, Anaemia, Hyperglycaemia, Dehydration, Neutropenia, Pain, Bone Pain, Hypokalaemia, Neutropenic Infection, Postoperative Wound Infection, Fatigue, Chest Pain, Depression, Lethargy, Vomiting, Dyspnoea, Lymphopenia, Alanine Aminotransferase Increased, Muscular Weakness, Febrile Neutropenia, Hypophosphataemia, Syncope, Arthralgia, Diarrhoea, Ejection Fraction Decreased, Hypermagnesaemia, Respiratory Tract Infection, Leukopenia, Infection

Drug(s) suspected as cause:
Vinorelbine Tartrate
    Dosage: on day 8 and 15 of the 21 days cycle
    Indication: Breast Cancer Metastatic

Herceptin

Docetaxel
    Indication: Breast Cancer Metastatic

Herceptin
    Indication: Breast Cancer Metastatic



Possible Herceptin side effects in male

Reported by a individual with unspecified qualification from Italy on 2012-06-12

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Ventricular Hypokinesia, N-Terminal Prohormone Brain Natriuretic Peptide Increased, Ejection Fraction Decreased, Troponin Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cisplatin
    Dosage: last dose prior to sae: 02/may/2012, last dose 80mg/m2
    Indication: Gastric Cancer
    Start date: 2012-04-05

Pertuzumab
    Dosage: last dose prior to sae: 02/may/2012, last dose 420mg/kg
    Indication: Gastric Cancer
    Start date: 2012-04-04

Herceptin
    Dosage: last dose prior to sae: 02/may/2012, last dose 426mg
    Indication: Gastric Cancer
    Start date: 2012-04-04

Xeloda
    Dosage: recent dose of capecitabine 16 may 2012
    Administration route: Oral
    Indication: Gastric Cancer
    Start date: 2012-04-04



Possible Herceptin side effects in male

Reported by a physician from Italy on 2012-06-08

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Ventricular Hypokinesia, N-Terminal Prohormone Brain Natriuretic Peptide Increased, Ejection Fraction Decreased, Troponin Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cisplatin
    Dosage: last dose prior to sae: 02/may/2012, last dose 80mg/m2
    Indication: Gastric Cancer
    Start date: 2012-04-05

Pertuzumab
    Dosage: last dose prior to sae: 02/may/2012, last dose 420mg/kg
    Indication: Gastric Cancer
    Start date: 2012-04-04

Xeloda
    Dosage: recent dose of capecitabine 16 may 2012
    Administration route: Oral
    Indication: Gastric Cancer
    Start date: 2012-04-04

Herceptin
    Dosage: last dose prior to sae: 02/may/2012, last dose 426mg
    Indication: Gastric Cancer
    Start date: 2012-04-04



Possible Herceptin side effects in male

Reported by a individual with unspecified qualification from Italy on 2012-06-08

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Ventricular Hypokinesia, N-Terminal Prohormone Brain Natriuretic Peptide Increased, Ejection Fraction Decreased, Troponin Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Herceptin
    Dosage: last dose prior to sae: 02/may/2012, last dose 426mg
    Indication: Gastric Cancer
    Start date: 2012-04-04

Cisplatin
    Dosage: last dose prior to sae: 02/may/2012, last dose 80mg/m2
    Indication: Gastric Cancer
    Start date: 2012-04-05

Pertuzumab
    Dosage: last dose prior to sae: 02/may/2012, last dose 420mg/kg
    Indication: Gastric Cancer
    Start date: 2012-04-04

Xeloda
    Dosage: last dose prior to sae: 16/may/2012, last dose 500mg/m2
    Administration route: Oral
    Indication: Gastric Cancer
    Start date: 2012-04-04



Possible Herceptin side effects in male

Reported by a individual with unspecified qualification from Italy on 2012-06-07

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Ventricular Hypokinesia, N-Terminal Prohormone Brain Natriuretic Peptide Increased, Ejection Fraction Decreased, Troponin Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pertuzumab
    Dosage: last dose prior to sae: 02/may/2012, last dose 420mg/kg
    Indication: Gastric Cancer
    Start date: 2012-04-04

Herceptin
    Dosage: last dose prior to sae: 02/may/2012, last dose 426mg
    Indication: Gastric Cancer
    Start date: 2012-04-04

Xeloda
    Dosage: last dose prior to sae: 16/may/2012, last dose 500mg/m2
    Administration route: Oral
    Indication: Gastric Cancer
    Start date: 2012-04-04

Cisplatin
    Dosage: last dose prior to sae: 02/may/2012, last dose 80mg/m2
    Indication: Gastric Cancer
    Start date: 2012-04-05



Possible Herceptin side effects in female

Reported by a individual with unspecified qualification from United States on 2012-06-05

Patient: female

Reactions: Vomiting, Wound Dehiscence, Nausea, Pain, Hyperglycaemia, Proteinuria, Ejection Fraction Decreased, Neutropenia, Hypertension, Blood Creatinine Increased, Thrombocytopenia, Infection

Drug(s) suspected as cause:
Herceptin
    Dosage: for 23 weeks

Avastin
    Dosage: for 23 weeks
    Indication: Breast Cancer

Herceptin
    Dosage: loading dose
    Indication: Breast Cancer

Herceptin
    Dosage: total 54 weeks

Paclitaxel
    Dosage: days 1, 8 and 15
    Indication: Breast Cancer

Avastin
    Dosage: total 54 weeks

Carboplatin
    Dosage: auc=6 for 6 cycles
    Indication: Breast Cancer



Possible Herceptin side effects in female

Reported by a physician from Italy on 2012-05-31

Patient: female

Reactions: Ejection Fraction Decreased, Chest Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in female

Reported by a consumer/non-health professional from Netherlands on 2012-05-30

Patient: female

Reactions: Fatigue, Pain in Extremity, Musculoskeletal Pain, Ejection Fraction Decreased, Alopecia, Musculoskeletal Chest Pain, Fluid Retention

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-05-28

Patient: 65 year old female, weighing 81.7 kg (179.8 pounds)

Reactions: Oropharyngeal Pain, Dysgeusia, Weight Increased, Fatigue, Diarrhoea, Swelling, DRY Mouth, Ejection Fraction Decreased

Drug(s) suspected as cause:
Herceptin

Other drugs received by patient: Flagyl; Taxotere; Hydrochlorothiazide; Vancomycin



Possible Herceptin side effects in female

Reported by a physician from Germany on 2012-05-17

Patient: female, weighing 62.0 kg (136.4 pounds)

Reactions: Supraventricular Tachycardia, Ejection Fraction Decreased, Atrial Fibrillation, Hemiparesis, Fall, Cerebral Ischaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Herceptin

Other drugs received by patient: Sertraline Hydrochloride; Levothyroxine Sodium; Hydrochlorothiazide; Ramipril; Bisoprolol Fumarate



Possible Herceptin side effects in 42 year old female

Reported by a physician from Germany on 2012-05-10

Patient: 42 year old female

Reactions: Tachycardia, Ejection Fraction Decreased, Pulmonary Embolism

Adverse event resulted in: death

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in 45 year old

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-04-25

Patient: 45 year old

Reactions: Ejection Fraction Decreased, Disease Progression

Drug(s) suspected as cause:
Herceptin
    Indication: Breast Cancer

Xeloda
    Administration route: Oral
    Indication: Breast Cancer

Other drugs received by patient: Lapatinib; Doxorubicin Hydrochloride



Possible Herceptin side effects in 62 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-19

Patient: 62 year old female

Reactions: Medical Device Removal, Catheter Removal, Mammoplasty, Ejection Fraction Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in female

Reported by a individual with unspecified qualification from Algeria on 2012-03-30

Patient: female

Reactions: Dyspnoea Exertional, Ejection Fraction Decreased, Pulmonary Arterial Hypertension, Cardiomegaly, Cardiac Disorder, Cough

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in female

Reported by a physician from Germany on 2012-03-21

Patient: female, weighing 62.0 kg (136.4 pounds)

Reactions: Ejection Fraction Decreased, Atrial Fibrillation, Hemiparesis, Fall, Cerebral Ischaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Herceptin

Other drugs received by patient: Sertraline Hydrochloride; Ramipril; Bisoprolol Fumarate; Levothyroxine Sodium; Hydrochlorothiazide



Possible Herceptin side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-08

Patient: female

Reactions: Aspiration, Ejection Fraction Decreased, Febrile Neutropenia, Neutropenia, Respiratory Distress, Cardiac Disorder

Adverse event resulted in: death

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: Breast Cancer

Herceptin
    Dosage: loading dose; over 90 minutes, day 1 cycle 1
    Indication: Breast Cancer

Docetaxel
    Indication: Breast Cancer

Herceptin
    Dosage: on day 1, 8 and 15

Herceptin



Possible Herceptin side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-08

Patient: female

Reactions: Hypotension, Ejection Fraction Decreased, Ovarian Cyst, Dizziness

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in female

Reported by a physician from United States on 2012-03-07

Patient: female, weighing 106.3 kg (233.9 pounds)

Reactions: Dyspnoea, Ejection Fraction Decreased

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 5088 mg

Neulasta
    Dosage: 60 mg

Doxorubicin HCL
    Dosage: 508 mg

Taxol
    Dosage: 2220 mg

Herceptin
    Dosage: 2160 mg



Possible Herceptin side effects in 64 year old female

Reported by a physician from Canada on 2012-03-07

Patient: 64 year old female

Reactions: Ejection Fraction Decreased, Idiopathic Thrombocytopenic Purpura

Drug(s) suspected as cause:
Herceptin
    Indication: Breast Cancer

Abraxane
    Indication: Breast Cancer

Perindopril Erbumine
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-26

Other drugs received by patient: Losec (Canada); Prednisone TAB



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