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Herceptin (Trastuzumab) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (1527)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Herceptin (Trastuzumab) all cases. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 1527   Next >>

Possible Herceptin side effects in female

Reported by a physician from Japan on 2012-08-27

Patient: female, weighing 54.0 kg (118.8 pounds)

Reactions: Skin Exfoliation

Drug(s) suspected as cause:
Herceptin
    Start date: 2012-06-11
    End date: 2012-06-11

Herceptin
    Start date: 2012-07-02
    End date: 2012-07-02

Herceptin
    Indication: Breast Cancer
    Start date: 2012-05-21
    End date: 2012-05-21



Possible Herceptin side effects in

Reported by a physician from South Africa on 2012-08-27

Patient:

Reactions: Psychotic Disorder

Drug(s) suspected as cause:
Herceptin

Other drugs received by patient: Paclitaxel



Possible Herceptin side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in 54 year old male

Reported by a physician from Brazil on 2012-08-27

Patient: 54 year old male

Reactions: Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Herceptin
    Indication: Metastatic Gastric Cancer

Oxaliplatin
    Indication: Metastatic Gastric Cancer
    Start date: 2009-03-18

Xeloda
    Indication: Metastatic Gastric Cancer
    Start date: 2009-03-18



Possible Herceptin side effects in female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-08-26

Patient: female

Reactions: Rheumatoid Arthritis, Pain

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

Herceptin
    Indication: Breast Cancer



Possible Herceptin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Breast Pain, Pruritus, Drug Ineffective, Pain, Breast Mass, Feeling Cold, Malaise, Nodule, Pulmonary Oedema, Lacrimation Increased, Infusion Related Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Herceptin
    Indication: Breast Cancer
    Start date: 2006-08-01

Perjeta
    Indication: Breast Cancer

Other drugs received by patient: Carboplatin; Taxotere; Tykerb



Possible Herceptin side effects in

Reported by a consumer/non-health professional from China on 2012-08-24

Patient:

Reactions: Coma

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in female

Reported by a individual with unspecified qualification from Colombia on 2012-08-23

Patient: female

Reactions: Supraventricular Tachycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female, weighing 77.1 kg (169.6 pounds)

Reactions: Angioedema, Urticaria

Drug(s) suspected as cause:
Herceptin

Other drugs received by patient: Prednisolone



Possible Herceptin side effects in female

Reported by a consumer/non-health professional from Slovakia (Slovak Republic) on 2012-08-23

Patient: female

Reactions: Suicidal Ideation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in female

Reported by a physician from Germany on 2012-08-23

Patient: female, weighing 75.0 kg (165.0 pounds)

Reactions: Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: 5 auc
    Indication: Breast Cancer
    Start date: 2012-04-25

Docetaxel
    Indication: Breast Cancer
    Start date: 2012-04-25

Herceptin
    Indication: Breast Cancer
    Start date: 2012-04-25

Herceptin

Placebo
    Indication: Breast Cancer
    Start date: 2012-04-25

Other drugs received by patient: Metoprolol Tartrate



Possible Herceptin side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: female, weighing 69.6 kg (153.2 pounds)

Reactions: Vomiting, Metabolic Acidosis, Diarrhoea, Nausea, Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Docetaxel
    Indication: Breast Cancer
    Start date: 2012-06-18
    End date: 2012-06-18

Herceptin
    Indication: Breast Cancer
    Start date: 2012-06-18
    End date: 2012-06-18

Pertuzumab
    Indication: Breast Cancer
    Start date: 2012-06-18
    End date: 2012-06-18

Other drugs received by patient: Neulasta; Taxol



Possible Herceptin side effects in 61 year old female

Reported by a physician from France on 2012-08-23

Patient: 61 year old female

Reactions: Jaundice, Hepatitis Cholestatic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Femara
    Administration route: Oral
    Indication: Breast Cancer Metastatic

Herceptin
    Indication: Breast Cancer Metastatic

Lapatinib
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    End date: 2011-08-06



Possible Herceptin side effects in female

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

Patient: female, weighing 50.0 kg (110.0 pounds)

Reactions: Upper Gastrointestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epirubicin Hydrochloride
    Dosage: most recent dose prior to ae onset on 30/jul/2012
    Indication: Breast Cancer
    Start date: 2012-05-05
    End date: 2012-08-14

Herceptin
    Dosage: most recent dose prior to ae onset on 08/aug/2012
    Indication: Breast Cancer
    Start date: 2012-05-05
    End date: 2012-08-14

Paclitaxel
    Dosage: most recent dose prior to ae onset on 07/aug/2012
    Indication: Breast Cancer
    Start date: 2012-05-05
    End date: 2012-08-07



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 Pakistan on 2012-08-22

Patient: female

Reactions: Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased

Drug(s) suspected as cause:
Docetaxel
    Indication: Breast Cancer
    Start date: 2009-08-25

Herceptin
    Dosage: loading dose
    Start date: 2009-08-25

Herceptin
    Indication: Breast Cancer
    Start date: 2009-08-25

Lapatinib
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2010-02-18



Possible Herceptin side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: male, weighing 89.9 kg (197.8 pounds)

Reactions: Vomiting, Dyspnoea, Nausea, Dehydration, Pneumomediastinum, Pneumothorax, Odynophagia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Indication: Oesophageal Cancer Metastatic
    Start date: 2011-05-17
    End date: 2011-11-15

Avastin
    Dosage: last dose recieved on 14 feb 2012
    End date: 2012-02-14

Herceptin
    Dosage: last dose recieved on 14 feb 2012.
    End date: 2012-02-14

Herceptin
    Dosage: last dose recieved on 14 feb 2012.
    Indication: Oesophageal Cancer Metastatic
    Start date: 2011-05-10
    End date: 2011-11-15

Oxaliplatin
    Indication: Oesophageal Cancer Metastatic
    Start date: 2011-05-17
    End date: 2011-11-15

Oxaliplatin
    End date: 2012-02-14

Xeloda
    End date: 2012-02-26

Xeloda
    Indication: Oesophageal Cancer Metastatic
    Start date: 2011-05-17
    End date: 2011-11-29

Other drugs received by patient: Actos; Lorazepam; DTO; Prilosec; Ritalin; Toprol-XL; Potassium Chloride; Lomotil; Dexamethasone; Compazine; Prednisone TAB; Citalopram Hydrobromide; Morphine Sulfate; Lisinopril; Metoprolol Tartrate; Dicyclomine; Methylphenidate; Zofran; Oxycodone HCL; Decadron Phosphate; Bentyl; Emend



Possible Herceptin side effects in 50 year old female

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

Patient: 50 year old female

Reactions: Metastases To Central Nervous System

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

Xeloda
    Administration route: Oral
    Indication: Breast Cancer

Other drugs received by patient: Lapatinib



Possible Herceptin side effects in female

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

Patient: female, weighing 57.0 kg (125.4 pounds)

Reactions: Atrial Fibrillation

Drug(s) suspected as cause:
Herceptin
    Dosage: maintanence dose

Herceptin
    Dosage: date of last dose prior to sae: 10/jul/2012, loading dose
    Indication: Breast Cancer
    Start date: 2012-05-28

Paclitaxel
    Dosage: date of last dose prior to sae:10/jul/2012
    Indication: Breast Cancer
    Start date: 2012-05-28
    End date: 2012-07-10

Paclitaxel
    Start date: 2012-07-31

Pertuzumab
    Dosage: maintanance dose

Pertuzumab
    Dosage: date of last dose prior to sae was 10/jul/2012, loading dose
    Indication: Breast Cancer
    Start date: 2012-05-28

Other drugs received by patient: Bisoprolol Fumarate; Epirubicin; Fluorouracil



Possible Herceptin side effects in female

Reported by a physician from Germany on 2012-08-21

Patient: female, weighing 77.0 kg (169.4 pounds)

Reactions: Pneumonia Cytomegaloviral

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Doxorubicin Hydrochloride
    Dosage: last dose prior to sae: 02/jul/2012
    Indication: Breast Cancer
    Start date: 2012-05-07
    End date: 2012-07-09

Herceptin
    Dosage: last dose prior to sae: 18/jun/2012
    Indication: Breast Cancer
    Start date: 2012-05-07
    End date: 2012-07-09

Lapatinib
    Dosage: last dose prior to sae: 14/jun/2012
    Indication: Breast Cancer
    Start date: 2012-05-07
    End date: 2012-06-14

Paclitaxel
    Dosage: last dose prior to sae: 02/jul/2012
    Indication: Breast Cancer
    Start date: 2012-05-07
    End date: 2012-07-09



Possible Herceptin side effects in 63 year old female

Reported by a physician from United Kingdom on 2012-08-20

Patient: 63 year old female, weighing 100.0 kg (220.0 pounds)

Reactions: Myalgia, Multi-Organ Failure, Malaise, Neutropenic Sepsis, Pain, Necrotising Fasciitis

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Docetaxel
    Indication: Breast Cancer Stage I
    Start date: 2010-04-30
    End date: 2010-05-24

Docetaxel
    Dosage: dose reduced,third dose not given.

Herceptin
    Indication: Breast Cancer Stage I

Other drugs received by patient: Cyclophosphamide; Fluorouracil; Dexamethasone; Epirubicin; Tinzaparin



Possible Herceptin side effects in female

Reported by a consumer/non-health professional from Argentina on 2012-08-20

Patient: female, weighing 55.0 kg (121.0 pounds)

Reactions: Muscle Contracture, Headache, Blindness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in 57 year old female

Reported by a physician from Germany on 2012-08-20

Patient: 57 year old female

Reactions: Thinking Abnormal, Depression

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 Colombia on 2012-08-20

Patient: female

Reactions: Hyperglycaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in 37 year old

Reported by a physician from Brazil on 2012-08-20

Patient: 37 year old

Reactions: Disease Progression

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in female

Reported by a physician from Bosnia and Herzegowina on 2012-08-20

Patient: female, weighing 95.0 kg (209.0 pounds)

Reactions: Gastrointestinal Haemorrhage

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in female

Reported by a physician from United Kingdom on 2012-08-20

Patient: female, weighing 74.4 kg (163.7 pounds)

Reactions: Migraine

Drug(s) suspected as cause:
Eribulin
    Dosage: on 12/jul/2012 most recent dose of 2.2 mg prior to event was taken
    Indication: Breast Cancer Metastatic
    Start date: 2012-05-25

Herceptin
    Dosage: on 5/jul/2012 most recent dose of 430.5 mg prior to event was taken
    Indication: Breast Cancer Metastatic
    Start date: 2012-05-25

Other drugs received by patient: Acetaminophen and Codeine Phosphate; Ibuprofen



Possible Herceptin side effects in

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-20

Patient:

Reactions: Abdominal Pain, Vomiting, Hypersensitivity, Nausea, Skin Toxicity, Mucosal Inflammation, Fatigue, Diarrhoea, Hepatotoxicity, Neutropenia

Adverse event resulted in: hospitalization

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

Epirubicin
    Indication: Breast Cancer

Fluorouracil
    Indication: Breast Cancer

Herceptin
    Dosage: loading dose
    Indication: Breast Cancer

Herceptin
    Dosage: maintenance dose

Lapatinib
    Dosage: arm b
    Administration route: Oral
    Indication: Breast Cancer

Lapatinib
    Dosage: arm c
    Administration route: Oral

Paclitaxel
    Indication: Breast Cancer



Possible Herceptin side effects in female

Reported by a consumer/non-health professional from Ecuador on 2012-08-20

Patient: female

Reactions: Pneumonia

Adverse event resulted in: death

Drug(s) suspected as cause:
Herceptin



Possible Herceptin side effects in female

Reported by a physician from Japan on 2012-08-20

Patient: female, weighing 54.0 kg (118.8 pounds)

Reactions: Skin Exfoliation

Drug(s) suspected as cause:
Herceptin
    Start date: 2012-06-11
    End date: 2012-06-11

Herceptin
    Start date: 2012-07-02
    End date: 2012-07-02

Herceptin
    Indication: Breast Cancer
    Start date: 2012-05-21
    End date: 2012-05-21



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