This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Herceptin (Trastuzumab) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (1527)
Death (260)
Life Threatening Events (120)
Disability (56)
Reports by Reaction Type
Diarrhoea (127),
Death (97),
Disease Progression (83),
Dehydration (83),
Nausea (76),
Neutropenia (74),
Vomiting (71),
Febrile Neutropenia (63),
Fatigue (60),
Dyspnoea (57),
Anaemia (53),
Ejection Fraction Decreased (53)
Below are a few examples of reports where side effects / adverse reactions may be related to Herceptin (Trastuzumab). For a complete list or a specific selection of reports, please use the links above.
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 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 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 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 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 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 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 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 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
Possible Herceptin side effects in female
Reported by a physician from Germany on 2012-08-20
Patient: female, weighing 55.0 kg (121.0 pounds)
Reactions: General Physical Health Deterioration
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Docetaxel
Indication: Breast Cancer
Start date: 2012-08-01
Herceptin
Indication: Breast Cancer
Start date: 2012-08-01
Placebo
Indication: Breast Cancer
Start date: 2012-08-01
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
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