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Taxotere (Docetaxel) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Taxotere (Docetaxel) 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 (655)
Death (177)
Life Threatening Events (48)
Disability (63)

Reports by Reaction Type

Interstitial Lung Disease (58)Dyspnoea (56)Neutropenia (53)Pyrexia (50)Diarrhoea (49)Nausea (37)Febrile Neutropenia (36)Dehydration (33)Death (31)Hypotension (30)Pneumonia (29)Thrombocytopenia (27)

Below are a few examples of reports where side effects / adverse reactions may be related to Taxotere (Docetaxel). For a complete list or a specific selection of reports, please use the links above.

Possible Taxotere side effects in 49 year old female

Reported by a consumer/non-health professional from France on 2012-08-27

Patient: 49 year old female

Reactions: Chills, Skin Burning Sensation, LIP Oedema, Erythema, Paraesthesia, Neuropathy Peripheral, Hot Flush, Arthralgia, Oral Candidiasis, Visual Impairment

Drug(s) suspected as cause:
Taxotere
    Start date: 2012-07-05

Taxotere
    Indication: Breast Operation
    Start date: 2012-05-25

Other drugs received by patient: Prednisolone; Tridesonit; Pyostacine; Acetaminophen; Trastuzumab; Prednisolone; Amitriptyline Hydrochloride



Possible Taxotere side effects in 72 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: 72 year old female

Reactions: Acute Respiratory Distress Syndrome

Adverse event resulted in: death

Drug(s) suspected as cause:
Taxotere
    Start date: 2012-05-18
    End date: 2012-05-18

Taxotere
    Start date: 2012-04-24
    End date: 2012-04-24

Taxotere
    Start date: 2012-06-08
    End date: 2012-06-08

Other drugs received by patient: Zometa; Neulasta; Duragesic-100; Corticosteroids; Acetaminophen; Vitamin D; Fentanyl; Avibon; Tramadol HCL



Possible Taxotere side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-24

Patient: female, weighing 101.6 kg (223.5 pounds)

Reactions: Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cisplatin
    Dosage: 150 mg
    End date: 2012-08-20

Taxotere
    Dosage: 150 mg
    End date: 2012-08-20



Possible Taxotere side effects in 70 year old male

Reported by a physician from Canada on 2012-08-24

Patient: 70 year old male, weighing 51.6 kg (113.5 pounds)

Reactions: Disease Progression

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Blinded Therapy
    Dosage: received every three weeks (day 1 of 21 day cycle)
    Indication: non-Small Cell Lung Cancer Stage IV
    Start date: 2012-05-11
    End date: 2012-05-11

Taxotere
    Dosage: received every three weeks (day 1 of 21 day cycle)
    Indication: non-Small Cell Lung Cancer Stage IV
    Start date: 2012-05-11
    End date: 2012-05-11

Other drugs received by patient: Bisoprolol Fumarate; Methadone Hydrochloride; Polyethylene Glycol; Hydromorphone HCL; Senokot / UNK /; Hydromorphone Hydrochloride; Vitamin D



Possible Taxotere side effects in 75 year old male

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

Patient: 75 year old male, weighing 65.0 kg (143.0 pounds)

Reactions: Interstitial Lung Disease, Hypoxia, Rash, Pyrexia

Adverse event resulted in: death

Drug(s) suspected as cause:
Garenoxacin Mesylate
    Administration route: Oral
    Indication: Pyrexia
    Start date: 2012-06-12

Taxotere
    Start date: 2012-04-05

Other drugs received by patient: Micardis; Calblock



Possible Taxotere side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-23

Patient: female

Reactions: Weight Increased, Disease Progression

Drug(s) suspected as cause:
Exemestane
    Indication: Product Used FOR Unknown Indication

Letrozole
    Administration route: Oral
    Indication: Breast Cancer

Taxotere
    Indication: Breast Cancer

Xeloda
    Indication: Breast Cancer



Possible Taxotere side effects in 44 year old female

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

Patient: 44 year old female, weighing 72.0 kg (158.4 pounds)

Reactions: Venous Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 1110 mg, q3wk
    Indication: Breast Cancer
    Start date: 2010-08-03
    End date: 2010-10-05

Neulasta
    Dosage: 6 mg, qd
    Indication: Colony Stimulating Factor Prophylaxis
    Start date: 2010-10-06

Taxotere
    Dosage: 138.75 mg, q3wk
    Indication: Breast Cancer
    Start date: 2010-08-03
    End date: 2010-10-05

Other drugs received by patient: Dexamethasone Sodium Phosphate; Dexamethasone Sodium Phosphate; Palonosetron; Mesna; Bromocriptin; Dexamethasone Sodium Phosphate; Mesna



Possible Taxotere side effects in 66 year old male

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

Patient: 66 year old male, weighing 66.0 kg (145.2 pounds)

Reactions: Visual Field Defect, Visual Acuity Reduced, Blindness Unilateral, Optic Neuritis, Optic Ischaemic Neuropathy, Septic Shock, Pneumonia Pneumococcal

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Taxotere

Other drugs received by patient: Dexamethasone; Estracyt



Possible Taxotere side effects in 83 year old male

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

Patient: 83 year old male

Reactions: Death, Alopecia, Nail Disorder

Adverse event resulted in: death

Drug(s) suspected as cause:
Taxotere



Possible Taxotere side effects in 77 year old male

Reported by a physician from China on 2012-08-17

Patient: 77 year old male, weighing 58.0 kg (127.6 pounds)

Reactions: Multi-Organ Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Taxotere

Other drugs received by patient: Sulbenicillin; Ambroxol; Prednisone TAB; Dexamethasone; Insulin; Dexamethasone



Possible Taxotere side effects in 69 year old female

Reported by a physician from Japan on 2012-08-17

Patient: 69 year old female, weighing 42.0 kg (92.4 pounds)

Reactions: Respiratory Failure, Depressed Level of Consciousness, Hypoxia

Adverse event resulted in: death

Drug(s) suspected as cause:
Taxotere

Other drugs received by patient: Trastuzumab



Possible Taxotere side effects in 72 year old female

Reported by a physician from Japan on 2012-08-17

Patient: 72 year old female

Reactions: Malaise, Alopecia, Decreased Appetite

Drug(s) suspected as cause:
Taxotere
    Dosage: on day one
    Indication: Gastric Cancer
    Start date: 2010-04-05
    End date: 2010-08-16

TS-1
    Dosage: on days 1-14, every three weeks
    Administration route: Oral
    Indication: Gastric Cancer
    Start date: 2010-04-05
    End date: 2010-08-16



Possible Taxotere side effects in male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-15

Patient: male

Reactions: Pseudomonas Infection, Febrile Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tarceva
    Dosage: 150 mg, uid/qd
    Administration route: Oral
    Indication: Lung Cancer Metastatic
    Start date: 2011-05-10
    End date: 2012-08-07

Taxotere
    Dosage: 140 mg, daily, cyclic
    Indication: Lung Cancer Metastatic
    Start date: 2012-07-20
    End date: 2012-07-20



Possible Taxotere side effects in 44 year old female

Reported by a pharmacist from Germany on 2012-08-15

Patient: 44 year old female, weighing 64.0 kg (140.8 pounds)

Reactions: Paraparesis, Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Taxotere

Other drugs received by patient: Dexamethasone



Possible Taxotere side effects in male

Reported by a physician from United Kingdom on 2012-08-14

Patient: male

Reactions: Sepsis, Hepatorenal Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Taxotere



Possible Taxotere side effects in male

Reported by a individual with unspecified qualification from United States on 2012-08-14

Patient: male, weighing 60.8 kg (133.7 pounds)

Reactions: Cellulitis, Inflammation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: 580 mg
    Start date: 2012-07-09
    End date: 2012-07-30

Taxotere
    Dosage: 130 mg
    Start date: 2012-07-09
    End date: 2012-07-30



Possible Taxotere side effects in 66 year old male

Reported by a physician from Japan on 2012-08-13

Patient: 66 year old male, weighing 66.0 kg (145.2 pounds)

Reactions: Visual Field Defect, Blindness Unilateral, Visual Acuity Reduced, Optic Ischaemic Neuropathy, Optic Neuritis, Septic Shock, Pneumonia Pneumococcal

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Taxotere

Other drugs received by patient: Dexamethasone; Estracyt



Possible Taxotere side effects in 53 year old female

Reported by a physician from Japan on 2012-08-13

Patient: 53 year old female

Reactions: Neuropathy Peripheral, Activities of Daily Living Impaired, Visual Acuity Reduced

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Capecitabine
    Start date: 2011-02-28
    End date: 2011-04-01

Paclitaxel
    Dosage: 9 courses administered
    Start date: 2011-04-25
    End date: 2011-11-09

Taxotere
    Start date: 2011-02-28
    End date: 2011-04-01



Possible Taxotere side effects in 80 year old male

Reported by a physician from Japan on 2012-08-13

Patient: 80 year old male

Reactions: Interstitial Lung Disease, Rales, Mycoplasma Test Positive, Cough

Drug(s) suspected as cause:
Taxotere
    Dosage: unk ukn, unk
    Start date: 2012-04-18

Zometa
    Dosage: 4 mg, unk
    Indication: Metastases To Bone
    Start date: 2012-04-18



Possible Taxotere side effects in 41 year old female

Reported by a physician from Algeria on 2012-08-09

Patient: 41 year old female

Reactions: Dyspnoea Exertional

Adverse event resulted in: death

Drug(s) suspected as cause:
Taxotere



Possible Taxotere side effects in female

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

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Interstitial Lung Disease, Cardiac Failure, Cerebral Infarction, Disseminated Intravascular Coagulation

Adverse event resulted in: death

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: doseage is uncertain
    Indication: Breast Cancer
    Start date: 2010-02-05
    End date: 2010-04-09

Herceptin
    Dosage: dose lowered
    Start date: 2010-07-09
    End date: 2010-07-09

Herceptin
    Start date: 2010-05-28
    End date: 2010-05-28

Herceptin
    Start date: 2010-06-18
    End date: 2010-06-18

Herceptin
    Indication: Breast Cancer
    Start date: 2010-05-07
    End date: 2010-05-07

Taxotere
    Dosage: dose is uncertain
    Indication: Breast Cancer
    Start date: 2010-05-07
    End date: 2010-07-09

Other drugs received by patient: Fluorouracil; Epirubicin Hydrochloride; Betamethasone; Sulpiride; Sulpiride; Prochlorperazine; Betamethasone; Prochlorperazine; Sulpiride; Betamethasone; Sulpiride; Prochlorperazine; Betamethasone; Prochlorperazine



Possible Taxotere side effects in female

Reported by a physician from United States on 2012-08-07

Patient: female, weighing 69.9 kg (153.8 pounds)

Reactions: Urinary Tract Infection, Bacterial Sepsis, Abscess, Peritonitis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: 792 mg
    End date: 2011-08-10

Herceptin
    Dosage: 140 mg
    End date: 2011-08-10

Taxotere
    Dosage: 130 mg
    End date: 2011-08-10



Possible Taxotere side effects in 60 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-06

Patient: 60 year old male

Reactions: Dysphagia, Fluid Intake Reduced, Oesophageal Stenosis

Drug(s) suspected as cause:
Cisplatin
    Dosage: (6 mg/m2)
    Indication: Gastric Cancer Stage I
    Start date: 2010-10-01

Cisplatin
    Dosage: (6 mg/m2)
    Indication: Oesophageal Squamous Cell Carcinoma Stage III
    Start date: 2010-10-01

Fluorouracil
    Dosage: (350 mg/m2)
    Indication: Oesophageal Squamous Cell Carcinoma Stage II
    Start date: 2010-10-01

Fluorouracil
    Dosage: (350 mg/m2)
    Indication: Gastric Cancer Stage I
    Start date: 2010-10-01

Taxotere
    Dosage: (60 mg/m2; every three weeks)
    Indication: Oesophageal Squamous Cell Carcinoma Stage II
    Start date: 2010-10-01

Taxotere
    Dosage: (60 mg/m2; every three weeks)
    Indication: Gastric Cancer Stage I
    Start date: 2010-10-01

Therapeutic Radiopharmaceuticals (Therapeutic Radiopharmaceuticals)
    Dosage: (60 gy)
    Indication: Oesophageal Squamous Cell Carcinoma Stage II
    Start date: 2010-10-01

Therapeutic Radiopharmaceuticals (Therapeutic Radiopharmaceuticals)
    Dosage: (60 gy)
    Indication: Gastric Cancer Stage I
    Start date: 2010-10-01



Possible Taxotere side effects in 64 year old male

Reported by a physician from Japan on 2012-08-03

Patient: 64 year old male, weighing 61.1 kg (134.5 pounds)

Reactions: Conjunctival Oedema, Visual Acuity Reduced, Macular Oedema

Drug(s) suspected as cause:
Taxotere
    Dosage: every 4 weeks
    Start date: 2010-03-05
    End date: 2012-04-01

Taxotere
    Dosage: frequency: every 4 weeks.
    Start date: 2012-06-04

Other drugs received by patient: Leuprolide Acetate; Dexamethasone; Zometa; Estracyt



Possible Taxotere side effects in

Reported by a individual with unspecified qualification from United States on 2012-08-03

Patient: , weighing 108.4 kg (238.5 pounds)

Reactions: Febrile Neutropenia, Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Leuprolide Acetate
    Dosage: 22.5 mg

Taxotere
    Dosage: 174 mg



Possible Taxotere side effects in 77 year old male

Reported by a physician from United States on 2012-08-03

Patient: 77 year old male, weighing 73.0 kg (160.6 pounds)

Reactions: Pulmonary Haemorrhage, Fatigue, Rash

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Simvastatin
    Indication: non-Small Cell Lung Cancer Stage IV
    Start date: 2012-06-07
    End date: 2012-07-19

Taxotere
    Start date: 2012-07-19
    End date: 2012-07-19

Taxotere
    Indication: non-Small Cell Lung Cancer Stage IV
    Start date: 2012-06-07
    End date: 2012-06-07



Possible Taxotere side effects in 71 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-02

Patient: 71 year old female, weighing 74.0 kg (162.8 pounds)

Reactions: Fatigue

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 1020 mg, q3wk
    Indication: Breast Cancer
    Start date: 2009-12-09
    End date: 2010-01-27

Neulasta
    Dosage: 6 mg, q3wk
    Indication: Premedication
    Start date: 2009-12-09
    End date: 2010-01-27

Neulasta
    Indication: Colony Stimulating Factor Prophylaxis

Taxotere
    Dosage: 128 mg, q3wk
    Indication: Breast Cancer
    Start date: 2009-12-09
    End date: 2010-01-27

Other drugs received by patient: Dexamethasone; Aloxi; Mesna; Dexamethasone



Possible Taxotere side effects in 80 year old male

Reported by a physician from Japan on 2012-08-02

Patient: 80 year old male

Reactions: Staphylococcal Infection, Disseminated Intravascular Coagulation, Febrile Neutropenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Taxotere

Other drugs received by patient: Therapeutic Radiopharmaceuticals; Decadron



Possible Taxotere side effects in 70 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient: 70 year old female, weighing 71.0 kg (156.2 pounds)

Reactions: Stomatitis, Radiation Injury, Oral Pain, Odynophagia, Thermal Burn

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dermoplast

Erbitux
    Dosage: 1st course:30-mar-2005. week 1 loading dose400 mg/m2. weeks 2-7, weekly 250 mg/m2. totaldose:435mg
    Indication: Head and Neck Cancer
    Start date: 2005-05-10
    End date: 2005-05-10

Taxotere
    Dosage: 1st course docetaxel 30-mar-2005. weeks 2-7 docetaxel weekly 15 mg/m2. total dose:26.1mg
    Indication: Head and Neck Cancer
    Start date: 2005-05-10
    End date: 2005-05-10

Other drugs received by patient: Colace; Cytomel; Allegra; Atenolol; Morphine Sulfate; Levaquin; Celebrex



Possible Taxotere side effects in male

Reported by a physician from Japan on 2012-07-31

Patient: male

Reactions: Ischaemia, Visual Field Defect, Blindness Unilateral, Optic Neuritis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Taxotere

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