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Taxol (Paclitaxel) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Taxol (Paclitaxel) 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 (777)
Death (96)
Life Threatening Events (28)
Disability (10)

Reports by Reaction Type

Nausea (100)Vomiting (80)Dehydration (76)Anaemia (72)Neutropenia (68)Diarrhoea (66)Fatigue (58)Dyspnoea (57)Febrile Neutropenia (54)Asthenia (53)Neutrophil Count Decreased (52)Abdominal Pain (48)

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

Possible Taxol side effects in 68 year old male

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

Patient: 68 year old male, weighing 74.5 kg (163.9 pounds)

Reactions: Lobar Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arixtra
    Indication: Venous Thrombosis
    Start date: 2012-07-18

Carboplatin
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-06-27

Taxol
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-06-27



Possible Taxol side effects in female

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

Patient: female, weighing 81.1 kg (178.5 pounds)

Reactions: Anaemia, Lymphocyte Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: 625 mg

Taxol
    Dosage: 320 mg



Possible Taxol side effects in 68 year old male

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

Patient: 68 year old male, weighing 74.5 kg (163.9 pounds)

Reactions: Lobar Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arixtra
    Indication: Venous Thrombosis

Carboplatin
    Indication: non-Small Cell Lung Cancer

Taxol
    Indication: non-Small Cell Lung Cancer



Possible Taxol side effects in female

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

Patient: female, weighing 70.0 kg (154.0 pounds)

Reactions: Weight Decreased, Escherichia Test Positive, Malaise, Vomiting, Nausea, Dysuria, Clostridium Difficile Colitis, Culture Urine Positive, Thrombocytopenia, Enterobacter Test Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: 376 mg

Taxol
    Dosage: 299 mg



Possible Taxol side effects in female

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

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Diarrhoea, Dysuria, Pelvic Pain, Pelvic Discomfort

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Taxol

Other drugs received by patient: Januvia; Iron; Atenolol; Prilosec; Vitamin D



Possible Taxol side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-22

Patient: female, weighing 63.7 kg (140.1 pounds)

Reactions: Hypomagnesaemia, Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: 400 mg

Erbitux
    Dosage: 1200 mg

Taxol
    Dosage: 330 mg

Other drugs received by patient: Gabapentin; Iron; Pepcid; Atenolol; Prochlorperazine; Aspirin; M.v.i.; Nitroglycerin; Amlodipine; Calcium Carbonate; Hydromorphone HCL; Ondansetron; Alendronate Sodium; Vitamin D



Possible Taxol side effects in 52 year old female

Reported by a consumer/non-health professional from France on 2012-08-22

Patient: 52 year old female

Reactions: Chest Wall Necrosis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Avastin
    Dosage: 1 df = 25mg/ml, concentrate for solution for infusion
    Start date: 2012-02-01
    End date: 2012-06-06

Taxol
    Start date: 2012-02-01
    End date: 2012-06-06



Possible Taxol side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-22

Patient: female, weighing 81.1 kg (178.5 pounds)

Reactions: Refusal of Treatment by Patient, Anaemia, Lymphocyte Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: 625 mg

Taxol
    Dosage: 320 mg



Possible Taxol side effects in 68 year old male

Reported by a physician from United States on 2012-08-21

Patient: 68 year old male, weighing 74.5 kg (163.9 pounds)

Reactions: Lobar Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arixtra
    Indication: Venous Thrombosis

Carboplatin
    Indication: non-Small Cell Lung Cancer

Taxol
    Indication: non-Small Cell Lung Cancer



Possible Taxol side effects in

Reported by a individual with unspecified qualification from United States on 2012-08-21

Patient: , weighing 61.4 kg (135.1 pounds)

Reactions: Neutropenia, Enterocolitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: 2150 mg
    Start date: 2012-07-13

Cyclophosphamide
    Dosage: 1000 mg
    Start date: 2012-08-09

Doxorubicin Hydrochloride
    Dosage: 100 mg
    Start date: 2012-08-09

Taxol
    Dosage: 1242 mg
    Start date: 2012-08-03



Possible Taxol side effects in male

Reported by a physician from United States on 2012-08-21

Patient: male, weighing 66.4 kg (146.1 pounds)

Reactions: Middle Insomnia, Pain, Febrile Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bevacizumab
    Dosage: 1000 mg

Carboplatin
    Dosage: 425 mg

Taxol
    Dosage: 366 mg



Possible Taxol side effects in 67 year old female

Reported by a consumer/non-health professional from Colombia on 2012-08-21

Patient: 67 year old female

Reactions: Flushing, Chest Discomfort, Bone Pain, Muscular Weakness

Drug(s) suspected as cause:
Taxol



Possible Taxol side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-20

Patient: female, weighing 81.1 kg (178.5 pounds)

Reactions: Haemoglobin Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: 625 mg

Taxol
    Dosage: 320 mg



Possible Taxol side effects in 86 year old male

Reported by a consumer/non-health professional from France on 2012-08-17

Patient: 86 year old male

Reactions: Leukoencephalopathy, Cerebellar Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: d1, d8 and d15
    Start date: 2012-02-13
    End date: 2012-02-27

Taxol
    Start date: 2012-02-13



Possible Taxol side effects in female

Reported by a physician from United States on 2012-08-16

Patient: female, weighing 84.8 kg (186.6 pounds)

Reactions: Dyspnoea, Pulmonary Embolism, Rash, Pyrexia, Fatigue, Pleural Effusion, Acute Respiratory Distress Syndrome, Feeling Abnormal, Asthenia, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: 673 mg
    End date: 2012-02-06

Taxol
    Dosage: 154 mg
    End date: 2012-02-13

Other drugs received by patient: Verapamil; Potassium; Reglan



Possible Taxol side effects in 80 year old male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 80 year old male, weighing 96.0 kg (211.2 pounds)

Reactions: White Blood Cell Count Decreased, Anaemia, Febrile Neutropenia, Platelet Count Decreased, Neutrophil Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cisplatin
    Dosage: 24aug10:55mg. delayed 8 dy dose reduced to 45mg.last dose on 08sep2010
    Indication: Oesophageal Adenocarcinoma
    Start date: 2010-07-27

Erbitux
    Dosage: 24aug10:570mg received 560 mg this course.last dose on 31aug2010.
    Indication: Oesophageal Adenocarcinoma
    Start date: 2010-07-27

Taxol
    Dosage: 24aug10:115mg. delayed 8 dy received 112mg this course.dose reduced to 90mg.last dose on 08sep2010
    Indication: Oesophageal Adenocarcinoma
    Start date: 2010-07-27



Possible Taxol side effects in female

Reported by a consumer/non-health professional from France on 2012-08-16

Patient: female

Reactions: Cytolytic Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Anafranil
    Dosage: 150 mg, unknown
    Administration route: Oral
    Indication: Major Depression
    Start date: 2012-06-22
    End date: 2012-07-04

Anafranil
    Dosage: 75 mg, unknown
    Administration route: Oral
    Start date: 2012-07-05

Anafranil
    Dosage: unk unk, unknown
    Start date: 2012-06-20
    End date: 2012-06-21

Avastin
    Dosage: 25 mg/ml, 1x/week
    Indication: Breast Cancer Recurrent
    Start date: 2012-02-01
    End date: 2012-07-16

Largactil / 00011902 /
    Dosage: 150 - 250 df 4% drops, unknown
    Administration route: Oral
    Indication: Major Depression
    Start date: 2012-06-20
    End date: 2012-06-28

Midodrine Hydrochloride
    Dosage: 15 mg (6 tablets), unknown
    Administration route: Oral
    Indication: Orthostatic Hypotension
    Start date: 2012-06-22
    End date: 2012-07-02

Midodrine Hydrochloride
    Dosage: 30 mg (12 tablets), unknown
    Administration route: Oral
    Start date: 2012-07-03
    End date: 2012-07-16

Ondansetron
    Dosage: 1 df, 1x/week
    Administration route: Oral
    Indication: Procedural Vomiting
    Start date: 2012-02-01
    End date: 2012-07-16

Taxol
    Dosage: 1 df, 1x/week
    Indication: Breast Cancer Recurrent
    Start date: 2012-02-01
    End date: 2012-07-16

Zyprexa
    Dosage: 10 mg, unknown
    Administration route: Oral
    Indication: Major Depression
    Start date: 2012-06-28
    End date: 2012-07-16

Other drugs received by patient: Corticosteroid NOS; Esomeprazole



Possible Taxol side effects in male

Reported by a physician from United States on 2012-08-16

Patient: male, weighing 103.0 kg (226.6 pounds)

Reactions: Acute Myeloid Leukaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Dosage: 1200 mg

Carboplatin
    Dosage: 750 mg

Pemetrexed
    Dosage: 726 mg

Taxol
    Dosage: 372 mg



Possible Taxol side effects in female

Reported by a pharmacist from United States on 2012-08-16

Patient: female, weighing 41.5 kg (91.4 pounds)

Reactions: Agitation, Dyspnoea, Cardio-Respiratory Arrest, Cyanosis, Blood Pressure Immeasurable, Oxygen Saturation Decreased, Panic Reaction, Infusion Related Reaction

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

Drug(s) suspected as cause:
Taxol



Possible Taxol side effects in 63 year old female

Reported by a consumer/non-health professional from Israel on 2012-08-15

Patient: 63 year old female

Reactions: Platelet Count Decreased

Drug(s) suspected as cause:
Carboplatin
    Dosage: 100mg per m2
    Start date: 2012-06-14
    End date: 2012-06-24

Erbitux
    Dosage: total :890mg 5mg/ml is the strength last infu:19jun12
    Indication: Squamous Cell Carcinoma of THE Cervix
    Start date: 2012-06-19
    End date: 2012-06-24

Taxol
    Dosage: 50mg per m2
    Start date: 2012-06-14
    End date: 2012-06-24



Possible Taxol side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-15

Patient: female, weighing 60.9 kg (134.0 pounds)

Reactions: Myalgia, Dyspnoea, Nausea, Hypophagia, Dehydration, Tachycardia, Blood Sodium Decreased, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin

Taxol
    Dosage: 295 mg

Other drugs received by patient: Promethazine; Ambien; Prolosec; Joint Health Complex; Multi-Vitamin; Lisinopril; Nitrofurantoin; Oxycodone / Acetaminophen



Possible Taxol side effects in male

Reported by a physician from United Kingdom on 2012-08-15

Patient: male

Reactions: Pulmonary Sepsis, Metabolic Acidosis, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Pemetrexed
    Dosage: 500 mg/m2, unk
    Indication: non-Small Cell Lung Cancer Metastatic
    Start date: 2012-07-26
    End date: 2012-07-26

Taxol
    Dosage: 175 mg/m2, unk
    Indication: non-Small Cell Lung Cancer Metastatic
    Start date: 2012-07-26
    End date: 2012-07-26

Other drugs received by patient: Dexamethasone; Vitamin B-12; Dexamethasone; Metoclopramide; Erythromycin; Folic Acid; Infumorph; Piperacillin and Tazobactam; Clarithromycin; Dexamethasone; Ramipril; Amlodipine; Dexamethasone; Omeprazole



Possible Taxol side effects in female

Reported by a physician from Japan on 2012-08-14

Patient: female

Reactions: Uterine Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: 642 mg,
    Start date: 2011-08-17

Tasigna
    Dosage: 200 mg, qd
    Administration route: Oral
    Start date: 2011-03-23
    End date: 2011-03-24

Tasigna
    Dosage: 400 mg,
    Administration route: Oral
    Start date: 2011-09-15
    End date: 2011-09-27

Tasigna
    Dosage: 200 mg,
    Start date: 2011-10-21
    End date: 2011-12-09

Tasigna
    Dosage: 200 mg,
    Start date: 2012-01-13

Tasigna
    Dosage: 200 mg,
    Start date: 2011-12-26
    End date: 2012-01-06

Tasigna
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2011-03-18
    End date: 2011-03-20

Tasigna
    Dosage: 400 mg, qd
    Administration route: Oral
    Start date: 2011-03-25
    End date: 2011-08-30

Taxol
    Dosage: 230 mg,
    Start date: 2011-08-17

Other drugs received by patient: Loxonin; Alendronate Sodium; Prednisolone; Lansoprazole; Decadron Phosphate



Possible Taxol side effects in male

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

Patient: male

Reactions: Pulmonary Sepsis, Metabolic Acidosis, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Pemetrexed
    Dosage: 500 mg/m2, unk
    Indication: non-Small Cell Lung Cancer Metastatic
    Start date: 2012-07-26
    End date: 2012-07-26

Taxol
    Dosage: 175 mg/m2, unk
    Indication: non-Small Cell Lung Cancer Metastatic
    Start date: 2012-07-26
    End date: 2012-07-26

Other drugs received by patient: Dexamethasone; Infumorph; Dexamethasone; Dexamethasone; Dexamethasone; Omeprazole; Clarithromycin; Piperacillin and Tazobactam; Erythromycin; Folic Acid; Ramipril; Amlodipine; Metoclopramide; Vitamin B-12



Possible Taxol side effects in female

Reported by a physician from Japan on 2012-08-14

Patient: female

Reactions: Uterine Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: 642 mg,
    Start date: 2011-08-17

Tasigna
    Dosage: 200 mg,
    Start date: 2011-12-26
    End date: 2012-01-06

Tasigna
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2011-03-18
    End date: 2011-03-20

Tasigna
    Dosage: 200 mg,
    Start date: 2011-10-21
    End date: 2011-12-09

Tasigna
    Dosage: 200 mg,
    Start date: 2012-01-13

Tasigna
    Dosage: 400 mg,
    Administration route: Oral
    Start date: 2011-09-15
    End date: 2011-09-27

Tasigna
    Dosage: 200 mg, qd
    Administration route: Oral
    Start date: 2011-03-23
    End date: 2011-03-24

Tasigna
    Dosage: 400 mg, qd
    Administration route: Oral
    Start date: 2011-03-25
    End date: 2011-08-30

Taxol
    Dosage: 230 mg,
    Start date: 2011-08-17

Other drugs received by patient: Alendronate Sodium; Prednisolone; Lansoprazole; Decadron Phosphate; Loxonin



Possible Taxol side effects in male

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

Patient: male, weighing 103.0 kg (226.6 pounds)

Reactions: Acute Myeloid Leukaemia, Platelet Count Decreased, Blood Test Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Dosage: 1200 mg

Carboplatin
    Dosage: 750 mg

Pemetrexed
    Dosage: 726 mg

Taxol
    Dosage: 372 mg



Possible Taxol side effects in female

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

Patient: female, weighing 100.0 kg (220.0 pounds)

Reactions: Interstitial Lung Disease, Pneumothorax

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Indication: Breast Cancer Metastatic
    Start date: 2012-05-01
    End date: 2012-05-01

Taxol
    Dosage: three one yasu
    Indication: Breast Cancer Metastatic
    Start date: 2012-05-01
    End date: 2012-05-15

Other drugs received by patient: Decadron Phosphate; Primperan (Japan); Decadron Phosphate; Brocin; Primperan (Japan); Vena; Vena; Lasix; Vena; Decadron Phosphate; Humulin N



Possible Taxol side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-08-10

Patient: 65 year old male

Reactions: Multi-Organ Failure, Gastrointestinal Haemorrhage, Dermatitis, Interstitial Lung Disease, Acute Respiratory Distress Syndrome

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Carboplatin
    Indication: Pharyngeal Cancer Stage Unspecified

Cetuximab
    Dosage: loading dose:600mg then 400mg
    Indication: Pharyngeal Cancer Stage Unspecified

Taxol
    Indication: Pharyngeal Cancer Stage Unspecified



Possible Taxol side effects in 52 year old female

Reported by a consumer/non-health professional from Germany on 2012-08-10

Patient: 52 year old female, weighing 71.0 kg (156.2 pounds)

Reactions: Visual Impairment

Drug(s) suspected as cause:
Taxol



Possible Taxol side effects in male

Reported by a individual with unspecified qualification from United States on 2012-08-10

Patient: male, weighing 97.3 kg (214.1 pounds)

Reactions: Vomiting, Dysphagia, Nausea, Treatment Noncompliance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cisplatin
    Start date: 2012-01-24

Taxol
    Dosage: 100 mg
    Start date: 2012-01-24

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