DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Paclitaxel (Paclitaxel) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to 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 (2186)
Death (363)
Life Threatening Events (182)
Disability (26)

Reports by Reaction Type

Dyspnoea (210)Anaemia (176)Fatigue (171)Nausea (159)Diarrhoea (148)Vomiting (127)Febrile Neutropenia (123)Pyrexia (104)Dehydration (95)Hypertension (94)Neutropenia (92)Pneumonia (77)

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

Possible Paclitaxel side effects in 72 year old female

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

Patient: 72 year old female, weighing 71.6 kg (157.5 pounds)

Reactions: Ventricular Arrhythmia

Drug(s) suspected as cause:
Avastin
    Dosage: 15 mg/kg iv over 30-90 minutes on day 1 on 2 cycle onwards
    Indication: Ovarian Epithelial Cancer

Carboplatin
    Dosage: auc 6 (cycle 1-6),6th cycle completed on 16/feb/2012
    Indication: Ovarian Epithelial Cancer
    Start date: 2011-11-23

Ipratropium Bromide
    Indication: Product Used FOR Unknown Indication

Paclitaxel
    Dosage: 175 mg/m2 over 3 hrs on day 1(cycle 1-6), 6th cycle completed on 16/feb/2012
    Indication: Ovarian Epithelial Cancer
    Start date: 2011-11-23



Possible Paclitaxel side effects in female

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

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Arthralgia, Autonomic Nervous System Imbalance, Abdominal Pain Upper

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Paclitaxel

Other drugs received by patient: Carboplatin



Possible Paclitaxel side effects in 57 year old female

Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-08-27

Patient: 57 year old female

Reactions: Breast Cancer Metastatic, Paraneoplastic Dermatomyositis, Pulmonary Embolism

Adverse event resulted in: death

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

Cisplatin
    Dosage: 6 cycles
    Indication: Breast Cancer

Cyclophosphamide
    Dosage: 6 cycles
    Indication: Breast Cancer

Doxorubicin Hydrochloride
    Dosage: 6 cycles
    Indication: Breast Cancer

Gemcitabine Hydrochloride
    Indication: Breast Cancer

Paclitaxel
    Indication: Breast Cancer



Possible Paclitaxel side effects in female

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

Patient: female, weighing 66.0 kg (145.2 pounds)

Reactions: Pneumonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lapatinib
    Dosage: 1000mg per day
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2012-04-27

Liposome Encapsulated Doxorubicin Citrate Complex
    Dosage: 20mgm2 weekly
    Indication: Breast Cancer
    Start date: 2012-04-27

Paclitaxel
    Dosage: 80mgm2 weekly
    Indication: Breast Cancer
    Start date: 2012-04-27

Trastuzumab
    Dosage: 6mgk every 3 weeks
    Indication: Breast Cancer
    Start date: 2012-04-27



Possible Paclitaxel side effects in female

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

Patient: female, weighing 72.0 kg (158.4 pounds)

Reactions: Stomatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Start date: 2012-05-16

Carboplatin
    Indication: Breast Cancer
    Start date: 2012-03-15
    End date: 2012-05-02

Doxorubicin Hydrochloride
    Indication: Breast Cancer
    Start date: 2012-03-15
    End date: 2012-05-02

Doxorubicin Hydrochloride
    Dosage: 4.7143 milligram daily;
    Start date: 2012-05-16

Lapatinib
    Dosage: 750 milligram daily;
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2012-03-15

Paclitaxel
    Indication: Breast Cancer
    Start date: 2012-03-15
    End date: 2012-05-02

Paclitaxel
    Dosage: 11.4286 mg/m2 daily;
    Start date: 2012-05-16

Trastuzumab
    Indication: Breast Cancer
    Start date: 2012-03-15
    End date: 2012-04-25

Other drugs received by patient: Granocyte; Ciprofloxacin HCL



Possible Paclitaxel side effects in male

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

Patient: male, weighing 99.9 kg (219.7 pounds)

Reactions: Failure To Thrive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Indication: Salivary Gland Cancer

OGX-011
    Start date: 2012-08-08
    End date: 2012-08-08

OGX-011
    Start date: 2012-08-10
    End date: 2012-08-10

OGX-011
    Indication: Salivary Gland Cancer
    Start date: 2012-08-06
    End date: 2012-08-06

Paclitaxel
    Indication: Salivary Gland Cancer

Other drugs received by patient: Oxycodone HCL; Duragesic-12; Atenolol; Tamsulosin HCL; Gabapentin; Finasteride



Possible Paclitaxel side effects in 62 year old male

Reported by a physician from United States on 2012-08-24

Patient: 62 year old male, weighing 55.0 kg (121.0 pounds)

Reactions: Performance Status Decreased, Nausea, Headache, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Paclitaxel
    Start date: 2012-07-30
    End date: 2012-08-03

Paclitaxel
    Start date: 2012-07-23
    End date: 2012-07-27

Ridaforolimus
    Dosage: 10 mg po day 12-5
    Administration route: Oral

Suboxone
    Dosage: 135/m2/auc 5
    Start date: 2012-07-23
    End date: 2012-07-23



Possible Paclitaxel side effects in female

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

Patient: female, weighing 78.0 kg (171.6 pounds)

Reactions: Pneumonia Primary Atypical

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Doxorubicin Hydrochloride
    Dosage: 39mg weekly
    Indication: Breast Cancer
    Start date: 2012-06-06

Lapatinib
    Dosage: 750mg per day
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2012-06-07

Paclitaxel
    Dosage: 154mg weekly
    Indication: Breast Cancer
    Start date: 2012-06-06

Other drugs received by patient: Dexamethasone; Franozytc



Possible Paclitaxel side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female

Reactions: Maternal Exposure During Pregnancy, Uterine Contractions During Pregnancy

Drug(s) suspected as cause:
Adriamycin PFS
    Indication: Breast Cancer Stage I

Cytoxan
    Indication: Breast Cancer Stage I

Fluorouracil
    Indication: Breast Cancer Stage I

Paclitaxel
    Indication: Breast Cancer Stage I



Possible Paclitaxel side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female

Reactions: Maternal Exposure During Pregnancy, PRE-Eclampsia

Drug(s) suspected as cause:
Adriamycin PFS
    Indication: Breast Cancer Stage II

Cytoxan
    Indication: Breast Cancer Stage II

Paclitaxel
    Indication: Breast Cancer Stage II



Possible Paclitaxel side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: , weighing 1.9 kg (4.3 pounds)

Reactions: Foetal Growth Restriction

Drug(s) suspected as cause:
Adriamycin PFS
    Indication: Breast Cancer Stage I

Cytoxan
    Indication: Breast Cancer Stage I

Fluorouracil
    Indication: Breast Cancer Stage I

Paclitaxel
    Indication: Breast Cancer Stage I



Possible Paclitaxel side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female

Reactions: Pneumocystis Jiroveci Pneumonia, Maternal Exposure During Pregnancy, Neutropenia, Premature Labour

Drug(s) suspected as cause:
Adriamycin PFS
    Indication: Breast Cancer Stage II

Cytoxan
    Indication: Breast Cancer Stage II

Paclitaxel
    Indication: Breast Cancer Stage II



Possible Paclitaxel side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: 65 year old male, weighing 83.0 kg (182.6 pounds)

Reactions: White Blood Cell Count Decreased, Platelet Count Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Dosage: 135mg/m2/auc 4
    Indication: Ovarian Cancer
    Start date: 2012-08-13
    End date: 2012-08-13

Paclitaxel
    Indication: Ovarian Cancer
    Start date: 2012-08-13
    End date: 2012-08-17

Ridaforolimus
    Dosage: 10mg po day 1-5
    Administration route: Oral



Possible Paclitaxel side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female, weighing 61.0 kg (134.2 pounds)

Reactions: Dyspnoea, Pneumonia, Tachycardia, Pyrexia, Multi-Organ Failure, Oedema, Hypoxia, Urosepsis, Asthenia, Escherichia Infection, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-18

Comparator Trastuzumab
    Dosage: 137 mg
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-10

Paclitaxel
    Dosage: 142 mg
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-03

Vancomycin
    Dosage: 1 g, q12h
    Start date: 2011-03-16

Other drugs received by patient: Duoneb; Lovenox; Xanax; Benadryl; Metoprolol Tartrate; Vicodin; Protonix



Possible Paclitaxel side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: , weighing 2.5 kg (5.4 pounds)

Reactions: Foetal Growth Restriction, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Adriamycin PFS
    Indication: Breast Cancer Stage III

Cytoxan
    Indication: Breast Cancer Stage III

Paclitaxel
    Indication: Breast Cancer Stage III



Possible Paclitaxel side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: , weighing 2.1 kg (4.7 pounds)

Reactions: Hyperbilirubinaemia

Drug(s) suspected as cause:
Adriamycin PFS
    Indication: Breast Cancer Stage II

Cytoxan
    Indication: Breast Cancer Stage II

Paclitaxel
    Indication: Breast Cancer Stage II



Possible Paclitaxel side effects in 74 year old male

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

Patient: 74 year old male, weighing 102.0 kg (224.4 pounds)

Reactions: Chronic Obstructive Pulmonary Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bevacizumab
    Dosage: last dose: 02aug12
    Indication: Bronchioloalveolar Carcinoma
    Start date: 2012-05-30

Carboplatin
    Dosage: last dose: 02aug12
    Indication: Bronchioloalveolar Carcinoma
    Start date: 2012-05-30

Paclitaxel
    Dosage: last dose: 02aug12
    Indication: Bronchioloalveolar Carcinoma
    Start date: 2012-05-30



Possible Paclitaxel side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female

Reactions: Premature Rupture of Membranes, Maternal Exposure During Pregnancy, Uterine Contractions During Pregnancy

Drug(s) suspected as cause:
Adriamycin PFS
    Indication: Breast Cancer Stage I

Cytoxan
    Indication: Breast Cancer Stage I

Paclitaxel
    Indication: Breast Cancer Stage I



Possible Paclitaxel side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: , weighing 1.9 kg (4.1 pounds)

Reactions: Foetal Growth Restriction, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Carboplatin
    Indication: Ovarian Cancer Stage I

Paclitaxel
    Indication: Ovarian Cancer Stage I



Possible Paclitaxel side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female

Reactions: Maternal Exposure During Pregnancy, PRE-Eclampsia

Drug(s) suspected as cause:
Adriamycin PFS
    Indication: Breast Cancer Stage II

Cytoxan
    Indication: Breast Cancer Stage II

Paclitaxel
    Indication: Breast Cancer Stage II



Possible Paclitaxel side effects in female

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

Patient: female, weighing 64.2 kg (141.2 pounds)

Reactions: Post Procedural Pneumonia, General Physical Health Deterioration, Perforated Ulcer

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Doxorubicin Hydrochloride
    Dosage: 20mgm2 weekly
    Indication: Breast Cancer
    Start date: 2012-05-30

Lapatinib
    Dosage: 750mg per day
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2012-05-30

Paclitaxel
    Dosage: 80mgm2 weekly
    Indication: Breast Cancer
    Start date: 2012-05-30

Trastuzumab
    Dosage: 6mgk every 3 weeks
    Indication: Breast Cancer
    Start date: 2012-05-30



Possible Paclitaxel side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: , weighing 2.4 kg (5.3 pounds)

Reactions: Neutropenia Neonatal, Pyloric Stenosis

Drug(s) suspected as cause:
Adriamycin PFS
    Indication: Breast Cancer Stage III

Cytoxan
    Indication: Breast Cancer Stage III

Docetaxel
    Indication: Breast Cancer Stage III

Paclitaxel
    Indication: Breast Cancer Stage III



Possible Paclitaxel side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-08-24

Patient: 67 year old female

Reactions: Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded: Ipilimumab
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-05-22

Carboplatin
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-04-10

Paclitaxel
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-04-10

Placebo
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-05-22

Other drugs received by patient: Miralax; Multi-Vitamin; Coumadin; Diphenhydramine Hydrochloride; Dexamethasone; Advair Diskus 100 / 50; Prednisone TAB; Spiriva; Magnesium Oxide; Potassium Chloride; Tramadol HCL; Calcium Carbonate; Coumadin; Omeprazole; Pristiq; Proair HFA



Possible Paclitaxel side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient:

Reactions: Asperger's Disorder, Jaundice, Hyperbilirubinaemia, Speech Disorder Developmental, Foetal Exposure During Pregnancy, Tourette's Disorder, Dyslexia

Drug(s) suspected as cause:
Cisplatin
    Indication: Ovarian Cancer Stage I

Paclitaxel
    Indication: Ovarian Cancer Stage I



Possible Paclitaxel side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: , weighing 1.4 kg (3.1 pounds)

Reactions: Selective IGA Immunodeficiency, Neonatal Respiratory Distress Syndrome, Premature Baby, Gastrooesophageal Reflux Disease, Apnoea, Constipation

Drug(s) suspected as cause:
Adriamycin PFS
    Indication: Breast Cancer Stage II

Cytoxan
    Indication: Breast Cancer Stage II

Paclitaxel
    Indication: Breast Cancer Stage II



Possible Paclitaxel side effects in female

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

Patient: female, weighing 62.0 kg (136.4 pounds)

Reactions: Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Carboplatin
    Indication: Breast Cancer
    Start date: 2012-06-15

Lapatinib
    Dosage: 750mg per day
    Indication: Breast Cancer
    Start date: 2012-06-15

Liposome Encapsulated Doxorubicin Citrate Complex
    Dosage: 20mgm2 weekly
    Indication: Breast Cancer
    Start date: 2012-06-15

Paclitaxel
    Dosage: 80mgm2 weekly
    Indication: Breast Cancer
    Start date: 2012-06-15

Trastuzumab
    Dosage: 6mgk every 3 weeks
    Indication: Breast Cancer
    Start date: 2012-06-15

Other drugs received by patient: Loperamide; Neupogen



Possible Paclitaxel side effects in male

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

Patient: male, weighing 100.7 kg (221.5 pounds)

Reactions: Nausea, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: no treatment
    Indication: Squamous Cell Carcinoma

Blinded NO Treatment Received
    Dosage: no treatment
    Indication: Squamous Cell Carcinoma

Fluorouracil
    Dosage: 1400 mg/24hrs civ over 120 hours
    Indication: Squamous Cell Carcinoma
    Start date: 2012-07-01
    End date: 2012-07-06

Fluorouracil
    Dosage: unk
    Start date: 2012-07-29

Fluorouracil
    Dosage: 1400 mg/24hrs civ over 120 hours
    Start date: 2012-07-15
    End date: 2012-07-20

Hydroxyurea
    Dosage: unk
    Administration route: Oral
    Start date: 2012-07-29

Hydroxyurea
    Dosage: 500 mg, bid
    Administration route: Oral
    Start date: 2012-07-15
    End date: 2012-07-20

Hydroxyurea
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Squamous Cell Carcinoma
    Start date: 2012-07-01
    End date: 2012-07-06

Paclitaxel
    Dosage: 228 mg qwk
    Start date: 2012-07-15
    End date: 2012-07-20

Paclitaxel
    Dosage: unk
    Start date: 2012-07-29

Paclitaxel
    Dosage: 228 mg qwk
    Indication: Squamous Cell Carcinoma
    Start date: 2012-07-02

Placebo
    Dosage: no treatment
    Indication: Squamous Cell Carcinoma

Other drugs received by patient: Fentanyl; Neosporin (Neomycin Sulfate / Polymyxin B Sulfate); Senna; Bacitracin; Filgrastim; Morphine; Famotidine; Fluconazole; Eucerin; Prochlorperazine; Esomeprazole Sodium; Guaifenesin; Enoxaparin; Amoxicillin and Clavulanate Potassium; Miralax; Lidocaine; Escitalopram; Ondansetron; Rosuvastatin; Docusate; Aquaphor; Hydromorphone Hydrochloride; Nystatin



Possible Paclitaxel side effects in 54 year old female

Reported by a physician from United States on 2012-08-22

Patient: 54 year old female, weighing 47.0 kg (103.4 pounds)

Reactions: Abdominal Pain, Vomiting, Nausea, Anaemia, Hypokalaemia, Small Intestinal Obstruction, Hypomagnesaemia, Platelet Count Decreased, Hypoalbuminaemia, Neutrophil Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Dosage: last dose prior to sae was taken on 29/jun/2012
    Indication: Ovarian Epithelial Cancer
    Start date: 2012-06-29

Carboplatin
    Dosage: auc= 6 over 30 minutes on day 1. last dose prior to sae was taken on 29/may/2012
    Indication: Ovarian Epithelial Cancer
    Start date: 2012-05-29

Paclitaxel
    Dosage: last dose prior to sae was taken on 06/jul/2012. day 15 held due to sbo.
    Indication: Ovarian Epithelial Cancer
    Start date: 2012-07-06

Veliparib
    Dosage: last dose prior to sae was taken on 03/jul/2012
    Administration route: Oral
    Indication: Ovarian Epithelial Cancer



Possible Paclitaxel side effects in female

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

Patient: female, weighing 72.0 kg (158.4 pounds)

Reactions: Headache

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Indication: Breast Cancer
    Start date: 2012-04-05

Carboplatin
    Indication: Breast Cancer
    Start date: 2012-04-05

Doxorubicin Hydrochloride
    Indication: Breast Cancer
    Start date: 2012-04-05

Paclitaxel
    Indication: Breast Cancer
    Start date: 2012-04-05



Possible Paclitaxel 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

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014