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 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 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 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 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 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 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 56 year old female
Reported by a physician from United States on 2012-08-22
Patient: 56 year old female, weighing 91.2 kg (200.6 pounds)
Reactions: Anaemia, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Indication: Breast Cancer
Start date: 2010-11-10
End date: 2011-01-12
Doxorubicin Hydrochloride
Dosage: 60mgm2 cyclic
Indication: Breast Cancer
Start date: 2010-11-10
End date: 2011-01-12
Paclitaxel
Dosage: 65mgm2 cyclic
Indication: Breast Cancer
Start date: 2011-02-03
End date: 2011-04-13
Pazopanib
Dosage: 400mg per day
Administration route: Oral
Indication: Breast Cancer
Start date: 2011-02-03
End date: 2011-04-10
Other drugs received by patient: Armodafinil
Possible Paclitaxel side effects in female
Reported by a physician from South Africa on 2012-08-22
Patient: female, weighing 52.0 kg (114.4 pounds)
Reactions: Diabetic Ulcer, Hyperglycaemia, Hyponatraemia, Neoplasm Progression, Hypokalaemia, Renal Impairment, Neoplasm Malignant, Skin Lesion, Sepsis, Dehydration, Cardiac Arrest, Pneumonitis
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Afinitor
Dosage: unk
Administration route: Oral
Indication: Breast Cancer Metastatic
Start date: 2010-08-10
Comparator Trastuzumab
Dosage: 2 mg/kg, qw
Indication: Breast Cancer Metastatic
Start date: 2010-08-10
Paclitaxel
Dosage: 80 mg/m2, qw
Indication: Breast Cancer Metastatic
Start date: 2010-08-10
Other drugs received by patient: Zamanon; Marinol; Metformin; Maxolon
Possible Paclitaxel side effects in female
Reported by a physician from Germany on 2012-08-22
Patient: female, weighing 89.0 kg (195.8 pounds)
Reactions: Alanine Aminotransferase Increased, Liver Disorder
Drug(s) suspected as cause:
Carboplatin
Indication: Breast Cancer
Start date: 2012-06-04
End date: 2012-07-02
Lapatinib
Administration route: Oral
Indication: Breast Cancer
Start date: 2012-06-04
End date: 2012-06-21
Npld (Non-Pegylated Liposomal Doxorubicin)
Indication: Breast Cancer
Start date: 2012-06-04
End date: 2012-07-23
Paclitaxel
Indication: Breast Cancer
Start date: 2012-06-04
End date: 2012-07-23
Trastuzumab
Indication: Breast Cancer
Start date: 2012-06-04
End date: 2012-07-02
Other drugs received by patient: Fraxiparina
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