This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Abraxane (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 (477)
Death (189)
Life Threatening Events (47)
Disability (18)
Reports by Reaction Type
Death (93),
Diarrhoea (34),
Anaemia (32),
Neutropenia (30),
Fatigue (26),
Nausea (26),
Vomiting (25),
Febrile Neutropenia (24),
Decreased Appetite (21),
White Blood Cell Count Decreased (21),
Dehydration (18),
Stomatitis (17)
Below are a few examples of reports where side effects / adverse reactions may be related to Abraxane (Paclitaxel). For a complete list or a specific selection of reports, please use the links above.
Possible Abraxane side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female
Reactions: Neutropenia, Septic Shock, Renal Failure Acute, Leukopenia
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Abraxane
Dosage: 125 milligram/sq. meter
Start date: 2012-03-28
Abraxane
Dosage: 125 milligram/sq. meter
Start date: 2012-04-04
End date: 2012-04-10
Gemcitabine Hydrochloride
Dosage: 1000 milligram/sq. meter
Start date: 2012-03-28
Gemcitabine Hydrochloride
Dosage: 1000 milligram/sq. meter
Start date: 2012-04-04
End date: 2012-04-10
Possible Abraxane side effects in male
Reported by a physician from United States on 2012-08-24
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Abraxane
Possible Abraxane side effects in male
Reported by a physician from United States on 2012-08-24
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Abraxane
Possible Abraxane side effects in male
Reported by a physician from United Kingdom on 2012-08-24
Patient: male, weighing 88.5 kg (194.7 pounds)
Reactions: Pneumonia, Cellulitis, Extravasation, Sepsis, Fall
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Abraxane
Dosage: 325 milligram
Start date: 2011-06-08
End date: 2011-06-15
Abraxane
Dosage: 325 milligram
Indication: Metastatic Malignant Melanoma
Start date: 2011-03-31
End date: 2011-04-27
Possible Abraxane side effects in female
Reported by a physician from Spain on 2012-08-23
Patient: female
Reactions: Abdominal Pain
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abraxane
Possible Abraxane side effects in female
Reported by a health professional (non-physician/pharmacist) from Norway on 2012-08-21
Patient: female
Reactions: Bronchospasm, Anaphylactic Shock
Adverse event resulted in: death
Drug(s) suspected as cause:
Abraxane
Other drugs received by patient: Zantac; Dexamethasone; Dexchlorpheniramine Maleate
Possible Abraxane side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Abraxane
Possible Abraxane side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Abraxane
Possible Abraxane side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Abraxane
Possible Abraxane side effects in female
Reported by a physician from Austria on 2012-08-16
Patient: female
Reactions: Arterial Thrombosis, Pyrexia, Aortic Thrombosis
Drug(s) suspected as cause:
Abraxane
Other drugs received by patient: Carboplatin
Possible Abraxane side effects in 75 year old female
Reported by a physician from Germany on 2012-08-16
Patient: 75 year old female, weighing 77.0 kg (169.4 pounds)
Reactions: Syncope, Diarrhoea, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abraxane
Start date: 2012-04-12
End date: 2012-04-25
Abraxane
Indication: Breast Cancer
Start date: 2012-02-23
End date: 2012-03-15
Capecitabine
Administration route: Oral
Start date: 2012-04-12
End date: 2012-04-25
Capecitabine
Dosage: 6000 milligram
Administration route: Oral
Start date: 2012-03-15
End date: 2012-04-05
Capecitabine
Dosage: 8000 milligram
Administration route: Oral
Indication: Breast Cancer
Start date: 2012-02-23
End date: 2012-03-07
Other drugs received by patient: Simvastatin; Aspirin; Bisoprolol; Levothyroxine Sodium; Simvastatin; Ramipril; Ramipril
Possible Abraxane side effects in male
Reported by a physician from United States on 2012-08-15
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Abraxane
Possible Abraxane side effects in 70 year old female
Reported by a physician from Germany on 2012-08-15
Patient: 70 year old female, weighing 56.0 kg (123.2 pounds)
Reactions: General Physical Health Deterioration
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abraxane
Indication: Breast Cancer
Start date: 2012-05-15
Capecitabine
Administration route: Oral
Indication: Breast Cancer
Start date: 2012-05-15
Other drugs received by patient: Neulasta
Possible Abraxane side effects in male
Reported by a physician from United States on 2012-08-15
Patient: male
Reactions: Malaise
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abraxane
Possible Abraxane side effects in 46 year old female
Reported by a physician from Germany on 2012-08-13
Patient: 46 year old female, weighing 55.0 kg (121.0 pounds)
Reactions: Optic Atrophy, Blindness Unilateral
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Abraxane
Indication: Metastases To Central Nervous System
Abraxane
Indication: Breast Cancer
Start date: 2012-05-31
End date: 2012-06-28
Abraxane
Indication: Metastases To Bone
Abraxane
Indication: Metastases To Liver
Avastin
Indication: Metastases To Central Nervous System
Start date: 2012-04-25
Avastin
Indication: Metastases To Liver
Avastin
Indication: Metastases To Bone
Other drugs received by patient: Metoprolol Tartrate; Dexamethasone; Levothyroxine Sodium; Enoxaparin Sodium
Possible Abraxane side effects in female
Reported by a physician from United States on 2012-08-13
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Abraxane
Possible Abraxane side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13
Patient: female, weighing 64.9 kg (142.8 pounds)
Reactions: Abdominal Pain, White Blood Cell Count Decreased, Vomiting, Gastrointestinal Haemorrhage, Nausea, Hyponatraemia, Hypokalaemia, Haemoglobin Decreased, Diarrhoea, Dehydration, Hypocalcaemia, Neutrophil Count Decreased, Blood Creatinine Increased, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abraxane
Dosage: 177 milligram
Start date: 2012-07-18
End date: 2012-07-25
Abraxane
Dosage: 80 microgram/sq. meter
Start date: 2012-08-01
Abraxane
Dosage: 177 milligram
Indication: Breast Cancer
Start date: 2012-06-13
Carboplatin
Dosage: 675 milligram
Indication: Breast Cancer
Start date: 2012-06-13
Carboplatin
Dosage: 675 milligram
Start date: 2012-07-18
Herceptin
Dosage: 139 milligram
Start date: 2012-07-18
Herceptin
Dosage: 139 milligram
Indication: Breast Cancer
Start date: 2012-06-13
Other drugs received by patient: Dexamethasone; Gabapentin; Ativan; Motrin; Ativan; Vicodin; Ativan; Ativan
Possible Abraxane side effects in 76 year old female
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-13
Patient: 76 year old female, weighing 78.0 kg (171.6 pounds)
Reactions: Syncope
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abraxane
Indication: Breast Cancer
Start date: 2012-06-12
End date: 2012-06-26
Capecitabine
Dosage: 2000 milligram
Administration route: Oral
Start date: 2012-06-12
Capecitabine
Dosage: 2000 milligram
Administration route: Oral
Indication: Breast Cancer
Start date: 2012-06-12
End date: 2012-06-26
Other drugs received by patient: Metoprolol Tartrate; Ramipril; Simvastatin
Possible Abraxane side effects in 46 year old female
Reported by a physician from Germany on 2012-08-13
Patient: 46 year old female, weighing 55.0 kg (121.0 pounds)
Reactions: Optic Atrophy, Blindness Unilateral
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Abraxane
Dosage: 17.1429 milligram/sq. meter
Indication: Breast Cancer
Start date: 2012-05-24
End date: 2012-06-28
Abraxane
Abraxane
Abraxane
Avastin
Avastin
Avastin
Dosage: .7143 milligram
Start date: 2012-04-25
Other drugs received by patient: Dexamethasone; Levothyroxine Sodium; Ibandronate Sodium; Enoxaparin Sodium; Metoprolol Tartrate
Possible Abraxane side effects in female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-13
Patient: female, weighing 44.0 kg (96.8 pounds)
Reactions: Fatigue, Hyperkalaemia, Sepsis, Enteritis Infectious, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abraxane
Dosage: 293 milligram
Indication: Gastric Cancer
Start date: 2012-06-19
End date: 2012-06-19
TS-1
Dosage: 100 milligram
Administration route: Oral
Indication: Gastric Cancer
Start date: 2012-06-19
End date: 2012-07-02
Other drugs received by patient: Betamethasone Sodium Phosphate; AZ; Propeto; Xylocaine
Possible Abraxane side effects in 48 year old female
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-13
Patient: 48 year old female, weighing 64.0 kg (140.8 pounds)
Reactions: Stomatitis, Vomiting, Nausea, Anaemia, Bone Pain, Palmar-Plantar Erythrodysaesthesia Syndrome, Rash, Neurotoxicity, Neuropathy Peripheral, Diarrhoea, Cardiotoxicity, Neutropenia, Thrombocytopenia
Drug(s) suspected as cause:
Abraxane
Possible Abraxane side effects in 72 year old female
Reported by a physician from Germany on 2012-08-10
Patient: 72 year old female, weighing 82.0 kg (180.4 pounds)
Reactions: Embolism
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Abraxane
Start date: 2012-07-11
Capecitabine
Administration route: Oral
Start date: 2012-07-11
Possible Abraxane side effects in female
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-09
Patient: female, weighing 70.0 kg (154.0 pounds)
Reactions: Pleuritic Pain, Cholangitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abraxane
Start date: 2012-07-12
Abraxane
Start date: 2012-07-05
Gemcitabine Hydrochloride
Start date: 2012-07-12
Gemcitabine Hydrochloride
Start date: 2012-07-05
Other drugs received by patient: Zoloft; Fexofenadine; Haloperidol; Zoloft; Quit Nicotine; Metformin Hydrochloride; Oxycodone HCL; Granisetron; Irbesartan; Acetaminophen
Possible Abraxane side effects in female
Reported by a consumer/non-health professional from Germany on 2012-08-07
Patient: female
Reactions: General Physical Health Deterioration
Adverse event resulted in: death
Drug(s) suspected as cause:
Abraxane
Other drugs received by patient: Ibandronic Acid; Dexamethasone; Granisetron
Possible Abraxane side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07
Patient: female
Reactions: Hypomagnesaemia, Gastritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abraxane
Indication: Head and Neck Cancer
Carboplatin
Indication: Head and Neck Cancer
Cetuximab
Dosage: 250 milligram/sq. meter
Indication: Head and Neck Cancer
Start date: 2012-06-18
End date: 2012-07-30
Other drugs received by patient: Fluid
Possible Abraxane side effects in female
Reported by a physician from Germany on 2012-08-07
Patient: female, weighing 67.0 kg (147.4 pounds)
Reactions: Breast Cancer Metastatic, Cerebral Disorder, Anaemia, General Physical Health Deterioration, Neutropenia, Asthenia, Leukopenia
Adverse event resulted in: death
Drug(s) suspected as cause:
Abraxane
Start date: 2011-06-27
End date: 2011-06-27
Abraxane
Start date: 2011-06-06
End date: 2011-06-06
Abraxane
Start date: 2011-07-18
End date: 2011-07-18
Other drugs received by patient: Antiemetic Drugs; Antiemetic Drugs; Antiemetic Drugs
Possible Abraxane side effects in 30 year old female
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-07
Patient: 30 year old female, weighing 70.0 kg (154.0 pounds)
Reactions: Diarrhoea, Pain, Anaemia, Alopecia, Epistaxis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abraxane
Dosage: 260 milligram/sq. meter
Start date: 2011-05-12
End date: 2011-08-23
Abraxane
Start date: 2011-09-14
End date: 2012-01-04
Other drugs received by patient: Herceptin; Herceptin; Neulasta; Epogen; Avastin; Antiemetics
Possible Abraxane side effects in 67 year old female
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-07
Patient: 67 year old female, weighing 60.0 kg (132.0 pounds)
Reactions: Blood Alkaline Phosphatase Increased, Alanine Aminotransferase Increased, Neoplasm Progression, Rash, Ascites, Generalised Oedema, Death, Aspartate Aminotransferase Increased, Oedema Peripheral, Thrombocytopenia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Abraxane
Dosage: 12.381 milligram/sq. meter
Start date: 2011-11-03
End date: 2011-11-03
Abraxane
Dosage: 12.381 milligram/sq. meter
Start date: 2011-09-15
End date: 2011-09-15
Abraxane
Dosage: 12.381 milligram/sq. meter
Start date: 2011-08-25
End date: 2011-08-25
Other drugs received by patient: Dexamethasone; Dexamethasone; Arimidex; Granisetron; Granisetron; Granisetron; Dexamethasone
Possible Abraxane side effects in female
Reported by a lawyer from United States on 2012-08-07
Patient: female, weighing 68.0 kg (149.7 pounds)
Reactions: Abdominal Pain, Osteomyelitis, Pyrexia, Gingival Abscess, Cyst, Loss of Consciousness, Abdominal Discomfort, Dyspepsia, Simplex Virus Test Positive, Multiple Injuries, Unevaluable Event, Immunosuppression, Back Pain, Dysphagia, Coronary Artery Disease, Nasal Congestion, Renal Cyst, Cardiomyopathy, Dysphonia, Insomnia, Ocular Icterus, Neutropenia, Vocal Cord Polyp, Jaundice, Pain, Chills, Hepatic Lesion, Haemorrhoidal Haemorrhage, Myalgia, Bone Loss, Fatigue, Anhedonia, Left Ventricular Dysfunction, Neck Pain, Pleural Effusion, Intervertebral Disc Degeneration, Decreased Appetite, Vulvovaginal Mycotic Infection, Bone Lesion, Rash, Dysgeusia, Anxiety, Agranulocytosis, Osteonecrosis of JAW, Cardiac Failure, Oral Disorder, Spinal Osteoarthritis, Asthenia, Leukopenia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Abraxane
Dosage: 170 mg, unk
Zometa
Dosage: unk ukn, every 4 weeks
Start date: 2006-04-01
End date: 2007-06-01
Other drugs received by patient: Xanax; Chemotherapeutics; Restoril; Oxycodone HCL; Humira; Neupogen; Acyclovir; Coumadin; Percocet; Fentanyl; Decadron; Ativan; Faslodex; Femara; Wellbutrin; Radiation; Compazine; Taxotere; Zofran; Aromasin; Neulasta
Possible Abraxane side effects in 68 year old female
Reported by a physician from Germany on 2012-08-07
Patient: 68 year old female, weighing 56.0 kg (123.2 pounds)
Reactions: Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Vomiting, Nausea, Anaemia, Pain, General Physical Health Deterioration, Pyrexia, Transaminases Increased, Myalgia, Breast Cancer Metastatic, Arthralgia, Alopecia, Blood Creatinine Increased, Infection
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Abraxane
|
