ABRAXANE: 303 Adverse Event Reports & Safety Profile

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303

Total FAERS Reports

152 (50.2%)

Deaths Reported

124

Hospitalizations

303

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 20090324 · Latest Report: 20140609

What Are the Most Common ABRAXANE Side Effects?

#1 Most Reported

Death

72 reports (23.8%)

#2 Most Reported

Nausea

25 reports (8.3%)

#3 Most Reported

Neutropenia

19 reports (6.3%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Death	72	23.8%	72	5
Nausea	25	8.3%	14	13
Neutropenia	19	6.3%	13	5
Pancreatic carcinoma	18	5.9%	17	4
Anaemia	17	5.6%	10	5
Fatigue	17	5.6%	10	5
Neuropathy peripheral	14	4.6%	11	2
Alopecia	12	4.0%	6	2
Pneumonia	12	4.0%	8	6
Renal failure	12	4.0%	10	8
Vomiting	12	4.0%	5	7
Constipation	10	3.3%	1	7
Dyspnoea	10	3.3%	3	7
Rash	10	3.3%	4	4
Abdominal pain	9	3.0%	5	9
Asthenia	9	3.0%	6	5
Breast cancer metastatic	9	3.0%	9	5
Diarrhoea	9	3.0%	5	6
Disease progression	9	3.0%	3	2
Febrile neutropenia	9	3.0%	5	6

Average age: 60.8 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2009	1	1	1
2011	7	1	4
2012	9	7	2
2013	72	29	43
2014	125	64	66

Indication	Reports
Product used for unknown indication	57
Pancreatic carcinoma	56
Breast cancer	38
Breast cancer metastatic	37
Pancreatic carcinoma metastatic	28
Ovarian cancer	9
Lung neoplasm malignant	8
Squamous cell carcinoma of lung	8
Breast cancer female	7
Gastric cancer	5

Official prescribing information from the FDA-approved drug label.