VIDAZA: 441 Adverse Event Reports & Safety Profile

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441

Total FAERS Reports

249 (56.5%)

Deaths Reported

173

Hospitalizations

441

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 200705 · Latest Report: 20140617

What Are the Most Common VIDAZA Side Effects?

#1 Most Reported

Acute myeloid leukaemia

68 reports (15.4%)

#2 Most Reported

Pneumonia

57 reports (12.9%)

#3 Most Reported

Platelet count decreased

55 reports (12.5%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Acute myeloid leukaemia	68	15.4%	63	11
Pneumonia	57	12.9%	48	34
Platelet count decreased	55	12.5%	23	30
Febrile neutropenia	49	11.1%	20	35
Death	42	9.5%	42	5
White blood cell count decreased	41	9.3%	17	21
Myelodysplastic syndrome	38	8.6%	31	14
Neutrophil count decreased	37	8.4%	10	18
Anaemia	36	8.2%	18	20
Infection	31	7.0%	26	7
Pyrexia	31	7.0%	14	20
Constipation	26	5.9%	13	12
Thrombocytopenia	25	5.7%	18	10
Diarrhoea	24	5.4%	10	13
Sepsis	24	5.4%	16	13
Neutropenia	21	4.8%	12	12
Treatment failure	21	4.8%	17	3
Nausea	19	4.3%	11	11
Haemoglobin decreased	15	3.4%	8	7
Pancytopenia	14	3.2%	11	7

Average age: 70.2 years. Most reports from: JP. View detailed demographics →

Year	Reports	Deaths	Hosp.
2007	2	0	1
2008	1	1	1
2009	2	2	0
2010	8	5	1
2011	50	29	26
2012	84	46	36
2013	103	47	60
2014	57	30	28

Indication	Reports
Myelodysplastic syndrome	247
Acute myeloid leukaemia	89
Product used for unknown indication	58
Refractory anaemia with an excess of blasts	24
Chronic myelomonocytic leukaemia	20

Official prescribing information from the FDA-approved drug label.