GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR: 220 Adverse Event Reports & Safety Profile

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220

Total FAERS Reports

51 (23.2%)

Deaths Reported

114

Hospitalizations

220

As Primary/Secondary Suspect

Life-Threatening

First Report: 19960816 · Latest Report: 20240211

What Are the Most Common GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR Side Effects?

#1 Most Reported

Hypotension

20 reports (9.1%)

#2 Most Reported

Off label use

16 reports (7.3%)

#3 Most Reported

Drug ineffective

13 reports (5.9%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Hypotension	20	9.1%	6	16
Off label use	16	7.3%	4	5
Drug ineffective	13	5.9%	7	4
Dyspnoea	12	5.5%	7	9
Pyrexia	12	5.5%	4	3
Capillary leak syndrome	11	5.0%	3	8
Diarrhoea	10	4.6%	1	10
Atrial fibrillation	9	4.1%	3	9
Death	9	4.1%	9	5
Fatigue	9	4.1%	2	6
Hypoxia	9	4.1%	4	7
Tachycardia	9	4.1%	2	7
Cough	8	3.6%	1	4
Decreased appetite	8	3.6%	1	4
Pancytopenia	8	3.6%	2	1
Syncope	8	3.6%	4	5
Abdominal pain	7	3.2%	2	5
Acute respiratory distress syndrome	7	3.2%	4	7
Bone marrow failure	7	3.2%	0	0
Cardiac arrest	7	3.2%	7	6

Gender: 40.7% female, 59.3% male. Average age: 33.7 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2008	1	1	0
2011	1	0	1
2012	1	0	0
2013	3	1	3
2014	6	0	6
2015	10	1	7
2016	29	8	25
2017	17	4	11
2018	5	0	3
2019	11	8	9
2020	15	1	7
2021	18	2	15
2022	15	1	13
2023	3	0	3
2024	1	0	0

Indication	Reports
Neuroblastoma	71
Malignant melanoma	40
Product used for unknown indication	15
Mesothelioma malignant	11
Neuroblastoma recurrent	11
Metastatic malignant melanoma	7
Metastatic renal cell carcinoma	7
Aspergillus infection	5

Official prescribing information from the FDA-approved drug label.