LUSPATERCEPT-AAMT: 1,683 Adverse Event Reports & Safety Profile

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1,683

Total FAERS Reports

246 (14.6%)

Deaths Reported

308

Hospitalizations

1,683

As Primary/Secondary Suspect

Life-Threatening

Disabilities

Prescription

Status

FDA Application: 761136 ·

First Report: 201911 · Latest Report: 20250922

What Are the Most Common LUSPATERCEPT-AAMT Side Effects?

#1 Most Reported

Death

162 reports (9.6%)

#2 Most Reported

Haemoglobin decreased

98 reports (5.8%)

#3 Most Reported

Fatigue

86 reports (5.1%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Death	162	9.6%	160	4
Haemoglobin decreased	98	5.8%	3	15
Fatigue	86	5.1%	0	12
Off label use	85	5.1%	5	20
Weight decreased	76	4.5%	0	9
Dizziness	64	3.8%	0	12
Product storage error	64	3.8%	0	0
Drug ineffective	58	3.5%	0	6
Dyspnoea	52	3.1%	1	10
Fall	51	3.0%	4	25
Weight increased	44	2.6%	0	3
Myelodysplastic syndrome	39	2.3%	8	10
Headache	37	2.2%	0	10
Hospitalisation	37	2.2%	1	36
Adverse event	36	2.1%	1	2
Bone pain	36	2.1%	0	6
Hypertension	33	2.0%	0	7
Product preparation error	33	2.0%	0	0
Asthenia	32	1.9%	0	10
Therapy non-responder	28	1.7%	2	3

Gender: 43.2% female, 56.8% male. Average age: 73.1 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2019	1	0	0
2020	88	11	22
2021	105	16	22
2022	132	19	28
2023	103	15	34
2024	208	37	61
2025	111	19	29

Indication	Reports
Product used for unknown indication	695
Myelodysplastic syndrome	609
Anaemia of malignant disease	120
Thalassaemia beta	113
Anaemia	66
Thalassaemia	21
Myelofibrosis	13
Myelodysplastic syndrome with ringed sideroblasts	12
Myelodysplastic syndrome with single lineage dysplasia	12
Off label use	7

Official prescribing information from the FDA-approved drug label.